Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Carbamazepine
Essential Pharma Ltd
N03AF01
Carbamazepine
125mg
Suppository
Rectal
No Controlled Drug Status
Valid as a prescribable product
BNF: 04080100; GTIN: 5060334120213
PACKAGE LEAFLET: INFORMATION FOR THE USER CARBAMAZEPINE ESSENTIAL PHARMA 125 AND 250 MG SUPPOSITORIES (CARBAMAZEPINE) WHAT YOU NEED TO KNOW ABOUT CARBAMAZEPINE ESSENTIAL PHARMA SUPPOSITORIES Your doctor has decided that you need this medicine to help treat your condition. PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO USE THE SUPPOSITORIES. IT CONTAINS IMPORTANT INFORMATION. Keep the leaflet in a safe place because you may want to read it again. If you have any other questions, or if there is something you don’t understand, please ask your doctor or pharmacist. This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Carbamazepine Essential Pharma Suppositories are and what they are used for 2. Things to consider before you are treated with 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. Further information 1. WHAT CARBAMAZEPINE ESSENTIAL PHARMA SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR Carbamazepine, the active ingredient in Carbamazepine Essential Pharma Suppositories, is an anti-convulsant medicine (prevents fits). Carbamazepine Essential Pharma Suppositories are used to treat some forms of epilepsy. They are useful in the short term, (maximum 7 days), for patients who cannot take medicines by mouth, e.g. after surgery or if unconscious. 2. THINGS TO CONSIDER BEFORE YOU ARE TREATED WITH CARBAMAZEPINE ESSENTIAL PHARMA SUPPOSITORIES SOME PEOPLE MUST NOT HAVE CARBAMAZEPINE ESSENTIAL PHARMA SUPPOSITORIES. MAKE SURE YOUR DOCTOR KNOWS IF; • you think you may be hypersensitive (allergic) to carbamazepine or similar drugs such as oxcarbazepine (Trileptal), or to any of a related group of Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Carbamazepine Essential Pharma 125mg Suppositories 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient is 5H-dibenzo[b,f]azepine-5-carboxamide (carbamazepine). Each suppository contains 125 mg carbamazepine Ph.Eur. 3 PHARMACEUTICAL FORM White to practically white, torpedo shaped suppositories 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Epilepsy - generalised tonic-clonic and partial seizures. Note: Carbamazepine Essential Pharma is not usually effective in absences (petit mal) and myoclonic seizures. Moreover, anecdotal evidence suggests that seizure exacerbation may occur in patients with atypical absences. No clinical data are available on the use of Carbamazepine Essential Pharma Suppositories in indications other than epilepsy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Before deciding to initiate treatment, patients of Han Chinese and Thai origin should whenever possible be screened for HLA-B*1502 as this allele strongly predicts the risk of severe carbamazepine-associated Stevens-Johnson syndrome (See information on genetic testings and cutaneous reactions in section 4.4). _Epilepsy: _ The dose of carbamazepine should be adjusted to the needs of the individual patient to achieve adequate control of seizures. Determination of plasma levels may help in establishing the optimum dosage. In the treatment of epilepsy, the dose of carbamazepine usually requires total plasma-carbamazepine concentrations of about 4 to 12 micrograms/mL (17 to 50 micromoles/litre) (see warnings and precautions). _Adults, Elderly, Children and Adolescents:_ 125mg and 250mg suppositories are available for short-term use as replacement therapy (maximum period recommended: 7 days) in patients for whom oral treatment is temporarily not possible, for example in post-operative or unconscious subjects. When switching from oral formulations to suppositories the dosage should be increased by approximately 25% (the 125 and 250mg suppositories correspond to 100 Lees het volledige document