Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
pramipexole dihydrochloride monohydrate, Quantity: 3.75 mg
Arrotex Pharmaceuticals Pty Ltd
pramipexole dihydrochloride monohydrate
Tablet, modified release
Excipient Ingredients: calcium hydrogen phosphate; hypromellose; silicon dioxide; magnesium stearate
Oral
10, 30
(S4) Prescription Only Medicine
For the treatment of signs and symptoms of idiopathic Parkinson's disease. It may be used as monotherapy or in combination with levodopa.
Visual Identification: White or nearly white, cylindrical and biconvex tablets marked with 262 on one side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2015-06-17
APO-PRAMIPEXOLE ER _MODIFIED RELEASE TABLETS_ _Pramipexole dihydrochloride monohydrate_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about pramipexole. 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 using this medicine 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 want to read it again. WHAT THIS MEDICINE IS USED FOR Pramipexole is used to treat symptoms of Parkinson's disease. It belongs to a group of medicines known as dopamine agonists. _HOW IT WORKS_ Parkinson's disease is a disease of the brain that affects body movement. The symptoms of Parkinson's disease are caused by a lack of dopamine, a naturally occurring chemical produced by certain brain cells. Dopamine binds to dopamine receptors and relays messages in the part of the brain that controls movement. When too little dopamine is produced, this results in Parkinson's disease. Pramipexole works by having a similar effect as dopamine in the brain. Pramipexole ER contains the active ingredient pramipexole dihydrochloride monohydrate. It belongs to a group of medicines known as dopamine agonists, which bind to dopamine receptors. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. This medicine is not addictive. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • any medicine containing pramipexole dihydrochloride monohydrate (the active • ingredient) or • any of the ingredients listed at the end of this leaflet. Some of the symptoms Citiți documentul complet
1 AUSTRALIAN PRODUCT INFORMATION – APO-PRAMIPEXOLE ER (PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE) MODIFIED RELEASE TABLET 1 NAME OF THE MEDICINE Pramipexole Dihydrochloride Monohydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each APO-Pramipexole ER modified release tablet contains pramipexole dihydrochloride monohydrate, as the active ingredient. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.375 MG MODIFIED RELEASE TABLETS White or nearly white, cylindrical, plans and bevel tablets marked with 026 on one side. PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.75 MG MODIFIED RELEASE TABLETS White or nearly white, cylindrical and biconvex tablets marked with 052 on one side. PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.5 MG MODIFIED RELEASE TABLETS White or nearly white, cylindrical and biconvex tablets marked with 105 on one side. PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 2.25 MG MODIFIED RELEASE TABLETS White or nearly white, cylindrical and biconvex tablets marked with 157 on one side. PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 3 MG MODIFIED RELEASE TABLETS: White or nearly white, cylindrical and biconvex tablets marked with 210 on one side. PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 3.75MG MODIFIED RELEASE TABLETS White or nearly white, cylindrical and biconvex tablets marked with 262 on one side. PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 4.5 MG MODIFIED RELEASE TABLETS White or nearly white, cylindrical, plans and bevel tablets marked with 315 on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Modified-release pramipexole tablets are indicated for: • The treatment of signs and symptoms of idiopathic Parkinson’s disease. It may be used as monotherapy or in combination with levodopa. 2 4.2 DOSE AND METHOD OF ADMINISTRATION APO-Pramipexole ER modified release tablets are for oral administration. Modified-release pramipexole tablets should be taken once daily at about the same time each day. Modified-release pramipexole tablets sh Citiți documentul complet