Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ISOTRETINOIN
SCHMIDT BIOMEDTECH SDN BHD
ISOTRETINOIN
15 Capsule Capsules; 15Tablet Tablets; 60 Capsule Capsules; 100Tablet Tablets
SWISSCAPS AG
ORATANE 5MG, 10 MG AND 20 MG CAPSULES (Isotretinoin) _Consumer Medication Information Leaflet (RiMUP)_ WHAT IS IN THIS LEAFLET 1. What ORATANE CAPSULES is used for 2. How ORATANE CAPSULES works 3. Before you use ORATANE CAPSULES 4. How to take ORATANE CAPSULES 5. While you are using ORATANE CAPSULES 6. Side effects 7. Storage and Disposal of ORATANE CAPSULES 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT ORATANE CAPSULES IS USED FOR The active ingredient in ORATANE CAPSULES is Oratane, 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. YOUR DOCTOR MAY HAVE PRESCRIBED ORATANE FOR ANOTHER PURPOSE. Ask your doctor if you have any questions about why ORATANE has been prescribed for you. ORATANE capsules are not addictive. How ORATANE capsules works ORATANE capsules work by cutting down the amount of oily substances (sebum) made by our glands in your skin. ORATANE capsules will also help to reduce the bacteria, inflammation and open clogged pores. BEFORE YOU USE ORATANE CAPSULES _- When you must not use it_ DO NOT TAKE ORATANE CAPSULES IF: 1. DO NOT USE IF YOU ARE PREGNANT OR THINKING OF BECOMING PREGNANT. YOUR DOCTOR CAN GIVE YOU MORE INFORMATION. IF YOU FALL PREGNANT WHILE TAKING ORATANE CAPSULES THERE IS AN EXTREMELY HIGH RISK OF HAVING A BABY THAT IS SEVERELY DEFORMED. THIS MEANS THAT YOU MUST USE EFFECTIVE CONTRACEPTION FOR ONE MONTH BEFORE, DURING AND AT LEAST ONE MONTH AFTER TREATMENT WITH ORATANE. 2. YOU ARE BREAST-FEEDING. Breastfeeding must stop before ORATANE treatment can start. Do not breast-feed while taking ORATANE capsules. 3. YOU HAVE HAD AN ALLERGIC REACTION TO ORATANE CAPSULES, VITAMIN A, OTHER RETINOIDS OR ANY INGREDIENTS LISTED AT THE END OF THIS LEAFLET. 4. YOU ARE TAKING TETRACYCLINE ANTIBIOTICS. These include Doxine®, DoxyTM Achromycin ®, and Minomycin®. 5. YOU HAVE KIDNEY OR LIVER DISEASE. Прочетете целия документ
PRESENTATION ORATANE 5 mg capsules are faint pinkish-cream to cream coloured, oval, soft-gelatin capsules containing a yellow/ orange, opaque, viscous liquid. ORATANE 10 mg capsules are opaque, violet, oval, length 10 mm and diameter 7 mm, containing 10 mg of isotretinoin. ORATANE 20 mg capsules are opaque, maroon, oval, length 13 mm and diameter 8 mm, containing 20 mg of isotretinoin. ACTIONS Isotretinoin is a retinoid with a specific antiseborrheic action for oral treatment of severe cystic acne and conglobate acne resistant to other forms of treatment. Isotretinoin, the active ingredient of ORATANE, is a synthetic stereoisomer of alltrans retinoic acid (tretinoin), an active substance which has proved effective in topical treatment of acne vulgaris, Isotretinoin is chemically identified as 13-cis retinoic acid: (2Z, 4E, 6E, 8E)-3,7-dimethyl-9-(2,6,6- trimethylcyclohexen-1-yl) nona-2,4,6,8-tetraenoic acid, molecular weight 300.42 and molecular formula is C 20 H 28 O 2 Administered orally, isotretinoin has a marked effect in severe forms of acne, which have proved insufficiently responsive to previous treatment. The mechanism of action of isotretinoin has not yet been elucidated in detail, but it has been established that the improvement observed in the clinical picture of severe acne is associated with doserelated suppression of sebaceous gland activity and a histologically demonstrated reduction in the size of the sebaceous glands. Furthermore, a dermal anti-inflammatory effect of isotretinoin has been established. PHARMACOKINETICS Time-related blood concentrations can be predicted on the basis of linear pharmacokinetics. _ABSORPTION:_ Peak plasma concentrations (Cmax) of approximately 200-300ng/ml have been achieved in healthy volunteers three to four hours (tmax) after administration of 40 mg isotretinoin. Taking isotretinoin with food increases bioavailability up to twofold relative to fasting conditions, probably as a result of easier absorption oft his highly lipophilic medication. Furthermore, there is a Прочетете целия документ