Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
ALITRETINOIN
Glaxo SmithKline UK Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
D11AH04
ALITRETINOIN 10 mg
SOFT CAPSULE
ALITRETINOIN 10 mg
POM
OTHER DERMATOLOGICAL PREPARATIONS
Withdrawn
2009-12-16
PACKAGE LEAFLET: INFORMATION FOR THE USER TOCTINO ® 10 MG CAPSULES, SOFT TOCTINO ® 30 MG CAPSULES, SOFT alitretinoin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Toctino is and what it is used for 2. What you need to know before you take Toctino 3. How to take Toctino 4. Possible side effects 5. How to store Toctino 6. Contents of the pack and other information 1. WHAT TOCTINO IS AND WHAT IT IS USED FOR The active substance in Toctino is alitretinoin. It belongs to a group of medicines known as _retinoids_ which are related to Vitamin A. Toctino capsules come in two strengths, containing 10 mg or 30 mg of alitretinoin. Toctino is used to treat adults with severe chronic hand eczema that has not got better after any other topical treatments, including steroids. Treatment with Toctino must be supervised by a specialist skin doctor (a dermatologist). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOCTINO DO NOT TAKE TOCTINO IF YOU ARE PREGNANT or if you can become pregnant and are not using effective birth control measures (SEE BELOW, “PREGNANCY AND BREAST-FEEDING”). If you are breast-feeding. If you have LIVER DISEASE. If you have SEVERE KIDNEY DISEASE. If you have HIGH BLOOD FATS (such as high cholesterol or raised triglycerides). If you have UNTREATED THYROID DISEASE. If you have VERY HIGH LEVELS OF VITAMIN A in your body (_hypervitaminosis_ A). If you are ALLERGIC to alitretinoin, to other retinoids (such as isotretinoin), to peanut or soya or any of the other ingredi Citiți documentul complet
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Toctino ® 10 mg capsules, soft Toctino ® 30 mg capsules, soft 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule, soft contains 10 mg or 30 mg of alitretinoin Excipients with known effect: Soya-bean 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”. 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 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 dispensing of Toctino should occur on the same day. Dispensing of Toctino should occur within a maximum of 7 days of the prescription. The recommended dose for Toctino is 10 mg or 30 mg once daily. The recommended starting dose for Toctino is 30 mg once daily. A dose reduction to 10 mg once daily may be considered in patients with unacceptable adverse r Citiți documentul complet