البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
TERBINAFINE AS HYDROCHLORIDE
TEVA ISRAEL LTD
D01BA02
CAPLETS
TERBINAFINE AS HYDROCHLORIDE 250 MG
PER OS
Required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
TERBINAFINE
TERBINAFINE
Fungal infections of the skin caused by dermatophytes such as trichophyton (e.g. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum. Oral Terbinafine should only be used to treat extensive, severe ringworm infections ( tinea corporis, tinea cruris and tinea pedis). Oral Terbinafine is not effective against vaginal candidiasis or pityriasis (tinea) versicolor.Onychomycoses ( tinea unguium, ringworm of the nails) due to infection with dermatophyte organisms ( hyphomycetes).
2020-05-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor's prescription only TERBINAFINE TEVA 250 MG Caplets COMPOSITION Each caplet contains: Terbinafine (as hydrochloride) 250 mg For information about inactive ingredients see section 6 – “Additional information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have additional questions, refer to the doctor or the pharmacist. This medicine has been prescribed for your treatment. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? For treatment of fungal infections of the skin and nails. THERAPEUTIC CLASS An oral antifungal agent. Terbinafine Teva caplets are used for the treatment of fungal infections of the fingernails and toenails, fungal infection of the hair and scalp (tinea capitis), of the groin and other areas of the body and of the feet (athlete’s foot), as well as yeast infections of the skin. When taken orally, terbinafine reaches the location of infection in sufficiently strong concentrations to eradicate the fungus or halt its growth. 2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient or to any of the other ingredients this medicine contains (see section 6 – “Additional information”). • You have or have had a liver disease. • You are breastfeeding. SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE Before treatment with Terbinafine Teva 250 mg, you should check whether the following conditions apply to you. If they do, inform the doctor or pharmacist, as Terbinafine Teva 250 mg may not be the right medicine for you: • You are pregnant or trying to become pregnant • You have any kidney or liver function problems. • You have psoriasis. • You have lupus. • You have a rash due to high level of white blood cells. CHI اقرأ الوثيقة كاملة
Terbinafine Teva 250 mg OKD 11/2021 Notification SUMMARY OF PRODUCT CHARACTERISTICS Terbinafine Teva 250 mg Caplets 1. NAME OF THE MEDICINAL PRODUCT Terbinafine Teva 250 mg Caplets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each caplet contains 281.3mg terbinafine hydrochloride, equivalent to 250mg terbinafine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Caplets for oral administration. White to off-white, capsule shaped biconvex tablet; on one side scored and debossed "T" on each side of the score; plain on the other side of the tablet. Terbinafine Teva 250 mg can be divided into two equal parts. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fungal infections of the skin caused by dermatophytes such as trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum. Oral Terbinafine should only be used to treat extensive, severe ringworm infections (tinea corporis, tinea cruris and tinea pedis). Oral Terbinafine is not effective against vaginal candidiasis or pityriasis (tinea) versicolor. Onychomycoses (tinea unguium, ringworm of the nails) due to infection with dermatophyte organisms (hyphomycetes). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The duration of treatment varies according to the indication and the severity of the infection. ADULTS 250mg once daily. SKIN INFECTIONS_ _ Recommended duration of treatment: Tinea pedis (interdigital, plantar/moccasin type): 2 to 6 weeks. Tinea corporis, cruris: 2 to 4 weeks. Cutaneous candidiasis: 2 to 4 weeks. Complete resolution of the signs and symptoms of infection may not occur until several weeks after mycological cure. Terbinafine Teva 250 mg OKD 11/2021 Notification HAIR AND SCALP INFECTIONS Recommended duration of treatment: Tinea capitis: 4 weeks. Tinea capitis occurs primarily in children _ _ ONYCHOMYCOSIS_ _ For most patients the duration of successful treatment is 6 to 12 weeks. Fingernail onychomycosis: Six weeks of therapy is suf اقرأ الوثيقة كاملة