MEDOFULVIN Tablet Ref.[28278] Active ingredients: Griseofulvin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2015  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

4.1. Therapeutic indications

Medofulvin is an antifungal antibiotic indicated for the treatment of fungal infection of skin, scalp, hair or nails where topical therapy has failed.

Griseofulvin is effective against dermatophytic fungi, including Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitalis, Trichophyton verrucosum, Trichophyton sulphureum, Trichophyton schoenleini, Trichophyton megnini, Trichophyton gallinae, Trichophyton crateriform, Microsporum audouini, Microsporum canis, Microsporum gypseum and Epidermophyton floccosum and other Epidermophyton sp.

4.2. Posology and method of administration

Method of administration

The tablets are for oral administration. They should be taken after meals.

Posology

Adults

Single dose of 500 to 1000 mg, but not less than 10 mg/ kg bodyweight daily is the normal daily dose for adult. Divided doses may be more effective in the patients having poorly response to the treatment.

Paediatric population:

Divided doses of 10 mg/kg bodyweight (5 mg/lb) daily are usually recommended.

Duration of treatment

The duration of treatment depends upon the thickness of keratin at the site of infection.

  • Hair and skin – at least 4 weeks;
  • Toe and finger nails – 6 to 12 months;

After all sign of infection have disappeared, therapy should be continued for at least two weeks.

4.9. Overdose

In the case of acute over dosage, treatment is unlikely to be required.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store below 25°C in the original package.

6.5. Nature and contents of container

Medofulvin tablets are packed in PVC-Aluminium blister.

Packs of 20 and 100 tablets are available for both strengths.

Hospital packs are also available.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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