البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
lacosamide, Quantity: 150 mg
Arrotex Pharmaceuticals Pty Ltd
Tablet, film coated
Excipient Ingredients: crospovidone; magnesium stearate; colloidal anhydrous silica; hyprolose; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black; lecithin
Oral
14 tablets, 56 tablets
(S4) Prescription Only Medicine
Lacosamide ARX tablets are indicated as:,? monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older.,? Add-on therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older.,? add-on therapy in the treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older.
Visual Identification: Salmon, oval, coated tablets, debossed "L" on one side and "150" on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2019-05-29
LACOSAMIDE ARX 1 LACOSAMIDE ARX 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 LACOSAMIDE ARX? LACOSAMIDE ARX contains the active ingredient lacosamide. LACOSAMIDE ARX is used by itself (in patients over 16 years) or in combination with other medicines to control epilepsy. For more information, see Section 1. Why am I using LACOSAMIDE ARX? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE LACOSAMIDE ARX? Do not use if you have ever had an allergic reaction to LACOSAMIDE ARX 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 LACOSAMIDE ARX? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with LACOSAMIDE ARX 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 LACOSAMIDE ARX? • Swallow LACOSAMIDE ARX tablets whole with a glass of water. More instructions can be found in Section 4. How do I use LACOSAMIDE ARX? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING LACOSAMIDE ARX? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using LACOSAMIDE ARX. • If you are pregnant or become pregnant while taking LACOSAMIDE ARX. THINGS YOU SHOULD NOT DO • Do not stop using this medicine suddenly. • Do not take LACOSAMIDE ARX to treat any other complaints unless your doctor tells you to. • Do not drink alcohol before or after taking this medicine. DRIVING OR USING MACHINES • Be careful driving or operating machinery until you know how this medicine affects you. DRINKING ALCOHOL • Do not drink alcohol before or after taking this medicine. LOOKING AFTER YOUR MEDICINE • Keep your tablets in t اقرأ الوثيقة كاملة
1 AUSTRALIAN PRODUCT INFORMATION – LACOSAMIDE ARX (LACOSAMIDE) 1 NAME OF THE MEDICINE Lacosamide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Lacosamide ARX film-coated tablets are available in strengths of 50 mg, 100 mg, 150 mg and 200 mg lacosamide. FOR THE FULL LIST OF EXCIPIENTS, SEE SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Film-coated tablets 50 mg: Pink-coloured, oval, film-coated tablets, debossed “L” on one side and “50” on other side. 100 mg: Dark yellow-coloured, oval, film-coated tablets, debossed “L” on one side and “100” on other side. 150 mg: Salmon-coloured, oval, film-coated tablets, debossed “L” on one side and “150” on other side. 200 mg: Blue-coloured, oval, film-coated tablets, debossed “L” on one side and “200” on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lacosamide ARX tablets are indicated as: • monotherapy in the treatment of partial seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. • add-on therapy in the treatment of partial seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older. 4.2 DOSE AND METHOD OF ADMINISTRATION Lacosamide film-coated tablets may be taken with or without food. Lacosamide oral solution and solution for injection formulations are unavailable in this brand however are available in other brands. Where correct dosing requires lacosamide oral solution or solution for injection formulations; other suppliers should be used and the specific product information for these formulations should be referred to for the complete dosage and administration instructions. In accordance with current clinical practice, if Lacosamide ARX has to be discontinued, it is recommended this be done gradually (e.g. taper the daily dose by 200 mg/week). 2 The following table summarises the recommended dose for lacosamide. More details are provided below. MONOTHERAPY ADD-ON THERAPY ADULTS ADOLESCENTS AND CHILDREN ADOLESCENTS AND CHILDREN اقرأ الوثيقة كاملة