Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Lamotrigine
PLIVA Pharma Ltd
N03AX09
Lamotrigine
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04080100
LAMOTRIGINE 25MG, 50MG, 100MG & 200MG TABLETS PACKAGE LEAFLET: INFORMATION FOR THE USER Lamotrigine have also had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor. IF YOU’RE TAKING LAMOTRIGINE FOR EPILEPSY The seizures in some types of epilepsy may occasionally become worse or happen more often while taking Lamotrigine. Some patients may experience severe seizures, which may cause serious health problems. If your seizures happen more often, or if you experience a severe seizure while you’re taking Lamotrigine, SEE A DOCTOR AS SOON AS POSSIBLE. LAMOTRIGINE SHOULD NOT BE GIVEN TO PEOPLE AGED UNDER 18 YEARS TO TREAT BIPOLAR DISORDER. Medicines to treat depression and other mental health problems increase the risk of suicidal thoughts and behaviour in children and adolescents aged under 18 years. OTHER MEDICINES AND LAMOTRIGINE TABLETS Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including herbal medicines or other medicines bought without a prescription. IF YOU ARE TAKING CERTAIN MEDICINES, YOUR DOCTOR MAY NEED TO CHECK THE DOSE OF LAMOTRIGINE. These include: • oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate, lacosamide, perampanel or zonisamide to treat for epilepsy • lithium, olanzapine or aripiprazole used to treat mental health problems • bupropion used to treat mental health problems or to stop smoking. Some medicines interact with Lamotrigine Tablets or make it more likely that you’ll have side effects. These include: • valproate (for epilepsy and mental health problems) • carbamazepine used to treat epilepsy and mental health problems • phenytoin, primidone or phenobarbitone (for epilepsy) • risperidone, used to treat mental health problems • rifampicin (an antibiotic) • a combination of lopinavir and ritonavir or atazanavir and ritonavir (to treat Human Immunodeficiency Virus infection) • hormonal contraceptives, such as the Pill (s Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lamotrigine 100 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Lamotrigine 100mg per tablet For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Pale yellow, round, flat, bevel edged, uncoated tablet de-bossed with “LMT” on one side and 100 on the other with a straight line separating “10” and “0”. 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 _Adults and adolescents aged 13 years and above _ - Adjunctive or monotherapy treatment of partial seizures and generalised seizures, including tonic-clonic seizures. - Seizures associated with Lennox-Gastaut syndrome. Lamotrigine is given as adjunctive therapy but may be the initial antiepileptic drug (AED) to start with in Lennox-Gastaut syndrome. _Children and adolescents aged 2 to 12 years _ - Adjunctive treatment of partial seizures and generalised seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut syndrome. - Monotherapy of typical absence seizures. Bipolar disorder _Adults aged 18 years and above _ - Prevention of depressive episodes in patients with bipolar I disorder who experience predominantly depressive episodes (see section 5.1). Lamotrigine is not indicated for acute treatment of manic and depressive episodes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Lamotrigine tablets should be swallowed whole, and should not be chewed or crushed. Lamotrigine dispersible/chewable tablets may be chewed, dispersed in a small volume of water (at least enough to cover the whole tablet) or swallowed whole with a little water. If the calculated dose of lamotrigine (for example for treatment of children with epilepsy or patients with hepatic impairment) does not equate to whole tablets, the dose to be administered is that equal to the lower number of whole tablets. Restarting therapy Prescribers should assess the need for escalation Прочитайте повний документ