Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
pramipexole dihydrochloride monohydrate, Quantity: 0.125 mg
Alphapharm Pty Ltd
pramipexole dihydrochloride monohydrate
Tablet
Excipient Ingredients: hyprolose; sodium citrate; crospovidone; magnesium stearate; mannitol; pregelatinised maize starch; colloidal anhydrous silica
Oral
10, 30, 100
(S4) Prescription Only Medicine
SIMPRAL is indicated for the treatment of signs and symptoms of idiopathic Parkinson's disease. It may be used as monotherapy or in combination with levodopa. It is also indicated for the symptomatic treatment of primary Restless Legs Syndrome.
Visual Identification: A white to off white, round, flat-faced tablet, debossed with 'PX1' on one side and 'M' on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-04-09
SIMPRAL _pramipexole dihydrochloride monohydrate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SIMPRAL. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking SIMPRAL against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT SIMPRAL IS USED FOR SIMPRALis used to treat the symptoms of Parkinson's disease 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 relays messages in the part of the brain that controls movement. When too little dopamine is produced, this results in Parkinson's disease. SIMPRAL works by having a similar effect as dopamine in the brain. _HOW SIMPRAL WORKS_ SIMPRAL contains the active ingredient pramipexole dihydrochloride monohydrate. Pramipexole dihydrochloride monohydrate 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 it for another reason. SIMPRAL is not addictive. This medicine is available only with a doctor's prescription. SIMPRAL is not recommended for use in children under 18 years of age as its safety and effectiveness in that age group have not been established. BEFORE YOU TAKE SIMPRAL _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE SIMPRAL IF YOU HAVE AN ALLERGY TO: • any medicine containing pramipexole dihydrochloride monohydrate (active ingredient) or • 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 o Läs hela dokumentet
AUSTRALIAN PRODUCT INFORMATION SIMPRAL _Pramipexole dihydrochloride monohydrate _ 1 NAME OF THE MEDICINE Pramipexole dihydrochloride monohydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each SIMPRAL tablet contains either 0.125 mg, 0.25 mg or 1 mg of pramipexole dihydrochloride monohydrate as the active ingredient. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM SIMPRAL 0.125 MG TABLETS : Each 0.125 mg tablet is presented as a white to off white, round, flat-faced tablet, debossed with PX1 on one side and M on the other side. SIMPRAL 0.25 MG TABLETS : Each 0.25 mg tablet is presented as a white to off-white, biconvex oval shaped tablet, debossed with PX2 on one side and M on one side of breakline on other side. SIMPRAL 1 MG TABLETS : Each 1 mg tablet is presented as a white to off white, round, flat-faced tablet, debossed with M over PX4 on one side and breakline on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SIMPRAL is indicated for the treatment of signs and symptoms of idiopathic Parkinson's disease. It may be used as monotherapy or in combination with levodopa. 4.2 DOSE AND METHOD OF ADMINISTRATION SIMPRAL tablets should be taken orally, swallowed with water. SIMPRAL can be taken either with or without food. The daily dosage is administered in equally divided doses three times per day. PARKINSON’S DISEASE _INITIAL TREATMENT _ Dosages should be increased gradually from a starting dose of 0.375 mg SIMPRAL per day and then increased every 5 to 7 days. Providing patients do not experience intolerable side effects, the dosage should be titrated to achieve a maximal therapeutic effect. TABLE 1: ASCENDING DOSAGE SCHEDULE OF SIMPRAL FOR PARKINSON’S DISEASE WEEK TOTAL DAILY DOSE OF PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE SIMPRAL TABLETS 1 0.375 mg 0.125 mg three times a day 2 0.75 mg 0.25 mg three times a day 3 1.5 mg 0.5 mg three times a day Simpral – PRODUCT INFORMATION 2 If a further dose increase is necessary the daily dose should be increased b Läs hela dokumentet