Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
Glenmark Pharmaceuticals Europe Limited
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
0.18 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Withdrawn
2014-01-17
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER GLEPARK 0.088mg tablets GLEPARK 0.18mg tablets GLEPARK 0.35mg tablets GLEPARK 0.7mg tablets (pramipexole) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What GLEPARK is and what it is used for 2. Before you take GLEPARK 3. How to take GLEPARK 4. Possible side effects 5. How to store GLEPARK 6. Further information 1. WHAT GLEPARK IS AND WHAT IT IS USED FOR GLEPARK belongs to a group of medicines known as dopamine agonists, which stimulate dopamine receptors in the brain. Stimulation of the dopamine receptors triggers nerve impulses in the brain that help to control body movements. GLEPARK is used to: treat the symptoms of primary Parkinson‟s disease. It can be used alone or in combination with levodopa (another medicine for Parkinson‟s disease). 2. BEFORE YOU TAKE GLEPARK DO NOT TAKE GLEPARK if you are allergic (hypersensitive) to pramipexole or to any of the other ingredients of the tablets (see Section 6, “Further information”). TAKE SPECIAL CARE WITH GLEPARK Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These are called impulse cont Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glepark 0.18 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Glepark 0.18 mg tablets contain 0.18 mg of pramipexole base (as 0.25 mg of pramipexole dihydrochloride monohydrate). Please note: Pramipexole doses as published in the literature refer to the salt form. Therefore, doses will be expressed in terms of both pramipexole base and pramipexole salt (in brackets). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Oval, white, flat bevelled uncoated tablets engraved with ‘PX’ and ‘1’ on either side of score line on one side and score line on the other side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Glepark is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson’s disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “on off” fluctuations). Glepark is indicated in adults for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in dosages up to 0.54 mg of base (0.75 mg of salt) (see section 4.2.). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Parkinson’s disease The daily dose is administered in equally divided doses 3 times a day. _Initial treatment:_ Doses should be increased gradually from a starting-dose of 0.264 mg of base (0.375 mg of salt) per day and then increased every 5 - 7 days. Providing patients do not experience intolerable undesirable effects, the dose should be titrated to achieve a maximal therapeutic effect. IRISH MEDICINES BO Lue koko asiakirja