Terfimed® 250
capsules
![TerfimedRR 250](javascript:obrazek_big("http://promedcs.cz//en/../img/baleni/600_Terfimed 250_14+28_3D(1).jpg", "en"); "TerfimedRR 250")
- Manufacturer:
- Laboratorios Liconsa S.A.,Barcelona, Spain.
- Marketing authorisation holder:
- PRO.MED.CS Praha a.s.
- Composition:
- Terbinafinum 250mg in 1 tablet.
- Indication group:
- antimycotic agent with systemic effect
The following information is for health professionals only.
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Characteristics:
Terbinafin is an allylamine fungistatic to fungicide antimycotic agent with a relatively wide antifungal spectrum, which penetrates well into the skin and its adnexes. The mechanism of effect consists in the interference into the synthesis of ergosterol, an important membrane component of micromycete cells. Terbinafin is completely biotransformed in the liver. Its biological half-life is 17 hours and it is excreted prevalently via the urine.
Indications:
Mycotic skin and nail infections: treatment of the diseases tinea corporis, tinea cruris and tinea pedis, when oral treatment is considered suitable on the basis of considering the site of occurrence, seriousness and extent of infection; treatment of onychomycosis caused by dermatophytes.
Contraindications:
Hypersensitivity to terbinafin and auxiliary substances, serious liver and renal disorders, lactation.
Undesirable effects:
Lack of appetite, nausea, feeling of fullness, abdominal pain, dyspepsia, diarrhoea, joint and muscle pain, allergic skin reactions (rash, urticaria), headache.
Interactions:
Effect of terbinafin is increased by cimetidine and decreased by rifampicin. Terbinafin minimally inhibits drug metabolism mediated by cytochrome P450 (cyclosporin, terfenadin, triazolam, tolbutamide, oral contraceptive preparations) excepting those which are metabolized by means of the enzyme CYP2D6 (metoprolol). In the case of necessity of concomitant administration of terbinafin and fluconazole, terbinafin dosing is to be adjusted in a pertinent way.
Caution:
The preparation is not recommended for children. Breast-feeding mothers should not undergo treatment with the preparation Terfimed®250. During pregnancy, the preparation may be administered only in inevitably necessary cases.
Dosage:
In skin infection, 1 tablet once a day for a period of 2 to 6 weeks, in onychomycosis of the hands 1 tablet once a day for a period of 6 weeks, in onychomycosis of the feet 1 tablet once a day for a period of 12 weeks. Tablets are swallowed whole and washed down with water. They may be taken with or without meals.
Package:
14 or 28 tablets.
For greater details about the preparation see the summary of product characteristics.
Date of the latest revision of the text: April 15, 2009.
The preparation is available for medical prescription only.