Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
levodopa, Quantity: 100 mg; benserazide hydrochloride, Quantity: 28.5 mg (Equivalent: benserazide, Qty 25 mg)
Roche Products Pty Ltd
Tablet, uncoated
Excipient Ingredients: crospovidone; microcrystalline cellulose; colloidal anhydrous silica; pregelatinised maize starch; docusate sodium; iron oxide red; calcium hydrogen phosphate; magnesium stearate; ethylcellulose; mannitol
Oral
100 tablets
(S4) Prescription Only Medicine
Parkinson's disease and parkinsonian symptoms including post- encephalitic and toxic forms, but excluding drug induced parkinsonism.
Visual Identification: Cylindrical, biconvex, pale red tablet, cross-scored on both sides; Container Type: Bottle; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius
Registered
1993-09-28
MADOPAR ® _(levodopa and benserazide)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Madopar tablets and capsules. 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 Madopar 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 MADOPAR IS USED FOR The name of your medicine is Madopar. It contains two active ingredients called levodopa and benserazide. Madopar belongs to a group of medicines called antiparkinsonian agents and is used for the treatment of Parkinson's disease. Antiparkinsonian agents work on the central nervous system. The symptoms of Parkinson's disease are caused by a deficiency of a natural substance in the brain called dopamine. Madopar helps to replace this substance. By improving muscle control, Madopar allows more normal movements of the body. The symptoms of patients suffering from Parkinson's disease can be reduced by taking this medicine. Madopar does not, however, cure the disease, since the cause of the dopamine deficiency within the brain is not removed. Your doctor, however, may have prescribed Madopar for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY MADOPAR HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE MADOPAR _DO NOT TAKE MADOPAR IF:_ DO NOT TAKE MADOPAR IF YOU HAVE AN ALLERGY TO: • any medicine containing levodopa or benserazide • any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin DO NOT TAKE MADOPAR IF: Lugege kogu dokumenti
Madopar 190620 1 AUSTRALIAN PRODUCT INFORMATION MADOPAR (LEVODOPA AND BENSERAZIDE HYDROCHLORIDE) 1. NAME OF THE MEDICINE Levodopa and benserazide hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Madopar 62.5 capsule contains 50 mg Levodopa and 14.25 mg Benserazide (equivalent to 12.5 mg of the base) Each Madopar 125 capsule contains 100 mg Levodopa and 28.5 mg Benserazide (equivalent to 25 mg of the base) Each Madopar 250 capsule contains 200 mg Levodopa and 57 mg Benserazide (equivalent to 50 mg of the base) Each Madopar HBS 125 capsule contains 100 mg Levodopa and 28.5 mg Benserazide (equivalent to 25 mg of the base) Each Madopar 125 tablet contains 100 mg Levodopa and 28.5 mg Benserazide (equivalent to 25 mg of the base) Each Madopar 250 tablet contains 200 mg Levodopa and 57 mg Benserazide (equivalent to 50 mg of the base) Each Madopar Rapid 62.5 dispersible tablet contains 50 mg Levodopa and 14.25 mg Benserazide (equivalent to 12.5 mg of the base) Each Madopar Rapid 125 dispersible tablet contains 100 mg Levodopa and 28.5 mg Benserazide (equivalent to 25 mg of the base) For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Madopar 62.5 capsules have a light grey opaque body with powder blue opaque cap, imprinted with 'ROCHE' on both ends Madopar 125 capsules have a flesh coloured opaque body and powder blue opaque cap, imprinted with 'ROCHE' on both ends Madopar 250 capsules have a caramel coloured opaque body and powder-blue opaque cap, imprinted with 'ROCHE' on both ends Madopar HBS (Hydrodynamically Balanced System) 125 capsules have a light blue opaque body and dark green opaque cap imprinted with ‘ROCHE’ in red ink on both ends Madopar 125 tablets are cylindrical, biconvex, pale red tablets, cross-scored on both sides Madopar 250 tablets are cylindrical, biconvex, pale red tablets, imprinted with ‘ROCHE’ and a hexagon on one side, cross-scored on both sides Madopar 190620 2 Madopar Rapid 62.5 dispersible tablets are off-white, cylindrical, bi-p Lugege kogu dokumenti