Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
lamotrigine, Quantity: 200 mg
Arrotex Pharmaceuticals Pty Ltd
Calcium carbonate,Lamotrigine
Tablet, chewable
Excipient Ingredients: magnesium stearate; colloidal anhydrous silica; aspartame; purified talc; povidone; crospovidone; microcrystalline cellulose; hyprolose; calcium carbonate; maltodextrin; Flavour
Oral
56 tablets per pack
(S4) Prescription Only Medicine
Lamotrigine is an antiepileptic drug for the treatment of partial and generalised seizures in adults and children. There is extensive experience with lamotrigine used initially as "add-on" therapy. The use of lamotrigine has also been found to be effective as monotherapy following withdrawal of concomitant antiepileptic drugs. Initial monotherapy treatment in newly diagnosed paediatric patients is not recommended.
Visual Identification: White to off-white, uncoated, circular flat beveled tablets debossed with "LI5" on one side and plain on the other side having characteristic fruity odour.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2010-01-20
APO-LAMOTRIGINE 1 APO-LAMOTRIGINE _Lamotrigine _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about lamotrigine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- Lamotrigine. It contains the active ingredient lamotrigine. Lamotrigine belongs to a group of medicines called "anti-epileptic drugs". It is used to treat epilepsy in adults and children aged 2 years and over. Usually lamotrigine is used in addition to other medicines for the treatment of epilepsy. Lamotrigine is used in partial seizures (seizures that affect only one part of the brain) or generalised seizures (seizures that affect the whole brain), including Lennox-Gastaut Syndrome (a severe form of epilepsy characterised by several seizure types). Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. There is no evidence that this medicine is addictive. _USE IN CHILDREN _ This medici Прочетете целия документ
AUSTRALIAN PRODUCT INFORMATION APO-LAMOTRIGINE (LAMOTRIGINE) TABLETS Severe, potentially life-threatening rashes have been reported in association with the use of lamotrigine, particularly in children. Accordingly, lamotrigine should be discontinued at the first sign of rash unless the rash is clearly not drug related (see section 4.2 DOSE AND METHOD OF ADMINISTRATION). 1 NAME OF THE MEDICINE Lamotrigine. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains lamotrigine 25 mg, 50 mg, 100 mg or 200 mg as the active ingredient. EXCIPIENT WITH KNOWN EFFECT Aspartame. For a complete list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 25 MG TABLETS: White to off-white, uncoated, circular flat beveled tablets debossed with “LI2” on one side, plain on the other side having a characteristic fruity odour. 50 MG TABLETS: White to off-white, uncoated, circular flat beveled tablets debossed with “LI3” plain on the other side having a characteristic fruity odour. 100 MG TABLETS: White to off-white, uncoated, circular flat beveled tablets debossed with “LI4” on one side, plain on the other side having a characteristic fruity odour. 200 MG TABLETS: White to off-white, uncoated, circular flat beveled tablets debossed with “LI5” on one side, plain on the other side having a characteristic fruity odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lamotrigine is an antiepileptic drug for the treatment of partial and generalised seizures in adults and children. There is extensive experience with lamotrigine used initially as "add-on" therapy. The use of lamotrigine has also been found to be effective as monotherapy following withdrawal of concomitant antiepileptic drugs. Initial monotherapy treatment in newly diagnosed paediatric patients is not recommended (see section 5.1 PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS). 4.2 DOSE AND METHOD OF ADMINISTRATION METHOD OF ADMINISTRATION APO-Lamotrigine tablets are intended for oral administration. APO-Lamotrigine tablets have been Прочетете целия документ