Abbott Healthcare Products Limited

Colofac 135 mg tablets

Mebeverine Hydrochloride 135 mg.

Excipients: also includes Lactose monohydrate 97.0 mg per tablet and Sucrose 79.0 mg per tablet.

For a full list of excipients, see section 6.1

Coated tablet.

White, circular, sugar coated tablet.

For use in the management of irritable bowel syndrome, (particularly gastrointestinal spasm).

Adults and children over 10 years:

One tablet three times a day preferably 20 minutes before meals.

After a period of several weeks when the desired effect has been obtained, the dosage may be gradually reduced.

Children and Infants:

Not recommended.

Use in patients with a known hypersensitivity to mebeverine.

Prior to treating patients with mebeverine, care should be taken to exclude organic disease of the bowel, particularly malignancy.

Patients with rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

None known.

Although studies in animals have not shown any teratogenic effect which can be definitely attributed to mebeverine, the safety of Colofac in human pregnancy has not been established. On basic principles therefore, its use is not recommended.

None known.

Very rarely hypersensitivity reactions may occur, in particular, urticaria, angioedema, face oedema and exanthema/rash.

On theoretical grounds, it may be predicted that CNS excitability will occur in cases of overdosage. No specific antidote is known; gastric lavage and symptomatic treatment is recommended.

Mebeverine is an antispasmodic with a direct action on the smooth muscle of the gastrointestinal tract, relieving spasm without affecting normal gut motility.

Mebeverine is rapidly and completely absorbed after oral administration in the form of tablets or suspension. Mebeverine is not excreted as such, but metabolised completely. The first step in the metabolism is hydrolysis, leading to veratric acid and mebeverine alcohol. Both veratric acid and mebeverine alcohol are excreted into the urine, the latter partly as the corresponding carboxylic acid and partly as the demethylated carboxylic acid.

None stated.

Lactose monohydrate

Starch (potato or maize)

Povidone

Talc

Magnesium stearate

Sucrose

Gelatin

Acacia

Carnauba wax

Not applicable.

5 years.

Do not store above 30°C.

Store in the original package.

AL/PVC blisters in boxes containing 4 (physician's sample) or 100 tablets.

No special requirements

Abbott Healthcare products Limited

Mansbridge Road

West End

Southampton

SO18 3JD

United Kingdom

PA 108/14/1

Date of first authorisation: 07 February 1983

Date of last renewal: 07 February 2008

February 2011