Product Information

Summary of product characteristics. Product Summary €“ 1. Name of the medicinal product. ANUSOL Cream 2. Qualitative and quantitative composition Anusol cream contains - Zinc oxide Ph Eur - 10.75 g, Bismuth oxide - 2.14 g, Balsam Peru Ph Eur - 1.8 g. For full list of excipients, see section 6.1. 3. Pharmaceutical form - A buff coloured cream 4. CLINICAL PARTICULARS 4.1 Therapeutic indications - ANUSOL cream provides antiseptic, astringent and emollient properties which help to relieve discomfort associated with minor ano-rectal conditions. ANUSOL cream also provides lubricating properties for use with suppositories. Indicated for the symptomatic relief of uncomplicated internal and external haemorrhoids, pruritus ani, proctitis and fissures. Also indicated post-operatively in ano-rectal surgical procedures and after incision of thrombosed or sclerosed ano-rectal veins. 4.2 Posology and method of administration €“ Topical - Adults and elderly (over 65 years): apply to the affected area at night, in the morning and after each evacuation until the condition is controlled. Thoroughly cleanse the affected area, dry and apply cream. ANUSOL cream is prepared in a vanishing cream base and may be gently smoothed on to the affected area without the need to apply a gauze dressing. For internal conditions, use rectal nozzle provided. Remove the nozzle cap. Clean the nozzle after each use. Not to be taken orally. Children: Not Recommended. 4.3 Contraindications - Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. 4.4 Special warnings and precautions for use - Patients with rectal bleeding or blood in the stool should talk to their doctor before using this product as these conditions may be the symptom of a more serious underlying disorder. If symptoms persist or worsen, patients should be instructed to stop use and consult a physician. 4.5 Interactions with other medicinal products and other forms of interaction - None known. 4.6 Pregnancy and lactation Whilst formal studies on the effect of this product during human pregnancy have not been conducted, there is no epidemiological evidence of adverse effect, either to the pregnant mother or foetus. This product should not be used during pregnancy and lactation unless the potential benefit of treatment to the mother outweighs the possible risk to the developing foetus or nursing infant. 4.7 Effects on ability to drive and use machines - None known. 4.8 Undesirable effects - No Adverse Drug Reactions (ADRs) have been identified from the analysis of post-marketing data for fixed combinations of Balsam Peru, bismuth oxide and zinc oxide. ADRs identified during Post-Marketing experience with Zinc Oxide (topical use) are included in the Table below. The frequencies are provided according to the following convention: Very common ‰¥1/10, Common ‰¥1/100 and < 1/10, Uncommon ‰¥1/1,000 and <1/100, Rare ‰¥1/10,000 and <1/1,000, Very rare <1/10,000, Not known (cannot be estimated from the available data). ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as 'Not known'. Other adverse reactions include: Skin sensitisation reactions and systemic contact dermatitis, attributed directly to Balsam Peru have been reported in published literature. Reporting of suspected adverse reactions - Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. System Organ Class (SOC) €“ Immune system disorders, Frequency €“ rare, Adverse Drug Reaction, hypersensitivity. System Organ Class (SOC) €“ General disorders and administration site conditions, Frequency €“ not known, Adverse Drug Reaction, Application site reaction (including Burn, erythema, Exfoliation, Irritation, Pain, Pruritus, Rash and Uticaria. 4.9 Overdose - Treatment of a large acute overdose should include gastric lavage, purgation with magnesium sulphate and complete bed rest. If necessary, apply oxygen and give general supportive measures. 5. Pharmacological properties 5.1 Pharmacodynamic properties - Pharmacotherapeutic group: Other agents for treatment of haemorrhoids and anal fissures for topical use, ATC code: C05AX. ANUSOL cream provides antiseptic, astringent and emollient properties which help to relieve discomfort associated with minor ano-rectal conditions. It also provides lubricating properties for use with suppositories. Bismuth oxide is weakly astringent with supposed antiseptic properties and has a protective action on mucous membranes and raw surfaces. Zinc oxide is an astringent and mild antiseptic and probably owes its actions to the ability of the zinc ion to precipitate protein, but other mechanisms may be involved. Zinc oxide is also used to absorb skin moisture and decrease friction and discourage growth of certain bacteria. Balsam Peru has a very mild antiseptic action by virtue of its content of cinnamic and benzoic acids. It is believed to promote the growth of epithelial cells. 5.2 Pharmacokinetic properties - The active ingredients exert their therapeutic effect without being absorbed into the systemic circulation. These observations are supported by evidence from various studies and reviews. 5.3 Preclinical safety data The active ingredients of ANUSOL are well known constituents of medicinal products and their safety profiles are well documented. 6. Pharmaceutical particulars - 6.1 List of excipients - Glycerol monostearate Ph Eur, Liquid paraffin Ph Eur, Propylene glycol Ph Eur, Polysorbate 60 Ph Eur, Sorbitan stearate BP , Titanium dioxide Ph Eur , Methyl p-hydroxybenzoate Ph Eur, Propyl p-hydroxybenzoate Ph Eur, Purified water Ph Eur 6.2 Incompatibilities - None known. 6.3 Shelf life - 3 years when stored in the original packaging. 6.4 Special precautions for storage - Store at a temperature not exceeding 25ï‚°C. For storage conditions after first opening of the medicinal product, see section 6.3 6.5 Nature and contents of container Pack size 23g, 30g or 43g, externally printed and internally lacquered aluminium tube with plastic cap. A plastic nozzle with cap is also provided for internal application. Not all pack sizes may be marketed 6.6 Special precautions for disposal - No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Administrative Data. 7. Marketing authorisation holder Church & Dwight UK Limited, Premier House, Shearway Business Park, Pent Road, Folkestone, Kent, CT19 4RJ United Kingdom 8. Marketing authorisation number - PL 00203/0231 9. Date of first authorisation/renewal of the authorisation - 15 September 1997. 10. Date of revision of the text - 30 June 2017

Summary of product characteristics. Product Summary- 1. Name of the medicinal product Anusol Ointment. 2. Qualitative and quantitative composition - Each 100g ointment contains: Zinc Oxide 10.75 g, Bismuth Subgallate 2.25 g, Balsam Peru 1.875 g, Bismuth Oxide 0.875 g, For full list of excipients, see section 6.1. 3. Pharmaceutical form - A light buff coloured ointment. 4. Clinical particulars 4.1. Therapeutic indications - Symptomatic relief of uncomplicated internal and external haemorrhoids, pruritus ani, proctitis and fissures. Also indicated post operatively in ano- rectal surgical procedures and after incision of thrombosed or sclerosed ano- rectal veins. Anusol Ointment provides antiseptic, astringent and emollient properties which help to relieve discomfort associated with minor ano-rectal conditions. 4.2. Posology and method of administration - Topical. Adults and Elderly (over 65 years): Apply to the affected area at night, in the morning and after each evacuation until the condition is controlled. Thoroughly cleanse the affected area, dry and apply ointment. Anusol Ointment should be applied on a gauze dressing. For internal conditions use rectal nozzle provided. Remove the nozzle cap. Clean the nozzle after each use. Not to be taken orally. Children: Not recommended. 4.3. Contraindications- Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. 4.4. Special warnings and precautions for use - Patients with rectal bleeding or blood in the stool should talk to their doctor before using this product as these conditions may be the symptom of a more serious underlying disorder. If symptoms persist or worsen, patients should be instructed to stop use and consult a physician. 4.5. Interactions with other medicinal products and other forms of interaction - None known. 4.6. Fertility, pregnancy and lactation - Whilst formal studies on the effect of this product during pregnancy have not been conducted, there is no epidemiological evidence of adverse effects either to the pregnant mother or foetus. This product should not be used during pregnancy and lactation unless the potential benefit of treatment to the mother outweighs the possible risk to the developing foetus or nursing infant. 4.7. Effects on ability to drive and use machines - None known. 4.8. Undesirable effects - No Adverse Drug Reactions (ADRs) have been identified from the analysis of post-marketing data for fixed combinations of Balsam Peru, bismuth oxide and zinc oxide. ADRs identified during Post-Marketing experience with Zinc Oxide (topical use) are included in the Table below. The frequencies are provided according to the following convention: Very common ‰¥1/10, Common ‰¥1/100 and < 1/10, Uncommon ‰¥1/1,000 and <1/100, Rare ‰¥1/10,000 and <1/1,000, Very rare <1/10,000, Not known (cannot be estimated from the available data). ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as 'Not known'. Other adverse reactions include: Skin sensitisation reactions and systemic contact dermatitis, attributed directly to Balsam Peru have been reported in published literature. Reporting of suspected adverse reactions - Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. System Organ Class (SOC) €“ Immune system disorders, Frequency €“ rare, Adverse Drug Reaction, hypersensitivity. System Organ Class (SOC) €“ General disorders and administration site conditions, Frequency €“ not known, Adverse Drug Reaction, Application site reaction (including Burn, erythema, Exfoliation, Irritation, Pain, Pruritus, Rash and Uticaria. 4.9. Overdose - No overdose related adverse drug reactions have been identified from the post- marketing data analysis of Balsam Peru, bismuth oxide, and zinc oxide. The ingestion of topical zinc oxide can potentiate gastrointestinal symptoms like stomach pain, nausea, vomiting, and diarrhoea. Symptoms of acute oral overdose of bismuth-containing preparations may include nausea, vomiting, renal failure and rarely liver damage. Encephalopathy and discolouration of mucous membranes may occur with chronic overdose. No cases of Balsam Peru overdose have been identified in the medical literature. Treatment of a large acute overdose should include gastric lavage, purgation with magnesium sulphate and complete bed rest. If necessary, apply oxygen and give general supportive measures. 5. Pharmacological properties - 5.1. Pharmacodynamic properties - Pharmacotherapeutic group: Other agents for treatment of haemorrhoids and anal fissures for topical use, ATC code: C05AX. Anusol Ointment provides antiseptic, astringent and emollient properties which help to relieve discomfort associated with minor ano-rectal conditions. Bismuth Oxide is weakly astringent with supposed antiseptic properties and has a protective action on mucous membranes and raw surfaces. Zinc Oxide is an astringent and mild antiseptic and probably owes its actions to the ability of the zinc ion to precipitate protein but other mechanisms may be involved. Zinc Oxide is also used to absorb skin moisture and decrease friction and discourage growth of certain bacteria. Balsam Peru has a very mild antiseptic action by virtue of its content of cinnamic and benzoic acids. It is believed to promote the growth of epithelial cells. 5.2. Pharmacokinetic properties - The active ingredients exert their therapeutic effect without being absorbed into the systemic circulation. These observations are supported by evidence from various studies and reviews. 5.3. Preclinical safety data - The active ingredients of Anusol are well known constituents of medicinal products and their safety profile is well documented. 6. Pharmaceutical particulars - 6.1. List of excipients - Anusol Ointment contains the following excipients:- Magnesium stearate, Cocoa butter, Lanolin anhydrous, Castor oil, Kaolin light, Petroleum Jelly White. 6.2. Incompatibilities None known. 6.3. Shelf life - Not less than 3 years when stored in the original packing. 6.4. Special precautions for storage - Do not store above 25° C. For storage conditions after first opening of the medicinal product, see section 6.3. 6.5. Nature and contents of container - Externally printed and internally lacquered 25 g aluminium tube with plastic cap. A plastic nozzle with cap is also provided for internal application. Not all pack sizes may be marketed. 6.6. Special precautions for disposal and other handling - No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Administrative Data - 7. MARKETING AUTHORISATION HOLDER - Church & Dwight UK Limited, Premier House, Shearway business Park, Pent Road, Folkestone, Kent, CT19 4RJ, United Kingdom. 8. Marketing authorisation number - PL 00203/0232 9. Date of first authorisation/renewal of the authorisation - 14 March 1997. 10. Date of revision of the text - 30 June 2017

Summary of product characteristics. Product Summary - 1. Name of the medicinal product -Anusol Suppositories 2. Qualitative and quantitative composition - Each suppository contains: Zinc oxide 296 mg, Bismuth subgallate 59 mg, Balsam peru 49 mg, Bismuth oxide 24 mg, For full list of excipients, see section 6.1. 3. Pharmaceutical form - Suppository 4. Clinical particulars - 4.1.Therapeutic indications - For the relief of internal haemorrhoids and other related ano-rectal conditions. 4.2. Posology and method of administration - Anal insertion. Adults Remove wrapper and insert one suppository into the anus at night, in the morning and after each evacuation. Not to be taken orally. Elderly (over 65 years) As for adults. Children - Not recommended. 4.3. Contraindications - Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. 4.4. Special warnings and precautions for use - Patients with rectal bleeding or blood in the stool should talk to their doctor before using this product as these conditions may be the symptom of a more serious underlying disorder. If symptoms persist or worsen, patients should be instructed to stop use and consult a physician. 4.5. Interactions with other medicinal products and other forms of interaction - None known. 4.6. Fertility, pregnancy and lactation - Whilst formal studies on the effect of this product during human pregnancy have not been conducted, there is no epidemiological evidence of adverse effect, either to the pregnant mother or foetus. This product should not be used during pregnancy and lactation unless the potential benefit of treatment to the mother outweighs the possible risk to the developing foetus or nursing infant. 4.7. Effects on ability to drive and use machines - None known. 4.8. Undesirable effects - No Adverse Drug Reactions (ADRs) have been identified from the analysis of post-marketing data for fixed combinations of Balsam Peru, bismuth oxide and zinc oxide. ADRs identified during Post-Marketing experience with Zinc Oxide (topical use) are included in the Table below. The frequencies are provided according to the following convention: Very common ‰¥1/10, Common ‰¥1/100 and < 1/10, Uncommon ‰¥1/1,000 and <1/100, Rare ‰¥1/10,000 and <1/1,000, Very rare <1/10,000, Not known (cannot be estimated from the available data). ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as 'Not known'. Other adverse reactions include: Skin sensitisation reactions and systemic contact dermatitis, attributed directly to Balsam Peru have been reported in published literature. Reporting of suspected adverse reactions - Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. System Organ Class (SOC) €“ Immune system disorders, Frequency €“ rare, Adverse Drug Reaction, hypersensitivity. System Organ Class (SOC) €“ General disorders and administration site conditions, Frequency €“ not known, Adverse Drug Reaction, Application site reaction (including Burn, erythema, Exfoliation, Irritation, Pain, Pruritus, Rash and Uticaria. System Organ Class (SOC) €“ Eye disorders, Frequency €“ Not known, Adverse Drug Reaction - Vision, blurred (see also section 4.4). 4.9. Overdose - No overdose related adverse drug reactions have been identified from the post- marketing data analysis of Balsam Peru, bismuth oxide, and zinc oxide. The ingestion of topical zinc oxide can potentiate gastrointestinal symptoms like stomach pain, nausea, vomiting, and diarrhoea. Symptoms of acute oral overdose of bismuth-containing preparations may include nausea, vomiting, renal failure and rarely liver damage. Encephalopathy and discolouration of mucous membranes may occur with chronic overdose. No cases of Balsam Peru overdose have been identified in the medical literature. Treatment of a large acute overdose should include gastric lavage, purgation with magnesium sulphate and complete bed rest. If necessary, give oxygen and general supportive measures. 5. Pharmacological properties - 5.1. Pharmacodynamic properties - Pharmacotherapeutic group: Other agents for treatment of haemorrhoids and anal fissures for topical use, ATC code: C05AX. Anusol Suppositories provide antiseptic, astringent and emollient properties which help to relieve discomfort associated with minor ano-rectal conditions. Bismuth Oxide, Zinc Oxide and Bismuth Subgallate exert a protective action on mucous membranes and raw surfaces. They are mildly astringent and are reported to have antiseptic properties. Balsam Peru has protective properties and a very mild antiseptic action by virtue of its content of Cinnamic and Benzoic Acids. It is believed to promote the growth of epithelial cells. 5.2. Pharmacokinetic properties - The active ingredients in Anusol Suppositories exert their therapeutic effect without being absorbed into the systemic circulation. These observations are supported by evidence from various studies and reviews. 5.3. Preclinical safety data - The active ingredients of Anusol are well known constituents of medicinal products and their safety profile is well documented. 6. Pharmaceutical particulars - 6.1. List of excipients - Hard Fat (Suppocire BS2), Kaolin light, Titanium Dioxide, Miglyol 812. 6.2. Incompatibilities - None known. 6.3. Shelf life - 3 years. 6.4. Special precautions for storage - Store at a temperature not exceeding 25oC. For storage conditions after first opening of the medicinal product, see section 6.3. 6.5. Nature and contents of container - 12 and 24 pack printed strip pack consisting of white opaque PVC/polyethylene laminated film. Not all pack sizes may be marketed. 6.6. Special precautions for disposal and other handling - No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Administrative Data. 7. Marketing authorisation holder - Church & Dwight UK Limited, Premier House, Shearway Business Park, Pent Road, Folkestone, Kent, CT19 4RJ, United Kingdom. 8. Marketing authorisation number - PL 00203/0233. 9. Date of first authorisation/renewal of the authorisation - 15th September 1997 / 19th July 2001 10. Date of revision of the text - 30 June 2017.

