Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
LAMOTRIGINE
McDermott Laboratories Ltd t/a Gerard Laboratories
N03AX09
LAMOTRIGINE
50 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Other antiepileptics
Authorised
2006-06-30
PACKAGE LEAFLET: INFORMATION FOR THE USER LAMOT 25 MG TABLETS LAMOT 50 MG TABLETS LAMOT 100 MG TABLETS LAMOT 200 MG TABLETS lamotrigine 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 Lamot is and what it is used for 2. What you need to know before you take Lamot 3. How to take Lamot 4. Possible side effects 5. How to store Lamot 6. Contents of the pack and other information 1. WHAT LAMOT IS AND WHAT IT IS USED FOR Lamot belongs to a group of medicines called anti-epileptics_. _It is used to treat two conditions – EPILEPSY and BIPOLAR DISORDER. LAMOT TREATS EPILEPSY People with epilepsy are prone to having periods of uncontrolled electrical signals in the brain. These periods of uncontrolled electrical activity may lead to seizures. Lamot treats epilepsy by blocking the signals in the brain that trigger epileptic seizures (fits). For adults and children aged 13 years and over, Lamot can be used on its own or with other medicines, to treat epilepsy. Lamot can also be used with other medicines to treat the seizures that occur with a condition called Lennox-Gastaut syndrome. For children aged between 2 and 12 years, Lamot can be used with other medicines, to treat those conditions. It can be used on its own to treat a type of epilepsy cal read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lamot 50 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg lamotrigine. Each 50 mg tablet contains 50 mg of lactose. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Yellow, round, flat faced, bevelled edge tablets marked “LG” over “50” on one side and “G” on the other side. 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. _Paediatric population 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 the acute treatment of manic or depressive episodes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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 to maintenance dose when restarting lamotrigine in patients who have discontinued lamotrigine for any reason, read_full_document