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 Mebeverine hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for This medicine is a capsule containing Mebeverine hydrochloride, which belongs to a group of medicines called antispasmodics. This medicine is used to treat the symptoms of irritable bowel syndrome (IBS). This is a very common condition which causes spasm and pain in the gut or intestine. The intestine is a long muscular tube which food passes down so it can be digested. If the intestine goes into spasm and squeezes too tightly, you get pain. The way this medicine works is by relieving the spasm, pain and other symptoms of IBS. The main symptoms of irritable bowel syndrome (IBS) include:
e Mebeverine Do not take Mebeverine:
Mebeverine Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any of these serious side effects, stop taking the capsules. See a doctor at once:
Mebeverine Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister pack. The expiry date refers to the last day of that month. Store Mebeverine in the original package. Store below 30°C. Return any unused capsules to a pharmacist. 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 Mebeverine contains The active substance is mebeverine hydrochloride. Each capsule contains 200mg of mebeverine hydrochloride in a modified release formulation. The other ingredients are: Capsule core Sugar spheres (sucrose, maize) Povidone Hypromellose Capsule Coating Ethyl cellulose N-45 Macrogol 6000 Magnesium stearate Capsule Shell Gelatin Titanium dioxide (E171) What Mebeverine looks like and the contents of the pack Mebeverine comes as creamy white hard capsules, filled with white to off white coloured spherical pellets. Packs may contain 10, 30 or 60 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Aspire Pharma Limited Unit 4, Rotherbrook Court, Bedford Road, Petersfield Hampshire, GU32 3QG, United Kingdom Alternative Manufacturer Wave Pharma Limited Ground Floor, Cavendish House, 369 Burnt Oak Broadway Edgware, HA8 5AW, United Kingdom This leaflet was last revised in 01/2023.
1010390-P3.1
Mebeverine 200mg modified release capsules comes as capsule containing 200mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Mebeverine 200mg modified release capsules is mebeverine hydrochloride.
This leaflet reproduces the patient information leaflet approved for Mebeverine 200mg modified release capsules, 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 symptomatic relief of irritable bowel syndrome.
Posology
One capsule of 200 mg twice daily, to be given one in the morning and one in the evening.
Paediatric Population
Mebeverine 200 mg modified release capsules are not recommended for use in children and adolescents below 18, due to insufficient data on safety and efficacy.
Duration of use is not limited.
If one or more doses are missed, the patient should continue with the next dose as prescribed; the missed dose(s) should not be taken in addition to the regular dose.
Special Population
No posology studies in elderly, renal and/or hepatic impaired patients have been performed. No specific risk for elderly, renal and/or hepatic impaired patients could be identified from available post-marketing data. No dosage adjustment is deemed necessary in elderly, renal and/or hepatic impaired patients.
Method of administration
Adults (including the elderly):
The capsules should be swallowed with a sufficient amount of water (at least 100 ml water). They should not be chewed because the coating is intended to ensure a prolonged release mechanism (see 5.2).
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltese insufficiency should not take this medicine.
No interaction studies have been performed, except with alcohol. In vitro and in vivo studies in animals have demonstrated the absence of any interaction between mebeverine hydrochloride and ethanol.
Pregnancy
There are no or limited amounts of data from the use of mebeverine in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Mebeverine is not recommended during pregnancy.
Breastfeeding
It is unknown whether mebeverine or its metabolites are excreted in human milk. The excretion of mebeverine in milk has not been studied in animals.
Mebeverine should not be used during breast-feeding.
Fertility
There are no clinical data on male or female fertility; however, animal studies do not indicate harmful effects of mebeverine (see section 5.3).
No studies on the effects on the ability to drive and use machines have been performed. The pharmacodynamic and pharmacokinetic profile as well as postmarketing experience do not indicate any harmful effect of mebeverine on the ability to drive or to use machines.
The following adverse reactions have been reported spontaneously during postmarketing use. A precise frequency cannot be estimated from available data.
Allergic reactions mainly but not exclusively limited to the skin have been observed.
Immune system disorders:
Hypersensitivity (anaphylactic reactions)
Skin and subcutaneous tissue disorders:
Urticaria, angioedema, face oedema, exanthema.
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.
Theoretically CNS excitability may occur in cases of overdose. In cases where mebeverine was taken in overdose, symptoms were either absent or mild and usually rapidly reversible. Observed symptoms of overdose were of a neurological and cardiovascular nature.
No specific antidote is known and symptomatic treatment is recommended.
Gastric lavage should only be considered in case of multiple intoxication or if discovered within about one hour. Absorption reducing measures are not necessary.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Mebeverine 200mg modified release capsules. 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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