Colofac

1. Name Of The Medicinal Product

Colofac^® MR

Colofac^® Tablets 135 mg

Colofac^® Liquid

2. Qualitative And Quantitative Composition

Capsules: mebeverine hydrochloride 200 mg.

Tablets: mebeverine hydrochloride 135mg.

Liquid: mebeverine pamoate equivalent to 50 mg mebeverine hydrochloride per 5 ml.

3. Pharmaceutical Form

Capsules: White, opaque, modified release capsule imprinted '

Tablets: Round white sugar coated tablets, with no superficial markings.

Liquid: A yellow, banana flavoured, sugar free suspension.

4. Clinical Particulars

4.1 Therapeutic Indications

Colofac MR – For the symptomatic relief of irritable bowel syndrome.

Colofac Tablets 135 mg, Colofac Liquid – For the symptomatic treatment of irritable bowel syndrome and other conditions usually included in this grouping, such as: chronic irritable colon, spastic constipation, mucous colitis, spastic colitis. Colofac is effectively used to treat the symptoms of these conditions, such as: colicky abdominal pain and cramps, persistent, non-specific diarrhoea (with or without alternating constipation) and flatulence.

4.2 Posology And Method Of Administration

Colofac MR– Adults (including the elderly): One capsule twice a day, preferably 20 minutes before meals.

Colofac Tablets 135 mg - Adults (including the elderly) and children 10 years and over: 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.

Colofac Liquid –Adults (including the elderly) and children 10 years and over: 15 ml (150 mg) 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: Not recommended.

4.3 Contraindications

Paralytic ileus. Hypersensitivity to any of the components of the product.

4.4 Special Warnings And Precautions For Use

Porphyria.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Pregnancy: Animal experiments have failed to show any teratogenic effects. However, the usual precautions concerning the administration of any drug during pregnancy should be observed.

Lactation: Mebeverine is not excreted in the milk of lactating women after therapeutic doses.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

In very rare cases allergic reactions have been reported, in particular erythematous rash, urticaria and angioedema.

4.9 Overdose

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.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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

5.2 Pharmacokinetic Properties

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.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Colofac MR: Magnesium stearate, copolymer of ethyl acrylate and methyl methacrylate, talc, methylhydroxypropylcellulose, methacrylic acid-ethyl acrylate copolymer (1:1) and glycerol triacetate.

Capsule shell: gelatin and titanium dioxide (E171).

Printing inks: shellac (E904), black iron oxide (E172), soya lecithin (E322) and Antifoam DC.

Colofac Tablets 135 mg – Lactose, starch (potato or maize), povidone (K25), talc, magnesium stearate, sucrose, gelatin, acacia, carnauba wax.

Colofac Liquid – Microcrystalline cellulose, carboxymethylcellulose sodium, citric acid monohydrate, sodium citrate, polysorbate 20, polyoxyl 40 hydrogenated castor oil, disodium pamoate monohydrate, sodium benzoate, saccharin sodium, banana flavour, simethicone emulsion, purified water. The sodium content is 20.5 mg/5 ml.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Capsules – 3 years when stored in the original container.

Tablets and Liquid – 5 years

6.4 Special Precautions For Storage

Capsules – Do not store above 25°C. Do not refrigerate or freeze. Store in the original package.

Tablets and Liquid – Do not store above 30°C. Store in the original package.

6.5 Nature And Contents Of Container

Colofac MR – Boxes containing 10 or 60 capsules in PVC-Al press through strips.

Colofac Tablets 135 mg – Boxes contain 100 tablets in blister strips.

Colofac Liquid – Amber glass bottle with polyethylene tamper evident cap. Each bottle contains 300 ml.

6.6 Special Precautions For Disposal And Other Handling

Tablets – None.

Colofac Liquid – Shake well before use. Dilution and subsequent storage not recommended. Mebeverine does not produce false positive reactions in standard diagnostic urine tests.

7. Marketing Authorisation Holder

Solvay Healthcare Ltd

Mansbridge Road

West End

Southampton

SO18 3JD

8. Marketing Authorisation Number(S)

Colofac MR – PL 00512/0155

Colofac Tablets 135 mg – PL 00512/0044

Colofac Liquid – PL 00512/0061

9. Date Of First Authorisation/Renewal Of The Authorisation

Colofac MR – 14 August 1998

Colofac Tablets 135 mg – March 1999

Colofac Liquid – 21 May 1997

10. Date Of Revision Of The Text

September 2000

Legal Category

POM