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

2. https://www.nhs.uk/conditions/laxatives/

3. https://cks.nice.org.uk/constipation

4. BNF Constipation treatment summary, available at https://bnf.nice.org.uk/treatment-summary/constipation.html

5. https://www.palliativedrugs.com/assets/pcf5/PCF5_sample_Chapt01.pdf

All references last accessed June 2021

DulcoEase^® 100 mg Capsules

Presentation: Capsules containing docusate sodium 100 mg. Excipients of known effect: Sorbitol and Sunset yellow (E110). Indications: Stool softener for the prevention and treatment of chronic constipation. Prevention of hard, dry stools and reduction of straining at stools in the presence of conditions like haemorrhoids or anal fissures. Dosage and administration: Adults and children 12 years and over: Up to a maximum of 500 mg daily in divided doses. Treatment should be commenced with large doses such as 100 mg three times daily, which should be adapted to the treatment response. Not recommended for use in children under 12 years of age. Contraindications: Hypersensitivity to docusate or to any of the excipients, abdominal pain if not constipation related, nausea, vomiting, intestinal obstruction. Warnings and precautions: Consult a doctor when constipation persists or worsens during treatment or when laxatives are needed for a long period of time. Organic disorders should be excluded prior to the administration of any laxative. Contains sorbitol; patients with hereditary fructose intolerance (HFI) should not take this medicine. Contains E110 sunset yellow which may cause allergic reactions. Interactions: Do not take with a mineral oil laxative such as liquid paraffin. Pregnancy and lactation: Pregnancy: There are no adequate data from the use of the drug in pregnant women.  The potential risk for humans is unknown.  Nonclinical studies are insufficient with respect to effects on pregnancy and fetal development. DulcoEase should be used during pregnancy only if the benefits outweigh the risks. Lactation: Non-clinical studies have shown excretion of docusate sodium and its metabolites into breast milk when administered systemically. DulcoEase should be used with caution in nursing mothers. Side effects: Rare: diarrhoea, nausea, abdominal cramps. Unknown frequency: skin rash, pruritus. RRP (ex VAT): 10s £1.80, 30s £4.38, 60s £7.99. Legal category: GSL. Product licence number: PL 04425/0713. 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: December 2020. MAT-GB-2005374 (v1.0)

Dulcolax^® Adult 5 mg Gastro-resistant Tablets (GSL)

Presentation: Tablets containing bisacodyl 5 mg. Indication: For the short-term relief of occasional constipation. Dosage and administration: Adults (over 18 years): One to two tablets daily before bedtime. Should not be used in children and adolescents under the age of 18 years. Once regularity has been restarted dosage should be reduced and can usually be stopped. Contraindications: Intestinal obstruction, ileus, acute abdominal conditions including appendicitis, acute inflammatory bowel diseases, severe abdominal pain associated with nausea and vomiting, severe dehydration, and hypersensitivity to bisacodyl or any other ingredient. Warnings and precautions: Not to be taken on a continuous daily basis for more than five days without investigating the cause of constipation. Long-term everyday use of stimulant laxatives may harm the intestinal function and should be avoided. If laxatives are needed every day the cause of the constipation should be investigated. Should only be used if a therapeutic effect cannot be achieved by a change of diet or the administration of bulk forming agents. Prolonged excessive use may lead to electrolyte imbalance and hypokalaemia. Intestinal loss of fluids can promote dehydration. Symptoms may include thirst and oliguria. In patients suffering from fluid loss where dehydration may be harmful (e.g. renal insufficiency, elderly patients) Dulcolax should be discontinued and only be restarted under medical supervision. Laxatives do not help with weight loss. If the symptoms worsen during the use, a doctor or pharmacist should be consulted. Contains a small amount of lactose and sucrose - patients with rare hereditary problems of fructose intolerance, galactose intolerance, total lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Interactions: The concomitant use of antacids and milk products may reduce the resistance of the coating of the tablets and result in dyspepsia and gastric irritation. The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses of Dulcolax are taken. Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides. The concomitant use of other laxatives may enhance the gastrointestinal side effects of Dulcolax. Pregnancy and lactation: Not to be taken in pregnancy, especially the first trimester, and during breast feeding, unless the expected benefit is thought to outweigh any possible risk to the foetus. Side effects: Common: abdominal pain, abdominal cramps, nausea and diarrhoea. Uncommon: dizziness, vomiting, haematochezia (blood in stool), abdominal discomfort and anorectal discomfort. Rare: anaphylactic reactions, angioedema, hypersensitivity, dehydration, syncope, colitis including ischaemic colitis. RRP (ex VAT): 10 tablets £1.34, 20 tablets £2.31. Legal category: GSL. Product licence number: PL 04425/0718. 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, UK. email:ukmedicalinformation@sanofi.com. Date of preparation: October 2020. MAT-GB-2003942 (v1.0)

