국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
CARBAMAZEPINE
Essential Pharma Ltd
N03AF01
CARBAMAZEPINE
250 Milligram
Suppositories
Product subject to prescription which may be renewed (B)
carbamazepine
Not Marketed
1994-04-19
Car125-250mgSupp/PL/IE/4 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CARBAMAZEPINE ESSENTIAL PHARMA 125 AND 250 MG SUPPOSITORIES Carbamazepine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE – BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. 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. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Carbamazepine Essential Pharma Suppositories are and what they are used for 2. What you need to know before you use Carbamazepine Essential Pharma Suppositories 3. How to use Carbamazepine Essential Pharma Suppositories 4. Possible side effects 5. How to store Carbamazepine Essential Pharma Suppositories 6. Contents of the pack and other information 1. WHAT CARBAMAZEPINE ESSENTIAL PHARMA SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR Carbamazepine Essential Pharma Suppositories contain a medicine called carbamazepine. Carbamazepine can affect the body in several different ways. Carbamazepine Essential Pharma Suppositories help to control messages passed from the brain to muscles along the nerve pathways in the body. It is an anti-epileptic medicine (prevents fits). Carbamazepine Essential Pharma Suppositories are used to treat some forms of epilepsy in adults and children, for up to 7 days, when treatment by mouth is not possible. This might be if you are having an operation, for example. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CARBAMAZEPINE ESSENTIAL PHARMA SUPPOSITORIES DO NOT USE CARBAMAZEPINE ESSENTIAL PHARMA SUPPOSITORIES IF: you are allergic to carbamazepine or similar medicines such as oxcarbazepine (Trileptal), or to any of a related group of medicines called tricyclic antidepressants 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Carbamazepine Essential Pharma 250 mg Suppositories 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each suppository contains 250 mg carbamazepine For a full list of excipients, see section 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). Carbamazepine Essential Pharma 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 Carbamazepine Essential Pharma 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 carbamazepine to suppositories the dosage should be increased by approximately 25% (the 125 mg and 250 mg suppositories correspond to the 100 and 200 mg tablets respectively). The final dose adjustment should always depend on the clinical response in the individual patient. Carbamazepine Essential Pharma 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 1000 mg (250 mg four times daily at 6 hourly intervals). _Use in the elderly_ Due to the potential for drug interactions, the dosage of Carbamazepine Essential Pharma should be selected with caution in elderly patients. _Use in paediatric patients_ Carbamazepine Essential Pharma suppositories are not recommended for very young children. SPECIAL POPULATIONS RENAL IMPAIRMENT / HEPATIC IMPAIRMENT H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ 전체 문서 읽기