Страна: Малайзія
мова: англійська
Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LAMOTRIGINE
UNIMED SDN BHD
LAMOTRIGINE
30 Tablets; 100 Tablets
Aurobindo Pharma Limited (Unit III),
EPSYLAM DT DISPERSIBLE TABLETS Lamotrigine (50mg, 100mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What EPSYLAM DT is used for 2. How EPSYLAM DT works 3. Before you use EPSYLAM DT 4. How to use EPSYLAM DT 5. While you are using it 6. Side effects 7. Storage and Disposal of EPSYLAM DT 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT EPSYLAM DT IS USED FOR EPSYLAM DT is used for the treatment of two types of the diseases: seizures and bipolar disorder. HOW EPSYLAM DT WORKS EPSYLAM DT works to prevent the depression in bipolar disorder. It is not known how Lamotrigine works in the brain to provide the above effects. BEFORE YOU USE EPSYLAM DT - _When you must not use it_ Do not take EPSYLAM DT if: • If you are allergic to lamotrigine or any other ingredient in the product. _Pregnancy and lactation _ Do not take EPSYLAM DT if you are pregnant, trying to get pregnant or think you may be pregnant. However, in therapy with Lamotrigine is considered necessary during pregnancy, the lowest possible therapeutic dose is recommended. Do not take EPSYLAM DT if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start to use it_ Inform your doctor if you have any of the following conditions: • you have ever had a rash while taking lamotrigine • you have suicidal behavior or thoughts • you are taking hormonal contraceptives to prevent pregnancies • you suffer from kidney failure • you have bipolar disorder - _Taking other medicines_ Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. Tell your doctor if you are particularly taking: • Valproate (medicine used to treat epilepsy and bipolar disorder and to prevent migraine headaches) • Carbamazepine, phenytoin, primidone, phenobarbitone (medicines used to prevent and control seizures) • Rifampicin (medicine used to treat bact Прочитайте повний документ
A) ADJUNCT THERAPY WITH INHIBITORS OF LAMOTRIGINE GLUCURONIDATION E.G. VALPROATE In patients taking glucuronidation inhibiting concomitant drugs such as valproate the initial Lamotrigine dose is 25 mg every alternate day for two weeks, followed by 25 mg once a day for two weeks. The dose should be increased to 50 mg once a day (or in two divided doses) in week 5. The usual target dose to achieve optimal response is 100 mg/day given once a day or in two divided doses. However, the dose can be increased to a maximum daily dose of 200 mg, depending on clinical response. B) ADJUNCT THERAPY WITH INDUCERS OF LAMOTRIGINE GLUCURONIDATION IN PATIENTS NOT TAKING INHIBITORS SUCH AS VALPROATE. THIS DOSAGE REGIMEN SHOULD BE USED WITH PHENYTOIN, CARBAMAZEPINE, PHENOBARBITONE, PRIMIDONE AND OTHER DRUGS KNOWN TO INDUCE LAMOTRIGINE GLUCURONIDATION (SEE INTERACTION WITH OTHER MEDICAMENTS). In those patients currently taking drugs that induce Lamotrigine glucuronidation and not taking valproate, the initial Lamotrigine dose is 50 mg once a day for two weeks, followed by 100 mg/day given in two divided doses for two weeks. The dose should be increased to 200 mg/day given as two divided doses in week 5. The dose may increased in week 6 to 300 mg/day however, the usual target dose to achieve optimal response is 400 mg/day given in two divided doses which may be given from week 7. C) MONOTHERAPY WITH LAMOTRIGINE OR ADJUNCTIVE THERAPY IN PATIENTS TAKING LITHIUM, BUPROPION, OLANZAPINE, OXCARBAZEPINE, OR OTHER AGENTS KNOWN NOT TO SIGNIFICANTLY INDUCE OR INHIBIT LAMOTRIGINE GLUCURONIDATION. The initial Lamotrigine dose in patients who are taking lithium, bupropion, olanzapine, oxcarbazepine and are not taking inducers or inhibitors of Lamotrigine glucuronidation or are taking Lamotrigine in monotherapy, is 25 mg once a day for two weeks, followed by 50 mg once a day (or in two divided doses) for two weeks. The dose should be increased to 100 mg/day in week 5. The usual target dose to achieve optimal response is 200 mg/day given once a day Прочитайте повний документ