Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Alitretinoin
Stiefel Laboratories (UK) Ltd
D11AH04
Alitretinoin
10mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 13050100; GTIN: 7640137530075
Toctino 10 mg capsules, soft Toctino 30 mg capsules, soft WARNING CAN SERIOUSLY HARM AN UNBORN BABY Women must use effective contraception Do not use if you are pregnant or you think you may be pregnant This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 breast-feeding ■ If there is any chance you could become pregnant, you must follow the precautions under “Pregnancy and prevention programme”, see section on “Warnings and precautions”. ■ If you have liver disease. ■ If you have severe Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Toctino 10 mg capsules, soft 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule, soft contains 10 mg of alitretinoin Excipients with known effect: Soya-bean oil. Each 10 mg capsule contains 176.50 mg soya-bean oil. Sorbitol. Each 10 mg capsule contains 20.08 mg sorbitol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, soft Brown oval capsule approximately 11 mm in length and 7 mm in width marked with “A1”. 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 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. 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 reactions to the 30 mg dose. In studies investigating 10 mg and 30 mg daily doses, both doses resulted in clearing of the disease. The 30 mg dose provided a more rapid response and a higher response rate. The 10 mg daily dose was associated with fewer adverse events (see section 5.1). _Duration of treatment _ A treatment course of Toctino may be given for 12 to 24 weeks depending on response. Discontinuation of Les hele dokumentet