País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Acitretin
Genus Pharmaceuticals Ltd
D05BB02
Acitretin
25mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 13050200; GTIN: 5030451004468
PACKAGE LEAFLET: INFORMATION FOR THE USER ACITRETIN 10 MG CAPSULES ACITRETIN 25 MG CAPSULES 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. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. WHAT IS IN THIS LEAFLET 1 What Acitretin is and what it is used for 2 What you need to know before you take Acitretin 3 How to take Acitretin 4 Possible side effects 5 How to store Acitretin 6 Contents of the pack and other information 1 WHAT ACITRETIN IS AND WHAT IT IS USED FOR The name of your medicine is “Acitretin 10 mg Capsules” or “Acitretin 25 mg Capsules” but will be referred to as “Acitretin” throughout the leaflet. Acitretin belongs to a group of medicines known as retinoids. Retinoids are derived from vitamin A. The medicine is used to treat severe skin problems where the skin has become thick and may be scaly and which does not respond to other conventional treatments satisfactorily. ACITRETIN IS USED TO TREAT • EXTENSIVE AND SERIOUS FORMS OF VARIOUS SKIN DISORDERS resulting from disturbances of the outer layer of skin (the epidermis), such as psoriasis, together with a dry, scaling, waxy rash • SPECIFIC SKIN DISORDERS CHARACTERIZED BY DRY SCALES as a result of marked keratinization (ichthyosis, an organic process by which keratin is deposited in cells an Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS ▼ 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. 1 NAME OF THE MEDICINAL PRODUCT Acitretin 25 mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule, hard of Acitretin 25 mg contains 25 mg acitretin. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard Acitretin 25 mg consists of a yellow to light yellow body and a brown cap, printed in black with “A25” on the capsule body and filled with a yellow powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Extensive and severe refractory forms of psoriasis; • Pustulous psoriasis of the hands and feet; • Severe congenital ichthyosis and ichthyosiform dermatitis; • Lichen ruber planus of skin and mucous membranes; • Other severe and refractory forms of dermatitis characterised by dyskeratosis and/or hyperkeratosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Acitretin should only be prescribed by doctors, who have experience in treatment with systemic retinoids and who are aware of the teratogenic risk associated with acitretin (see sections 4.4 and 4.6). The dosage is based on the clinical appearance of the disorder and the tolerability of the product. The treating physician must determine the dosage individually for each patient. The following information can serve as a guide. This product is available in two strengths: Acitretin 10 mg capsules Acitretin 25 mg capsules Adults An initial daily dose of 25 or 30 mg acitretin (i.e. 1 capsule of Acitretin 25 mg or 3 capsules of Acitretin 10 mg) for 2 to 4 weeks is recommended. After this initial phase, it may be necessary in some cases to increase the dose up to a maximum of 75 mg acitretin per day (i.e. 3 capsules of Acitretin 25 mg). This maximum dose should not be exceeded. In patients with Dari Leia o documento completo