ADDITIONAL LIFESTYLE ADVICE

1. Lacy et al. Scandinavian Journal of Gastroenterology. 2013; 48:926-935

2. Agrawal A, Whorwell P J. Irritable bowel syndrome: diagnosis and management BMJ 2006; 332 :280

3. https://www.nhs.uk/conditions/irritable-bowel-syndrome-ibs/diet-lifestyle-and-medicines/

4. https://www.nhs.uk/conditions/flatulence/

5. https://www.nhs.uk/conditions/constipation/

Online references last accessed March 2021.

Buscomint^® Peppermint oil 0.2 ml gastro-resistant capsules
Presentation: Capsules containing 0.2 ml of peppermint oil. Indications: Herbal medicinal product for the symptomatic relief of abdominal pain, minor spasms of the gastrointestinal tract and flatulence, especially in patients with irritable bowel syndrome. Dosage and administration: Adults and children over 12 years (who weigh at least 40 kg): one capsule three times a day. Take capsules 30 minutes before a meal with plenty of liquid. Take Buscomint until symptoms resolve, usually within one or two weeks. After two weeks, seek medical advice in case of persistent or deteriorating symptoms. When the symptoms are more persistent, the capsules can be taken for periods up to 3 months per treatment course. Contraindications: Hypersensitivity to menthol or any of the ingredients, patients with liver disease, cholangitis, achlorhydria, gallstones and other biliary disorders, children under 12 years of age and patients with a body weight less than 40 kg. Warnings and precautions: Swallow the capsules whole to avoid release of the peppermint oil prematurely, which may cause local irritation of the mouth and oesophagus. Patients who suffer from heartburn or hiatus hernia may have exacerbation of these symptoms after taking peppermint oil; treatment should be discontinued in these patients. In case unexplained abdominal pain persists or worsens, or occurs together with symptoms like fever, jaundice, vomiting, changes in bowel movement frequency, or blood in stool medical advice should sought immediately. Contains less than 1 mmol sodium (23 mg) per capsule. Interactions: Food or antacids administered at the same time may cause early release of the capsule contents. Medicines used to decrease stomach acid, like histamine-2 blockers and proton pump inhibitors, may cause premature dissolution of the enteric coating and should be avoided. Pregnancy and lactation: Pregnancy: There are no or limited amount of data from the use of peppermint oil in pregnant women. In the absence of sufficient data, the use during pregnancy is not recommended. Lactation: Clinical data have shown that 1,8 cineol, one constituent of peppermint oil, can be excreted into human breast milk. Buscomint is therefore not recommended during lactation. Side effects: Unknown frequency: anaphylactic shock due to allergic reaction to menthol, muscle tremor, ataxia, headache, blurred vision, bradycardia, heartburn, perianal burning, nausea, vomiting, faeces with abnormal menthol smell, inflammation of the glans of the penis, erythematous skin rash, urine with abnormal menthol odour, dysuria. RRP (ex VAT): 24 capsules £5.83. Legal category: GSL. Product licence number: PL 04425/0757. Product licence holder: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK. Further information is available from Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT. Email: ukmedicalinformation@sanofi.com. Date of preparation: June 2020.

