البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
ISOTRETINOIN
TARO INTERNATIONAL LTD, ISRAEL
D10BA01
CAPSULES SOFT GELATIN
ISOTRETINOIN 20 MG
PER OS
Required
DOUGLAS PHARMACEUTICALS LTD, NEW ZEALAND
ISOTRETINOIN
ISOTRETINOIN
For the treatment of severe cystic acne that does not respond to other treatment.
2020-11-30
Page_ _1 of 12 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor's prescription only CURATANE 5 MG SOFT GELATIN CAPSULES CURATANE 10 MG SOFT GELATIN CAPSULES CURATANE 20 MG SOFT GELATIN CAPSULES CURATANE 30 MG SOFT GELATIN CAPSULES CURATANE 40 MG SOFT GELATIN CAPSULES COMPOSITION: Each capsule contains: 5 mg isotretinoin Each capsule contains: 10 mg isotretinoin Each capsule contains: 20 mg isotretinoin Each capsule contains: 30 mg isotretinoin Each capsule contains: 40 mg isotretinoin Inactive ingredients and allergens in this medicine: See section 2 'Important information about some of this medicine's ingredients' and section 6 'Additional information'. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, consult your 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 to yours. In addition to the patient information leaflet, Curatane has a patient information brochure. This brochure contains important safety information that you need to know before starting treatment with Curatane, and which you must follow. Read the patient information brochure and patient information leaflet before using this medicine. Keep the brochure in case you need to read it again. _ _ Important information that you should read: SPECIAL WARNINGS FOR WOMEN/TEENAGE GIRLS CURATANE IS HIGHLY LIKELY TO HARM AN UNBORN BABY (IN MEDICAL LANGUAGE: THE MEDICINE IS TERATOGENIC) – IT CAN CAUSE SERIOUS ABNORMALITIES OF THE UNBORN BABY'S BRAIN, FACE, EAR, EYE, HEART AND CERTAIN GLANDS (THE THYMUS GLAND AND THE PARATHYROID GLAND). IT ALSO INCREASES THE RISK OF MISCARRIAGE. THIS MAY HAPPEN EVEN IF CURATANE IS TAKEN ONLY FOR A SHORT TIME DURING PREGNANCY. THEREFORE: 1. YOU MUST NOT TAKE CURATANE IF YOU ARE PREGNANT OR THINK YOU MIGHT BE PR اقرأ الوثيقة كاملة
Page 1 of 16 CURATANE (ISOTRETINOIN) CAPSULES PATIENT SAFETY INFORMATION GUIDE The marketing of Curatane is subject to a risk management plan (RMP) including a 'Patient Safety Information Guide'. The 'Patient Safety Information Guide', emphasizes important safety information that the patient should be aware of before and during treatment. Please explain to the patient the need to review the guide before starting treatment. PRESCRIBER GUIDE This product is marketed with prescriber guide providing important safety information. Please ensure you are familiar with this material as it contains important safety information. PRESCRIBER CHECKLIST Physician checklist for prescribing to female patients is to be completed by the Physician for all female patients prescribed Curatane and kept with patient notes to document compliance with the Curatane Pregnancy Prevention Programme. 1. NAME OF THE MEDICINAL PRODUCT Curatane 5 mg, 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mg soft gelatin capsule contains: 5 mg isotretinoin. Each 10 mg soft gelatin capsule contains: 10 mg isotretinoin. Each 20 mg soft gelatin capsule contains: 20 mg isotretinoin. Each 30 mg soft gelatin capsule contains: 30 mg isotretinoin. Each 40 mg soft gelatin capsule contains: 40 mg isotretinoin. Excipients with known effect: Contain soya bean oil (refined, hydrogenated and partially hydrogenated) and sorbitol. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Each 5 mg capsule has a faint pinkish-cream to cream coloured oblong soft gelatin shell with a yellow/orange opaque liquid. Each 10 mg capsule has a light violet coloured oblong soft gelatin shell with a yellow/orange opaque liquid. Each 20 mg capsule has a maroon coloured oblong soft gelatin shell with a yellow/orange opaque liquid. Each 30 mg capsule has a pink coloured oval soft gelatin shell with a yellow/orange opaque viscous liquid. Each 40 mg capsule has a light orange coloured oval soft gelatin shell with a yell اقرأ الوثيقة كاملة