Health is our business

Colofac 135 mg

Gastroenterology

Colofac 135 mg

Colofac 135 mg

coated tablets

135 mg mebeverine hydrochloride

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or pharmacist.

This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

QUALITATIVE AND QUANTITATIVE COMPOSITION

One coated tablet contains 135 mg mebeverine hydrochloride. Each Colofac 135 mg tablet contains 79 mg sucrose and 97 mg lactose monohydrate.

Excipients with a known effect: lactose monohydrate and sucrose.

For a full list of excipient, see “list of excipient”

PHARMACEUTICAL FORM

Round, shite sugar-coated tablet

CLINICAL PARTICLES

THERAPEUTIC INIDICATIOS

Adults and children over the age of 10 years.

Symptomatic treatment of abdominal pain and cramps, bowel disturbances and intestinal discomfort related to irritable bowel syndrome.

Treatment of gastro-intestinal spasm secondary to organ disease.

Posology and method of administration

For oral use.

The coated tablets must be taken with a sufficient quantity of water (at least 100 ml). They must not be chewed because of the unpleasant taste.

Adults and children over the age of 10 years

Three times daily 1 tablet of 135 mg, to be taken approximately 20 minutes before a meal.

There are no safety risks for a duration of use up to 1 year. However, when the desired effect has been achieved after a few weeks, the dose may be reduced gradually.

If one or more doses have not been taken, the patient must continue with the next dose as prescribed; the missed dose should not be taken on top of the usual dose.

Pediatric population

Colofac 135 mg should not be used in children below the age of 10 years because the safety and efficacy have not been established in this target group.

Elderly patients and patients with kidney and/or liver disorders No dose studies have been performed in elderly patients and patients with kidney and/or liver disorders.

Contraindication

Hypersensitivity to mebeverine or one of excipients.

Special warnings and precautions for use

Because Colofac 135 mg coated tablets contain lactose, patients with rare hereditary disorders, such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, should not use this medicinal product.

Because Colofac 135 mg coated tablets contain sucrose, patients with rare hereditary disorders, such as fructose intolerance, glucose-galactose malabsorption or sucrose- isomaltase insufficiency, should not use this medicinal product.

Interactions with other medicinal products and other forms of interactions

As far as known, mebeverine has no interactions with other medicinal products.

Fertility, pregnancy and lactation

Pregnancy

There are no or limited amount of data from the use of mebeverine in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. The use of Colofac 135 mg is not recommended during pregnancy.

Lactation

It is unknown whether mebeverine or one of its metabolites     is excreted in human milk. Excretion of mebeverine in breast milk has not been investigated in animals. Colofac 135 mg should not be used during breast-feeding.

Fertility

No clinical data are available on the fertility in men or women; however, animal studies do not indicate damaging effects from Colofac 135 mg.

Effects on ability to drive and use machines

No studies have been carried out into the effect on the ability to drive and use machines. Neither the pharmacodynamics and pharmacokinetic profiles, nor the post-marketing experience indicate an adverse effect of mebeverine on the ability to drive and use machines.

Undesirable effects

The following undesirable effects have been reported spontaneously during post-marketing use.  No exact frequency can be determined from the available data.

The observed allergic reactions are mainly, but not exclusively, limited to the skin.

 

Skin and subcutaneous tissue disorders: Urticaria, angioedema, facial edema, exanthema

Immune system disorders: Hypersensitivity (anaphylactic reactions)

Report of suspected undesirable effects

It is important to report suspected undesirable effects after approval of the medicinal product. In this way the relationship between benefits and risks of the medicinal product can be constantly monitored.

Overdose

Symptoms

Very little is reported in the literature about symptoms after mebeverine overdose. In cases of mebeverine overdose, the symptoms were either absent or mild and usually quickly reversible. Observed overdose symptoms are of a neurological nature.

Treatment

There is no known specific antidote; symptomatic treatment is recommended. Measures to decrease absorption are not necessary.

 

PHARMACEUTICAL PARTICULARS

List of excipients

Tablet core: lactose monohydrate, starch, povidone, talc and magnesium stearate.

Tablet coating: talc, sucrose, gelatin, acacia and carnauba wax.

Incompatibilities

Not applicable.

Shelf life

5 years.

Special precautions for storage

Do not store above 30°C. Do not freeze.

Store in the original packaging.

Nature and contents of container

Colofac 135 mg coated tablets are supplied in packages containing 9, 10, 20, 30, 50, 60, 90, 100, 250, 500, 1000 tablets per pack (not all pack sizes may be marketed).

The blisters are made of PVC with aluminum lidding foil.

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Manufactured by

Mylan Laboratories SAS

01400 Carillon-sur-Chalaronne - FRANCE

For:

Abbott Healthcare Products B.V. The Netherlands

DATE OF REVISION OF THE TEXT

8 June 2015.

THIS MEDICATION

Is a product which affects your health and its use contrary to instructions is dangerous to you.

Strictly follow the doctor’s prescription, the method of use and the instructions of the pharmacist who sold you the medication.

- The doctor and the pharmacist are the experts in medicines, their benefits and risks.

- Do not interrupt the period of treatment prescribed.

- Do not repeat the same prescription without first consulting your doctor.

- Keep all medications out of reach of children. Council of Arab Health Ministers,

Union of Arab Pharmacists.