País: Nova Zelândia
Língua: inglês
Origem: Medsafe (Medicines Safety Authority)
Isotretinoin 40mg; ;
Douglas Pharmaceuticals Limited
Isotretinoin 40 mg
40 mg
Soft gelatin capsule
Active: Isotretinoin 40mg Excipient: Butylated hydroxyanisole Disodium edetate dihydrate Gelatin Glycerol All-rac-alpha-tocopherol Purified water Sorbitol Soya bean oil, hydrogenated Soya oil Sunset yellow FCF Titanium dioxide Yellow beeswax
Blister pack, PVC/PVDC/Al, 30 capsules
Prescription
Prescription
Siegfried PharmaChemikalien Minden GmbH
Severe forms of nodulo-cystic acne which are resistant to therapy, particularly cystic acne and acne conglobata, especially when the lesions involve the trunk. ORATANE should only be prescribed by physicians who are experienced in the use of systemic retinoids, preferably dermatologists, and understand the risk of teratogenicity if ORATANE is used during pregnancy.
Package - Contents - Shelf Life: Blister pack, PVC/PCTFE/Al or PVC/PVDC/Al - 30 capsules - 36 months from date of manufacture stored at or below 25°C
2004-10-14
CONSUMER MEDICINE INFORMATION Page 1 of 6 ORATANE* _Isotretinoin _ 5 mg, 10 mg, 20 mg, 30 mg and 40 mg Capsules WHAT IS IN THIS LEAFLET PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ORATANE. This leaflet answers some common questions about ORATANE. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking ORATANE against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. YOU MAY NEED TO READ IT AGAIN. WHAT ORATANE IS USED FOR The active ingredient in ORATANE capsules is isotretinoin, a substance very similar to vitamin A. ORATANE belongs to a group of medicines called retinoids. ORATANE capsules are used to treat acne. Of the many acne medicines, ORATANE is used for more severe cases. ORATANE capsules work by cutting down the amount of oily substances (sebum) made by your glands in your skin. ORATANE capsules will also help to reduce the bacteria, inflammation and open clogged pores. Your doctor may have prescribed ORATANE for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ORATANE HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. ORATANE capsules are not addictive. BEFORE YOU TAKE ORATANE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE ORATANE IF YOU ARE PREGNANT OR FOR AT LEAST ONE MONTH BEFORE YOU INTEND TO BECOME PREGNANT. If you fall pregnant while taking ORATANE capsules, there is an extremely high risk of having a baby that is severely deformed. PREGNANCY TESTING SHOULD BE PERFORMED BEFORE, DURING (EVERY MONTH IS STRONGLY RECOMMENDED) AND FOR A MONTH AFTER TREATMENT HAS FINISHED. YOU MUST USE EFFECTIVE CONTRACEPTION (BIRTH CONTROL) FOR ONE MONTH BEFORE, DURING AND AT LEAST ONE MONTH AFTER TREATMENT WITH ORATANE. It is recommended that two complementary forms of contraception inclu Leia o documento completo
1 | P a g e NEW ZEALAND DATA SHEET 1. PRODUCT NAME ORATANE* 5 mg soft gelatin capsule ORATANE* 10 mg soft gelatin capsule ORATANE* 20 mg soft gelatin capsule ORATANE* 30 mg soft gelatin capsule ORATANE* 40 mg soft gelatin capsule 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ORATANE 5 mg soft gelatin capsule contains 5 mg of isotretinoin. Each ORATANE 10 mg soft gelatin capsule contains 10 mg of isotretinoin. Each ORATANE 20 mg soft gelatin capsule contains 20 mg of isotretinoin. Each ORATANE 30 mg soft gelatin capsule contains 30 mg of isotretinoin. Each ORATANE 40 mg soft gelatin capsule contains 40 mg of isotretinoin. EXCIPIENT(S) WITH KNOWN EFFECT ORATANE soft gelatin capsules contain soyabean products. Sulfur dioxide is present as a residue in gelatin. For the full list of excipients, _see Section 6.1._ 3. PHARMACEUTICAL FORM ORATANE 5 mg capsules: Soft gelatin oval opaque white capsules, approximately 8 mm in length and 5 mm in diameter. ORATANE 10 mg capsules: Soft gelatin oval opaque violet capsules, approximately 10 mm in length and 7 mm in diameter. ORATANE 20 mg capsules: Soft gelatin oval opaque maroon capsules, approximately 13 mm in length and 8 mm in diameter. ORATANE 30 mg capsules: Soft gelatin oval opaque pink capsules, approximately 12 mm length and 8 mm in diameter. ORATANE 40 mg capsules: Soft gelatin oval opaque light orange capsules, approximately 13 mm length and 8 mm in diameter. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Severe forms of nodulo-cystic acne which are resistant to therapy, particularly cystic acne and acne conglobata, especially when the lesions involve the trunk. 2 | P a g e ORATANE should only be prescribed by physicians who are experienced in the use of systemic retinoids, preferably dermatologists, and understand the risk of teratogenicity if ORATANE is used during pregnancy. 4.2. DOSE AND METHOD OF ADMINISTRATION DOSE The therapeutic response to isotretinoin and some of the adverse effects are dose-related and vary between patients. This necessitates adapt Leia o documento completo