Krajina: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
LAMOTRIGINE
GLAXO SMITH KLINE (ISRAEL) LTD
N03AX09
DISPERSIBLE/CHEWABLE TABLETS
LAMOTRIGINE 25 MG
PER OS
Required
GLAXO SMITHKLINE TRADING SERVICES LIMITED, IRELAND
LAMOTRIGINE
LAMOTRIGINE
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. Lamictal 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).Lamictal is not indicated for the acute treatment of manic or depressive episodes.
2020-09-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed according to a physician's prescription only Lamictal Dispersible/Chewable Tablets 5 mg Each Lamictal Dispersible/Chewable Tablet 5 mg contains 5 mg lamotrigine. Lamictal Dispersible/Chewable Tablets 25 mg Each Lamictal Dispersible/Chewable Tablet 25 mg contains 25 mg lamotrigine. Lamictal Dispersible/Chewable Tablets 50 mg Each Lamictal Dispersible/Chewable Tablet 50 mg contains 50 mg lamotrigine. Lamictal Dispersible/Chewable Tablets 100 mg Each Lamictal Dispersible/Chewable Tablet 100 mg contains 100 mg lamotrigine. Lamictal Dispersible/Chewable Tablets 200 mg Each Lamictal Dispersible/Chewable Tablet 200 mg contains 200 mg lamotrigine. For the list of the inactive and allergenic ingredients in the medicine, see section 2 – "Important information about some of the ingredients in the medicine" and section 6 – "Additional information". Read the leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the physician or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Lamictal is intended for the treatment of epilepsy (Lamictal Dispersible/Chewable Tablets: 5, 25, 50, 100, 200 mg) In adults and adolescents aged 13 years and above: • Lamictal is given as monotherapy or in combination with other medicines to treat partial seizures and generalized seizures, including tonic-clonic seizures. • Seizures that occur with Lennox-Gastaut syndrome. Lamictal is given as combination therapy with other medicines but may be used as the initial antiepileptic drug to start treatment in Lennox-Gastaut syndrome. In children and adolescents aged 2 to 12 years: • Lamictal is given as combination therapy with other medicines to treat partial seizures a Prečítajte si celý dokument
1 1. NAME OF THE MEDICINAL PRODUCT Lamictal Dispersible/Chewable Tablets 5mg Lamictal Dispersible/Chewable Tablets 25mg Lamictal Dispersible/Chewable Tablets 50mg Lamictal Dispersible/Chewable Tablets 100mg Lamictal Dispersible/Chewable Tablets 200mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lamictal Dispersible/Chewable Tablets 5mg: contain 5mg lamotrigine. Lamictal Dispersible/Chewable Tablets 25mg: contain 25mg lamotrigine. Lamictal Dispersible/Chewable Tablets 50mg: contain 50mg lamotrigine. Lamictal Dispersible/Chewable Tablets 100mg: contain 100mg lamotrigine. Lamictal Dispersible/Chewable Tablets 200mg: contain 200mg lamotrigine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable/Dispersible tablet. Lamictal Dispersible/Chewable Tablets 5mg are white to off-white, elongated, biconvex, tablets, with a blackcurrant odour, marked “GS CL2” on one side and “5” on the other. The tablets may be slightly mottled. Lamictal Dispersible/Chewable Tablets 25mg are white to off-white, multifaceted, super elliptical tablets with a blackcurrant odour, marked “GSCL5” on one side “25” on the other. The tablets may be slightly mottled. Lamictal Dispersible/Chewable Tablets 50mg are white to off-white, multifaceted, super elliptical tablets with a blackcurrant odour, marked “GSCX7” on one side and “50” on the other. The tablets may be slightly mottled. Lamictal Dispersible/Chewable Tablets 100mg are white to off-white, multifaceted, super elliptical tablets with a blackcurrant odour, marked “GSCL7” on one side and “100” on the other. The tablets may be slightly mottled. Lamictal Dispersible/Chewable Tablets 200mg are white to off-white, multifaceted, super elliptical tablets with a blackcurrant odour, marked “GSEC5” on one side and “200” on the other. The tablets may be slightly mottled 2 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Epilepsy (Lamictal Disp/Chewable Tablets: 5MG, 25MG, 50MG, 100MG, 200MG) _Adults and adolescents aged 13 years and a Prečítajte si celý dokument