Essential Information for Senokot 7.5 mg Tablets 12 Years Plus

Name and Active substances: Senokot 7.5 mg Tablets 12 Years Plus. Each tablet contains powdered Alexandrian Senna fruit (pods) and Tinnevelly Senna fruit (pods) equivalent to 7.5mg hydroxyanthracene glycosides, calculated as sennoside B. Each tablet also contains 15.82 mg lactose monohydrate. Indications: For the short-term relief of occasional constipation. Dosage Instructions: For oral administration. The correct individual dose is the smallest required to produce a comfortable soft-formed motion. Adults, the elderly and children over 12 years: Swallow one to two tablets at night Should not be used in children or adolescents under the age of 12 years. New users should start with the lowest dose and increase it to the maximum dose if necessary. Once regularity has been regained dosage should be reduced and can usually be stopped. If no bowel action has occurred after three days of progressively increased dosage, a medical examination should be considered. Duration of use: Not to be used for more than 1 week. Usually it is sufficient to take this medicinal product up to two to three times during that week. If the symptoms persist during the use of the medicinal product, a doctor or a pharmacist should be consulted. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Not to be used at the same time as other laxative agents. Cases of intestinal obstructions and stenosis, atony, appendicitis, inflammatory bowel diseases (e.g Crohn’s disease, ulcerative colitis), abdominal pain of unknown origin, severe dehydration state with water and electrolyte depletion. Children under 12 years of age. Warnings & Precautions: If the symptoms worsen during the use of the medicinal product or there is no bowel movement after three days, a doctor or pharmacist should be consulted. If laxatives are needed every day, or abdominal pain persists, a doctor should be consulted. If laxatives are needed every day the cause of the constipation should be investigated. Long-term use of laxatives should be avoided. The product contains lactose monohydrate. One tablet contains 15.82mg lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Do not exceed the stated dose. Patients taking cardiac glycosides, antiarrhythmic medicinal products, medicinal products inducing QT-prolongation, diuretics, adrenocorticosteroids or liquorice root, have to consult a doctor before taking senna leaf preparation concomitantly. Like all laxatives, Senokot should not be taken by patients suffering from faecal impaction and undiagnosed, acute or persistent gastro-intestinal complaints, e.g. abdominal pain, nausea and vomiting, unless advised by a doctor, because these symptoms can be signs of potential or existing intestinal blockage (ileus). Long-term use of stimulant laxatives should be avoided, as use for more than a brief period of treatment may lead to impaired function of the intestine and dependence on laxatives. 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 use may precipitate the onset of an atonic, non-functioning colon. Prolonged excessive use may lead to fluid and electrolyte imbalance and hypokalaemia. Patients with kidney disorders should be aware of possible electrolyte imbalance. Intestinal loss of fluids may 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)

Senokot should be discontinued and only be restarted under medical supervision. When products containing senna leaf preparations are administered to incontinent adults, pads should be changed more frequently to prevent extended skin contact with faeces. Stimulant laxatives (including Senokot) do not help with weight loss.

The leaflet will state:
“Before you take this medicine” section
Does this help with weight loss?

Stimulant laxatives (including Senokot) do not help with weight loss. They do not reduce the absorption of calories or nutrients. They can cause watery stools (diarrhoea), abdominal cramps and dehydration. Dehydration can seem like weight loss.

Overuse of laxatives may damage your health by:

• Causing disturbances of electrolyte and mineral balances. Sodium, potassium, magnesium, and phosphorus are electrolytes and minerals that are present in very specific amounts necessary for proper functioning of the nerves and muscles, including those of the colon and heart. Upsetting this delicate balance can cause incorrect functioning of these vital organs.
• Severe dehydration may cause tremors, weakness, blurry vision, fainting, kidney damage, and, in extreme cases, death. Dehydration often requires medical treatment.
• Overuse of laxatives can cause the colon to stop reacting to usual doses of laxatives so that larger and larger amounts of laxatives may be needed to produce bowel movements.
• Laxative dependency occurs from overuse.

The label will state:
Front of pack:

• Does not help with weight loss.
• Overuse can be harmful.

