Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Pramipexole dihydrochloride monohydrate
Milpharm Ltd
N04BC05
Pramipexole dihydrochloride monohydrate
180microgram
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04090100
Number of tablets Total daily dose (mg) ST 1 WEEK 1 tablet Pramipexole 0.088 mg three times a day 0.264 Number of tablets ND 2 WEEK 1 tablet Pramipexole 0.18 mg three times a day OR 2 tablets Pramipexole 0.088 mg three times a day 1 tablet Pramipexole 0.35 mg three times a day OR 2 tablets Pramipexole 0.18 mg three times a day RD 3 WEEK Total daily dose (mg) 0.54 1.1 PRAMIPEXOLE 0.088 MG TABLETS PRAMIPEXOLE 0.18 MG TABLETS PRAMIPEXOLE 0.7 MG TABLETS Pramipexole PACKAGE LEAFLET: INFORMATION FOR THE USER 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 is and what it is used for 2. What you need to know before you take Pramipexole 3. How to take Pramipexole 4. Possible side effects 5. How to store Pramipexole 6. Contents of the pack and other information Pramipexole 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 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 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. DO NOT TAKE PRAMIPEXOLE - if you are allergic to pramipexole or to any of the other ingredients of this medicine (listed in Les hele dokumentet
OBJECT 1 PRAMIPEXOLE 0.18MG TABLETS Summary of Product Characteristics Updated 09-Aug-2017 | Aurobindo Pharma - Milpharm Ltd. 1. Name of the medicinal product Pramipexole 0.18 mg Tablets 2. Qualitative and quantitative composition Each tablet contains 0.25 mg of pramipexole dihydrochloride monohydrate equivalent to 0.18 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, oval, biconcave, beveled edge, uncoated tablets, debossed with 'Y' and '42' separated by score line on one side and plain with score line on other side. The size is 6.5 mm X 4.5 mm. The tablet can be divided into equal doses. 4. Clinical particulars 4.1 Therapeutic indications Pramipexole 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. 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 If a further dose increase is necessary the daily dose should be increased by Les hele dokumentet