Summary of product characteristics. Product Summary - 1. Name of the medicinal product - ANUSOL SOOTHING RELIEF OINTMENT. 2. Qualitative and quantitative composition - Each 100 g of ointment contains the following active ingredients:- Hydrocortisone acetate 0.25 g, Benzyl benzoate 1.25 g, Bismuth subgallate 2.25 g, Bismuth oxide 0.875 g, Balsam peru 1.875 g, Zinc oxide 10.75 g, For full list of excipients, see section 6.1. 3. Pharmaceutical form - Ointment. A smooth, homogeneous buff coloured ointment with the characteristic odour of Balsam Peru. 4. Clinical particulars - 4.1 Therapeutic indications - Symptomatic treatment of uncomplicated internal and external haemorrhoids and pruritus ani. 4.2 Posology and method of administration - Topical administration. ADULTS (over 18 years) - To be applied sparingly to the affected area at night, in the morning and after each evacuation up to a maximum of 4 applications a day. Thoroughly cleanse the affected area, dry and apply ointment on a gauze dressing. For internal conditions use rectal nozzle provided. Remove the nozzle cap. Clean the nozzle after each use. Use for a maximum period of one week. Not to be taken orally. ELDERLY (over 65 years) As for adults. CHILDREN (under 18 years) Not recommended. 4.3 Contra-indications - Tubercular, fungal and most viral lesions including herpes simplex, vaccinia and varicella. Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Do not use in pregnancy or breastfeeding. 4.4 Special warnings and precautions for use - Patients with rectal bleeding or blood in the stool should talk to their doctor before using this product as these conditions may be the symptom of a more serious underlying disorder. As with all products containing topical steroids, the possibility of systemic absorption should be borne in mind. Prolonged or excessive use may produce systemic corticosteroid. Do not use for more than 7 days unless under the direction of a doctor. The product should be discontinued and the patient advised to consult a medical practitioner if symptoms do not improve or worsen or if rectal bleeding occurs. Visual disturbance - Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids. 4.5 Interactions with other medicinal products and other forms of interactions - Concurrent use with other corticosteroid preparations, either topically or orally may increase the likelihood of systemic effects. Co-treatment with CYP3A inhibitors, including cobicistat containing products, is expected to increase the risk of systemic effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects. 4.6 Fertility pregnancy and lactation - There is inadequate evidence of safety in human pregnancy and there may be a very small risk of cleft palate and intrauterine growth retardation as well as suppression of the neonatal hypothalamic-pituitary-adrenal axis. There is evidence of harmful effects in animals. Do not use in pregnancy or breastfeeding. 4.7 Effects on ability to drive and use machines - No effects have been reported on ability to drive or use machinery. 4.8 Undesirable effects- No Adverse Drug Reactions (ADRs) have been identified from the analysis of post-marketing data for fixed combinations of Balsam Peru, bismuth oxide and zinc oxide. ADRs identified during Post-Marketing experience with Zinc Oxide (topical use) are included in the Table below. The frequencies are provided according to the following convention: Very common ‰¥1/10, Common ‰¥1/100 and < 1/10, Uncommon ‰¥1/1,000 and <1/100, Rare ‰¥1/10,000 and <1/1,000, Very rare <1/10,000, Not known (cannot be estimated from the available data). ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as 'Not known'. Other adverse reactions include: Skin sensitisation reactions and systemic contact dermatitis, attributed directly to Balsam Peru have been reported in published literature. Reporting of suspected adverse reactions - Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card scheme at: www.mhra.gov.uk/yellowcard. System Organ Class (SOC) €“ Immune system disorders, Frequency €“ rare, Adverse Drug Reaction, hypersensitivity. System Organ Class (SOC) €“ General disorders and administration site conditions, Frequency €“ not known, Adverse Drug Reaction, Application site reaction (including Burn, erythema, Exfoliation, Irritation, Pain, Pruritus, Rash and Uticaria. System Organ Class (SOC) €“ Eye disorders, Frequency €“ Not known, Adverse Drug Reaction - Vision, blurred (see also section 4.4). 4.9 Overdose symptoms, emergency procedures, antidotes - No overdose related adverse drug reactions have been identified from the post- marketing data analysis of Balsam Peru, benzyl benzoate, bismuth oxide, bismuth subgallate, hydrocortisone acetate and zinc oxide. If swallowed, fever, nausea, vomiting, stomach cramps and diarrhoea may develop 3-12 hours after ingestion. Symptoms of acute oral overdose of bismuth-containing preparations may include nausea, vomiting, renal failure and rarely liver damage. Encephalopathy and discolouration of mucous membranes may occur with chronic overdose. No cases of Balsam Peru overdose have been identified in the medical literature. Hydrocortisone normally does not produce toxic effects in an acute single overdose. Prolonged use of topical corticosteroids may increase potential for local adverse effects, including steroid atrophy (thinning of the skin), striae (stretch marks), and Telangiectasia (visible blood vessels). Systemic availability after rectal administration is very low; however, excessive administration of corticosteroids may increase the potential for systemic effects, such as hypothalamic-pituitary axis suppression. Treatment of a large acute overdose should include gastric lavage, purgation with magnesium sulphate and complete bed rest. If necessary oxygen and general supportive measures should be given. Methaemoglobinaemia should be treated by intravenous methylthioninium chloride. 5. Pharmacological properties - 5.1 Pharmacodynamic properties - Pharmacotherapeutic group: Agents for treatment of haemorrhoids and anal fissures for topical use, ATC code: C05A A01. This product provides antiseptic, astringent, emollient and decongestant properties. In addition hydrocortisone exerts anti-inflammatory actions. Bismuth oxide, zinc oxide, and bismuth subgallate exert a protective action on mucous membranes and raw surfaces. They are mildly astringent and are reported to have antiseptic properties. Balsam Peru has protective properties and a very mild antiseptic action by virtue of its contents of cinnamic and benzoic acids. It is believed to promote the growth of epithelial cells. Benzyl benzoate is used as a solubilizing agent and has mild antiseptic and preservative properties. Hydrocortisone acetate has the general properties of hydrocortisone and this anti- inflammatory action is of primary interest of this product. ATC code: D07B, corticosteroids, combinations with antiseptics. 5.2 Pharmacokinetic properties - Systemic absorption of hydrocortisone acetate from the rectum may occur but estimates of the extent of absorption have been variable and have always been less than 30%. Following absorption it is metabolised in the liver and most body tissues before being excreted in the urine. Biological half life is approximately 100 minutes and it is 90% bound to plasma protein. The other active ingredients in this product exert their therapeutic effect without being absorbed into the systemic circulation. These are supported by evidence from various studies and reviews. 5.3 Preclinical safety data - The active ingredients of Anusol are well known constituents of medicinalproducts and their safety profile is well documented. There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC. 6. Pharmaceutical particulars - 6.1 List of excipients Kaolin light, Magnesium stearate, Castor oil, Cocoa butter, Lanolin anhydrous, Petroleum jelly white, Calcium hydrogen phosphate. 6.2 Major incompatibilities No incompatibilities have been reported. 6.3 Shelf life - 3 years. 6.4 Special precautions for storage - Do not store above 25°C. For storage conditions after first opening of the medicinal product, see section 6.3. 6.5 Nature and contents of container - Externally printed aluminium tube with wadded plastic cap, containing 15 g of ointment. A plastic nozzle with cap is also provided for internal application. Not all pack sizes may be marketed 6.6 Special precautions for disposal and other handling - No Special Requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 7. Marketing authorisation holder - Church & Dwight UK Limited, Premier House, Shearway Business Park, Pent Road, Folkestone, Kent, CT19 4RJ, United Kingdom. 8. Marketing authorisation number - PL 00203/0234. 9. Date of the first authorisation or renewal - 21 November 2013 10. Date of revision of the text - 30 June 2017.

