国: イスラエル
言語: 英語
ソース: Ministry of Health
TOLNAFTATE
TEVA ISRAEL LTD
D01AE
CREAM
TOLNAFTATE 1 %
TOPICAL
Not required
TEVA ISRAEL LTD, ISRAEL
OTHER ANTIFUNGALS FOR TOPICAL USE
Topical treatment of superficial dermatomycoses.
2021-11-30
PITR CRE PL SH 200220 PITR CRE PL SH 200220 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed without a doctor’s prescription Pitrex ® Cream Composition: Tolnaftate 1% w/w For information on the inactive and allergenic ingredients, see section 2 – “Important information about some of the ingredients of the medicine” and section 6 – “Further Information”. Read the leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. Use this preparation according to the instructions in the dosage section of this leaflet. Consult a pharmacist if you need further information. Refer to a doctor if the symptoms of the disease are not improving after 10 days. 1. WHAT IS THE MEDICINE INTENDED fOR? Cream for topical treatment of superficial fungal skin diseases. Therapeutic group: Topical antifungal. 2. BEfORE USING THE MEDICINE Do not use the medicine: • If you are sensitive )allergic( to the active ingredient or to any of the additional ingredients contained in the medicine. See section 6 “Further Information”. • To treat nail or scalp infections. Drug interactions If you are taking, or have recently taken, other medicines, including non-prescription medicines and nutritional supplements, tell the doctor or pharmacist. Important information about some of the ingredients of the medicine The preparation contains butylated hydroxytoluene )E 321(, which may cause a localized skin reaction )e.g., contact dermatitis( or irritation of the eyes or mucous membranes. 3. HOW SHOULD YOU USE THE MEDICINE? Check with the doctor or pharmacist if you are uncertain about the dosage and treatment regimen of the preparation. The usual dosage is generally: Apply a thin layer on the affected area 2-3 times a day. Do not exceed the recommended dose. This medicine is not generally intended for children and infants under two years 完全なドキュメントを読む
Pitrex Cream SZ/LC 12/2021 Notification SUMMARY OF PRODUCT CHARACTERISTICS PITREX ® 1. NAME OF THE MEDICINAL PRODUCT Pitrex ® Cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tolnaftate 1.0% w/w For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream Pure white, smooth homogeneous cream, free from specks and the like. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Topical treatment of superficial dermatomycoses. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Apply a thin layer on the affected area 2-3 times daily. Do not exceed the recommended dosage. This medicine is not usually intended for administration to children and infants under 2 years of age. If there is no improvement in the condition within 10 days, the patient should refer to the doctor. 4.3 CONTRAINDICATIONS Contraindicated in nail or scalp infections. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE For external use only. Keep out of eyes. If symptoms do not improve within 10 days, discontinue use and consult your doctor. Keep out of the reach and sight of children. The product contains butylated hydroxytoluene (E 321) which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes. If irritation or rash occurs, use of the product should be discontinued and medical advice should be sought. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Not relevant to topical use Pitrex Cream SZ/LC 12/2021 Notification 4.6 PREGNANCY AND LACTATION No known restrictions. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None stated. 4.8 UNDESIRABLE EFFECTS Adverse reactions have been ranked under headings of frequency using the following convention: Very common ≥ 1/10 Common ≥ 1/100 to ≥ 1/10 Uncommon ≥ 1/1,000 to < 1/100 Rare ≥ 1/10,000 to < 1/1,000 Very rare <1/10,000 Not known (cannot be estimated from the available data) Within each frequency grouping, undesirable ef 完全なドキュメントを読む