Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Pramipexole dihydrochloride monohydrate
Bluefish Pharmaceuticals AB
N04BC; N04BC05
Pramipexole dihydrochloride monohydrate
0.18 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Dopamine agonists; pramipexole
Marketed
2010-07-16
PACKAGE LEAFLET: INFORMATION FOR THE USER PRAMIPEXOLE BLUEFISH 0.18 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 Bluefish is and what it is used for 2. What you need to know before you take Pramipexole Bluefish 3. How to take Pramipexole Bluefish 4. Possible side effects 5. How to store Pramipexole Bluefish 6. Contents of the pack and other information 1. WHAT PRAMIPEXOLE BLUEFISH IS AND WHAT IT IS USED FOR Pramipexole Bluefish 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 BLUEFISH 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 PRAMIPEXOLE BLUEFISH DO NOT TAKE PRAMIPEXOLE BLUEFISH: if you are allergic (hypersensitive) to pramipexole or to any of the other ingredients of this medicine (see listed in Section 6). WARNINGS AND PRECAUTIONS: Talk to your doctor before taking Pramipexole Bluefish. Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any of the following: Kidney disease. Hallucinations (seeing, hearing or feeling things that are not there). Most hallucinations are visual. Dyskinesia (e.g. abnormal Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pramipexole Bluefish 0.18 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Pramipexole Bluefish 0.18 mg tablets contain 0.18 mg of pramipexole base (as 0.25 mg 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 the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, oblong, 9 mm x 4.5 mm, uncoated tablets with score line. The tablets can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pramipexole Bluefish 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 dose should be titrated to achieve a maximal therapeutic effect. 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 H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Citiți documentul complet