Dulcolax^® Adult Pico Liquid

Presentation: Oral solution containing sodium picosulfate 5 mg / 5ml. Indication: For the short-term relief of occasional constipation. Dose and administration: Adults (over 18 years): one to two 5 ml spoonfuls daily at night. Should not be used in children and adolescents under the age of 18 years. Once regularity has been restarted, dosage should be reduced and can usually be stopped. Contraindications: Intestinal obstruction, ileus, severe painful and/or feverish acute abdominal conditions (e.g. appendicitis) potentially associated with nausea and vomiting, acute inflammatory bowel diseases, severe dehydration, hypersensitivity to sodium picosulfate or any other ingredient. Warnings and precautions: Not to be taken on a continuous daily basis for more than five days without investigating the cause of constipation. Long-term everyday use of stimulant laxatives may harm the intestinal function and should be avoided. If laxatives are needed every day the cause of the constipation should be investigated. Should only be used if a therapeutic effect cannot be achieved by a change of diet or the administration of bulk forming agents. Prolonged excessive use may lead to electrolyte imbalance and hypokalaemia. Intestinal loss of fluids can promote dehydration. Symptoms may include thirst and oliguria. In patients suffering from fluid loss where dehydration may be harmful (e.g. renal insufficiency, elderly patients) sodium picosulfate should be discontinued and only be restarted under medical supervision. Stimulant laxatives do not help with weight loss. If the symptoms worsen during use, a doctor or a pharmacist should be consulted. Dulcolax Adult Pico Liquid contains 4.8 % ethanol (alcohol); may be harmful for those suffering from alcoholism and should be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy. Contains the preservatives methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed). Interactions: After excessive doses, the concomitant use with diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance. Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides. Concurrent antibiotics may reduce laxative action. Pregnancy and lactation: Not to be taken in pregnancy, especially the first trimester, and during breast feeding unless the expected benefit is thought to outweigh any possible risk to the foetus. Side effects: Very common: diarrhoea Common: abdominal discomfort, abdominal pain, abdominal cramps. Uncommon: nausea, vomiting, dizziness. Not known: hypersensitivity, syncope, skin reactions such as angioedema, drug eruption, rash and pruritus. RRP (ex VAT): 100 ml £3.99. Legal category: GSL. Product licence number: PL 04425/0731. 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: October 2020. MAT-GB-2003111 (v1.0)

Dulcolax^® Twelve Plus 5 mg Gastro-resistant Tablets

Presentation: Tablets containing bisacodyl 5 mg. Indication: For the short-term relief of occasional constipation. Dosage and administration: Adults and children over 12 years: One to two tablets daily before bedtime. Should not be used in children and adolescents under the age of 12 years. Contraindications: Intestinal obstruction, ileus, acute abdominal conditions including appendicitis, acute inflammatory bowel diseases, severe abdominal pain associated with nausea and vomiting, severe dehydration, and hypersensitivity to bisacodyl or any other ingredient. Warnings and precautions: Not to be taken on a continuous daily basis for more than five days without investigating the cause of constipation. Long-term everyday use of stimulant laxatives may harm the intestinal function and should be avoided. If laxatives are needed every day the cause of the constipation should be investigated. Should only be used if a therapeutic effect cannot be achieved by a change of diet or the administration of bulk forming agents. Prolonged excessive use may lead to electrolyte imbalance and hypokalaemia. Intestinal loss of fluids can promote dehydration. Symptoms may include thirst and oliguria. In patients suffering from fluid loss where dehydration may be harmful (e.g. renal insufficiency, elderly patients) Dulcolax should be discontinued and only be restarted under medical supervision. Laxatives do not help with weight loss. If the symptoms worsen during use a doctor or pharmacist should be consulted. Contains a small amount of lactose and sucrose; patients with rare hereditary problems of fructose intolerance, galactose intolerance, total lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.  Interactions: The concomitant use of antacids and milk products may reduce the resistance of the coating of the tablets and result in dyspepsia and gastric irritation. The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses of Dulcolax are taken. Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides. The concomitant use of other laxatives may enhance the gastrointestinal side effects of Dulcolax. Pregnancy and lactation: Not to be taken in pregnancy, especially the first trimester, and during breast feeding, unless the expected benefit is thought to outweigh any possible risk to the foetus. Side effects: Common: abdominal pain, abdominal cramps, nausea and diarrhoea. Uncommon: dizziness, vomiting, haematochezia (blood in stool), abdominal discomfort and anorectal discomfort. Rare: anaphylactic reactions, angioedema, hypersensitivity, dehydration, syncope, colitis including ischaemic colitis. RRP (ex VAT): 40 tablets £4.18, 60 tablets £5.65, 100 tablets £6.18. Legal category: P Product licence number: PL 04425/0719. 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, UK. email:ukmedicalinformation@sanofi.com.  Date of preparation: October 2020. MAT-GB-2003943 (v1.0)

