ETC / RX - Alimentary system drugs - Opeverin
Each film coated tablet contains:
- Active ingredient: Mebeverine HCl 135 mg
- Excipients: Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone, talc, magnesium stearate, opadry II white.
DESCRIPTION OF PRODUCT:
Ivory-white film coated tablet.
Mebeverine hydrochloride is an antispasmodic with a direct action on the smooth muscle of the gastrointestinal tract.
Mebeverine is rapidly absorbed after oral doses with peak plasma concentrations occurring in 1 to 3 hours. It is 75% bound to albumin in plasma. Mebeverine is completely metabolised by hydrolysis to veratric acid and mebeverine alcohol. The metabolites are excreted in the urine.
- Symptomatic treatment of irritable bowel syndrome and other conditions including chronic irritable colon, spastic constipation, mucous colitis, spastic colitis with the symptoms such as: colicky abdominal pain and cramps, persistent, non-specific diarrhoea (with or without alternating constipation) and flatulence.
- Treatment of gastrointestinal spasm secondary to organic diseases.
ADMINISTRATION AND DOSAGE:
- Adults and children over 10 years of age: 1 tablet x 3 times a day, preferably 20 minutes before meals.
- Swalow with water, do not chew.
- Hypersensitivity to any ingredient of drug.
WARNINGS AND PRECAUTIONS:
- Use in children: mebeverine is not recommended in children under 10 years.
- Pregnancy and Lactation: Mebeverine is not recommended during pregnancy and breast-feeding.
- Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.
Generally mebeverine is well tolerated. Few side-effects like skin rash, urticaria and angioedema may appear.
In case of an unexpected reaction, consult your physician.
No interaction studies have been performed.
OVERDOSE AND TREATMENT:
- Symptoms: 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.
- Treatment: No specific antidote is known and symptomatic treatment is recommended.
Box of 5 blisters x 10 film coated tablets
Storage: Store at temperature below 300C, in a dry place, protect from light.
Shelf-life: 36 months from manufacturing date. Do not use after expiry date.