Country: Малта
Језик: Енглески
Извор: Medicines Authority
ACITRETIN
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
D05BB02
ACITRETIN 25 mg
CAPSULE
ACITRETIN 25 mg
POM
ANTIPSORIATICS
Withdrawn
2005-12-23
Acitretine 10mg and 25mg capsules leaflet - Teva UK/Malta item no: print proof no: origination date: originated by: revision date: revised by: dimensions: pharmacode: colours/plates: approved for print/date Non Printing Colours 1. pms 281 2. 3. 4. 5. 6. 1. Profile 2. 3. date sent: supplier: technically app. date: min pt size: TECHNICAL APPROVAL AAAJ6631 02 02-03-2017 NM 07-03-2017 NM Cenexi Osny 125 x 210 4p 7.5 pts 02-03-2017 03-03-2017 PLEASE 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 become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. WHAT NEOTIGASON IS AND WHAT IT IS USED FOR 2. BEFORE YOU TAKE NEOTIGASON 3. IMPORTANT INFORMATION FOR WOMEN 4. HOW TO TAKE NEOTIGASON 5. POSSIBLE SIDE EFFECTS 6. HOW TO STORE NEOTIGASON 7. FURTHER 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. BEFORE YOU TAKE NEOTIGASON DO NOT TAKE NEOTIGASON IF YOU ARE ALLERGIC (HYPERSENSITIVE) TO: • Acitretin or any of the other ingredients of Neotigason (listed in Section 7: Further Information). • Other ‘retinoid’ medicines. These include isotretinoin and tazarotene. Do not take Neotigason if any of the above apply to you. If you are not sure, talk to your doctor Прочитајте комплетан документ
Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Neotigason10 mg hard capsules Neotigason 25 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 10 mg or 25 mg acitretin. 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. 25 mg: Capsules with brown cap and yellow body with “Actavis” printed in black on the cap and “25” printed in black on the body; capsule size 1. 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 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. Posology Because there are differences in the absorption and rate of metabolism of acitretin, the dosage must be individually adjusted. The following will serve as guidelines. Page 2 of 12 _Adults _ The _initial daily dosage_, 25 mg (i.e. 1 capsule 25 mg) or 30 mg (i.e. 3 capsules 10 mg) for about 2-4 weeks may give satisfactory therapeutic results. The _maintenance dose_ must be based on clinical efficacy and tolerability. In general, a daily dosage of 25-50 mg taken for a further 6-8 weeks achieves optimal therapeutic results. It may be necessary in some cases to increase the dose up to a maximum of 75 mg/day (i.e. 3 capsules 25 mg). Therapy can be terminated in patients with _ psoriasis_ whose lesions have resolved sufficiently. Relapses should be treated as des Прочитајте комплетан документ