Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
DB Ashbourne Ltd
N04BC05
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
0.26 Milligram
Tablet Prolonged Release
Product subject to prescription which may be renewed (B)
Dopamine agonists
Authorised
2016-09-16
PACKAGE LEAFLET: INFORMATION FOR THE USER Pipexus 0.26 mg prolonged-release tablets Pipexus 0.52 mg prolonged-release tablets Pipexus 1.05 mg prolonged-release tablets Pipexus 1.57 mg prolonged-release tablets Pipexus 2.1 mg prolonged-release tablets Pipexus 2.62 mg prolonged-release tablets Pipexus 3.15 mg prolonged-release 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, pharmacist or nurse . - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4 WHAT IS IN THIS LEAFLET 1. What Pipexus is and what it is used for 2. What you need to know before you take Pipexus 3. How to take Pipexus 4. Possible side effects 5. How to store Pipexus 6. Contents of the pack and other information 1. WHAT PIPEXUS IS AND WHAT IT IS USED FOR Pipexus 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. Pipexus 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 PIPEXUS DO NOT TAKE PIPEXUS - 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 before taking Pipexus. Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any of the following: - Kidney disease. - Hallucinations (seeing, he Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pipexus 0.26 mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.26 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 Prolonged-release tablet. The round tablets of 9 mm diameter are white or nearly white, have a flat surface with bevelled edges and are marked with 026 on one side 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pipexus 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 Pipexus prolonged-release tablets are a once-a-day oral formulation of pramipexole. _Initial treatment_ Doses should be increased gradually from a starting dose of 0.26 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 0.52 mg of base (0.75 mg of salt) at weekly intervals up to a maximum dose of 3.15 mg of base (4.5 mg of salt) per day. However, it should be noted that the incidence of somnolence is increased at doses higher than 1.05 mg of base (1.5 mg of salt) per day (see section 4.8). Patients already taking pramipexole tablets may be switched to Pipexus prolonged-release tablets overnight, at the same daily dose. Af Lire le document complet