País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Carbamazepine
Sun Pharma UK Ltd
N03AF01
Carbamazepine
20mg/1ml
Oral suspension
Oral
No Controlled Drug Status
Caution - AMP level prescribing advised
BNF: 04080100; GTIN: 5060011720002
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CARBAMAZEPINE SUN 100 MG/5 ML ORAL SUSPENSION carbamazepine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU TAKE THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have further questions, please 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 SUN is and what it is used for 2. What you need to know before you take Carbamazepine SUN 3. How to take Carbamazepine SUN 4. Possible side effects 5. How to store Carbamazepine SUN 6. Contents of the pack and other information 1. WHAT CARBAMAZEPINE SUN IS AND WHAT IT IS USED FOR Carbamazepine SUN is a pale orange suspension that contains carbamazepine, the active ingredient. Carbamazepine SUN is an anti-convulsant medicine (prevents fits), it can also modify some types of pain and can control mood disorders. Carbamazepine SUN 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 SUN DO NOT TAKE CARBAMAZEPINE SUN - if you are allergic to carbamazepine or similar drugs such as oxcarbazepine (Trileptal), or to any of a related group of drugs known as tricyclic antidepressants (such as amitriptyline or imipramine) or any of the other ingredients of this medicine (listed in section 6). If you are allergic to carbamazepine there is a one in four (25%) chance that you could also have an allergic reaction to oxcarbazepine - if you have any heart problems - if you have ever had problems with your bone marrow - if you have a blood disorder called p Leer el documento completo
OBJECT 1 CARBAMAZEPINE 100 MG/5 ML ORAL SUSPENSION Summary of Product Characteristics Updated 04-Sep-2017 | Ranbaxy (UK) Limited a Sun Pharmaceutical Company 1. Name of the medicinal product Carbamazepine SUN 100 mg/5 ml Oral Suspension 2. Qualitative and quantitative composition Each 5 ml of the oral suspension contains 100 mg carbamazepine. Excipients with known effect: Sorbitol (E420) and orange yellow S For the full list of excipients, see section 6.1 3. Pharmaceutical form Oral suspension. An orange to pale orange suspension. 4. Clinical particulars 4.1 Therapeutic indications Carbamazepine is indicated for - 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 - the prophylaxis of manic-depressive psychosis in patients unresponsive to lithium therapy. 4.2 Posology and method of administration POSOLOGY Since a given dose of carbamazepine oral suspension will produce higher peak levels than the same dose in tablet form, it is advisable to start with low doses of the liquid and to increase them slowly so as to avoid adverse effects on the central nervous system such as dizziness and lethargy. When switching a patient from tablets to liquid the same overall dose may be used but in smaller, more frequent, doses. 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 Leer el documento completo