Fertility, pregnancy and lactation: There are no reports of undesirable or damaging effects during pregnancy and on the foetus when used at the recommended dosage schedule. However, as a consequence of experimental data concerning a genotoxic risk of several anthranoids, e.g emodin and aloe-emodin, use is not recommended during pregnancy. Use during breastfeeding is not recommended as there are insufficient data on the excretion of metabolites in breast milk. Small amounts of active metabolites (rhein) are excreted in breast milk. A laxative effect in breast fed babies has not been reported. There are no data on the effects of the product on fertility. Side-Effects: Hypersensitivity, urticaria, asthma, hypogammaglobulinaemia, hypokalaemia, cachexia, abdominal pain, abdominal spasm, diarrhoea, gastrointestinal tract mucosal pigmentation, pruritus, local or generalised exanthema, chromaturia, finger clubbing, tetany and hypertrophic osteoarthropathy. Frequency unknkown. Retail Price: 60s £6.49 Marketing Authorisation: PL 00063/0768 Marketing Authorisation Holder: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS Supply Classification: P Date of preparation: Feb 2020

Essential Information for Senokot 7.5 mg/5 ml Syrup 12 Years Plus.

Name and active substances: Senokot 7.5 mg/5 ml Syrup 12 Years Plus. Each 5 ml of syrup contains sennosides, as calcium salts, equivalent to 7.5 mg hydroxyanthracene glycosides, calculated as sennoside B. Indication: For the short-term relief of occasional constipation. Dosage and administration: For oral administration. The correct individual dose is the smallest required to produce a comfortable soft-formed motion. Adults, the elderly and children over 12 years: one to two 5 ml spoonfuls at night. A higher dose may be prescribed under medical guidance. The maximum recommended daily dose of hydroxyanthracene glycosides is 30 mg (20ml). Should not be used in children or adolescents under the age of 12 years (see section 4.3). New users should start the lowest dose and increase, to the maximum dose for each age group, if necessary, by one half of the initial dose each day. Once regularity has been regained the dosage should be reduced and can usually be stopped. If no bowel action has occurred after three days of progressively increased dosage, medical examination should be considered. Not to be used for more than 1 week. Usually it is sufficient to take this medicinal product up to two to three times during that week. If the symptoms persist or worsen during the use of the medicine, a doctor or a pharmacist should be consulted. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Not to be used the same time as other laxative agents. Cases of intestinal obstructions and stenosis, atony, appendicitis, inflammatory colon diseases (e.g. Crohn’s disease, ulcerative colitis), abdominal pain of unknown origin, severe dehydration state with water and electrolyte depletion. Children under 2 years of age. Warnings & precautions: If there is no bowel movement after three days, a doctor should be consulted. If laxatives are needed every day or abdominal pain persists a doctor should be consulted. Long-term use of stimulant laxatives should be avoided, as use for more than a brief period of treatment may lead to impaired function of the intestine and dependence on laxatives. 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. Do not exceed the stated dose. Patients taking cardiac glycosides, antiarrhythmic medicines, medicinal products inducing QT-prolongation, diuretics, adrenocorticosteroids or liquorice root, have to consult a doctor before taking this product concomitantly. Like all laxatives, Senokot 7.5 mg/5 ml Syrup 12 Years Plus should not be taken by patients suffering from faecal impaction and undiagnosed, acute or persistent gastro-intestinal complaints, e.g. abdominal pain, nausea and vomiting, unless advised by a doctor, because these symptoms can be signs of potential or existing intestinal blockage (ileus). Prolonged use may precipitate the onset of an atonic, non-functioning colon. Prolonged and excessive use may lead to fluid and electrolyte imbalance and hypokalaemia. Intestinal loss of fluids may 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) Senokot 7.5 mg/5 ml Syrup 12 Years Plus should be discontinued and only be restarted under medical supervision. Patients with kidney disorders should be aware of possible electrolyte imbalance. When products containing senna leaf preparations are administered to incontinent adults, pads should be changed more frequently to prevent extended skin contact with faeces. Stimulant laxatives (including Senokot 7.5 mg/5 ml Syrup 12 Years Plus) do not help with weight loss. They do not reduce the absorption of calories or nutrients. They can cause watery stools (diarrhoea), abdominal cramps and dehydration. Dehydration can seem like weight loss. If the symptoms worsen during the use of the medicinal product, a doctor or a pharmacist should be consulted. Each 5 ml of syrup can provide up to 3.2 kcal and this should be taken into account in patients with diabetes mellitus. Methyl and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed) .Contains maltitol liquid. Patients with rare hereditary problems of fructose intolerance should not take this medicine. This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per dose. Fertility, pregnancy and lactation: Pregnancy: There are no reports of undesirable or damaging effects during pregnancy and on the foetus when used at the recommended dosage. However, as a consequence of experimental data concerning a genotoxic risk of several anthranoids, e.g emodin and aloe-emodin, use is not recommended in pregnancy. Lactation: Use during breastfeeding is not recommended as there are insufficient data on the excretion of metabolites in breast milk. Small amounts of active metabolites, such as rhein, are excreted in breast milk in small amounts. A laxative effect in breast fed babies has not been reported. Fertility: There are no data on the effects of the product on fertility. Side-effects: Hypersensitivity, urticaria, asthma, hypogammaglobulinaemia, hypokalaemia, cachexia, abdominal pain, abdominal spasm, diarrhoea, gastrointestinal tract mucosal pigmentation, pruritus, local or generalised exanthema, finger clubbing, tetany, hypertrophic osteoarthropathy, chromaturia. Frequency unknown. In the treatment of chronic condition, under long-term treatment, additional adverse effects may occur. Chronic use may lead to disorders in water equilibrium and electrolyte metabolism and may result in albuminuria and haematuria. Marketing Authorisation: PL 00063/0129 Marketing Authorisation Holder: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom Supply classification: P Date of preparation: April 2020

