Land: Armenië
Taal: Engels
Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
isotretinoin
Pharmathen International S.A.
D10BA01
isotretinoin
20mg
capsules soft
(30/3x10/) in blister
Prescription
Registered
2023-03-10
PACKAGE LEAFLET: INFORMATION FOR THE USER A-CNOTREN 10 MG CAPSULES, SOFT A-CNOTREN 20 MG CAPSULES, SOFT Isotretinoin 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. Healthcare professionals are asked to report any suspected adverse reactions. See section 4 for how to report adverse reactions 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. WHAT IS IN THIS LEAFLET 1. What A-cnotren is and what it is used for 2. What you need to know before you take A-cnotren 3. How to take A-cnotren 4. Possible side effects 5. How to store A-cnotren 6. Contents of the pack and other information 1. WHAT A-CNOTREN IS AND WHAT IT IS USED FOR A-CNOTREN contains the active ingredient isotretinoin-a substance related to vitamin A, and one of a group of medicines called retinoids (for treatment of acne). A-CNOTREN IS USED TO TREAT SEVERE FORMS OF ACNE (such as nodular or conglobate acne or acne at risk of causing permanent scarring) in adults and adolescents from 12 years of age only after puberty. You will use A-cnotren when your acne has not got better with anti-acne treatments, including antibiotics and skin treatments. THE A-CNOTREN TREATMENT MUST BE SUPERVISED BY A DERMATOLOGIST (a doctor specialised in the treatment of skin problems). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE A-CNOTREN DO NOT TAKE A-CNOTREN: IF YOU ARE ALLE Lees het volledige document
A-CNOTREN, SOFT 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 4 for how to report adverse reactions 1. NAME OF THE MEDICINAL PRODUCT A-cnotren 10 mg capsules, soft A-cnotren 20 mg capsules, soft 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 mg soft capsule contains 10 mg of isotretinoin. Each 20 mg soft capsule contains 20 mg of isotretinoin. Excipients with known effect: Contains refined soya-bean oil, hydrogenated soya-bean oil, partially hydrogenated soya- bean oil. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, soft. 10 mg capsules are oval, red/orange (size 3). 20 mg capsules are oval, red/orange (size 6). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe forms of acne (such as nodular or conglobate acne or acne at risk of permanent scarring) resistant to adequate courses of standard therapy with systemic anti-bacterials and topical therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Isotretinoin should only be prescribed by or under the supervision of physicians with expertise in the use of systemic retinoids for the treatment of severe acne and a full understanding of the risks of isotretinoin therapy and monitoring requirements. The capsules should be taken with food once or twice daily. _ _ _Paediatric Population _ A-cnotren should not be used for the treatment of prepubertal acne and is not recommended in children less than 12 years of age due to a lack of data on efficacy and safety. _ _ _Adults including adolescents and the elderly_ Isotretinoin therapy should be started at a dose of 0.5 mg/kg daily. The therapeutic response to isotretinoin and some of the adverse events are dose-related and vary between patients. This necessitates individual dose adjustment during therapy. For most patients, the dose ranges from 0.5-1.0 mg/kg per day. Long-term remission and relapse rat Lees het volledige document