Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
CARBAMAZEPINE
IPS Healthcare Limited
200 Milligram
Tablets
2011-07-22
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tegretol 200mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg carbamazepine. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet _Product imported from UK:_ White round, flat tablet with bevelled – edges, approximately 9mm in diameter. One side bears the imprint ‘CG’, the other ‘G/K’ and a score-line. The score-line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. As an anticonvulsant in the management of epilepsy (generalised tonic – clonic and partial seizure types). 2. The paroxysmal pain of trigeminal neuralgia and the lancinating component of other forms of differentiation pain, for example glossopharyngeal neuralgia, peripheral diabetic neuropathy, tabetic lightning pain, superior laryngeal neuralgia, stump pain, phantom limb pain and post herpetic neuralgia. 3. Management of alcohol withdrawal symptoms. 4. Treatment of mania and prophylaxis of manic-depressive illness, especially in patients unresponsive to lithium. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Tegretol is given orally, usually in two to four divided doses. Tegretol may be taken during, after or between meals. The tablets should be taken with a little liquid, e.g. a glass of water. 1. EPILEPSY It is advised that with a gradually increasing dosage scheme is used and this should be adjusted to suit the needs of the individual patient. It may be helpful to monitor the plasma concentration of carbamazepine to establish the optimum dose (see section 4.4 special warnings and precautions for use). Wherever possible, anti-epileptic agents should be prescribed as the sole anti-epileptic agent Прочитайте повний документ