Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom
Adults and children over 10 years.
For the symptomatic relief of irritable bowel syndrome.
One capsule of 200 mg twice daily; one in the morning and one in the evening.
There are no safety risks for continued use up to a period of 1 year. However, once the desired effect is achieved after several weeks, the dose can be gradually reduced.
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.
Aurobeverine MR is not recommended for use in children aged under 10 years as the safety and effectiveness has not been established in this group.
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.
Aurobeverine MR 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 controlled release (see section 5.2).
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.
For blister packs: 36 months.
For HDPE container packs: 24 months.
In use shelf life for HDPE container packs: 3 months.
Blister Pack:
Do not store above 30°C. Do not refrigerate or freeze. Store in the original package in order to protect from moisture.
HDPE container pack:
Store below 25°C. Store in the original container in order to protect from light and moisture.
Blister pack: PVC/PVdC – Aluminium blisters in cartons.
Pack sizes of blister: 30 and 60 capsules.
HDPE container pack: HDPE bottles fitted with round white screw type continuous thread cap.
Pack sizes of HDPE container: 250 capsules.
Not all pack sizes may be marketed.
No special requirements for disposal.
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