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ETC / RX - Alimentary system drugs - Opeverin

COMPOSITION:

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.


PHARMACODYNAMICS:

Mebeverine hydrochloride is an antispasmodic with a direct action on the smooth muscle of the gastrointestinal tract.


PHARMACOKINETICS:

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.


INDICATIONS:

  • 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.

CONTRAINDICATIONS:

  • 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.

SIDE EFFECTS:

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.


INTERACTIONS:

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.

PRESENTATION:

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.