国: イスラエル
言語: 英語
ソース: Ministry of Health
CLINDAMYCIN PHOSPHATE
TARO INTERNATIONAL LTD, ISRAEL
D10AF01
GEL
CLINDAMYCIN PHOSPHATE 1 %W/W
DERMAL
Required
DR. AUGUST WOLFF GMBH & CO., GERMANY
CLINDAMYCIN
CLINDAMYCIN
Zindaclin is indicated for the treatment of acne vulgaris.
2023-06-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only ZINDACLIN 1% GEL COMPOSITION: Each gram of gel contains 10 mg clindamycin (1% w/w) equivalent to 11.88 mg clindamycin phosphate. For a list of inactive ingredients and allergens in the preparation - see section 6 “Further Information”. READ THE PACKAGE INSERT CAREFULLY IN ITS ENTIRETY BEFORE USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. The medicine is not intended for infants and children under the age of 12. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended for the treatment of acne vulgaris. THERAPEUTIC GROUP: Clindamycin is a lincosamide antibiotic. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are breastfeeding. • You are sensitive (allergic) to the active ingredient or to any of the other ingredients contained in the medicine. For the list of inactive ingredients - see section 6 “Further Information”. • You are sensitive (allergic) to lincomycin - another type of antibiotic. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE: BEFORE USING ZINDACLIN 1% GEL, TELL THE DOCTOR IF: • You are pregnant, think that you might be pregnant or are trying to become pregnant. • You suffer, or have suffered in the past, from impaired function of the digestive system (e.g., ulcer), inflammation of the colon. • You suffered from diarrhea while taking an antibiotic. • You are sensitive to any food or medicine. IF YOU ARE TAKING, OR HAVE RECENTLY TAKEN, OTHER MEDICINES, INCLUDING NON-PRESCRIPTION MEDICINES AND NUTRITIONAL SUPPLEMENTS, TELL YOUR DOCTOR OR PHARMACIST. PREGNANCY AND BREASTFEEDING • If you are pregnant, think that you might be pregnant or are trying to become 完全なドキュメントを読む
1 Zindaclin 1% Gel- SPC – 06.2023 _ _ SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Zindaclin 1% Gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The gel contains clindamycin phosphate equivalent to clindamycin 1% w/w. 3. PHARMACEUTICAL FORM Gel A white translucent gel. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Zindaclin 1% Gel is indicated for the treatment of mild to moderate acne vulgaris. 4.2 Posology and method of administration Cutaneous use. Adults and adolescents Apply a thin film of Zindaclin 1% Gel once daily to the affected area. Patient response should be reviewed periodically. Children Zindaclin 1% Gel is not indicated for use in children below the age of 12 years. 4.3 Contraindications Zindaclin 1% Gel is contra-indicated in patients with a hypersensitivity to the active substance clindamycin or to any of the excipients in the medicinal product. Although cross-sensitisation to lincomycin has not been demonstrated, it is recommended that Zindaclin 1% Gel should not be used in patients who have demonstrated lincomycin sensitivity. 4.4 Special warnings and precautions for use The product contains approximately 20% ethanol. Each gram contains approximately 0.2 gram alcohol. Do not light a cigarette or come in contact with an open flame until the product has been completely dried off. Oral and parenteral clindamycin, as well as most other antibiotics, have been associated with severe pseudomembranous colitis. Topical clindamycin has very 2 Zindaclin 1% Gel- SPC – 06.2023 _ _ rarely been associated with pseudomembranous colitis; however if diarrhea occurs the product should be discontinued immediately. Studies indicate a toxin(s) produced by _Clostridium difficile_ is the major cause of antibiotic-associated colitis. Colitis is usually characterized by severe persistent diarrhea and abdominal cramps. Should antibiotic associated colitis occur, appropriate diagnostic and therapeutics measures (Such as vancomycin treatment) should be taken immediately. Responses may not be 完全なドキュメントを読む