Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
lamotrigine, Quantity: 50 mg
Alphapharm Pty Ltd
Tablet, dispersible
Excipient Ingredients: microcrystalline cellulose; sodium starch glycollate; povidone; silicon dioxide; saccharin sodium; mannitol; magnesium stearate; Flavour
Oral
28 Tablets, 100 Tablets, 56 Tablets, 14 Tablets, 30 Tablets
(S4) Prescription Only Medicine
Lamotrigine is an anti-epileptic drug used for the treatment of partial and generalised seizures in adults and children. There is extensive experience with lamotrigine used initially as add-on therapy. Lamotrigine has also been found to be effective as monotherapy following withdrawal of concomitant anti-epileptic drugs. Initial monotherapy treatment in newly diagnosed paediatric patients is not recommended (see section 5.1 Clinical Trials).
Visual Identification: White to off-white, round, flat faced, bevelled edge tablets with 'LY' over '50' on one side and plain on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2005-03-17
LOGEM ® _lamotrigine_ CONSUMER MEDICINE INFORMATION THERE ARE REPORTS OF SEVERE, POTENTIALLY LIFE THREATENING RASHES ASSOCIATED WITH LOGEM TREATMENT, PARTICULARLY IN CHILDREN. LOGEM SHOULD BE DISCONTINUED AT THE FIRST SIGN OF RASH UNLESS THE RASH IS CLEARLY NOT DRUG RELATED. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about LOGEM. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking LOGEM against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT LOGEM IS USED FOR LOGEM contains lamotrigine as the active ingredient and belongs to a group of medicines called "anti- epileptic drugs". Anti-epileptic drugs, such as LOGEM, are used to treat epilepsy in adults and children aged 2 years and older. Epilepsy is a condition where you have repeated seizures (fits). Initially, LOGEM is usually used in addition to other medicines for the treatment of epilepsy including partial or generalised seizures and Lennox-Gastaut Syndrome. It is thought that this medicine works by changing the levels of some chemicals associated with seizures. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is only available with a doctor's prescription. This medicine is not addictive. BEFORE YOU TAKE LOGEM _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE LOGEM IF YOU HAVE AN ALLERGY TO: • any medicine containing lamotrigine • any of the ingredients listed at the end of this leaflet Symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty in breathing • swelling of the face, lips, tongue or any other parts of the body • rash, itching or hives on the skin DO NOT TAKE THIS ME Прочетете целия документ
AUSTRALIAN PRODUCT INFORMATION LOGEM ® _lamotrigine chewable/dispersible tablet _ 1 NAME OF THE MEDICINE Lamotrigine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable/dispersible tablet contains lamotrigine as the active ingredient. Each LOGEM chewable/dispersible tablet contains either 25 mg, 50 mg, 100 mg or 200 mg of the active ingredient. Excipients of known effect: saccharin and sulfites For the full list of excipients, see section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM LOGEM chewable/dispersible tablets have a blackcurrant odour. LOGEM 25 mg tablets are white to off-white, round, flat faced, bevelled edge tablets with “LY” over “25” on one side and plain on the other side. LOGEM 50 mg tablets are white to off-white, round, flat faced, bevelled edge tablets with “LY” over “50” on one side and plain on the other side. LOGEM 100 mg tablets are white to off-white, round, flat faced, bevelled edge tablets with “LY” over “100” on one side and plain on the other side. LOGEM 200 mg tablets are white to off-white, round, flat faced, bevelled edge tablets with “LY” over “200” on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lamotrigine is an anti-epileptic drug used for the treatment of partial and generalised seizures in adults and children. There is extensive experience with lamotrigine used initially as add-on therapy. Lamotrigine has also been found to be effective as monotherapy following withdrawal of concomitant anti-epileptic drugs. Initial monotherapy treatment in newly diagnosed paediatric patients is not recommended (see section 5.1 Clinical Trials). 4.2 DOSE AND METHOD OF ADMINISTRATION RESTARTING THERAPY Prescribers should assess the need for escalation to maintenance dose when restarting lamotrigine in patients who have discontinued lamotrigine for any reason, since the risk of serious rash is associated with high initial doses and exceeding the recommended dose escalation for lamotrigine (see section 4.4 Special W Прочетете целия документ