Country: Ավստրալիա
language: անգլերեն
source: Department of Health (Therapeutic Goods Administration)
isotretinoin, Quantity: 20 mg
Roche Products Pty Ltd
Capsule, soft
Excipient Ingredients: yellow beeswax; hydrogenated soya oil; Soya Oil; Gelatin; glycerol; titanium dioxide; partially hydrogenated soya oil; iron oxide red; maize starch; sorbitol; mannitol; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid
Oral
60 capsules, 30 capsules
(S4) Prescription Only Medicine
ROACCUTANE is indicated for the treatment of severe cystic acne, and a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. If a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off drug. Because of significant adverse effects associated with its use, ROACCUTANE should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.
Visual Identification: one half brown-red, opaque, one half white, opaque, oval shaped, imprinted with 'ROA 20'.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1994-12-13
ROACCUTANE ® _contains the active ingredient isotretinoin_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Roaccutane. 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 Roaccutane 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 ROACCUTANE IS USED FOR Roaccutane contains the active ingredient isotretinoin. Roaccutane is used to treat acne. Roaccutane belongs to a group of medicines called retinoids, which are similar to vitamin A. Retinoids work by reducing the amount of the oily substance (i.e. sebum) made by glands in your skin, reducing bacteria and inflammation and opening clogged pores. There are many different types of medicines used to treat acne. Roaccutane is used for more severe cases. YOUR DOCTOR, HOWEVER, MAY HAVE PRESCRIBED ROACCUTANE FOR ANOTHER PURPOSE. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ROACCUTANE HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. Roaccutane is not addictive. BEFORE YOU TAKE ROACCUTANE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE ROACCUTANE IF: 1. YOU ARE PREGNANT, OR FOR AT LEAST ONE MONTH BEFORE YOU PLAN TO FALL PREGNANT IF YOU FALL PREGNANT WHILE TAKING ROACCUTANE THERE IS AN EXTREMELY HIGH RISK OF HAVING A BABY THAT IS SEVERELY DEFORMED. YOU MUST USE EFFECTIVE CONTRACEPTION FOR ONE MONTH BEFORE, DURING AND ONE MONTH AFTER TREATMENT. 2. YOU ARE BREASTFEEDING YOU MUST STOP BREASTFEEDING BEFORE TREATMENT BEGINS. DO NOT BREASTFEED WHILE TAKING ROACCUTANE. 3. YOU HAVE HAD AN ALLERGIC REACTION TO ROACCUTANE, VITAMIN A, OTHER RETINOIDS OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET 4. YOU ARE TAKING TETRACYCLINE ANTIBIOTICS 5. YOU HAVE SEVERE LIVER DIS read_full_document
Roaccutane ® PI 190415 1 AUSTRALIAN PRODUCT INFORMATION ROACCUTANE (ISOTRETINOIN) 1. NAME OF THE MEDICINE Isotretinoin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Roaccutane 20 mg capsule contains isotretinoin 20mg Excipients with known effect Contains soya bean oil (refined, hydrogenated and partially hydrogenated). For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Roaccutane 20 mg - half brown-red soft capsule half opaque white, imprinted with ROA 20 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Roaccutane is indicated for the treatment of severe cystic acne, and a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. If a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off drug. Because of significant adverse effects associated with its use, Roaccutane should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE The therapeutic response to Roaccutane is dose related and varies between patients. This necessitates individual adjustment of dosage according to the response of the condition and the patient's tolerance of the drug. In most cases complete or near-complete suppression of acne is achieved with a 16 week course of treatment. All patients initially should receive Roaccutane at doses up to 0.5 mg/kg/day bodyweight daily for a period of two to four weeks, when their responsiveness to the drug will usually be apparent. It should be noted that transient exacerbation of acne is occasionally seen during this initial period. Satisfactory initial responses have been reported from 0.05 mg/kg/day. Relapse rates on the lower doses are higher (a second course may be required in about two-thirds of patients on 0.1 mg/kg/day for 16 weeks), but read_full_document