Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom
For the symptomatic relief of irritable bowel syndrome.
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).
One capsule of 200 mg twice daily, to be given one in the morning and one in the evening.
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.
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.
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.
3 years when stored in the original container.
Do not store above 30°C.
Do not refrigerate or freeze.
Store in the original package.
Boxes containing 10 or 60 capsules in PVC-Al press through strips.
None.
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