Essential Information for Senokot Max Strength Tablets 12 Years Plus

Name and active substance: Senokot Max Strength Tablets 12 year plus. Each tablet contains powdered Alexandrian Senna fruit (pods) and Tinnevelly Senna fruit (pods) equivalent to 15mg hydroxyanthracene glycosides, calculated as sennoside B. Each tablet also contains 15.82 mg lactose monohydrate. Indication: For the short-term relief of occasional constipation. Dosage and administration: For oral use only. Adults, the elderly and children over 12 years: 1 tablet taken at night. Should not be used in children or adolescents under the age of 12 years. Not to be used for more than 1 week. Usually it is sufficient to take this medicinal product up to two to three times during that week. If the symptoms persist during the use of the medicinal product, a doctor or a pharmacist should be consulted. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Not to be used at the same time as other laxative agents. Cases of intestinal obstructions and stenosis, atony, appendicitis, inflammatory colon diseases (e.g Crohn’s disease, ulcerative colitis), abdominal pain of unknown origin, severe dehydration state with water and electrolyte depletion. Children and adolescents under 12 years of age. Warnings & Precautions If the symptoms worsen during the use of the medicinal product, or there is no bowel movement after three days, a doctor or pharmacist should be consulted. If laxatives are needed every day the cause of the constipation should be investigated. Long-term use of laxatives should be avoided. The product contains lactose monohydrate. One tablet contains 15.82mg lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Do not exceed the stated dose. Patients taking cardiac glycosides, antiarrhythmic medicinal products, medicinal products inducing QT-prolongation, diuretics, adrenocorticosteroids or liquorice root, have to consult a doctor before taking senna leaf preparation concomitantly. Like all laxatives, Senokot should not be taken by patients suffering from faecal impaction and undiagnosed, acute or persistent gastro-intestinal complaints, e.g. abdominal pain, nausea and vomiting, unless advised by a doctor, because these symptoms can be signs of potential or existing intestinal blockage (ileus). Long-term use of stimulant laxatives should be avoided, as use for more than a brief period of treatment may lead to impaired function of the intestine and dependence on laxatives. 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 use may precipitate the onset of an atonic, non-functioning colon. Prolonged excessive use may lead to fluid and electrolyte imbalance and hypokalaemia. Patients with kidney disorders should be aware of possible electrolyte imbalance. Intestinal loss of fluids may 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) Senokot should be discontinued and only be restarted under medical supervision. When products containing senna leaf preparations are administered to incontinent adults, pads should be changed more frequently to prevent extended skin contact with faeces. Stimulant laxatives (including Senokot) do not help with weight loss.

The leaflet will state:
“Before you take this medicine” section
Does this help with weight loss?

Stimulant laxatives (including Senokot) do not help with weight loss. They do not reduce the absorption of calories or nutrients. They can cause watery stools (diarrhoea), abdominal cramps and dehydration. Dehydration can seem like weight loss.

