Krajina: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Lamotrigine 25mg
GlaxoSmithKline NZ Limited
Lamotrigine 25 mg
25 mg
Chewable/dispersible tablet
Active: Lamotrigine 25mg Excipient: Aluminium magnesium silicate Blackcurrant flavour 502009 AP0551 Calcium carbonate Hyprolose Magnesium stearate Povidone Saccharin sodium Sodium starch glycolate
Blister pack, 56 tablets
Prescription
Prescription
Divi's Laboratories Limited
Epilepsy Adults (over 12 years of age) Lamictal is indicated as adjunctive therapy in the treatment of epilepsy, for partial seizures and generalised seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut Syndrome. Children (2 to 12 years of age) Lamictal is indicated as adjunctive therapy in the treatment of epilepsy, for partial seizures and generalised seizures including tonic-clonic seizures and the seizures associated with Lennox-Gaustaut syndrome.
Package - Contents - Shelf Life: Blister pack, Child Resistant PVC/PVdC - 56 tablets - 36 months from date of manufacture stored at or below 30°C protect from light
1994-05-31
LAMICTAL 1 LAMICTAL CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING LAMICTAL? LAMICTAL contains the active ingredient lamotrigine. LAMICTAL tablets are used to treat epilepsy in adults and children aged 2 years and over. For more information, see Section 1. Why am I using LAMICTAL? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE LAMICTAL? Do not use if you have ever had an allergic reaction to LAMICTAL or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use LAMICTAL? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with LAMICTAL and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE LAMICTAL? • It is usual for the dose of LAMICTAL tablets to start at quite a low level and be slowly increased during the first few weeks of treatment. • The doses that your doctor prescribes will generally depend on any other anti-epileptic medications you are taking and your response to LAMICTAL tablets. More instructions can be found in Section 4. How do I use LAMICTAL? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING LAMICTAL? THINGS YOU SHOULD DO • Remind any doctor, dentist, pharmacist or nurse you visit that you are using LAMICTAL. • Tell your doctor immediately if you become pregnant or intend to become pregnant whilst using LAMICTAL. THINGS YOU SHOULD NOT DO • Do not stop using this medicine suddenly without checking with your doctor. • Do not use LAMICTAL tablets to treat any other complaints unless your doctor says to. DRIVING OR USING MACHINES • Be careful before you drive or use any machines or tools until you know how LAMICT Prečítajte si celý dokument
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME LAMICTAL lamotrigine 2 mg, 5 mg, 25 mg, 50 mg, 100 mg dispersible/chewable tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg, 5 mg, 25 mg, 50 mg, or 100 mg of lamotrigine. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Dispersible/chewable tablets. _2 mg:_ white to off-white, round tablets with ‘LTG’ over ‘2’ on one side and scored on the other. _5 mg:_ white to off-white, elongated, biconvex, unscored tablets with 'GS CL2' on one side and ‘5’ on the other. _25 mg:_ white to off-white, multi-faceted, superelliptical, unscored tablet with ”GSCL5” on one side and “25” on the other. The tablets may be slightly mottled. _50 mg:_ white to off-white, multi-faceted, superelliptical, unscored tablet with ”GSCX7” on one side and “50” on the other. The tablets may be slightly mottled. _100 mg:_ white to off-white, multi-faceted, superelliptical, unscored tablet with ”GSCL7” on one side and “100” on the other. The tablets may be slightly mottled. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Epilepsy _Adults and Adolescents (over 12 years of age) _ LAMICTAL is indicated as adjunctive therapy in the treatment of epilepsy, for partial seizures and generalised seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut syndrome. _Children (2 to 12 years of age) _ LAMICTAL is indicated as adjunctive therapy in the treatment of epilepsy, for partial seizures and generalised seizures including tonic-clonic seizures and the seizures associated with Lennox-Gastaut syndrome. 2 Bipolar Disorder (Adults 18 years of age and over) LAMICTAL is indicated for the prevention of mood episodes in patients with bipolar disorder, predominantly by preventing depressive episodes. 4.2 DOSE AND METHOD OF ADMINISTRATION Dose RESTARTING THERAPY Prescribers should assess the need for escalation to maintenance dose when restarting lamotrigine in patients who have discon Prečítajte si celý dokument