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CLARITHROMYCIN Film-coated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Clarithromycin 250 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 250 mg of clarithromycin. For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet. Light yellow coloured, oval shaped, biconvex film-coated tablets, with D debossed on one side and 62 on the other side. The size is 15.1 mm x 7.1 mm.

Therapeutic indications

Clarithromycin film-coated tablets are indicated for the treatment of the following bacterial infections, when caused by clarithromycin-susceptible bacteria (see section 4.4 and 5.1). Bacterial pharyngitis. ...

Posology and method of administration

Posology The dosage of Clarithromycin film-coated tablets depends on the type and severity of the infection and has to be defined in any case by the physician. Adults and adolescents (12 years and older) ...

Contraindications

Clarithromycin is contraindicated in patients with known hypersensitivity to the active substance clarithromycin, to other macrolides or to any of the excipients listed in section 6.1. Concomitant administration ...

Special warnings and precautions for use

The physician should not prescribe clarithromycin to pregnant women without carefully weighing the benefits against risk, particularly during the first three months of pregnancy (see section 4.6). Caution ...

Interaction with other medicinal products and other forms of interaction

The use of the following drugs is strictly contraindicated due to the potential for severe drug interaction effects Cisapride, pimozide, astemizole and terfenadine Elevated cisapride levels have been reported ...

Pregnancy and lactation

Pregnancy The safety of clarithromycin for use during pregnancy has not been established. Based on variable results obtained from studies in mice, rats, rabbits and monkeys, the possibility of adverse ...

Effects on ability to drive and use machines

There are no data on the effect of clarithromycin on the ability to drive or use machines. The potential for dizziness, vertigo, confusion and disorientation, which may occur with the medication, should ...

Undesirable effects

a. Summary of the safety profile The most frequent and common adverse reactions related to clarithromycin therapy for both adult and pediatric populations are abdominal pain, diarrhea, nausea, vomiting ...

Overdose

Symptoms of intoxication Reports indicate that the ingestion of large amounts of clarithromycin can be expected to produce gastrointestinal symptoms. One patient who had a history of bipolar disorder ingested ...

Pharmacodynamic properties

Pharmacotherapeutic group: Macrolides ATC code: J01FA09 Mode of action Clarithromycin is a semi-synthetic derivative of erythromycin A. It exerts its antibacterial action by binding to the 50s ribosomal ...

Pharmacokinetic properties

Absorption Clarithromycin is rapidly and well absorbed from the gastrointestinal tract – primarily in the jejunum – but undergoes extensive first-pass metabolism after oral administration. The absolute ...

Preclinical safety data

In 4-week-studies in animals, toxicity of clarithromycin was found to be related to the dose and to the duration of the treatment. In all species, the first signs of toxicity were observed in the liver, ...

List of excipients

Core: Microcrystalline cellulose Croscarmellose sodium Silica, colloidal anhydrous Magnesium stearate Povidone (K-30) Coating: Hypromellose Propylene glycol Titanium dioxide (E171) Hydroxypropyl cellulose ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Clarithromycin 250 mg tablets are available in clear PVC /PVdC/Aluminium blister packs of: 7, 12, 14 and 21 film-coated tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

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

Marketing authorization holder

Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom

Marketing authorization number(s)

PL 16363/0413

Date of first authorization / renewal of the authorization

12/05/2014

Date of revision of the text

27/06/2018

Πηγαίο έγγραφο

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