Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
CARBAMAZEPINE
Novartis Pharmaceuticals UK Ltd
CARBAMAZEPINE
125 Milligram
Suppositories
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
TEGRETOL ® 125MG SUPPOSITORIES TEGRETOL ® 250MG SUPPOSITORIES CARBAMAZEPINE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have any further questions please ask your doctor or pharmacist. This medicine has been prescribed only for you. Do not use it for any other illness; do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If any of the side effects affects you severely, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET 1 What Tegretol Suppositories is and what it is used for 2 Before you take Tegretol Suppositories 3 How to take Tegretol Suppositories 4 Possible side effects 5 Storing Tegretol Suppositories 6 Further information The name of your medicine is Tegretol Suppositories. It contains the active ingredient carbamazepine. Tegretol Suppositories also have inactive ingredients: hypromellose and hard fat. These suppositories are white or off-white in colour and are available in two strengths. The lower dose contains 125mg carbamazepine and weighs approximately 1g, and the higher dose contains 250mg carbamazepine and weighs approximately 2g. There are five Tegretol Suppositories in each pack. MARKETING AUTHORISATION HOLDER Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom. MANUFACTURER Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom. PRODUCT AUTHORISATION NUMBER: 13/81/7-8 1 WHAT TEGRETOL SUPPOSITORIES IS AND WHAT IT IS USED FOR Tegretol Suppositories belongs to a group of medicines called antiepileptics (medicine for seizures). Due to its mode of action it can be used for other diseases too. Tegretol Suppositories is used to treat certain types of seizures (epilepsy). It is also used to treat some neurological disea Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tegretol 125mg Suppositories 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each suppository contains 125 mg carbamazepine For a full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Suppository White to off-white, torpedo shaped suppositories with a fatty odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an anticonvulsant in the management of epilepsy (generalised tonic-clonic and partial seizures). Tegretol suppositories are for short-term use as replacement therapy in patients where oral treatment is temporarily not possible. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Tegretol is available in suppositories, for short term use. They are intended as replacement therapy (maximum period recommended: 7 days) in patients for whom oral treatment is temporarily not possible, for example in post-operative patients. When switching from oral formulations of Tegretol to suppositories the dosage should be increased by approximately 25% (the 125mg and 250mg suppositories correspond to the 100 and 200mg tablets respectively). The final dose adjustment should always depend on the clinical response in the individual patient. Tegretol suppositories, in appropriate doses, have been shown to provide plasma levels which are well within the therapeutic range. The pharmacokinetic properties of the suppositories are such that the maximum daily dose is limited to 1000mg (250mg four times daily at 6 hourly intervals). _Use in the elderly_ Due to the potential for drug interactions, the dosage of Tegretol should be selected with caution in elderly patients. _Use in paediatric patients_ Tegretol suppositories are not recommended for very young children. SPECIAL POPULATIONS RENAL IMPAIRMENT / HEPATIC IMPAIRMENT No data are available on the Przeczytaj cały dokument