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 contains mebeverine hydrochloride which belongs to a group of medicines called antispasmodics. This medicine is used to treat symptoms of irritable bowel syndrome (IBS) and similar problems such as chronic irritable colon, spastic constipation, mucous colitis and spastic colitis. Irritable bowel syndrome (IBS) 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 this medicine Do not take this medicine if:
Warnings and precautions Talk to your doctor or pharmacist before taking this medicine:
this medicine Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
If you take more of this medicine than you should If you or someone else takes too much of this medicine (an overdose), talk to a doctor or go to a hospital straight away. Take the medicine pack with you. If you forget to take this medicine If you miss a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking this medicine Do not stop taking this medicine without talking to your doctor, even if you feel better. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4 Possible side effects 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 this medicine. See a doctor at once:
you can help provide more information on the safety of this medicine.
What this medicine looks like and contents of the pack Mebeverine hydrochloride 135mg film-coated tablets are white coloured, round shaped, biconvex film-coated tablets and plain on both sides. Packs may contain 10, 15, 84 or 100 film-coated tablets. 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.
this medicine
stated on the carton and blister pack after EXP. The expiry date refers to the last day of that month.
What this medicine contains The active substance is mebeverine hydrochloride. Each tablet contains 135mg of mebeverine hydrochloride. The other ingredients are: Core tablet Microcrystalline cellulose, lactose monohydrate, sodium starch glycolate type A, povidone, magnesium stearate, talc. Film coating Opadry white (ingredients: hypromellose (E464), titanium dioxide (E171), polyethylene glycol/macrogol and talc).
DRUGS/TS/23/2007
1010408-P3.1
Mebeverine hydrochloride 135mg film-coated tablets comes as tablet containing 135mg. 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 hydrochloride 135mg film-coated tablets is mebeverine hydrochloride.
Medicines with the same active substance, strength and form include: Boots IBS Symptom Relief 135mg Tablets, Mebeverine 135mg film-coated tablets, Mebeverine hydrochloride 135 mg Film-coated Tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Mebeverine hydrochloride 135mg film-coated tablets, 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 treatment of irritable bowel syndrome and other conditions usually included in this grouping, such as: chronic irritable colon, spastic constipation, mucous colitis, spastic colitis. The medicine is effectively used to treat the symptoms of these conditions, such as: colicky abdominal pain and cramps, persistent, non-specific diarrhoea (with or without alternating constipation) and flatulence.
For oral use.
The coated tablets should be swallowed with a sufficient amount of water (at least 100 ml water). They should not be chewed because of the unpleasant taste.
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.
Adults (including the elderly):
One tablet three times a day, preferably 20 minutes before meals. After a period of several weeks, when the desired effect has been obtained, the dosage may be gradually reduced.
Paediatric Population
Mebeverine 135 mg film-coated tablets are not recommended for use in children and adolescents below 18, due to insufficient data on safety and efficacy.
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.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Since Mebeverine film-coated tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
Ask anything about Mebeverine hydrochloride 135mg film-coated 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.
We use essential cookies to make the site work. We would also like to set optional cookies to understand how the site is used, so we can improve it. We will not set optional cookies unless you accept. See our cookie policy and privacy policy.