Quốc gia: Israel
Ngôn ngữ: Tiếng Anh
Nguồn: Ministry of Health
ALITRETINOIN
GLAXO SMITH KLINE (ISRAEL) LTD
D11AX19
CAPSULES SOFT
ALITRETINOIN 30 MG
PER OS
Required
GLAXOSMITHKLINE TRADING SERVICES LIMITED
ALITRETINOIN
ALITRETINOIN
For use in adults who have severe chronic hand eczema that is unresponsive to treatment with potent topical corticosteroids .Patients in whom the eczema has predominantly hyperkeratotic features are more likely to respond to treatment than in those in whom the eczema predominantly presents as pompholyx .
2021-11-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a physician’s prescription only For the list of inactive and allergenic ingredients in the preparation, see section 2: Important information about some of the ingredients of the medicine and section 6: Additional 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 physician 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 children under 18 years of age. In addition to the leaflet, Toctino has a Patient Pamphlet. This pamphlet contains important safety information that you must know and adhere to before and during the treatment with Toctino. Read the Patient Pamphlet and the patient leaflet before starting to use the preparation. Keep the pamphlet for further reading, if necessary. WOMEN OF CHILD-BEARING POTENTIAL MUST AVOID BECOMING PREGNANT FOR ONE MONTH BEFORE STARTING TREATMENT, DURING THE COURSE OF TREATMENT AND FOR ONE MONTH AFTER DISCONTINUING TREATMENT. USE EFFECTIVE CONTRACEPTIVES. DURING THE COURSE OF TREATMENT, MONTHLY PREGNANCY TESTS SHOULD BE PERFORMED. IF YOU DISCOVER THAT YOU ARE PREGNANT DURING THE COURSE OF TREATMENT OR ONE MONTH AFTER TREATMENT, STOP THE TREATMENT IMMEDIATELY AND REPORT TO THE ATTENDING PHYSICIAN. USE OF THIS MEDICINE DURING PREGNANCY CAUSES RISK OF DEFECTS IN THE UNBORN BABY AND INCREASES THE RISK OF MISCARRIAGE. SEE ADDITIONAL INFORMATION IN SECTION PREGNANCY PREVENTION PROGRAM AND SECTION PREGNANCY AND BREASTFEEDING. DO NOT USE THE MEDICINE IF YOU ARE PREGNANT OR THINK YOU MIGHT BE PREGNANT. TOCTINO 10 MG SOFT CAPSULES The active ingredient and its quantity: EACH CAPSULE CONTAINS: Alitretinoin 10 mg TOCTINO 30 MG SOFT CAPSULES The active ingredient and its quantity: Đọc toàn bộ tài liệu
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT TOCTINO 10 MG TOCTINO 30 MG 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule, soft contains 10 mg or 30 mg of alitretinoin Excipients with known effect: Soybean oil. Each 10 mg capsule contains 176.50 mg soya-bean oil. Each 30 mg capsule contains 282.40 mg soya-bean oil. Sorbitol. Each 10 mg capsule contains 20.08 mg sorbitol. Each 30 mg capsule contains 25.66 mg sorbitol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, soft The Toctino 10 mg capsule is a brown oval capsule approximately 11 mm in length and 7 mm in width marked with “A1”. The Toctino 30 mg capsule is a red-brown oval capsule approximately 13 mm in length and 8 mm in width marked with “A3”. PATIENT SAFETY INFORMATION CARD The marketing of Toctino is subject to a risk management plan (RMP) including a ‘Patient safety information card’. The ‘Patient safety information card’, 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 card before starting treatment. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Toctino is indicated for use in adults who have severe chronic hand eczema that is unresponsive to treatment with potent topical corticosteroids. Patients in whom the eczema has predominantly hyperkeratotic features are more likely to respond to treatment than in those in whom the eczema predominantly presents as pompholyx (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 2 Toctino should only be prescribed by dermatologists, or physicians with experience in the use of systemic retinoids who have full understanding of the risks of systemic retinoid therapy and monitoring requirements. Prescriptions of Toctino for women of childbearing potential should be limited to 30 days of treatment and continuation of treatment requires a new prescription. Ideally, pregnancy testing, issuing a prescription and dispens Đọc toàn bộ tài liệu