COLOFAC Coated tablet (2016)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Colofac Tablets 135 mg.

2. Qualitative and quantitative composition

Mebeverine hydrochloride 135mg. Excipients with known effect: Lactose and Sucrose. For a full list of excipients, see section 6.1.

3. Pharmaceutical form

Coated tablets (Tablets). Round white sugar coated tablets, with no superficial markings.

4.1. Therapeutic indications

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. ...

4.2. Posology and method of administration

For oral use. The coated tablets should be swallowed with a sufficient amount of water (at least 100 ml water). They should not be chewed because of the unpleasant taste. Duration of use is not limited. ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients.

4.4. Special warnings and precautions for use

Since Mebeverine coated tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. ...

4.5. Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed, except with alcohol. In vitro and in vivo studies in animals have demonstrated the absence of any interaction between mebeverine hydrochloride ...

4.6. Fertility, pregnancy and lactation

Pregnancy There are no or limited amounts of data from the use of mebeverine in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Mebeverine is not ...

4.7. Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. The pharmacodynamic and pharmacokinetic profile as well as postmarketing experience do not indicate any harmful effect ...

4.8. Undesirable effects

The following adverse reactions have been reported spontaneously during postmarketing use. A precise frequency cannot be estimated from available data. Allergic reactions mainly but not exclusively limited ...

4.9. Overdose

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. Observed symptoms of ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Synthetic anticholinergics, esters with tertiary amino group ATC-Code: A03AA04 Mebeverine is a musculotropic antispasmodic with a direct action on the smooth muscle ...

5.2. Pharmacokinetic properties

Absorption Mebeverine is rapidly and completely absorbed after oral administration of tablets. Distribution No significant accumulation occurs after multiple doses. Biotransformation Mebeverine hydrochloride ...

5.3. Preclinical safety data

Effects in repeat-dose toxicity studies, after oral and parenteral doses, were indicative of central nervous involvement with behavioural excitation, mainly tremor and convulsions. In the dog, the most ...

6.1. List of excipients

Lactose Starch (potato) Povidone Talc Magnesium stearate Sucrose Gelatin Acacia Carnauba wax

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Do not store above 30°C. Store in the original package.

6.5. Nature and contents of container

Boxes containing 10, 15, 84 or 100 tablets in blister strips.

6.6. Special precautions for disposal and other handling

None.

7. Marketing authorization holder

Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

8. Marketing authorization number(s)

PL 46302/0021

9. Date of first authorization / renewal of the authorization

14 March 1978/21 April 2005

10. Date of revision of the text

26 August 2016

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