国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Lamotrigine
Actavis UK Ltd
N03AX09
Lamotrigine
100mg
Dispersible tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04080100; GTIN: 5012617015600
AAAH7370 _Continued top of next column_ Lamotrigine 5mg, 25mg & 100mg tablet leaflet - UK item no: print proof no: origination date: originated by: revision date: revised by: dimensions: pharmacode: colours/plates: approved for print/date Non Printing Colours 1. Black 2. 3. 4. 5. 6. 1. 2. 3. date sent: supplier: technically app. date: min pt size: TECHNICAL APPROVAL AAAH7370 2 05.03.15 jh 10.03.15 jh Iceland 170 x 320 7 05.03.15 06.03.15 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET 1 WHAT LAMOTRIGINE TABLETS IS AND WHAT IT IS USED FOR 2 BEFORE YOU TAKE LAMOTRIGINE TABLETS 3 HOW TO TAKE LAMOTRIGINE TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE LAMOTRIGINE TABLETS 6 FURTHER INFORMATION 1 WHAT LAMOTRIGINE TABLETS IS AND WHAT IT IS USED FOR Lamotrigine tablets belong to a group of medicines called anti-epileptics. It is used to treat two conditions - EPILEPSY and BIPOLAR DISORDER. Lamotrigine tablets TREATS EPILEPSY by blocking the signals in the brain that trigger epileptic seizures (fits). • For adults and children aged 13 years and over, Lamotrigine tablets can be used on its own or with other medicines, to treat epilepsy. Lamotrigine tablets 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, Lamotrigine tablets can be used with other medicines, to treat those conditions. It can be used on its own to treat a type of epilepsy called typical absence seizures. Lamotrigine tablets also TREATS BIPOLAR DISORDER. People with bipolar disorder (sometimes called 完全なドキュメントを読む
OBJECT 1 LAMOTRIGINE ACTAVIS 100MG DISPERSIBLE TABLETS Summary of Product Characteristics Updated 04-Aug-2015 | Accord-UK Ltd 1. Name of the medicinal product Lamotrigine Actavis 100mg Dispersible Tablets 2. Qualitative and quantitative composition Each tablet contains lamotrigine 100mg For excipients, see 6.1. 3. Pharmaceutical form Dispersible Tablet White or almost white, round, flat-faced, uncoated tablets with 100 marked on one 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 Dispersible Tablets 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 Dispersible Tablets is not indicated for the acute treatment of manic or depressive episodes. 4.2 Posology and method of administration Administration Lamotrigine Dispersible Tablets may be chewed, dispersed in a small volume of water (at least enough to cover the 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 to maintenance dose when restarting Lamotrigine Dispersible Tablets in patients w 完全なドキュメントを読む