Overuse of laxatives may damage your health by:

• Causing disturbances of electrolyte and mineral balances. Sodium, potassium, magnesium, and phosphorus are electrolytes and minerals that are present in very specific amounts necessary for proper functioning of the nerves and muscles, including those of the colon and heart. Upsetting this delicate balance can cause incorrect functioning of these vital organs.
• Severe dehydration may cause tremors, weakness, blurry vision, fainting, kidney damage, and, in extreme cases, death. Dehydration often requires medical treatment.
• Overuse of laxatives can cause the colon to stop reacting to usual doses of laxatives so that larger and larger amounts of laxatives may be needed to produce bowel movements.
• Laxative dependency occurs from overuse.

The label will state:
Front of pack:

• Does not help with weight loss.
• Overuse can be harmful.

Fertility, pregnancy and Lactation: There are no reports of undesirable or damaging effects during pregnancy and on the foetus when used at the recommended dosage. However, as a consequence of experimental data concerning a genotoxic risk of several anthranoids, e.g emodin and aloe-emodin, use is not recommended in pregnancy. Use during breastfeeding is not recommended as there are insufficient data on the excretion of metabolites in breast milk. Small amounts of active metabolites (rhein) are excreted in breast milk. A laxative effect in breast fed babies has not been reported. There are no data on the effects of the product on fertility. Side-effects: Hypersensitivity, urticaria, asthma, hypogammaglobulinaemia, hypokalaemia, cachexia, abdominal pain, abdominal spasm, diarrhoea, gastrointestinal tract mucosal pigmentation, pruritus, local or generalised exanthema, finger clubbing, tetany and hypertrophic osteoarthropathy, chromaturia. Frequency unknown. Retail Price: 24s £4.99, 48s £8.79. Marketing Authorisation: PL 00063/0770 Marketing Authorisation Holder: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS United Kingdom Supply Classification: P Date of preparation: April 2020

Essential Information for Senokot Max Strength Tablets Adult

Name and active substance: Senokot Max Strength Tablets Adult. Each tablet contains powdered Alexandrian Senna fruit (pods) and Tinnevelly Senna fruit (pods) equivalent to 15mg hydroxyanthracene glycosides, calculated as sennoside B. Each tablet also contains 15.82 mg lactose monohydrate. Indication: For the short-term relief of occasional constipation. Dosage and administration: For oral use only. Adults, the elderly and children over 18 years: 1 tablet taken at night. Should not be used in children or adolescents under the age of 18 years. Not to be used for more than 1 week. Usually it is sufficient to take this medicinal product up to two to three times during that week. If the symptoms persist during the use of the medicinal product, a doctor or a pharmacist should be consulted. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Not to be used at the same time as other laxative agents. Cases of intestinal obstructions and stenosis, atony, appendicitis, inflammatory colon diseases (e.g Crohn’s disease, ulcerative colitis), abdominal pain of unknown origin, severe dehydration state with water and electrolyte depletion. Children and adolescents under 18 years of age. Warnings & precautions If the symptoms worsen during the use of the medicinal product, or there is no bowel movement after three days, a doctor or pharmacist should be consulted. The product contains lactose monohydrate. One tablet contains 15.82mg lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Do not exceed the stated dose. Patients taking cardiac glycosides, antiarrhythmic medicinal products, medicinal products inducing QT-prolongation, diuretics, adrenocorticosteroids or liquorice root, have to consult a doctor before taking senna leaf preparation concomitantly. Like all laxatives, Senokot should not be taken by patients suffering from faecal impaction and undiagnosed, acute or persistent gastro-intestinal complaints, e.g. abdominal pain, nausea and vomiting, unless advised by a doctor, because these symptoms can be signs of potential or existing intestinal blockage (ileus). Long-term use of stimulant laxatives should be avoided, as use for more than a brief period of treatment may lead to impaired function of the intestine and dependence on laxatives. 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 use may precipitate the onset of an atonic, non-functioning colon. Prolonged excessive use may lead to fluid and electrolyte imbalance and hypokalaemia. Patients with kidney disorders should be aware of possible electrolyte imbalance. Intestinal loss of fluids may 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) Senokot should be discontinued and only be restarted under medical supervision. When products containing senna/sennoside preparations are administered to incontinent adults, pads should be changed more frequently to prevent extended skin contact with faeces. Should not be used in children or adolescents under the age of 18 years. Stimulant laxatives (including Senokot) do not help with weight loss.