Summary of product characteristics. Product Summary - 1. Name of the medicinal product - Anusol Soothing Relief Suppositories. 2. Qualitative and quantitative composition - Anusol Soothing Relief Suppositories contain: Hydrocortisone acetate 10 mg, Benzyl benzoate 33 mg, Bismuth subgallate 59 mg, Bismuth oxide 24 mg, Balsam peru 49 mg, Zinc oxide 296 mg, For full list of excipients, see section 6.1. 3. Pharmaceutical form - Suppository, white. 4. Clinical particulars - 4.1. Therapeutic indications - Symptomatic treatment of uncomplicated internal haemorrhoids and pruritis ani. 4.2. Posology and method of administration Anal insertion. Adults (over 18 years) - Remove wrapper and insert one suppository into the anus at night, in the morning and after each evacuation up to a maximum of three per day for a maximum period of one week. Not to be taken orally. Elderly (over 65 years) - As for adults. Children (under 18 years) Do not use. 4.3. Contra-indications - Tubercular, fungal and most viral lesions including herpes simplex, vaccinia and varicella. Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Do not use in pregnancy or breastfeeding. 4.4. Special warnings and precautions for use- Patients with rectal bleeding or blood in the stool should talk to their doctor before using this product as these conditions may be the symptom of a more serious underlying disorder. As with all products containing topical steroids, the possibility of systemic absorption should be borne in mind. Prolonged or excessive use may produce systemic corticosteroid effects. Do not use for more than 7 days unless under the direction of a doctor. The product should be discontinued and the patient advised to consult a medical practitioner if symptoms do not improve or worsen or if rectal bleeding occurs. Visual disturbance - Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids. 4.5. Interactions with other medicinal products and other forms of interactions - Concurrent use with other corticosteroid preparations, either topically or orally, may increase the likelihood of systemic effects. Co-treatment with CYP3A inhibitors, including cobicistat containing products, is expected to increase the risk of systemic effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects. 4.6. Fertility, pregnancy and lactation - There is inadequate evidence of safety in human pregnancy and there may be a very small risk of cleft palate and intrauterine growth retardation as well as suppression of the neonatal hypothalamic-pituitary-adrenal axis. There is evidence of harmful effects in animals. Do not use in pregnancy or breastfeeding. 4.7. Effects on ability to drive and use machines - No effects have been reported on ability to drive or use machinery. 4.8. Undesirable effects - No Adverse Drug Reactions (ADRs) have been identified from the analysis of post-marketing data for fixed combinations of Balsam Peru, bismuth oxide and zinc oxide. ADRs identified during Post-Marketing experience with Zinc Oxide (topical use) are included in the Table below. The frequencies are provided according to the following convention: Very common ‰¥1/10, Common ‰¥1/100 and < 1/10, Uncommon ‰¥1/1,000 and <1/100, Rare ‰¥1/10,000 and <1/1,000,Very rare <1/10,000, Not known (cannot be estimated from the available data). ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as 'Not known'. Other adverse reactions include: Skin sensitisation reactions and systemic contact dermatitis, attributed directly to Balsam Peru have been reported in published literature. Reporting of suspected adverse reactions - Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. System Organ Class (SOC) €“ Immune system disorders, Frequency €“ rare, Adverse Drug Reaction, hypersensitivity. System Organ Class (SOC) €“ General disorders and administration site conditions, Frequency €“ not known, Adverse Drug Reaction, Application site reaction (including Burn, erythema, Exfoliation, Irritation, Pain, Pruritus, Rash and Uticaria. System Organ Class (SOC) €“ Eye disorders, Frequency €“ Not known, Adverse Drug Reaction - Vision, blurred (see also section 4.4). 4.9. Overdose symptoms, emergency procedures, antidotes - No overdose related adverse drug reactions have been identified from the post- marketing data analysis of Balsam Peru, benzyl benzoate, bismuth oxide, bismuth subgallate, hydrocortisone acetate and zinc oxide. If swallowed, fever, nausea, vomiting, stomach cramps and diarrhoea may develop 3-12 hours after ingestion. Symptoms of acute oral overdose of bismuth-containing preparations may include nausea, vomiting, renal failure and rarely liver damage. Encephalopathy and discolouration of mucous membranes may occur with chronic overdose. No cases of Balsam Peru overdose have been identified in the medical literature. Hydrocortisone normally does not produce toxic effects in an acute single overdose. Prolonged, use of topical corticosteroids may increase potential for local adverse effects, including steroid atrophy (thinning of the skin), striae (stretch marks), and Telangiectasia (visible blood vessels). Systemic availability after rectal administration is very low, however, excessive administration of corticosteroids may increase the potential for systemic effects, such as hypothalamic-pituitary axis suppression. Treatment of a large acute overdose should include gastric lavage, purgation with magnesium sulphate and complete bed rest. If necessary give oxygen and general supportive measures. Methaemoglobinaemia should be treated by intravenous methylene blue. 5. Pharmacological properties - 5.1. Pharmacodynamic properties - Pharmacotherapeutic group: Agents for treatment of haemorrhoids and anal fissures for topical use, ATC code: C05A A01. This product provides antiseptic, astringent, emollient and decongestant properties. In addition, hydrocortisone exerts an anti-inflammatory action. Bismuth oxide, zinc oxide and bismuth subgallate exert a protective action on mucous membranes and raw surfaces. They are mildly astringent and are reported to have antiseptic properties. Balsam Peru has protective properties and very mild antiseptic action by virtue of its content of cinnamic and benzoic acids. It is believed to promote the growth of epithelial cells. Benzyl benzoate is used as a solubilizing agent and has mild antiseptic and preservative properties. Hydrocortisone acetate has the general properties of hydrocortisone and the anti- inflammatory action is of primary interest in the product. 5.2. Pharmacokinetic properties - Systemic absorption of hydrocortisone acetate from the rectum may occur but estimates of the extent of absorption have been variable and have always been less than 30%. Following absorption it is metabolised in the liver and most body tissues before being excreted in the urine. Biological half-life is approximately 100 minutes and it is 90% bound to plasma protein. The other active ingredients in this product exert their therapeutic effect without being absorbed into the systemic circulation. These observations are supported by evidence from various studies and reviews. 5.3. Preclinical safety data - The active ingredients of Anusol are well known constituents of medicinal products and their safety profile is well documented. 6. Pharmaceutical particulars - 6.1. List of Excipients - Kaolin light, Hard Fat (Suppocire BS2). 6.2. Major Incompatibilities - No incompatibilities have been reported. 6.3. Shelf life - 3 years. 6.4. Special precautions for storage - Do not store above 25oC. For storage conditions after first opening of the medicinal product, see section 6.3. 6.5. Nature and contents of container - Printed strip pack consisting of white opaque PVC/polyethylene laminated film. Each pack contains 12 suppositories. Not all pack sizes may be marketed. 6.6. Special precautions for disposal and other handling - No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 7. Marketing authorisation holder - Church & Dwight UK Limited, Premier House, Shearway Business Park, Pent Road, Folkestone, Kent, CT19 4RJ, United Kingdom. 8. Marketing authorisation number PL 00203/0235. 9. Date of first authorisation or renewal - 21 November 2013. 10. Date of revision of the text - 30 June 2017.

