ERMYCIN Film-coated tablet Ref.[28204] Active ingredients: Erythromycin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

4.1. Therapeutic indications

Ermycin film-coated tablets are indicated in adults and children aged over 8 years for the treatment of infections caused by erythromycin-sensitive organisms. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2. Posology and method of administration

Posology

Adults and children over 8 years

For mild to moderate infections 1-2 g daily in divided doses. Up to 4g daily in severe infections.

Elderly

No special dosage recommendations.

Paediatric population

Ermycin fc tablets are not recommended for use in children aged under 8 years. For younger children, infants and babies, Ermyced, erythromycin ethylsuccinate suspensions, are normally recommended.

Hepatic impairment

Erythromycin should be used with caution in patients with impaired hepatic function (see sections 4.4 & 5.2).

Method of Administration

For Oral administration.

Optimal serum levels of erythromycin are reached when erythromycin stearate is taken in the fasting state or immediately before meals.

4.9. Overdose

Symptoms

Diarrhoea, severe nausea, vomiting and hearing loss.

Treatment

Gastric lavage, general supportive measures.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store below 25°C, protected from light and moisture.

6.5. Nature and contents of container

Ermycin 250 mg film-coated tablets:

PVC/Aluminium blisters. Pack sizes of 20, 100 and 1000 film-coated tablets.

PP containers with PE closure. Pack size of 1000 film-coated tablets.

Ermycin 500 mg film-coated tablets:

PVC/Aluminium blisters. Pack sizes of 12, 20, 100 and 1000 film-coated tablets.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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