The leaflet will state:
“Before you take this medicine” section.
Does this help with weight loss?
Stimulant laxatives (including Senokot) do not help with weight loss. They do not reduce the absorption of calories or nutrients. They can cause watery stools (diarrhoea), abdominal cramps and dehydration. Dehydration can seem like weight loss. Overuse of laxatives may damage your health by:

• Causing disturbances of electrolyte and mineral balances. Sodium, potassium, magnesium, and phosphorus are electrolytes and minerals that are present in very specific amounts necessary for proper functioning of the nerves and muscles, including those of the colon and heart. Upsetting this delicate balance can cause incorrect functioning of these vital organs
• Severe dehydration may cause tremors, weakness, blurry vision, fainting, kidney damage, and, in extreme cases, death. Dehydration often requires medical treatment
• Overuse of laxatives can cause the colon to stop reacting to usual doses of laxatives so that larger and larger amounts of laxatives may be needed to produce bowel movements
• Laxative dependency occurs from overuse

The label will state:
Front of pack:

• Does not help with weight loss
• Overuse can be harmful

The following warnings must also be included:

• Do not take more medicine than the label tells you to
• If there is no bowel movement after 3 days, or if symptoms persist, in particular if you have persistent abdominal pain or are passing blood, consult your doctor

Fertility, pregnancy and lactation: There are no reports of undesirable or damaging effects during pregnancy and on the foetus when used at the recommended dosage. However, as a consequence of experimental data concerning a genotoxic risk of several anthranoids, e.g emodin and aloeemodin, use is not recommended in pregnancy. Use during breastfeeding is not recommended as there are insufficient data on the excretion of metabolites in breast milk. Small amounts of active metabolites (rhein) are excreted in breast milk. A laxative effect in breast fed babies has not been reported. There are no data on the effects of the product on fertility. Side-effects: Hypersensitivity, urticaria, asthma, hypogammaglobulinaemia, hypokalaemia, cachexia, abdominal pain, abdominal spasm, diarrhoea, gastrointestinal tract mucosal pigmentation, pruritus, local or generalised exanthema, finger clubbing, tetany and hypertrophic osteoarthropathy, chromaturia. Frequency unknown. Retail Price: 10s £2.99 Marketing Authorisation: PL 00063/0118 Marketing Authorisation Holder: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS United Kingdom Supply Classification: GSL Date of preparation: April 2020

Essential Information for Senokot 7.5 mg Tablets Adult

Name and active substances: Senokot 7.5 mg Tablets Adult. Each tablet contains powdered Alexandrian Senna fruit (pods) and Tinnevelly Senna fruit (pods) equivalent to 7.5mg hydroxyanthracene glycosides, calculated as sennoside B. Each tablet also contains 15.82 mg lactose monohydrate. Indications: For the short-term relief of occasional constipation. Dosage instructions: For oral administration. The correct individual dose is the smallest required to produce a comfortable soft-formed motion. Adults and the elderly: Swallow one to two tablets at night Should not be used in children or adolescents under the age of 18 years. New users should start with the lowest dose and increase it to the maximum dose if necessary. Once regularity has been regained dosage should be reduced and can usually be stopped. If no bowel action has occurred after three days of progressively increased dosage, a medical examination should be considered. Duration of use: Not to be used for more than 1 week. Usually it is sufficient to take this medicinal product up to two to three times during that week. If the symptoms persist during the use of the medicinal product, a doctor or a pharmacist should be consulted. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Not to be used at the same time as other laxative agents. Cases of intestinal obstructions and stenosis, atony, appendicitis, inflammatory bowel diseases (e.g Crohn’s disease, ulcerative colitis), abdominal pain of unknown origin, severe dehydration state with water and electrolyte depletion. Warnings & precautions: If the symptoms worsen during the use of the medicinal product or there is no bowel movement after three days, a doctor or pharmacist should be consulted. If laxatives are needed every day, or abdominal pain persists, a doctor should be consulted. If laxatives are needed every day the cause of the constipation should be investigated. Long-term use of laxatives should be avoided. The product contains lactose monohydrate. One tablet contains 15.82mg lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Do not exceed the stated dose. Patients taking cardiac glycosides, antiarrhythmic medicinal products, medicinal products inducing QT-prolongation, diuretics, adrenocorticosteroids or liquorice root, have to consult a doctor before taking senna leaf preparation concomitantly. Like all laxatives, Senokot should not be taken by patients suffering from faecal impaction and undiagnosed, acute or persistent gastro-intestinal complaints, e.g. abdominal pain, nausea and vomiting, unless advised by a doctor, because these symptoms can be signs of potential or existing intestinal blockage (ileus). Long-term use of stimulant laxatives should be avoided, as use for more than a brief period of treatment may lead to impaired function of the intestine and dependence on laxatives. 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 use may precipitate the onset of an atonic, non-functioning colon. Prolonged excessive use may lead to fluid and electrolyte imbalance and hypokalaemia. Patients with kidney disorders should be aware of possible electrolyte imbalance. Intestinal loss of fluids may 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) Senokot should be discontinued and only be restarted under medical supervision. When products containing senna/sennoside preparations are administered to incontinent adults, pads should be changed more frequently to prevent extended skin contact with faeces. Should not be used in children or adolescents under the age of 18 years. Stimulant laxatives (including Senokot) do not help with weight loss.

