Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Bisacodyl may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for
Bisacodyl 5mg Laxative Tablets 12+ years are used for the short-term relief of occasional constipation. Bisacodyl 5mg Laxative Tablets 12+ years contain bisacodyl and belong to a group of medicines known as stimulant laxatives, which increase bowel movements. This medicine does not help with weight loss. What is constipation? Normal and regular bowel movement is important for most people. However, what is "normal and regular" varies from person to person. Some may have a bowel movement every day, others less often. Whatever it is like for you, it is best that your bowel movement has a regular pattern.
e Bisacodyl 5mg Laxative Tablets 12+ years Do not take Bisacodyl 5mg Laxative Tablets 12+ years if: • • • • • • • •
You are allergic (hypersensitive) to bisacodyl or any of the other ingredients in the product (listed in Section 6: Contents of the pack and other information) You are intolerant to or cannot digest some sugars (as the tablet contains a small amount of lactose and sucrose) You have severe dehydration You have a bowel condition called "ileus" (blockage in the intestine) You have a serious abdominal condition such as appendicitis You have severe abdominal pain with nausea and vomiting You have a blocked bowel (intestinal obstruction) You have inflammation of the bowel (small or large intestine)
Do not take this medicine if any of the above applies to you. Do not use in children under the age of 12 years. If you are not sure talk to your pharmacist or doctor before taking this medicine. Does this help with weight loss? Stimulant laxatives (including bisacodyl) 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 must be avoided as it may harm the intestinal function.
Other medicines and Bisacodyl 5mg Laxative Tablets 12+ years
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Bisacodyl 5mg Laxative Tablets 12+ years can affect the way some other medicines work. Also, some other medicines can affect the way Bisacodyl 5mg Laxative Tablets 12+ years work.
In particular, tell your doctor or pharmacist if you are taking:
Pregnancy and breast feeding
Talk to your pharmacist or doctor before taking Bisacodyl 5mg Laxative Tablets 12+ years ifyou are pregnant, planning to become pregnant or are breast feeding.
Driving and using machines
Some people may feel dizzy or faint while taking this medicine. If this happens to you, wait until these feelings go away before driving or using machines.
Bisacodyl 5mg Laxative Tablets 12+ years contain lactose and sucrose
The tablets contain a small amount of lactose and sucrose in each tablet. Patients with rare hereditary problems of fructose intolerance, galactose intolerance, total lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not use this medicine. If you have an intolerance to some sugars, contact your doctor before taking this medicine.
Bisacodyl 5mg Laxative Tablets 12+ years Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your pharmacist if you are not sure. For constipation: Adults (including the elderly) and children over 12 years: 1 to 2 tablets at night.
Length of treatment These tablets should not be used every day for more than 5 days. If you need laxatives every day, then you should see your doctor to find the cause of your constipation. Overuse can be harmful. If you take more Bisacodyl 5 mg Laxative Tablets 12+ years than you should It may be harmful to:
Imbalance of fluid and salts in the body. This can affect the tightness of muscles such as those in the bowel. It can also affect the salts in the blood. Low levels of potassium in the blood (called 'hypokalaemia'). This can make you tired, dizzy, make your muscles weak and cause an uneven heart-beat. Dehydration, making you thirsty, feel faint and giving you headaches. It can also mean you cannot pass enough urine.
If you take more of this medicine than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you; this is so the doctor knows what you have taken. If you have any questions on the use of this product, ask your pharmacist or doctor.
Like all medicines, Bisacodyl 5mg Laxative Tablets 12+ years can cause side effects, although not everybody gets them. If you experience any of the following side effects, please stop taking the medicines and see your doctor straight away:
Rare side effects (affect less than 1 in 1000 people) •
• •
Severe allergic reactions which may cause swelling of the face or throat and difficulty in breathing or dizziness. If you have a severe allergic reaction, stop taking this medicine and see a doctor straight away. Colitis (inflammation of the large intestine which causes abdominal pain and diarrhoea) Dehydration
• •
Allergic reactions which may cause a skin rash Fainting
Uncommon side effects (affect less than 1 in 100 people) • • • • •
Blood in the stools Vomiting Abdominal discomfort Discomfort inside and around the back passage Dizziness
Common side effects (affect less than 1 in 10 people) • • •
Abdominal cramps or pain Diarrhoea Nausea
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Bisacodyl 5mg Laxative Tablets 12+ years • • • • •
Keep this medicine out of the sight and reach of children Do not take Bisacodyl 5mg Laxative Tablets 12+ years after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month Do not store above 25°C Keep the blister within the outer carton Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Bisacodyl 5mg Laxative 12+ years Tablets contain
The active ingredient (the ingredient which makes this medicine work) is Bisacodyl. Each tablet contains 5mg of Bisacodyl. The tablets also contain: lactose, maize starch, cellulose acetate phthalate, diethyl phthalate, sucrose, povidone, magnesium stearate, pregelatinised maize starch, talc, E171 (titanium dioxide) and E104 (quinoline yellow).
What your tablets look like and the contents of the pack
Bisacodyl 5mg Laxative Tablets 12+ years are round, yellow, sugar-coated tablets. They are packed in cartons containing blister strips of 8, 10, 20, 28, 30, 40, 50, 56, 60, 84 or 100 tablets Not all pack sizes may be marketed. If you want to know more about your medicine, ask your doctor or pharmacist who can give you more information.
Marketing authorisation holder and manufacturer
Dr. Reddy's Laboratories (UK) Ltd. 410 Cambridge Science Park, Milton Road Cambridge, CB4 0PE, United Kingdom
This leaflet was revised in February 2024
Bisacodyl 5 mg Laxative Tablets 12+ years PL 08553/0200 ©Dr. Reddy's Laboratories (UK) Ltd
Bisacodyl 5mg Laxative Tablets 12+ years comes as tablet containing 5mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Bisacodyl 5mg Laxative Tablets 12+ years is bisacodyl.