Buscopan^® Cramps
Presentation: tablets containing hyoscine butylbromide 10 mg. Indications: For the relief of spasm of the genito-urinary tract or gastro-intestinal tract and for the symptomatic relief of Irritable Bowel Syndrome. Dosage and administration: For spasm of the genitourinary tract or gastro-intestinal tract: adults: 2 tablets four times daily, children 6-12 years: 1 tablet three times daily. For Irritable Bowel Syndrome: adults: initially 1 tablet three times daily, increasing if necessary, to 2 tablets four times a day. Contraindications: Myasthenia gravis, mechanical stenosis in the gastrointestinal tract, paralytical or obstructive ileus, megacolon, narrow angle glaucoma, known hypersensitivity to any component. Warnings and precautions: Should not be taken for extended periods without investigating the cause of abdominal pain. Use with caution in conditions characterised by tachycardia; those susceptible to intestinal or urinary outlet obstruction; pyrexia. Warn patients to seek medical advice if they develop a painful red eye with loss of vision whilst or after taking Buscopan Cramps. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency consult their doctor before taking Buscopan Cramps if: age over 40 years; recent rectal bleeding; severe constipation; nausea or vomiting; loss of appetite or weight; difficulty or pain passing urine; fever; recent travel abroad, looking pale and feeling tired, abnormal vaginal bleeding or discharge. Advise patients to consult their doctor if they develop new symptoms, or if symptoms worsen, or if they do not improve after 2 weeks of treatment. Interactions: The anticholinergic effect of drugs, e.g. tri- and tetracyclic antidepressants, antihistamines, quinidine, amantadine, antipsychotics (e.g. butyrophenones, phenothiazines), disopyramide and other anticholinergics (e.g. tiotropium, ipratropium, atropine-like compounds) may be intensified by Buscopan Cramps. Co-administration with a dopamine antagonist may diminish the effect of both medicines. The tachycardic effects of beta-adrenergic agents may be enhanced by Buscopan Cramps. Pregnancy & lactation: Use during pregnancy and breastfeeding is not recommended. Side effects: Uncommon: dry mouth, tachycardia, skin reactions (e.g. urticaria, pruritus), abnormal sweating. Rare: urinary retention. Not known: anaphylactic shock, anaphylactic reactions, dyspnoea, rash, erythema, other hypersensitivity. RRP (ex VAT): 20 tablets £4.16. Legal category: P. Product licence number: PL 04425/0709. Product licence holder: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK. Further information is available from Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT. Email uk-medicalinformation@sanofi.com. Date of preparation: December 2020

Buscopan^® IBS Relief
Presentation: tablets containing hyoscine butylbromide 10 mg. Indication: Relief of gastrointestinal tract spasm associated with medically confirmed Irritable Bowel Syndrome. Dosage and administration: Adults and children (over 12 years) only: initially 1 tablet three times daily, increasing if necessary, to 2 tablets four times a day. Contraindications: Myasthenia gravis, mechanical stenosis in the gastrointestinal tract, paralytical or obstructive ileus, megacolon, narrow angle glaucoma, known hypersensitivity to any component. Warnings and precautions: Should not be taken for extended periods without investigating the cause of abdominal pain. Use with caution in conditions characterised by tachycardia; those susceptible to intestinal or urinary outlet obstruction; pyrexia. Warn patients to seek medical advice if they develop a painful red eye with loss of vision whilst or after taking Buscopan IBS Relief. Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take Buscopan IBS Relief since the tablet coat contains sucrose. Advise patients to consult their doctor before taking IBS Relief if: age over 40 years and some time since the last attack of IBS or the symptoms are different; recent rectal bleeding; severe constipation; nausea or vomiting; loss of appetite or weight; difficulty or pain passing urine; fever; recent travel abroad. Advise patients to consult their doctor if they develop new symptoms, or if symptoms worsen, or if they do not improve after 2 weeks of treatment. Interactions: The anticholinergic effect of drugs, e.g. tri- and tetracyclic antidepressants, antihistamines, quinidine, amantadine, antipsychotics (e.g. butyrophenones, phenothiazines), disopyramide and other anticholinergics (e.g. tiotropium, ipratropium, atropine-like compounds) may be intensified by Buscopan IBS Relief tablets. Co-administration with a dopamine antagonist may diminish the effect of both medicines. The tachycardic effects of beta-adrenergic agents may be enhanced by Buscopan IBS Relief tablets. Pregnancy & lactation: Use during pregnancy and breastfeeding is not recommended. Side effects: Uncommon: dry mouth, tachycardia, skin reactions (e.g. urticaria, pruritus), abnormal sweating. Rare: urinary retention. Not known: anaphylactic shock, anaphylactic reactions, dyspnoea, rash, erythema, other hypersensitivity. RRP (ex VAT): 8 tablets £2.08, 20 tablets £4.16, 40 tablets £6.95, Legal category: GSL. Product licence number: PL 04425/0711. Product licence holder: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK. Further information is available from Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT. Email uk-medicalinformation@sanofi.com. Date of preparation: December 2020

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card on the Google Play or Apple App Store. Adverse events should also be reported to Sanofi drug safety department on 0800 0902314.