Summary of product characteristics Product Summary 1. Name of the medicinal product - ANUSOL PLUS HC OINTMENT 2. Qualitative and quantitative composition - Each 100 g of ointment contains the following active ingredients:- Hydrocortisone acetate 0.25 g, Benzyl benzoate 1.25 g, Bismuth subgallate 2.25 g, Bismuth oxide0.875 g, Balsam peru 1.875 g, Zinc oxide 10.75 g. For full list of excipients, see section 6.1 3. Pharmaceutical form - Ointment. 4 Clinical particulars - 4.1 Therapeutic indications - Symptomatic treatment of internal and external haemorrhoids and pruritus ani. 4.2 Posology and method of administration - Topical administration. Adults (over 18 years) - To be applied sparingly to the affected area at night, in the morning and after each evacuation up to a maximum of 4 applications a day. Thoroughly cleanse the affected area, dry and apply ointment on a gauze dressing. For internal conditions use rectal nozzle provided. Remove the nozzle cap. Clean the nozzle after each use. Use for a maximum period of one week. Not to be taken orally. Elderly (over 65 years) As for adults. Children (under 18 years) Not recommended. 4.3 Contra-indications - Tubercular, fungal and most viral lesions including herpes simplex, vaccinia and varicella. Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Do not use in pregnancy or breast-feeding. 4.4 Special warnings and precautions for use - Patients with rectal bleeding or blood in the stool should talk to their doctor before using this product as these conditions may be the symptom of a more serious underlying disorder. As with all products containing topical steroids, the possibility of systemic absorption should be borne in mind. Prolonged or excessive use may produce systemic corticosteroid effects and use for periods longer than seven days is not recommended. Do not use for more than 7 days unless under the direction of a doctor. The product should be discontinued and the patient advised to consult a medical practitioner if symptoms do not improve or worsen or if rectal bleeding occurs. Visual disturbance - Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids. 4.5 Interactions with other medicinal products and other forms of interactions - Concurrent use with other corticosteroid preparations, either topically or orally may increase the likelihood of systemic effects. Co-treatment with CYP3A inhibitors, including cobicistat containing products, is expected to increase the risk of systemic effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects. 4.6 Fertility, pregnancy, and lactation - There is inadequate evidence of safety in human pregnancy and there may be a very small risk of cleft palate and intrauterine growth retardation as well as suppression of the neonatal hypothalamic-pituitary-adrenal axis. There is evidence of harmful effects in animals. Do not use in pregnancy or breastfeeding. 4.7 Effects on ability to drive and use machines - No effects have been reported on ability to drive or use machinery. 4.8 Undesirable effects - No Adverse Drug Reactions (ADRs) have been identified from the analysis of post-marketing data for fixed combinations of Balsam Peru, bismuth oxide and zinc oxide. ADRs identified during Post-Marketing experience with Zinc Oxide (topical use) are included in the Table below. The frequencies are provided according to the following convention: Very common ‰¥1/10, Common ‰¥1/100 and < 1/10, Uncommon ‰¥1/1,000 and <1/100, Rare ‰¥1/10,000 and <1/1,000, Very rare <1/10,000, Not known (cannot be estimated from the available data). ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as 'Not known'. Other adverse reactions include: Skin sensitisation reactions and systemic contact dermatitis, attributed directly to Balsam Peru have been reported in published literature. Reporting of suspected adverse reactions - Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. System Organ Class (SOC) €“ Immune system disorders, Frequency €“ rare, Adverse Drug Reaction, hypersensitivity. System Organ Class (SOC) €“ General disorders and administration site conditions, Frequency €“ not known, Adverse Drug Reaction - Application site reaction (including Burn, erythema, Exfoliation, Irritation, Pain, Pruritus, Rash and Uticaria. System Organ Class (SOC) €“ Eye disorders, Frequency €“ Not known, Adverse Drug Reaction - Vision, blurred (see also section 4.4). 4.9 Overdose symptoms, emergency procedures, antidotes - No overdose related adverse drug reactions have been identified from the post- marketing data analysis of Balsam Peru, benzyl benzoate, bismuth oxide, bismuth subgallate, hydrocortisone acetate and zinc oxide. If swallowed, fever, nausea, vomiting, stomach cramps and diarrhoea may develop 3-12 hours after ingestion. Symptoms of acute oral overdose of bismuth-containing preparations may include nausea, vomiting, renal failure and rarely liver damage. Encephalopathy and discolouration of mucous membranes may occur with chronic overdose. No cases of Balsam Peru overdose have been identified in the medical literature. Hydrocortisone normally does not produce toxic effects in an acute single overdose. Prolonged use of topical corticosteroids may increase potential for local adverse effects, including steroid atrophy (thinning of the skin), striae (stretch marks), and Telangiectasia (visible blood vessels). Systemic availability after rectal administration is very low; however, excessive administration of corticosteroids may increase the potential for systemic effects, such as hypothalamic-pituitary axis suppression. Treatment of a large acute overdose should include gastric lavage, purgation with magnesium sulphate and complete bed rest. If necessary oxygen and general supportive measures should be given. Methaemoglobinaemia should be treated by intravenous methylthioninium chloride. 5 pharmacological properties - 5.1 Pharmacodynamic properties - Pharmacotherapeutic group: Agents for treatment of haemorrhoids and anal fissures for topical use, ATC code: C05A A01. ANUSOL PLUS HC provides antiseptic, astringent, emollient and decongestant properties. in addition hydrocortisone exerts anti-inflammatory actions. Bismuth oxide, zinc oxide, and bismuth subgallate exert a protective action on mucous membranes and raw surfaces. They are mildly astringent and are reported to have antiseptic properties. Balsam Peru has protective properties and a very mild antiseptic action by virtue of its contents of cinnamic and benzoic acids. It is believed to promote the growth of epithelial cells. Benzyl benzoate is used as a solubilizing agent and has mild antiseptic and preservative properties. Hydrocortisone acetate has the general properties of hydrocortisone and this anti- inflammatory action is of primary interest of this product. 5.2 Pharmacokinetic properties - Systemic absorption of hydrocortisone acetate from the rectum may occur but estimates of the extent of absorption have been variable and have always been less than 30%. Following absorption it is metabolised in the liver and most body tissues before being excreted in the urine. Biological half life is approximately 100 minutes and it is 90% bound to plasma protein. The other active ingredients in Anusol Plus HC Ointment exert their therapeutic effect without being absorbed into the systemic circulation. These are supported by evidence from various studies and reviews. 5.3 Preclinical safety data - The active ingredients of Anusol are well known constituents of medicinal products and their safety profile is well documented. 6 pharmaceutical particulars - 6.1 List of excipients - Kaolin light, Magnesium stearate, Castor oil, Cocoa butter, Lanolin anhydrous, Petroleum jelly white, Calcium hydrogen phosphate. 6.2 Major incompatibilities - No incompatibilities have been reported. 6.3 Shelf life - 3 years. 6.4 Special precautions for storage - Do not store above 25°C. For storage conditions after first opening of the medicinal product, see section 6.3. 6.5 Nature and contents of container - Externally printed aluminium tube with wadded plastic cap, containing 15 g of ointment. A plastic nozzle with cap is also provided for internal application. Not all pack sizes may be marketed. 6.6 Special precautions for disposal and other handling - No Special Requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 7. Marketing authorisation holder Church & Dwight UK Limited, Premier House, Shearway Business Park, Pent Road, Folkestone, Kent, CT19 4RJ, United Kingdom. 8 marketing authorisation number - PL 00203/0236 9. Date of the first authorisation or renewal - 9 March 2009 10. Date of revision of the text - 30 June 2017.