Dulcolax^® Twelve Plus 10 mg Suppositories

Presentation: Suppositories containing bisacodyl 10 mg. Indications: For the short-term relief of occasional constipation. Dosage and administration: Adults and children over 12 years: One 10 mg suppository daily for immediate effect. Dulcolax 10 mg Suppositories should not be used in children and adolescents under 12 years of age. Contraindications: Intestinal obstruction, ileus, acute abdominal conditions including appendicitis, acute inflammatory bowel diseases, severe abdominal pain associated with nausea and vomiting, severe dehydration, and hypersensitivity to bisacodyl or any other ingredient. Dulcolax Suppositories should not be used when anal fissures or ulcerative proctitis with mucosal damage are present. Warnings and precautions: Should not be used in children and adolescents under the age of 12 years. Not to be used on a continuous daily basis for more than five days without investigating the cause of constipation. Long-term everyday use of stimulant laxatives may harm the intestinal function and should be avoided. If laxatives are needed every day the cause of the constipation should be investigated. This product should only be used if a therapeutic effect cannot be achieved by a change of diet or the administration of bulk forming agents. Prolonged excessive use may lead to electrolyte imbalance and hypokalaemia. Intestinal loss of fluids can promote dehydration; symptoms may include thirst and oliguria. In patients suffering from fluid loss where dehydration may be harmful (e.g. renal insufficiency, elderly patients) Dulcolax should be discontinued and only be restarted under medical supervision. Laxatives do not help with weight loss. If symptoms worsen during the use of the medicinal product, a doctor or pharmacist should be consulted. Interactions: The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses of Dulcolax are taken. Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides. The concomitant use of other laxatives may enhance the gastrointestinal side effects of Dulcolax. Pregnancy and lactation: Not to be used in pregnancy, especially the first trimester, and during breast feeding, unless the expected benefit is thought to outweigh any possible risk to the foetus. Side effects: Common: abdominal pain, abdominal cramps, nausea and diarrhoea. Uncommon: dizziness, vomiting, haematochezia (blood in stool), abdominal discomfort and anorectal discomfort. Rare: anaphylactic reactions, angioedema, hypersensitivity, dehydration, syncope, colitis including ischaemic colitis. RRP (ex VAT): Pack of 12, £4.23. Legal category: P. Product licence number: PL 04425/0716. 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: July 2020. MAT-GB-2000281 (v1.0)

Dulcolax^® Twelve Plus Pico Liquid

Presentation: Oral solution containing sodium picosulfate 5 mg / 5ml. Indication: For the short-term relief of occasional constipation. Dose and administration: Adults and children over 12 years: one to two 5 ml spoonfuls daily at night. Should not be used in children and adolescents under the age of 12 years. Once regularity has been restarted, dosage should be reduced and can usually be stopped. Contraindications: Intestinal obstruction, ileus, severe painful and/or feverish acute abdominal conditions (e.g. appendicitis) potentially associated with nausea and vomiting, acute inflammatory bowel diseases, severe dehydration and hypersensitivity to sodium picosulfate or any other ingredient. Warnings and precautions: Not to be taken on a continuous daily basis for more than five days without investigating the cause of constipation. Long-term everyday use of stimulant laxatives may harm the intestinal function and should be avoided. If laxatives are needed every day the cause of the constipation should be investigated. Should only be used if a therapeutic effect cannot be achieved by a change of diet or the administration of bulk forming agents. Prolonged excessive use may lead to electrolyte imbalance and hypokalaemia. Intestinal loss of fluids can promote dehydration. Symptoms may include thirst and oliguria. In patients suffering from fluid loss where dehydration may be harmful (e.g. renal insufficiency, elderly patients) sodium picosulfate should be discontinued and only be restarted under medical supervision. Stimulant laxatives do not help with weight loss. If the symptoms worsen during use, a doctor or a pharmacist should be consulted. Dulcolax Twelve Plus Pico Liquid contains 4.8 % ethanol (alcohol); may be harmful for those suffering from alcoholism and should be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy. Contains the preservatives methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed). Interactions: After excessive doses, the concomitant use with diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance. Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides. Concurrent antibiotics may reduce laxative action. Pregnancy and lactation: Not to be taken in pregnancy, especially the first trimester, and during breast feeding unless the expected benefit is thought to outweigh any possible risk to the foetus. Side effects: Very common: diarrhoea Common: abdominal discomfort, abdominal pain, abdominal cramps. Uncommon: nausea, vomiting, dizziness. Not known: hypersensitivity, syncope, skin reactions such as angioedema, drug eruption, rash and pruritus. RRP (ex VAT): 300 ml £6.64. Legal category: P. Product licence number: PL 04425/0714. 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: October 2020. MAT-GB-2003113 (v1.0)

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov/yellowcard 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