Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Pramipexole dihydrochloride monohydrate
Consilient Health Ltd
N04BC05
Pramipexole dihydrochloride monohydrate
2.1mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04090100; GTIN: 5391512452445
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OPRYMEA 0.26 MG PROLONGED-RELEASE TABLETS OPRYMEA 0.52 MG PROLONGED-RELEASE TABLETS OPRYMEA 1.05 MG PROLONGED-RELEASE TABLETS OPRYMEA 1.57 MG PROLONGED-RELEASE TABLETS OPRYMEA 2.1 MG PROLONGED-RELEASE TABLETS OPRYMEA 2.62 MG PROLONGED-RELEASE TABLETS OPRYMEA 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 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 Oprymea is and what it is used for 2. What you need to know before you take Oprymea 3. How to take Oprymea 4. Possible side effects 5. How to store Oprymea 6. Contents of the pack and other information 1. WHAT OPRYMEA IS AND WHAT IT IS USED FOR Oprymea 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. Oprymea 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 OPRYMEA DO NOT TAKE OPRYMEA: - if you are allergic to pramipexole or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor before taking Oprymea. 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 feel Read the complete document
OBJECT 1 OPRYMEA 2.1 MG PROLONGED-RELEASE TABLETS Summary of Product Characteristics Updated 20-May-2016 | Consilient Health Ltd 1. Name of the medicinal product Oprymea 2.1 mg prolonged-release tablets 2. Qualitative and quantitative composition Each prolonged-release tablet contains 2.1 mg pramipexole (as 3 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 Prolonged-release tablet White or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P4 on one side, with bevelled edges and possible spots. 4. Clinical particulars 4.1 Therapeutic indications Oprymea 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 Oprymea 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. Ascending dose schedule of Oprymea prolonged-release tablets Week Daily dose (mg of base) Daily dose (mg of salt) 1 0.26 0.375 2 0.52 0.75 3 1.05 1.5 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 Read the complete document