Summary of product characteristics . Product Summary - 1. Name of the medicinal product - Anusol Plus HC Suppositories. 2. Qualitative and quantitative composition - Anusol Plus HC Suppositories contain: Hydrocortisone acetate 10 mg, Benzyl benzoate 33 mg, Bismuth subgallate 59 mg, Bismuth oxide 24 mg, Balsam peru 49 mg, Zinc oxide 296 mg. For full list of excipients, see section 6.1. 3. Pharmaceutical form - Suppository. 4. Clinical particulars - 4.1. Therapeutic indications - Symptomatic treatment of internal haemorrhoids and pruritus ani. 4.2. Posology and method of administration - Anal insertion. Adults (over 18 years) - Remove wrapper and insert one suppository into the anus at night, in the morning and after each evacuation up to a maximum of three per day for a maximum period of one week. Not to be taken orally. Elderly (over 65 years) - As for adults, Children (under 18 years) - Not recommended. 4.3. Contra-indications - Tubercular, fungal and most viral lesions including herpes simplex, vaccinia and varicella. Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Do not use in pregnancy or breast-feeding. 4.4. Special warnings and precautions for use - Patients with rectal bleeding or blood in the stool should talk to their doctor before using this product as these conditions may be the symptom of a more serious underlying disorder. As with all products containing topical steroids, the possibility of systemic absorption should be borne in mind. Prolonged or excessive use may produce systemic corticosteroid effects, and use for periods longer than seven days is not recommended. Do not use for more than 7 days unless under the direction of a doctor. The product should be discontinued and the patient advised to consult a medical practitioner if symptoms do not improve or worsen or if rectal bleeding occurs. Visual disturbance - Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids. 4.5. Interactions with other medicinal products and other forms of interactions - Concurrent use with other corticosteroid preparations, either topically or orally, may increase the likelihood of systemic effects. Co-treatment with CYP3A inhibitors, including cobicistat containing products, is expected to increase the risk of systemic effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects. 4.6. Fertility, pregnancy, and lactation - There is inadequate evidence of safety in human pregnancy and there may be a very small risk of cleft palate and intrauterine growth retardation as well as suppression of the neonatal hypothalamic-pituitary-adrenal axis. There is evidence of harmful effects in animals. Do not use in pregnancy or breastfeeding. 4.7. Effects on ability to drive and use machines - No effects have been reported on ability to drive or use machinery. 4.8. Undesirable effects - No Adverse Drug Reactions (ADRs) have been identified from the analysis of post-marketing data for fixed combinations of Balsam Peru, bismuth oxide and zinc oxide. ADRs identified during Post-Marketing experience with Zinc Oxide (topical use) are included in the Table below. The frequencies are provided according to the following convention: Very common ‰¥1/10, Common ‰¥1/100 and < 1/10, Uncommon ‰¥1/1,000 and <1/100, Rare ‰¥1/10,000 and <1/1,000, Very rare <1/10,000, Not known (cannot be estimated from the available data). ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as 'Not known'. Other adverse reactions include: Skin sensitisation reactions and systemic contact dermatitis, attributed directly to Balsam Peru have been reported in published literature. Reporting of suspected adverse reactions - Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. System Organ Class (SOC) €“ Immune system disorders, Frequency €“ rare, Adverse Drug Reaction, hypersensitivity. System Organ Class (SOC) €“ General disorders and administration site conditions, Frequency €“ not known, Adverse Drug Reaction, Application site reaction (including Burn, erythema, Exfoliation, Irritation, Pain, Pruritus, Rash and Uticaria. System Organ Class (SOC) €“ Eye disorders, Frequency €“ Not known, Adverse Drug Reaction - Vision, blurred (see also section 4.4). 4.9. Overdose symptoms, emergency procedures, antidotes - No overdose related adverse drug reactions have been identified from the post- marketing data analysis of Balsam Peru, benzyl benzoate, bismuth oxide, bismuth subgallate, hydrocortisone acetate and zinc oxide. If swallowed, fever, nausea, vomiting, stomach cramps and diarrhoea may develop 3-12 hours after ingestion. Symptoms of acute oral overdose of bismuth-containing preparations may include nausea, vomiting, renal failure and rarely liver damage. Encephalopathy and discolouration of mucous membranes may occur with chronic overdose. No cases of Balsam Peru overdose have been identified in the medical literature. Hydrocortisone normally does not produce toxic effects in an acute single overdose. Prolonged, use of topical corticosteroids may increase potential for local adverse effects, including steroid atrophy (thinning of the skin), striae (stretch marks), and Telangiectasia (visible blood vessels). Systemic availability after rectal administration is very low, however, excessive administration of corticosteroids may increase the potential for systemic effects, such as hypothalamic-pituitary axis suppression. Treatment of a large acute overdose should include gastric lavage, purgation with magnesium sulphate and complete bed rest. If necessary give oxygen and general supportive measures. Methaemoglobinaemia should be treated by intravenous methylene blue. 5. Pharmacological properties - 5.1. Pharmacodynamic properties - Pharmacotherapeutic group: Agents for treatment of haemorrhoids and anal fissures for topical use, ATC code: C05A A01. Anusol Plus HC provides antiseptic, astringent, emollient and decongestant properties. In addition, hydrocortisone exerts an anti-inflammatory action. Bismuth oxide, zinc oxide and bismuth subgallate exert a protective action on mucous membranes and raw surfaces. They are mildly astringent and are reported to have antiseptic properties Balsam Peru has protective properties and very mild antiseptic action by virtue of its content of cinnamic and benzoic acids. It is believed to promote the growth of epithelial cells. Benzyl benzoate is used as a solubilizing agent and has mild antiseptic and preservative properties. Hydrocortisone acetate has the general properties of hydrocortisone and the anti- inflammatory action is of primary interest in the product. 5.2. Pharmacokinetic properties - Systemic absorption of hydrocortisone acetate from the rectum may occur but estimates of the extent of absorption have been variable and have always been less than 30%. Following absorption it is metabolised in the liver and most body tissues before being excreted in the urine. Biological half-life is approximately 100 minutes and it is 90% bound to plasma protein. The other active ingredients in Anusol HC Plus Suppositories exert their therapeutic effect without being absorbed into the systemic circulation. These observations are supported by evidence from various studies and reviews. 5.3. Preclinical safety data - The active ingredients of Anusol are well known constituents of medicinal products and their safety profile is well documented. 6. Pharmaceutical particulars - 6.1. List of Excipients - Kaolin light, Hard Fat (Suppocire BS2). 6.2. Major Incompatibilities - No incompatibilities have been reported. 6.3. Shelf life - 3 years. 6.4. Special precautions for storage - Do not store above 25oC. For storage conditions after first opening of the medicinal product, see section 6.3. 6.5. Nature and contents of container - Printed strip pack consisting of white opaque PVC/polyethylene laminated film. Each pack contains 12 suppositories. Not all pack sizes may be marketed. 6.6. Special precautions for disposal and other handling No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 7. Marketing authorisation holder - Church & Dwight UK Limited, Premier House, Shearway Business Park, Pent Road, Folkestone, Kent, CT19 4RJ, United Kingdom. 8. Marketing authorisation number - PL 00203/0237. 9. Date of first authorisation or renewal - 10 March 2009 10. Date of revision of the text - 30 June 2017

