Ülke: Birleşik Krallık
Dil: İngilizce
Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)
Carbamazepine
DE Pharmaceuticals
N03AF01
Carbamazepine
200mg
Oral tablet
Oral
No Controlled Drug Status
Caution - AMP level prescribing advised
BNF: 04080100
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Tablets are and what they are used for 2. What you need to know before you take Carbamazepine Tablets 3. How to take Carbamazepine Tablets 4. Possible side effects 5. How to store Carbamazepine Tablets 6. Contents of the pack and other information 1. WHAT CARBAMAZEPINE TABLETS ARE AND WHAT THEY ARE USED FOR Carbamazepine, the active ingredient in Carbamazepine Tablets, can affect the body in several different ways. It is an anti-convulsant medicine (prevents fits), it can also modify some types of pain and can control mood disorders. Carbamazepine is used: • To treat some forms of epilepsy • To treat a painful condition of the face called trigeminal neuralgia • To help control serious mood disorders when some other medicines don’t work. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARBAMAZEPINE TABLETS DO NOT TAKE CARBAMAZEPINE TABLETS: • If you are allergic to carbamazepine or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include swelling of the face or mouth (angioedema), breathing problems, runny nose, skin rash, blistering or peeling. • If you are allergic to similar kind of drugs as carbamazepine such as oxcarbazepine (Trileptal), or to any of a related group of drugs known as tricyclic antidepressants (such as amitriptyline or imipramine). If you are allergic to carbamazepine there is a one in four (25%) chance that you could also have an allergic reaction to o Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Carbamazepine Medreich 200 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each uncoated tablet contains 200 mg of Carbamazepine. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet: White to off white, round, flat, uncoated tablets with beveled edges, having 200 mg with score line on one side and plain on other side. 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 Epilepsy - generalised tonic-clonic and partial seizures. Note: Carbamazepine 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. The paroxysmal pain of trigeminal neuralgia. For the prophylaxis of manic-depressive psychosis in patients unresponsive to lithium therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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: _ It is advised that with all formulations of carbamazepine, a gradually increasing dosage scheme is used and this should be adjusted to suit the needs of the individual patient. Carbamazepine should be taken in a number of divided doses although initially 100- 200mg once or twice da Belgenin tamamını okuyun