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Colofac 200mg

Gastroenterology

Colofac 200mg

Colofac

MR 200 mg Modified Release Capsules

Name of the medicinal product

Colofac® MR. Modified release capsule.

Qualitative and quantitative composition

Mebeverine hydrochloride 200 mg.

For excipients, see section 6.1

Pharmaceutical form

Modified release capsule.

White, opaque, modified release capsule imprinted with “245”

Clinical particulars

Therapeutic indications

For the symptomatic relief of irritable bowel syndrome.

Posology and method of administration

Adults (including the elderly):

The capsules should be swallowed with a sufficient amount of water (at least 100 ml water). They should not be chewed because the coating is intended to ensure a prolonged release mechanism (see 5.2).

One capsule of 200 mg twice daily, to be given one in the morning and one in the evening.

Pediatric Population

Mebeverine 200 mg modified release capsules are not recommended for use in children and adolescents below 18, due to insufficient data on safety and efficacy.

Duration of use is not limited.

If one or more doses are missed, the patient should continue with the next dose as prescribed; the missed dose(s) should not be taken in addition to the regular dose.

Special Population

No posology studies in elderly, renal and/or hepatic impaired patients have been performed. No specific risk for elderly, renal and/or hepatic impaired patients could be identified from available post-marketing data. No dosage adjustment is deemed necessary in elderly, renal and/or hepatic impaired patients.

Contraindications

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

Special warnings and precautions for use

None

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 and ethanol.

Pregnancy and lactation

Pregnancy

There are no or limited amounts of data from the use of mebeverine in pregnant women. mebeverine is not recommended during pregnancy.

Lactation

It is unknown whether mebeverine or its metabolites are excreted in human milk. The excretion of mebeverine in milk has not been studied in animals. Mebeverine should not be used during breast-feeding.

Fertility

There are no clinical data on male or female fertility; however, animal studies do not indicate harmful effects of mebeverine (see section 5.3).

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 pharmacodynamics and pharmacokinetic profile as well as post marketing experience do not indicate any harmful effect of mebeverine on the ability to drive or to use machines

Undesirable effects

The following adverse reactions have been reported spontaneously during post marketing use. A precise frequency cannot be estimated from available data.

Allergic reactions mainly but not exclusively limited to the skin have been observed.

Immune system disorders:

Hypersensitivity (anaphylactic reactions)

Skin and subcutaneous tissue disorders:

Urticaria, angioedema, face edema, exanthema.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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 overdose were of a neurological and cardiovascular nature.

No specific antidote is known and symptomatic treatment is recommended.

Gastric lavage should only be considered in case of multiple intoxication or if discovered within about one hour. Absorption reducing measures are not necessary.

 

All formulations of mebeverine were generally safe and well tolerated in the recommended dose regimen.

Pediatric population

The efficacy and safety of the product has only been evaluated in adults.

was devoid of genotoxic effects. No carcinogenicity studies have been performed.

Pharmaceutical particulars

List of excipients

Capsule content Modified release granules:

Magnesium stearate, polyacrylate dispersion 30%, talc, hypromellose, methacrylic-acid ethyl acrylate copolymer 1:1 dispersion 30%, glycerol triacetate

Capsule shell:

Gelatin, titanium dioxide (E171), printing inks: shellac (E904), black iron oxide (E172), propylene glycol, concentrated ammonia solution, potassium hydroxide.

Incompatibilities

Not applicable.

Shelf life

3 years when stored in the original container.

Special precautions for storage

Do not store above 30°C.

Do not refrigerate or freeze.

Store in the original package.

Nature and contents of container

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

Special precautions for disposal and other handling

None.

Marketing authorization holder

Mylan Products Ltd.

20 Station Close

Potters Bar

Herts

EN6 1TL

United Kingdom

Marketing authorization number(s)

PL 46302/0023

Date of first authorization/renewal of the authorization

14/08/1998 / 04/07/2003

Date of revision of the text

26 August 2016

Legal category

POM

Company Contact Details

Mylan

Address

Building 4, Trident Place, Mosquito Way, Hatfield, Hertfordshire, AL10 9UL

Telephone

+44 (0)1707 853 000

Medical Information Direct Line

+44 (0)1707 853 000

Customer Care direct line

+44 (0)1707 853 000 select option 2

Stock Availability

+44 (0)1707 853 000 select option 2

WWW

http://www.mylan.com

Fax

+44 (0)1707 261 803

Medical Information e-mail

info@mylan.co.uk

Medical Information Fax

+44 (0)1707 261 803