Država: Malezija
Jezik: engleski
Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVODOPA; BENSERAZIDE HYDROCHLORIDE
ROCHE (MALAYSIA) SDN. BHD.
LEVODOPA; BENSERAZIDE HYDROCHLORIDE
30Capsule Capsules; 100Capsule Capsules
Delpharm Milano s.r.l
_ _ _ _ _Consumer Medication Information Leaflet (RiMUP) _ _ _ MADOPAR ® _Contains active ingredient Levodopa and Benserazide _ _ _ 1 WHAT IS IN THIS LEAFLET 1. What Madopar is used for 2. How Madopar works 3. Before you use Madopar 4. How to use Madopar 5. While you are using it 6. Side effects 7. Storage and disposal of Madopar 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of Revision 12. Serial Number WHAT MADOPAR IS USED FOR The name of your medicine is Madopar. It contains two active ingredients called levodopa and benserazide. 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 why Madopar has been prescribed for you. This medicine is available only with a doctor's prescription. HOW MADOPAR WORKS Madopar belongs to a group of medicines called antiparkinsonian agents and is used for the treatment of Parkinson’s disease. Antiparkinsonian agents are used to treat Parkinson's disease and 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. BEFORE YOU USE MADOPAR - _WHEN YOU MUST NOT USE IT _ Do not take Madopar if: you have had an allergic reaction to any of the ingredients listed in the Ingredients section of this leaflet you have taken a non- selective monoamine oxidase inhibitor (MAOI) medicine you have taken a combination of a selective MAO-A inhibitor such as moclobemide with a selective MAO-B inhibitor such as selegiline you have untreated heart, liver, kidney, lung, blood or endocrine (hormonal) disease you have narrow (closed) angle glaucoma (high pressu Pročitajte cijeli dokument
PACK INSERT FOR MALAYSIA Madopar P ® P Levodopa + Benserazide For the treatment of parkinsonian patients Composition Active ingredient: Madopar is a combination of levodopa and the decarboxylase inhibitor benserazide (as hydrochloride) in the ratio of 4:1. Excipients : Madopar contains the colorants indigotine (E 132), titanium dioxide (E 171) or iron oxide (E 172) depending on the formulation. The preparation is available as capsules of three different strengths, as cross -scored tablets of two diff erent strengths, as dispersible tablets of two different strengths and as capsules with a controlled -release action: Madopar ‘62.5’(blue and light grey capsules) with 50 mg levodopa + 12.5 mg benserazide (as hydrochloride); Madopar ‘125’ (blue and pink cap sules) with 100 mg levodopa + 25 mg benserazide (as hydrochloride); Madopar ‘250’ (blue and brown capsules) with 200 mg levodopa + 50 mg benserazide (as hydrochloride); Madopar ‘125’ cross scored (pink tablets) with 100 mg levodopa + 25 mg benserazide (as hydrochloride); Madopar ‘250’ cross scored (pink tablets) with 200 mg levodopa + 50 mg benserazide (as hydrochloride); Madopar ‘dispersible 62.5’ scored (off -white tablets) with 50 mg levodopa + 12.5 mg benserazide (as hydrochloride); Madopar ‘dispersible 125’ scored (off -white tablets) with 100 mg levodopa + 25 mg bens e- razide (as hydrochloride); Madopar HBS (Hydrodynamically Balanced System) (controlled -release green and light blue capsules) with 100 mg levodopa + 25 mg benserazide (as hydrochloride). Mad opar HBS capsules must not be opened or chewed before swallowing because the controlled -release characteristics will be lost! Pharmacological Properties and E ffects Pharmacotherapeutic group: Anti -parkinson drugs, ATC code: N04BA02 Pharmacodynamics Proper ties Mechanism of Action Dopamine, which acts as a neurotransmitter in the brain, is not present in sufficient quant i- ties in the basal ganglia of parkinsonian patients. Replacement therapy is performed by ad Pročitajte cijeli dokument