MEDOFLORAN Tablet Ref.[28281] Active ingredients: Terbinafine

Posology

Adults

250 mg once daily.

The duration of treatment varies according to the indication and the severity of the infection.

Skin Infections

Likely durations of treatment are as follows
Tinea pedis (interdiginal, plantar/moccasin type): 2 to 6 weeks;
Tinea corporis: 4 weeks
Tinea cruris: 2 to 4 weeks

Onychomycosis

The duration of treatment for most patients is between 6 weeks and 3 months. Treatment periods of less than 3 months can be anticipated in patients with fingernail infection, toenail infection other than of the big toe, or patients of younger age.

In the treatment of toenail infections, 3 months is usually sufficient although a few patients may require treatment of 6 months or longer. Poor nail outgrowth during the first weeks of treatment may enable identification of those patients in whom longer therapy is required.

Complete resolution of the signs and symptoms of infection may not occur until several weeks after mycological cure.

Additional information on special population

Liver impairment

Medofloran is not recommended for patients with chronic or active liver disease (see section 4.4).

Renal impairment

The use of terbinafine has not been adequately studied in patients with renal impairment and is therefore not recommended in this population (see section 4.4 and section 5.2).

Paediatric population

A review of safety experience with oral terbinafine in children, which includes 314 patients involved in the UK LAMISIL Post Marketing Surveillance study, has shown that the adverse event profile in children is similar to that seen in adults. No evidence of any new, unusual or more severe reactions to those seen in the adult population have been noted. However, as data is still limited its use is not recommended.

Elderly

There is no evidence to suggest that elderly patients (aged 65 years or above) require different dosages or experience side effects different from those in younger patients. The possibility of impairment of liver or kidney function should be considered in this age group (see section 4.4).

Method of administration

The scored tablets are taken orally with water. They should preferably be taken at the same time each day and can be taken on an empty stomach or after a meal.

Symptoms

A few cases of overdose (up to 5g) have been reported, giving rise to headache, nausea, upper abdominal pain and dizziness.

Management

The recommended treatment of overdosage consists of eliminating the drug, primarily by the administration of activated charcoal, and giving symptomatic supportive therapy if needed.

36 months.

This medicinal product does not require any special storage conditions. Store in the original package.

PVC-A1 blisters of 7 tablets each. Packs of 14 and 28 tablets are available.

Not all pack sizes may be marketed.

No special requirements for disposal.