Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
Niche Generics Limited
0.088 Milligram
Tablets
2012-01-06
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mirexel 0.088mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Tablet contains 0.088mg of pramipexole base (equivalent to 0.125mg pramipexole dihydrochloride monohydrate). For a full list of excipients, see Section 6.1. 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). 3 PHARMACEUTICAL FORM Tablet White, round, without scores, marked “P” on one side and “1” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mirexel 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 Parkinson’s disease The daily dosage is administered in equally divided doses 3 times a day. _Initial treatment_ Dosages 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 side-effects, the dosage should be titrated to achieve a maximal therapeutic effect. If a further dose increase is necessary the daily dose should be increased by 0.54 mg base (0.75 mg salt) at weekly Ascending – Dose Schedule of Mirexel WEEK DOSAGE (MG OF BASE) TOTAL DAILY DOSE (MG OF BASE) DOSAGE (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 Read the complete document