国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
lacosamide, Quantity: 200 mg
Accord Healthcare Pty Ltd
Tablet, film coated
Excipient Ingredients: hyprolose; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; crospovidone; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; lecithin; indigo carmine aluminium lake
Oral
56 tablets
(S4) Prescription Only Medicine
Lacosam 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. ? 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: Blue, oval, coated tablets, debossed "L" on one side and "200" on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2019-05-29
LACOSAM CONSUMER MEDICINE INFORMATION Version: 1.2 -2018- Page: 1 of 4 LACOSAM (LACOSAMIDE FILM-COATED TABLETS 50 MG, 100 MG, 150 MG, 200 MG) CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Lacosam. 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 Lacosam against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT LACOSAM IS USED FOR Lacosam are used by itself (in patients over 16 years) or in combination with other medicines to control epilepsy. Epilepsy is a condition where you have repeated seizures. There are many different types of seizures, ranging from mild to severe. This medicine belongs to a group of medicines called antiepileptics. These medicines are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. There is no evidence that Lacosam is addictive. This medicine is available only with a doctor's prescription. Lacosam is not recommended for use in children under the age of 4 years as its safety and effectiveness has not been established in this age group. BEFORE YOU TAKE LACOSAM WHEN YOU MUST NOT TAKE IT DO NOT TAKE LACOSAM IF YOU HAVE AN ALLERGY TO • ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin _ _ DO NOT TAKE LACOSAM IF YOU HAVE, OR HAVE HAD, A HEART CONDITION CAUSING AN UNEVEN HEART BEAT. If you 完全なドキュメントを読む
1 AUSTRALIAN PRODUCT INFORMATION – LACOSAM (Lacosamide) 1 NAME OF THE MEDICINE Lacosamide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Lacosam 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 Lacosam 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 Lacosam 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 weighing 50 kg or more, and 完全なドキュメントを読む