Land: Malta
Språk: engelsk
Kilde: Medicines Authority
ACITRETIN
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
D05BB02
ACITRETIN 10 mg
CAPSULE
ACITRETIN 10 mg
POM
ANTIPSORIATICS
Withdrawn
2005-12-23
Patient Information Leaflet UK (Actavis Logo) NEOTIGASON 10MG AND 25MG CAPSULES Acitretin 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 medicinal product 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 your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET: 1. WHAT NEOTIGASON IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEOTIGASON 3 HOW TO TAKE NEOTIGASON 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE NEOTIGASON 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT NEOTIGASON IS AND WHAT IT IS USED FOR Neotigason contains a medicine called acitretin. This belongs to a group of medicines called ‘retinoids’. Neotigason is used to treat severe skin problems where the skin has become thick and maybe scaly. These skin problems include psoriasis, ichthyosis and keratosis follicularis (Darier’s disease). It works by making your skin grow more normally. Neotigason is normally used while under the care of a specialist dermatologist (skin doctor). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEOTIGASON DO NOT TAKE NEOTIGASON IF YOU ARE ALLERGIC () TO: • Acitretin or any of the other ingredients of Neotigason (listed in Section 7:). • Other ‘retinoid’ medicines. These include isotretinoin and tazarotene. Do not take Neotigason if any Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Neotigason10 mg hard capsules ▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section “Undesirable effects” for how to report adverse reactions. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 10 mg Excipient with known effect Glucose (see section 4.4). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard 10 mg: Capsules with brown cap and white body with “Actavis” printed in black on the cap and “10” printed in black on the body; capsule size 4. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe forms of psoriasis including: - erythrodermic psoriasis; - local or generalized pustular psoriasis. Severe disorders of keratinisation such as: - congenital ichthyosis; - pityriasis rubra pilaris; - Darier’s disease; - other disorders of keratinisation which may be resistant to other therapies. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Acitretin should only be prescribed by physicians who are experienced in the use of systemic retinoids and understand the risk of teratogenicity associated with acitretin therapy. See section 4.6. The capsules should be taken once daily with meals or with milk. There is a wide variation in the absorption and rate of metabolism of Acitretin. This necessitates individual adjustment of dosage. For this reason the following dosage recommendations can serve only as a guide. _Adults _ Initial daily dose should be 25mg or 30mg for 2 to 4 weeks. After this initial treatment period the involved areas of the skin should show a marked response and/or side-effects should be apparent. Following assessment of the initial treatment period, titration of the dose upwards or downwards may be necessary to achieve the desired therapeutic response with the minimum of side-effects. The maintenance dose must b Les hele dokumentet