Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PRAMIPEXOLE
Rowex Ltd
N04BC05
PRAMIPEXOLE
0.088 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Dopamine agonists
Authorised
2010-02-26
1.1.1 1.3.1.3 PATIENT INFORMATION LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PRAPEXIN 0.088 MG TABLETS PRAPEXIN 0.18 MG TABLETS PRAPEXIN 0.7 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 Prapexin is and what it is used for 2. What you need to know before you take Prapexin 3. How to take Prapexin 4. Possible side effects 5. How to store Prapexin 6. Contents of the pack and other information 1. WHAT PRAPEXIN IS AND WHAT IT IS USED FOR Prapexin 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. Prapexin IS USED TO: treat the symptoms of primary Parkinson’s disease in adults. It can be used alone or in combination with levodopa (another medicine for Parkinson’s disease). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRAPEXIN DO NOT TAKE PRAPEXIN: - if you are allergic to pramipexole or to any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Prapexin if you have (had) or develop any medical conditions or symptoms, especially any of the following: kidney disease hallucin Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prapexin 0.088 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.088 mg pramipexole (as 0.125 mg pramipexole dihydrochloride monohydrate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to off- white, uncoated, round shaped tablet, plain on both the sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prapexin 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 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 dosage should be titrated to achieve a maximal therapeutic effect. Ascending – Dose Schedule of Pramipexole Week Dose (mg of base) Total Daily Dose (mg of base) Dose (mg of salt) Total Daily Dose (mg of salt) 1 3 x 0.088 0.264 3 x 0.125 0.375 2 3 x 0.18 0.54 3 x 0.25 0.75 3 3 x 0.35 1.1 3 x 0.5 1.50 HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 13/01/2015_ _CRN 2152842_ _page number: 1_ If a further dose increase is necessary the daily dose should be increased by 0.54 mg of base (0.75 mg of sal Read the complete document