Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Pergolide mesilate
Dowelhurst Ltd
N04BC02
Pergolide mesilate
1mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04090100
PACKAGE LEAFLET: INFORMATION FOR THE USER PERGOLIDE 50 MICROGRAMS, 250 MICROGRAMS AND 1 MG TABLETS (PERGOLIDE MESILATE) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. x Keep this leaflet. You may need to read it again. x If you have any further questions, ask your doctor or pharmacist. x 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. x If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. WHAT PERGOLIDE IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERGOLIDE 3. HOW TO TAKE PERGOLIDE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE PERGOLIDE 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT PERGOLIDE IS AND WHAT IT IS USED FOR Pergolide belongs to a group of drugs known as dopamine receptor agonists. Pergolide is used to help control and reduce the effects or symptoms of Parkinson’s disease when patients are intolerant to or have failed alternate treatments with other medicines. Pergolide is sometimes used with other medicines that contain levodopa, e.g. Madopar £ and Sinemet £ . 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERGOLIDE DO NOT TAKE PERGOLIDE IF YOU: x are allergic (hypersensitive) to pergolide or any of the other ingredients of this medicine listed in section 6 x have a known sensitivity to any other ‘ergot’ medicines e.g. bromocriptine or lisuride, or 'ergot' medicines used to treat or prevent migraine e.g. ergotamine or methysergide x have ever experienced shortness of breath, chest or back pain, swollen legs or heart trouble after previously taking ergot medicines x have or had fibrotic reactions (scar tissue) affecting your heart x have heart valve problems. x are pregnant or breast-feeding. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING PERGOLIDE IF YOU: x have or had Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pergolide 1 milligram Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains, as the active ingredient, pergolide mesilate equivalent to 1 milligram of pergolide. 3. PHARMACEUTICAL FORM Tablet: light pink, rectangular shaped, scored, marked ‘G’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Second-line therapy of Parkinson’s disease, or as adjunctive treatment to levodopa, when treatment with dopamine agonist is considered and when non-ergot alkaloids are contraindicated or are no longer adequate. The treatment should be initiated under specialist supervision. The benefit of continuing treatment should be regularly reassessed taking into account the risk of fibrotic reactions and valvulopathy (see sections 4.3, 4.4 and 4.8). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration to adults only. _Monotherapy _ The following titration should be used for initiation of pergolide as monotherapy: Day Morning Noon Evening Total Dosage 1 - - 50 micrograms 50 micrograms 2 – 4 - 50 micrograms 50 micrograms 100 micrograms 5 – 7 50 micrograms 50 micrograms 100 micrograms 200 micrograms 8 – 10 100 micrograms 100 micrograms 100 micrograms 300 micrograms 11 – 13 100 micrograms 150 micrograms 150 micrograms 400 micrograms 14 – 17 200 micrograms 200 micrograms 200 micrograms 600 micrograms 18 – 21 250 micrograms 250 micrograms 250 micrograms 750 micrograms 22 – 24 500 micrograms 250 micrograms 250 micrograms 1000 micrograms 25 – 27 500 micrograms 500 micrograms 250 micrograms 1250 micrograms 28 – 30 500 micrograms 500 micrograms 500 micrograms 1500 micrograms After day 30, the daily dose should be increased by at most 250 micrograms twice a week until an optimal therapeutic response is achieved. Pergolide mesilate is usually administered in divided doses 3 times per day. In clinical studies of pergolide as monotherapy, the mean dose was 2100 micrograms per day at 3 months and 2510 micrograms per day at 1 ye Read the complete document