The leaflet will state:

“Before you take this medicine” section

Does this help with weight loss?
Stimulant laxatives (including Senokot) do not help with weight loss. They do not reduce the absorption of calories or nutrients. They can cause watery stools (diarrhoea), abdominal cramps and dehydration. Dehydration can seem like weight loss. Overuse of laxatives may damage your health by:

• Causing disturbances of electrolyte and mineral balances. Sodium, potassium, magnesium, and phosphorus are electrolytes and minerals that are present in very specific amounts necessary for proper functioning of the nerves and muscles, including those of the colon and heart. Upsetting this delicate balance can cause incorrect functioning of these vital organs
• Severe dehydration may cause tremors, weakness, blurry vision, fainting, kidney damage, and, in extreme cases, death. Dehydration often requires medical treatment
• Overuse of laxatives can cause the colon to stop reacting to usual doses of laxatives so that larger and larger amounts of laxatives may be needed to produce bowel movements
• Laxative dependency occurs from overuse

The label will state:
Front of pack:

• Does not help with weight loss
• Overuse can be harmful

The following warnings must also be included:

• Do not take more medicine than the label tells you to
• If there is no bowel movement after 3 days, or if symptoms persist, in particular if you have persistent abdominal pain or are passing blood, consult your doctor

Fertility, pregnancy and lactation: There are no reports of undesirable or damaging effects during pregnancy and on the foetus when used at the recommended dosage schedule. However, as a consequence of experimental data concerning a genotoxic risk of several anthranoids, e.g emodin and aloeemodin, use is not recommended during pregnancy.
Use during breastfeeding is not recommended as there are insufficient data on the excretion of metabolites in breast milk. Small amounts of active metabolites (rhein) are excreted in breast milk. A laxative effect in breast fed babies has not been reported. There are no data on the effects of the product on fertility.

Side-effects: Hypersensitivity, urticaria, asthma, hypogammaglobulinaemia, hypokalaemia, cachexia, abdominal pain, abdominal spasm, diarrhoea, gastrointestinal tract mucosal pigmentation, pruritus, local or generalised exanthema, chromaturia, finger clubbing, tetany and hypertrophic osteoarthropathy. Frequency unknkown. Retail price: 20s £2.49 Marketing authorisation: PL 00063/5000R Marketing authorisation holder: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS Supply classification: GSL Date of preparation: April 2020

