Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Acitretin
Actavis Group PTC ehf
D05BB; D05BB02
Acitretin
25 milligram(s)
Capsule, hard
Product subject to prescription which may not be renewed (A)
Retinoids for treatment of psoriasis; acitretin
Marketed
1992-06-16
Package Leaflet: Information for the user NEOTIGASON® 10 MG CAPSULES NEOTIGASON® 25 MG CAPSULES Acitretin WARNING CAN SERIOUSLY HARM AN UNBORN BABY Women must use effective contraception Do not use if you are pregnant or 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 PLEASE 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 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 may be 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). You must talk to a doctor if you do not feel better or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEOTIGASON DO NOT TAKE NEOTIGASON IF YOU: • are pregnant or breast-feeding • there is any chance you could become pregnant, you must follow the precau Prečítajte si celý dokument
Health Products Regulatory Authority 18 December 2020 CRN009ZFL Page 1 of 11 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 4.8 for how to report adverse reactions. 1 NAME OF THE MEDICINAL PRODUCT Neotigason 25 mg capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Capsules containing 25 mg of acitretin. Excipients: Glucose 41.00 mg. For the full list of excipients, _see section 6.1._ 3 PHARMACEUTICAL FORM Capsule, hard. Capsule with a brown cap and yellow body with ‘25’ printed in black on the body; capsule size 1. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe extensive psoriasis which is resistant to other forms of therapy. Palmo-plantar pustular psoriasis. Severe congenital ichthyosis. Severe Darier's disease (keratosis follicularis). Severe lichen planus. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Neotigason 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 4.4 and 4.6. Neotigason capsules are for oral administration. The capsules should be taken once daily with meals or with milk. There is wide variation in the absorption and rate of metabolism of Neotigason. 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 25 mg or 30 mg for two to four 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 increase the therapeutic effect. In general, a daily dosage of 25-50 mg taken for a further six to eight weeks achieves optimal therapeutic res Prečítajte si celý dokument