MEBEVERINE

Posology 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 years, 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.

Method of administration For oral use. The film-coated tablets should be swallowed with a sufficient amount of water (at least 100 ml water). Tablets should not be chewed because of the unpleasant taste.

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 reported.

Immune system disorders:

Hypersensitivity (anaphylactic reactions) Skin and subcutaneous tissue disorders: Urticaria, angioedema, face oedema and 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

If this is the first time you have had these symptoms talk to your doctor before using this medicine. This is to make sure it is suitable for you. Do not use this medicine without talking to your doctor if you: - are over 40 years of age - have passed blood in your stools or motions - are feeling sick or being sick - have lost your appetite or lost weight - look pale and feel tired - are very constipated - have a fever - have recently travelled abroad - are or may be pregnant - have abnormal vaginal bleeding or discharge - have difficulty or pain passing water Talk to your doctor if you get new symptoms, your symptoms get worse or if they do not improve after 2 weeks of treatment.

Excipients:

Mebeverine contains lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Mebeverine contains sodium This medicine contains less than 1 mmol sodium (23 mg) per each hard capsule, that is to say essentially ‘sodium-free’.

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