Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
Milpharm Limited
N04BC05
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
0.088 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Dopamine agonists
Authorised
2012-11-23
PACKAGE LEAFLET: INFORMATION FOR THE USER PRAMIPEXOLE AUROBINDO 0.088 MG TABLETS PRAMIPEXOLE AUROBINDO 0.18 MG TABLETS PRAMIPEXOLE AUROBINDO 0.7 MG TABLETS PRAMIPEXOLE AUROBINDO 1.1 MG TABLETS Pramipexole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Pramipexole Aurobindo is and what it is used for 2. What you need to know before you take Pramipexole Aurobindo 3. How to take Pramipexole Aurobindo 4. Possible side effects 5. How to store Pramipexole Aurobindo 6. Contents of the pack and other information 1. WHAT PRAMIPEXOLE AUROBINDO IS AND WHAT IT IS USED FOR Pramipexole Aurobindo contains the active substance pramipexole and 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. PRAMIPEXOLE AUROBINDO 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). Pramipexole Aurobindo may also be authorised to treat other conditions which are not mentioned in this leaflet. Ask your doctor or pharmacist if you have further questions. 2. WHAT YOU NEE Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pramipexole Aurobindo 0.088 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.125 mg of pramipexole dihydrochloride monohydrate equivalent to 0.088 mg pramipexole. _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 the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to off-white, round [5.5 mm in diameter], flat, beveled edge, uncoated tablets, debossed with ‘Y’ on one side ‘41’ on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pramipexole Aurobindo 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). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Parkinson’s disease The daily doses 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. If a further dose increase is necessary the daily dose should be increased by 0.54 mg of base (0.75 mg of salt) at weekly intervals up to a maximum dose of 3.3 mg of base (4.5 mg of salt) per day. Ascending – Dose Schedule of P Read the complete document