Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
lacosamide, Quantity: 150 mg
UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia
Lacosamide
Tablet, film coated
Excipient Ingredients: hyprolose; microcrystalline cellulose; crospovidone; magnesium stearate; colloidal anhydrous silica; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black
Oral
168 tablets, 14 tablets, 56 tablets
(S4) Prescription Only Medicine
Vimpat (lacosamide) tablets and oral solution 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 tablet debossed with 'SP' on one side and '150' on the other; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2012-07-31
_ _ 1 VIMPAT _ _tablets & oral solution (pronounced "vim-PAT") _Contains the active ingredient lacosamide (pronounced "la-KOE-sa-mide")_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Vimpat. 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 Vimpat 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 VIMPAT IS USED FOR Vimpat tablets and oral solution are used in patients over 4 years in combination with other medicines to control epilepsy. Vimpat tablets and oral solution can only be used by itself in patients over 16 years. 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 Vimpat is addictive. This medicine is available only with a doctor’s prescription. Vimpat 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 VIMPAT _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE VIMPAT IF YOU HAVE AN ALLERGY TO: • Lacosamide or 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 s Les hele dokumentet
Vimpat Tablets PI 1 AUSTRALIAN PRODUCT INFORMATION VIMPAT (LACOSAMIDE) FILM-COATED TABLETS AND ORAL SOLUTION 1 NAME OF THE MEDICINE Lacosamide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Vimpat film-coated tablets are available in strengths of 50 mg, 100 mg, 150 mg and 200 mg lacosamide. Vimpat oral solution is available as 10 mg/mL strength. Vimpat oral solution contains the following excipients: sorbitol and hydroxybenzoates. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Film-coated tablets 50 mg: Pinkish, oval debossed with ‘SP’ on one side and ‘50’ on the other side. 100 mg: Dark yellow, oval debossed with ‘SP’ on one side and ‘100’ on the other side. 150 mg: Salmon, oval debossed with ‘SP’ on one side and ‘150’ on the other side. 200 mg: Blue, oval debossed with ‘SP’ on one side and ‘200’ on the other side. Oral Solution Colourless to yellow or yellow brown liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vimpat (lacosamide) tablets and oral solution 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. 4.2 DOSE AND METHOD OF ADMINISTRATION Vimpat therapy can be initiated with either oral or IV administration. The oral solution may be diluted in a glass of water. Both the film-coated tablets and oral solution may be taken with or without food. Vimpat Tablets PI 2 The film-coated tablets must not be divided. A nasogastric tube or gastrostomy tube may be used when administering the oral solution. The nasogastric tube or gastrostomy tube should be flushed (twice the volume of dead space) after the product deliver Les hele dokumentet