COLOFAC IBS

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. If symptoms persist for more than 2 weeks, consult your doctor.

Warning:

Do not exceed the stated dose. Paediatric Population Mebeverine 135 mg 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.

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. uk/yellowcard.

Since Mebeverine 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. The coated tablets contain sucrose and should not be used by patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.

If this is the first time you have had these symptoms, consult your doctor before using any treatment. If any of the following apply, do not use mebeverine. It may not be the right treatment for you. See your doctor as soon as possible.

- you are aged 40 years or over - you have passed blood form the bowel - you are feeling sick or vomiting - you are looking pale and feeling tired - you are suffering from severe constipation - you have a fever - you have recently travelled abroad - you are or may be pregnant - you have abnormal vaginal bleeding or discharge - you have difficulty or pain passing urine Consult your doctor if you have developed new symptoms, or if your symptoms worsen, or if they do not improve after 2 weeks treatment.

Hypersensitivity to the active substance or to any of the excipients.