Summary of product characteristics Product Summary 1. Name of the medicinal product - ANUSOL PLUS HC OINTMENT 2. Qualitative and quantitative composition - Each 100 g of ointment contains the following active ingredients:- Hydrocortisone acetate 0.25 g, Benzyl benzoate 1.25 g, Bismuth subgallate 2.25 g, Bismuth oxide0.875 g, Balsam peru 1.875 g, Zinc oxide 10.75 g. For full list of excipients, see section 6.1 3. Pharmaceutical form - Ointment. 4 Clinical particulars - 4.1 Therapeutic indications - Symptomatic treatment of internal and external haemorrhoids and pruritus ani. 4.2 Posology and method of administration - Topical administration. Adults (over 18 years) - To be applied sparingly to the affected area at night, in the morning and after each evacuation up to a maximum of 4 applications a day. Thoroughly cleanse the affected area, dry and apply ointment on a gauze dressing. For internal conditions use rectal nozzle provided. Remove the nozzle cap. Clean the nozzle after each use. Use for a maximum period of one week. Not to be taken orally. Elderly (over 65 years) As for adults. Children (under 18 years) Not recommended. 4.3 Contra-indications - Tubercular, fungal and most viral lesions including herpes simplex, vaccinia and varicella. Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Do not use in pregnancy or breast-feeding. 4.4 Special warnings and precautions for use - Patients with rectal bleeding or blood in the stool should talk to their doctor before using this product as these conditions may be the symptom of a more serious underlying disorder. As with all products containing topical steroids, the possibility of systemic absorption should be borne in mind. Prolonged or excessive use may produce systemic corticosteroid effects and use for periods longer than seven days is not recommended. Do not use for more than 7 days unless under the direction of a doctor. The product should be discontinued and the patient advised to consult a medical practitioner if symptoms do not improve or worsen or if rectal bleeding occurs. Visual disturbance - Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids. 4.5 Interactions with other medicinal products and other forms of interactions - Concurrent use with other corticosteroid preparations, either topically or orally may increase the likelihood of systemic effects. Co-treatment with CYP3A inhibitors, including cobicistat containing products, is expected to increase the risk of systemic effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects. 4.6 Fertility, pregnancy, and lactation - There is inadequate evidence of safety in human pregnancy and there may be a very small risk of cleft palate and intrauterine growth retardation as well as suppression of the neonatal hypothalamic-pituitary-adrenal axis. There is evidence of harmful effects in animals. Do not use in pregnancy or breastfeeding. 4.7 Effects on ability to drive and use machines - No effects have been reported on ability to drive or use machinery. 4.8 Undesirable effects - No Adverse Drug Reactions (ADRs) have been identified from the analysis of post-marketing data for fixed combinations of Balsam Peru, bismuth oxide and zinc oxide. ADRs identified during Post-Marketing experience with Zinc Oxide (topical use) are included in the Table below. The frequencies are provided according to the following convention: Very common ‰¥1/10, Common ‰¥1/100 and < 1/10, Uncommon ‰¥1/1,000 and <1/100, Rare ‰¥1/10,000 and <1/1,000, Very rare <1/10,000, Not known (cannot be estimated from the available data). ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as 'Not known'. Other adverse reactions include: Skin sensitisation reactions and systemic contact dermatitis, attributed directly to Balsam Peru have been reported in published literature. Reporting of suspected adverse reactions - Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. System Organ Class (SOC) €“ Immune system disorders, Frequency €“ rare, Adverse Drug Reaction, hypersensitivity. System Organ Class (SOC) €“ General disorders and administration site conditions, Frequency €“ not known, Adverse Drug Reaction - Application site reaction (including Burn, erythema, Exfoliation, Irritation, Pain, Pruritus, Rash and Uticaria. System Organ Class (SOC) €“ Eye disorders, Frequency €“ Not known, Adverse Drug Reaction - Vision, blurred (see also section 4.4). 4.9 Overdose symptoms, emergency procedures, antidotes - No overdose related adverse drug reactions have been identified from the post- marketing data analysis of Balsam Peru, benzyl benzoate, bismuth oxide, bismuth subgallate, hydrocortisone acetate and zinc oxide. If swallowed, fever, nausea, vomiting, stomach cramps and diarrhoea may develop 3-12 hours after ingestion. Symptoms of acute oral overdose of bismuth-containing preparations may include nausea, vomiting, renal failure and rarely liver damage. Encephalopathy and discolouration of mucous membranes may occur with chronic overdose. No cases of Balsam Peru overdose have been identified in the medical literature. Hydrocortisone normally does not produce toxic effects in an acute single overdose. Prolonged use of topical corticosteroids may increase potential for local adverse effects, including steroid atrophy (thinning of the skin), striae (stretch marks), and Telangiectasia (visible blood vessels). Systemic availability after rectal administration is very low; however, excessive administration of corticosteroids may increase the potential for systemic effects, such as hypothalamic-pituitary axis suppression. Treatment of a large acute overdose should include gastric lavage, purgation with magnesium sulphate and complete bed rest. If necessary oxygen and general supportive measures should be given. Methaemoglobinaemia should be treated by intravenous methylthioninium chloride. 5 pharmacological properties - 5.1 Pharmacodynamic properties - Pharmacotherapeutic group: Agents for treatment of haemorrhoids and anal fissures for topical use, ATC code: C05A A01. ANUSOL PLUS HC provides antiseptic, astringent, emollient and decongestant properties. in addition hydrocortisone exerts anti-inflammatory actions. Bismuth oxide, zinc oxide, and bismuth subgallate exert a protective action on mucous membranes and raw surfaces. They are mildly astringent and are reported to have antiseptic properties. Balsam Peru has protective properties and a very mild antiseptic action by virtue of its contents of cinnamic and benzoic acids. It is believed to promote the growth of epithelial cells. Benzyl benzoate is used as a solubilizing agent and has mild antiseptic and preservative properties. Hydrocortisone acetate has the general properties of hydrocortisone and this anti- inflammatory action is of primary interest of this product. 5.2 Pharmacokinetic properties - Systemic absorption of hydrocortisone acetate from the rectum may occur but estimates of the extent of absorption have been variable and have always been less than 30%. Following absorption it is metabolised in the liver and most body tissues before being excreted in the urine. Biological half life is approximately 100 minutes and it is 90% bound to plasma protein. The other active ingredients in Anusol Plus HC Ointment exert their therapeutic effect without being absorbed into the systemic circulation. These are supported by evidence from various studies and reviews. 5.3 Preclinical safety data - The active ingredients of Anusol are well known constituents of medicinal products and their safety profile is well documented. 6 pharmaceutical particulars - 6.1 List of excipients - Kaolin light, Magnesium stearate, Castor oil, Cocoa butter, Lanolin anhydrous, Petroleum jelly white, Calcium hydrogen phosphate. 6.2 Major incompatibilities - No incompatibilities have been reported. 6.3 Shelf life - 3 years. 6.4 Special precautions for storage - Do not store above 25°C. For storage conditions after first opening of the medicinal product, see section 6.3. 6.5 Nature and contents of container - Externally printed aluminium tube with wadded plastic cap, containing 15 g of ointment. A plastic nozzle with cap is also provided for internal application. Not all pack sizes may be marketed. 6.6 Special precautions for disposal and other handling - No Special Requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 7. Marketing authorisation holder Church & Dwight UK Limited, Premier House, Shearway Business Park, Pent Road, Folkestone, Kent, CT19 4RJ, United Kingdom. 8 marketing authorisation number - PL 00203/0236 9. Date of the first authorisation or renewal - 9 March 2009 10. Date of revision of the text - 30 June 2017.

