Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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SOVOLAX 5mg Tablets

⚠ This medicine appears to have been discontinued

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.

Active substance: Bisacodyl

Equivalent medicines (same active substance, strength and form)

and 1 more with the same active substance, strength and form

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for SOVOLAX is used for the short-term relief of occasional constipation. SOVOLAX contains bisacodyl and belongs 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.

  • Constipation is an occasional problem for some people. For others, it may happen more often
  • It happens when the normal muscle actions in the bowel (large intestine) slow down. This can mean that material is not easily eliminated from the body The cause of constipation is often not known. It can be associated with:
  • Sudden change of diet
  • A diet with not enough fibre
  • Not drinking enough fluids
  • Loss of 'tone' of the bowel muscles in older people
  • Pregnancy
  • Medicines such as morphine or codeine
  • Having to stay in bed for a long time
  • Lack of exercise

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Whatever the cause, constipation can be uncomfortable. It may make you feel bloated and heavy or generally "off colour". Sometimes it causes headaches. It is recommended to use changes in diet and bulk forming medicines to control constipation before using this medicine. These healthy tips are recommended to try to prevent constipation happening:

  • Eat a balanced diet including fresh fruit and vegetables
  • Drink enough water so that you do not become dehydrated
  • Keep up your exercise and stay fit
  • Make time to empty your bowels when your body tells you

What you need to know before you take it

e SOVOLAX Do not take SOVOLAX if you:

  • are allergic to bisacodyl (hypersensitive) or any of the other ingredients in the medicine (listed in Section 6).
  • are intolerant to or cannot digest some sugars (as the tablet contains a small amount of lactose monohydrate)
  • have severe dehydration
  • have a bowel condition called "ileus" (blockage in the intestine)
  • have a serious abdominal condition such as appendicitis
  • have severe abdominal pain with nausea and vomiting
  • have a blocked bowel (intestinal obstruction)
  • 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 18 years. If you are not sure, talk to your doctor or pharmacist before taking SOVOLAX. Warnings and precautions As with all laxatives, SOVOLAX should not be taken every day for more than five days. If you need laxatives every day, or if you have abdominal pain which does not go away, you should see your doctor. 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 SOVOLAX Please tell your pharmacist or doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is 2

because SOVOLAX can affect the way some other medicines work. Also, some other medicines can affect the way SOVOLAX works. In particular, tell your doctor or pharmacist if you are taking:

  • Water tablets (diuretics) such as bendrofluazide or furosemide (frusemide).
  • Steroid medicines such as prednisolone.
  • Other laxative medicines. If you are not sure if any of the above applies to you, talk to your pharmacist or doctor before taking SOVOLAX. Pregnancy and breast feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 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. SOVOLAX contains lactose monohydrate and tartrazine (E102) If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. SOVOLAX also contains tartrazine (E102), which may cause allergic reactions.

How to take it

SOVOLAX Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Dose for oral tablets For constipation: Adults (including the elderly) 1 to 2 tablets at night.

  • Swallow the tablets whole with water. Do not crush or chew the tablets.
  • Milk, antacids or proton-pump inhibitors (medicines which reduce stomach acid) should not be taken within one hour before or after taking SOVOLAX. This is because they will stop SOVOLAX from working properly. If you have not taken SOVOLAX before, start with one tablet and increase to two if necessary. When your bowel regularity has returned to normal, the dose can usually be stopped. 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 SOVOLAX than you should 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. It may be harmful to:
  • Take too many SOVOLAX tablets
  • Take SOVOLAX tablets for too long 3

This is because taking too much for too long may lead to:

  • A 'lazy bowel', where the muscle in the bowel becomes too relaxed. This means that bowel emptying happens less often. This can lead to long-term constipation.
  • 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 'hypo-kalaemia'). 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 forget to take your medicine If you forget to take your tablets, just take the next dose at the usual time, DO NOT take a double dose to make up for the forgotten dose. If you have any further questions on the use of this medicine, ask your pharmacist or doctor.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following side effects, please stop taking the medicine 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, pharmacist or nurse. 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. 4

How to store it

SOVOLAX Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister and on the carton. The expiry date refers to the last day of that month. Do not store above 25oC. Store in the original package in order to protect from moisture. 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.

Contents of the pack and other information

What SOVOLAX contains The active substance is bisacodyl. SOVOLAX 5 mg gastro-resistant tablets contain 5 mg of bisacodyl. The other ingredients are lactose monohydrate, maize starch, magnesium stearate, hypromellose, triacetin, talc, methacrylic acid and ethyl acrylate copolymer, triethyl citrate, titanium dioxide, colloidal anhydrous silica, sodium bicarbonate, sodium lauryl sulfate, macrogol and tartrazine (E102). What SOVOLAX looks like and contents of the pack SOVOLAX tablets are yellow coloured, circular, biconvex, film coated tablets plain on both sides. The tablets are supplied in blisters packed in cartons containing 10 and 20 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Sovereign Medical, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, UK Manufacturer Waymade Plc, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR, UK This leaflet was last revised in January 2026. PL 06464/2353 SOVOLAX 5 mg Tablets

To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the above address or telephone: 01268 535200 (select option Medical Information) / e-mail: [email protected]

5

Frequently asked questions about SOVOLAX 5mg Tablets

How do I take SOVOLAX 5mg Tablets?

SOVOLAX 5mg Tablets 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.

What is the active substance in SOVOLAX 5mg Tablets?

The active substance in SOVOLAX 5mg Tablets is bisacodyl.

Are there equivalent medicines to SOVOLAX 5mg Tablets?

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.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for SOVOLAX 5mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get SOVOLAX 5mg Tablets without a prescription?

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.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Bisacodyl (9 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

• For the short-term relief of occasional constipation.

4.2. Posology and method of administration

Posology

Adults (including the elderly): 1 to 2 coated tablets (5-10 mg) daily before bedtime.

• Should not be used in children or adolescents under the age of 18 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.

Method of administration

For oral use.

It is recommended to take the coated tablets at night to have a bowel movement the following morning. The tablets 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.

4.3. Contraindications

Bisacodyl is 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 is also contraindicated in severe dehydration and in patients with known hypersensitivity to bisacodyl or any other component of the product.

In case of rare 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.

4.4. Special warnings and precautions for use

i) 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.

ii) 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.

iii) Prolonged excessive use may lead to fluid and electrolyte imbalance and hypokalaemia.

iv) 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.

v) Stimulant laxatives (including bisacodyl) do not help in long-term weight loss.

vi) Patients may experience haematochezia (blood in stool) that is generally mild and self-limiting.

vii) 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.

Should not be used in children or adolescents under the age of 18 years.

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 labelling will state:

Front of pack:

• Does not help with weight loss.

• Overuse can be harmful.

This medicine contains lactose. Patients with rare hereditary problems of galactose or fructose intolerance, total lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Contains tartrazine (E102): May cause allergic reactions.

4.5. Interaction with other medicinal products and other forms of interaction

The concomitant use of antacids and milk containing products may reduce the resistance of the tablet coating 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.

4.6. Fertility, pregnancy and lactation

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.

Fertility

No studies on the effect on human fertility have been conducted.

4.7. Effects on ability to drive and use machines

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.

4.8. Undesirable effects

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 this medicine 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.

4.9. Overdose

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 about this leaflet

Ask anything about SOVOLAX 5mg Tablets. 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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