Medicines with the same active substance, strength and form include: Bisalax Constipation Relief 5mg Tablets Adult, Boots Constipation Relief 5mg Tablets Adult, Dulcolax Adult 5 mg Gastro-resistant Tablets (GSL). In total there are 6 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Bisacodyl 5mg Laxative Tablets 12+ years, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
For the short-term relief of occasional constipation.
Adults and children over 12 years:
1 to 2 coated tablets (5 - 10 mg) daily before bedtime. Should not be used in children and adolescents under the age of 12 years.
It is recommended to start with the lowest dose. The dose may be adjusted up to the maximum recommended dose to produce regular stools.
The maximum daily dose should not be exceeded.
In the management of constipation, once regularity has been restarted dosage should be reduced and can usually be stopped.
Instructions for use
It is recommended to take the coated tablets at night to have a bowel movement the following morning.
They should be swallowed whole with an adequate amount of fluid.
The coated tablets should not be taken together with products which reduce the acidity of the upper gastrointestinal tract, such as milk, antacids or proton pump inhibitors, in order not to prematurely dissolve the enteric coating.
No specific information on the use of this product in the elderly is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported.
Bisacodyl Laxative Tablets are contraindicated in patients with ileus, intestinal obstruction, acute abdominal conditions including appendicitis, acute inflammatory bowel diseases, and severe abdominal pain associated with nausea and vomiting which may be indicative of the aforementioned severe conditions.
Bisacodyl Laxative Tablets are also contraindicated in severe dehydration and in patients with Known hypersensitivity to bisacodyl or any other component of the product.
In case of hereditary conditions that may be incompatible with an excipient of the product (please refer to “Special warnings and special precautions for use”) the use of the product is contraindicated.
Should not be used in children and adolescents under the age of 12 years.
As with all laxatives, bisacodyl should not 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. 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 fluid and 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) bisacodyl should be discontinued and only be restarted under medical supervision.
Stimulant laxatives (including bisacodyl) do not help with weight loss (see section 5.1 Pharmacodynamic properties).
Patients may experience haematochezia (blood in stool) that is generally mild and self-limiting.
If the symptoms worsen during the use of the medicinal product, a doctor or pharmacist should be consulted.
Dizziness and / or syncope have been reported in patients who have taken Bisacodyl. The details available for these cases suggest that the events would be consistent with defaecation syncope (or syncope attributable to straining at stool), or with a vasovagal response to abdominal pain related to the constipation, and not necessarily to the administration of bisacodyl itself.
There have been isolated reports of abdominal pain and bloody diarrhoea occurring after taking bisacodyl. Some cases have been shown to be associated with colonic mucosal ischaemia.
Bisacodyl Laxative Tablets contain a small amount of lactose and sucrose in each tablet. 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.
The leaflet will state:
“Before you take this medicine” section
Does this help with weight loss?
Stimulant laxatives (including bisacodyl) 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 must be avoided as it may harm the intestinal function.
The label will state:
Front of pack:
• Does not help with weight loss.
• Overuse can be harmful.
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 Bisacodyl 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 Bisacodyl.
Fertility
No studies on the effect on human fertility have been conducted.
Pregnancy
There are no adequate and well-controlled studies in pregnant women. Long experience has shown no evidence of undesirable or damaging effects during pregnancy.
Lactation
Clinical data show that neither the active moiety of bisacodyl (BHPM or bis-(p-hydroxyphenyl)-pyridyl-2-methane) nor its glucuronides are excreted into the milk of healthy lactating females.
Nevertheless, as with all medicines, bisacodyl should not be taken in pregnancy, especially the first trimester, and during breast feeding unless the expected benefit is thought to outweigh any possible risk and only on medical advice.
No studies on the effects of Bisacodyl on the ability to drive and use machines have been performed.
However, patients should be advised that due to a vasovagal response (e.g. to abdominal spasm) they may experience dizziness and / or syncope. If patients experience abdominal spasm they should avoid potentially hazardous tasks such as driving or operating machinery.
The most commonly reported adverse reactions during treatment are abdominal pain and diarrhoea.
Adverse events have been ranked under headings of frequency using the following convention: Very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10000, <1/1000); very rare (<1/10000).
Immune system disorders
Rare: anaphylactic reactions, angioedema, hypersensitivity.
Metabolism and nutrition disorders
Rare: dehydration.
Nervous system disorders
Uncommon: dizziness.
Rare: Syncope.
Dizziness and syncope occurring after taking bisacodyl appear to be consistent with a vasovagal response (e.g. to abdominal spasm, defaecation).
Gastrointestinal disorders
Uncommon: haematochezia (blood in stool), vomiting, abdominal discomfort, anorectal discomfort.
Common: abdominal cramps, abdominal pain, diarrhoea and nausea.
Rare: colitis including ischaemic colitis.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
Symptoms: If high doses are taken watery stools (diarrhoea), abdominal cramps and a clinically significant loss of fluid, potassium and other electrolytes can occur.
Laxatives when taken in chronic overdose may cause chronic diarrhoea, abdominal pain, hypokalaemia, secondary hyperaldosteronism and renal calculi. Renal tubular damage, metabolic alkalosis and muscle weakness secondary to hypokalaemia have also been described in association with chronic laxative abuse.
Therapy: After ingestion of oral forms of Bisacodyl, absorption can be minimised or prevented by inducing vomiting or gastric lavage. Replacement of fluids and correction of electrolyte imbalance may be required. This is especially important in the elderly and the young. Administration of antispasmodics may be of value.
Ask anything about Bisacodyl 5mg Laxative Tablets 12+ years. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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