Essential Information for Fybogel Hi-Fibre Orange/Lemon

Name and actives: Fybogel Hi-Fibre Orange, Fybogel Hi-Fibre Lemon. Each sachet contains 3.5g ispaghula husk BP. Indication: For the treatment of patients requiring a high fibre regimen: for example, for the relief of constipation, including constipation in pregnancy and the maintenance of regularity; for the management of bowel function in patients with haemorrhoids. Dosage and administration: Fybogel Hi-Fibre Orange/Lemon is intended for oral administration in a suspension in a drink of water. The granules should be stirred into a glass of water and taken as soon as possible, preferably after meals. Adults and children over 12 years: One sachet morning and evening. Elderly: There is no indication that dosage needs to be modified for the elderly. Children aged 6 to 12 years: Half to one level 5 ml spoonful depending on size and age, morning and evening. If there has been no bowel movement after three days of treatment the doctor should be consulted. Contraindications: Fybogel Hi-Fibre Orange/Lemon is contra-indicated in cases of intestinal obstruction, faecal impaction and colonic atony such as senile mega-colon. Warnings & precautions: Due to its aspartame content Fybogel Hi-Fibre Orange/Lemon should not be given to patients with phenylketonuria. If symptoms persist consult your doctor. Fybogel Hi-Fibre Orange/Lemon should not be given to patients with natural or drug induced failure of gut motility. Undesirable effects: A small amount of abdominal distension and flatulence may sometimes occur. MRRP: 10s £3.49, 30s £7.49. Product licence number: Fybogel Hi-Fibre Orange: PL 00063/0064 Fybogel Hi-Fibre Lemon: PL 00063/0150. Product Licence Holder: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS Legal category: GSL Date of preparation: 22/02/2010

Essential Information for Fybogel Mebeverine

Name and active: Fybogel Mebeverine, A sachet contains 3.5g ispaghula husk BP and 135mg mebeverine hydrochloride BP. Therapeutic indications: For the symptomatic relief of irritable bowel syndrome Posology and administration: Adults and children over 12: One sachet morning and evening, taken half an hour before meals. A third dose may be taken before the midday meal if necessary. Not recommended for Children below 12. The contents of one sachet should be stirred into a glass of cold water (150 ml minimum) and drunk immediately. The product should be taken during the day at least ½ to 1 hour before or after intake of other medicines. Contraindications: Hypersensitivity to ispaghula husk, mebeverine or to any of the excipients. Sudden change in bowel habit that has persisted more than two weeks. Undiagnosed rectal bleeding and failure to defecate following the use of a laxative. Patients suffering from abnormal constrictions in the gastro-intestinal tract, with diseases of the oesophagus and cardia, potential or existing intestinal blockage (ileus), paralysis of the intestine or megacolon. Difficulty in swallowing or any throat problems. Precautions and warnings: Not recommended in children below 12 years of age. Laxative bulk producers should be used before using other purgatives if change of nutrition is not successful. Fybogel Mebeverine should not be taken in the dry form and should always be taken mixed with fluid. Gastrointestinal obstruction or impaction have been reported with hydrophilic mucilloid preparations when taken with insufficient liquid. Ispaghula husk should not be used by patients with faecal impaction, abdominal pain, nausea and vomiting unless advised by a doctor. If abdominal pain occurs or in cases of any irregularity of faeces, the use of ispaghula husk should be discontinued and medical advice must be sought. When taken with inadequate fluid amounts, bulk forming agents can cause obstruction of the throat and oesophagus with choking and intestinal obstruction. Symptoms can be chest pain, vomiting, or difficulty in swallowing or breathing. Supervision required in the case of debilitated patients and / or elderly patients. Ispaghula husk should not be used together with medicinal products known to inhibit peristaltic movement. This product should not be taken immediately before going to bed. The product should not be given to patients with phenylketonuria. Consult your doctor if you have developed new symptoms, or if your symptoms worsen, or if they do not improve after two weeks of treatment. Warning on hypersensitivity reactions: In individuals with continued occupational contact to powder of Plantago ovata seeds (e.g. healthcare workers and caregivers) allergic sensitisation may occur due to inhalation. Product contains potassium (97.6mg/sachet), sodium (58.9mg/sachet) & aspartame which should be considered in patients on a controlled salt dies or reduced kidney function. Side effects: Immune system disorders: hypersensitivity disorders. Eye disorders: conjunctivitis; Respiratory, Thoracic and Mediastinal Disorders: Rhinitis; Gastrointestinal Disorders: Flatulence, abdominal distension, intestinal obstruction, oesophageal obstruction, faecal impaction; Skin and Subcutaneous Tissue Disorders: skin rash. Legal category: P. Product licence Numbers: PL 00063/0025. Licence Holder: Reckitt Benckiser Healthcare (UK) Limited HU8 7DS. Last revision of SmPC: July 2017. RRP: £8.89 Ten Sachets. For full information refer to: https://www.medicines.org.uk/emc/product/1099