Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LEVODOPA BENSERAZIDE
B & S Healthcare
200/50 Milligram
Capsules Hard
2010-10-15
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Madopar 200mg/50mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 200mg levodopa and 50mg benserazide (as benserazide hydrochloride). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsules, hard (Capsules) _Product imported from _the UK: Light brown and pale blue capsules imprinted with the name ‘ROCHE’ in black ink on both sections 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of Parkinsonism of idiopathic, post-encephalitic or arteriosclerotic type. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ADULTS OVER THE AGE OF 25 YEARS ONLY:_ Madopar 200mg/50mg capsules are only for maintenance therapy once the optimal dosage has been determined using Madopar 100mg/25mgdispersible tablets. _Patients not previously treated with levodopa: _The recommended initial dose is one dispersible tablet of Madopar 50mg/12.5mg three or four times daily. If the disease is at an advanced stage, the starting dose should be one dispersible tablet of Madopar 100mg/25mg three times daily. The daily dosage should then be increased by one dispersible tablet of Madopar 100mg/25mg, or the equivalent, once or twice weekly until a full therapeutic effect is obtained, or side effects supervene. In some elderly patients, it may suffice to initiate treatment with one dispersible tablet of Madopar 50mg/12.5mg once or twice daily, increasing by one capsule every third or fourth day. The effective dose usually lies within the range of four to eight dispersible tablets of Madopar 100mg/25mg (two to four capsules of Madopar 200mg/50mg) daily in divided doses, most patients requiring no more than six dispersible tablets of Madopar 100mg/25mg daily. Optimal improvement is usu Read the complete document