RESTATIN Coated tablet Ref.[51080] Active ingredients: Nystatin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

4.1. Therapeutic indications

Intestinal candidosis: Also for use in patients who may be susceptible to candidal overgrowth e.g. patients with malignant disease especially if receiving cytotoxic drugs, and those patients receiving high doses or prolonged courses of antibiotics or corticosteroids.

4.2. Posology and method of administration

Posology

The adult dose for the treatment of candidosis is one tablet four times daily, but this dose may be doubled. For prophylaxis a total daily dose of one million units has been found to suppress the overgrowth of Candida albicans in patients receiving broad-spectrum antibiotic therapy.

Elderly

No specific dosage recommendations or precautions.

Method of administration

Oral administration.

4.9. Overdose

Since absorption of nystatin from the gastro-intestinal tract is negligible, accidental ingestion causes no systemic toxicity.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store below 25°C. Protect from light moisture.

6.5. Nature and contents of container

PVC/Aluminium blisters. Pack sizes of 20, 30 and 100 coated tablets.

PP containers with PE closure. Pack sizes of 100 and 1000 coated tablets.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special instructions.

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