País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
lacosamide, Quantity: 200 mg
Sandoz Pty Ltd
Tablet, film coated
Excipient Ingredients: hyprolose; microcrystalline cellulose; crospovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake
Oral
14 tablets, 56 tablets
(S4) Prescription Only Medicine
Lacosamide Sandoz (lacosamide) 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.,Paediatric patents weighing less than 50 kg should not receive Lacosamide Sandoz film-coated tablets. Paediatric patients weighing less than 50 kg should be accurately dosed on a mg/kg basis with other lacosamide products.
Visual Identification: Blue coloured, oval shaped tablets debossed with I76 on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Registered
2021-07-06
Lacosamide Sandoz® 1 LACOSAMIDE SANDOZ® 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 SANDOZ? Lacosamide Sandoz contains the active ingredient lacosamide. Lacosamide Sandoz is used in patients over 4 years in combination with other medicines to control epilepsy. Lacosamide Sandoz tablets are used by itself (in patients over 16 years) to control epilepsy. For more information, see Section 1. Why am I using Lacosamide Sandoz? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE LACOSAMIDE SANDOZ? Do not use Lacosamide Sandoz if you have ever had an allergic reaction to lacosamide 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 Sandoz? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Lacosamide Sandoz 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 SANDOZ? • Your doctor will tell you how much Lacosamide Sandoz you will need to take each day. This may depend on your condition, your body weight and whether or not you are taking any other medicines. • Your doctor may start you on a low dose of Lacosamide Sandoz first of 50 mg or 100 mg twice a day. Your doctor may slowly increase your dose up to a maximum of 300 mg twice a day, until you are taking enough to control your epilepsy and you are not having any seizures. More instructions can be found in Section 4. How do I use Lacosamide Sandoz? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING LACOSAMIDE SANDOZ? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Lacosamide Sandoz. • Tell yo Leia o documento completo
211122-lacosamide-sandoz-pi Page 1 of 23 AUSTRALIAN PRODUCT INFORMATION LACOSAMIDE SANDOZ (LACOSAMIDE) FILM-COATED TABLETS 1 NAME OF THE MEDICINE Lacosamide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Lacosamide Sandoz 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 50 MG FILM-COATED TABLETS: Pink coloured, oval shaped tablets debossed with “I73” on one side and plain on other side. 100 MG FILM-COATED TABLETS: Dark yellow coloured, oval shaped tablets debossed with “I74” on one side and plain on other side. 150 MG FILM-COATED TABLETS: Peach coloured, oval shaped tablets debossed with “I75” on one side and plain on other side. 200 MG FILM-COATED TABLETS: Blue coloured, oval shaped tablets debossed with “I76” on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC I NDICATIONS Lacosamide Sandoz (lacosamide) 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. Paediatric patents weighing less than 50 kg should not receive Lacosamide Sandoz film-coated tablets. Paediatric patients weighing less than 50 kg should be accurately dosed on a mg/kg basis with other lacosamide products. 4.2 D OSE AND METHOD OF ADMINISTRATION _Lacosamide oral solution and injection are unavailable in this brand however are available in _ _other brands. Where correct dosing requires lacosamide oral solution and injection formulations _ _refer to the specific product information for these formulations for their complete dosage and _ _administration i Leia o documento completo