Summary of product characteristics. Product Summary - 1. Name of the medicinal product - Anusol HC Suppositories 2. Qualitative and quantitative composition - Each suppository contains: Hydrocortisone acetate 10mg, Bismuth subgallate 59mg, Bismuth oxide 24mg, Balsam Peru 49mg, Benzyl benzoate 33mg, Zinc oxide 296mg. For full list of excipients, see section 6.1 3. Pharmaceutical form - White/off white suppository. 4. Clinical particulars - 4.1. Therapeutic indications - Anusol HC Suppositories are indicated for the symptomatic relief of internal haemorrhoids and pruritus ani. 4.2. Posology and method of administration - Anal insertion. Adults Remove wrapper and insert one suppository into the anus at night, in the morning and after each evacuation up to a maximum of three per day for a maximum period of one week. Not to be taken orally. Elderly (over 65 years) As for adults. Children Not recommended. 4.3. Contraindications - Tubercular, fungal and most viral lesions including herpes simplex, vaccinia and varicella. Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 Do not use in pregnancy or breast-feeding. 4.4. Special warnings and precautions for use - Following symptomatic relief, definitive diagnosis should be established. Patients with rectal bleeding or blood in the stool should talk to their doctor before using this product as these conditions may be the symptom of a more serious underlying disorder. As with all products containing topical steroids, the possibility of systemic absorption should be borne in mind. If symptoms persist or worsen patients should be instructed to stop use and consult a physician. Prolonged or excessive use may produce systemic corticosteroid effects. Do not use for more than 7 days unless under the direction of a doctor. Visual disturbance - Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids. 4.5. Interactions with other medicinal products and other forms of interaction - Concurrent use with other corticosteroid preparations, either topically or orally may increase the likelihood of systemic effects. Co-treatment with CYP3A inhibitors, including cobicistat containing products, is expected to increase the risk of systemic effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects. 4.6. Fertility, pregnancy and lactation - There is inadequate evidence of safety in human pregnancy and there may be a very small risk of cleft palate and intrauterine growth retardation as well as suppression of the neonatal HPA axis. There is evidence of harmful effects in animals. Do not use in pregnancy or breastfeeding. 4.7. Effects on ability to drive and use machines - Not applicable. 4.8. Undesirable effects - No Adverse Drug Reactions (ADRs) have been identified from the analysis of post-marketing data for fixed combinations of Balsam Peru, bismuth oxide and zinc oxide. ADRs identified during Post-Marketing experience with Zinc Oxide (topical use) are included in the Table below. The frequencies are provided according to the following convention: Very common ‰¥1/10, Common ‰¥1/100 and < 1/10, Uncommon ‰¥1/1,000 and <1/100, Rare ‰¥1/10,000 and <1/1,000, Very rare <1/10,000, Not known (cannot be estimated from the available data). ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as 'Not known'. Other adverse reactions include: Skin sensitisation reactions and systemic contact dermatitis, attributed directly to Balsam Peru have been reported in published literature. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. System Organ Class (SOC) €“ Immune system disorders, Frequency €“ rare, Adverse Drug Reaction, hypersensitivity. System Organ Class (SOC) €“ General disorders and administration site conditions, Frequency €“ not known, Adverse Drug Reaction, Application site reaction (including Burn, erythema, Exfoliation, Irritation, Pain, Pruritus, Rash and Uticaria. 4.9. Overdose - No overdose related adverse drug reactions have been identified from the post- marketing data analysis of Balsam Peru, benzyl benzoate, bismuth oxide, bismuth subgallate, hydrocortisone acetate and zinc oxide. If swallowed, fever, nausea, vomiting, stomach cramps and diarrhoea may develop 3-12 hours after ingestion. Symptoms of acute oral overdose of bismuth-containing preparations may include nausea, vomiting, renal failure and rarely liver damage. Encephalopathy and discolouration of mucous membranes may occur with chronic overdose. No cases of Balsam Peru overdose have been identified in the medical literature. Hydrocortisone normally does not produce toxic effects in an acute single overdose. Prolonged, use of topical corticosteroids may increase potential for local adverse effects, including steroid atrophy (thinning of the skin), striae (stretch marks), and Telangiectasia (visible blood vessels). Systemic availability after rectal administration is very low, however, excessive administration of corticosteroids may increase the potential for systemic effects, such as hypothalamic-pituitary axis suppression. Treatment of a large acute overdose should include gastric lavage, purgation with magnesium sulphate and complete bed rest. If necessary, give oxygen and general supportive measures. Methaemoglobinaemia should be treated by intravenous methylthioninium chloride. 5. Pharmacological properties - 5.1. Pharmacodynamic properties - Pharmacotherapeutic group: Agents for treatment of haemorrhoids and anal fissures for topical use, ATC code: C05A A01. This product provides antiseptic, astringent, emollient and anti-inflammatory actions. Bismuth oxide, zinc oxide, and bismuth subgallate exert a protective action on mucous membranes and raw surfaces. They are mildly astringent and are reported to have antiseptic properties. Balsam Peru has protective properties and a very mild antiseptic action by virtue of its content of cinnamic and benzoic acids. It is believed to promote the growth of epithelial cells. Benzyl benzoate is used as a solubilizing agent and has mild antiseptic and preservative properties. Hydrocortisone acetate has the general properties of hydrocortisone and the anti- inflammatory action is of primary interest in this product. 5.2. Pharmacokinetic properties - It is well known that topically applied corticosteroids can be absorbed percutaneously. This appears to be more likely upon repeated or prolonged use. The other active ingredients in Anusol HC Suppositories exert their therapeutic effect without being absorbed into the systemic circulation. These observations are supported by evidence from various studies and reviews. 5.3. Preclinical safety data - Pre-clinical safety data do not add anything of further significance to the prescriber. 6. Pharmaceutical particulars - 6.1. List of excipients - Each suppository contains: Kaolin light, Suppocire BS2 pastilles (Hard fat) 6.2. Incompatibilities - None applicable. 6.3. Shelf life - 36 months. 6.4. Special precautions for storage - Do not store above 25°C. For storage conditions after first opening of the medicinal product, see section 6.3. 6.5. Nature and contents of container - Printed strip pack consisting of white opaque PVC/polyethylene laminated film. Boxes of 12 and 24 suppositories. Not all pack sizes may be marketed 6.6. - Special precautions for disposal and other handling Not applicable. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Administrative Data 7. Marketing authorisation holder - Church & Dwight UK Limited, Premier House, Shearway Business Park, Pent Road, Folkestone, Kent, CT19 4RJ, United Kingdom. 8. Marketing authorisation number - PL 00203/0239. 9. Date of first authorisation/renewal of the authorisation - 14th August 1998 / 14th January 2002, 1st June 2002 (Transfer of Ownership) 10. Date of revision of the text - 30 June 2017.