EPILIM Tablets Gastro-Resistant 500 Milligram
Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Карактеристике производа
(SPC)
30-04-2024
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Активни састојак:
VALPROATE SODIUM
Доступно од:
Imbat Limited
Дозирање:
500 Milligram
Фармацеутски облик:
Tablets Gastro-Resistant
Датум одобрења:
2009-08-28
Карактеристике производа
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Epilim Enteric 500mg Gastro-resistant Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 500mg of sodium valproate
Excipients: Contains amaranth lake (E123)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant coated tablets.
_Product imported from _the UK:
Lilac, biconvex, gastro-resistant coated tablet, plain on both sides
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of generalised, partial or other epilepsy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Epilim Enteric 500mg Gastro-resistant Coated Tablets are for oral administration.
Daily dosage requirements vary according to age and body weight.
Epilim tablets may be given twice daily. Tablets should be swallowed whole and not crushed or chewed.
In patients where adequate control has been achieved Epilim Chrono formulations are interchangeable with other
Epilim conventional or prolonged release formulations on an equivalent daily dosage basis.
DOSAGE
Usual requirements are as follows:
_ADULTS_
Dosage should start at 600mg daily increasing by 200mg at three-day intervals until control is achieved. This is
generally within the dosage range 1000mg to 2000mg per day, i.e. 20-30mg/kg/day body weight. Where adequate
control is not achieved within this range the dose may be further increased to 2500mg per day.
_CHILDREN OVER 20KG_
Initial dosage should be 400mg/day (irrespective of weight) with spaced increases until control is achieved; this is
usually within the range 20-30mg/kg body weight per day. Where adequate control is not achieved within this range the
dose may be increased to 35mg/kg body weight per day.
_CHILDREN UNDER 20KG_
20mg/kg of body weight per day; in sev
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