Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
brivaracetam, Quantity: 10 mg
UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia
brivaracetam
Tablet, film coated
Excipient Ingredients: magnesium stearate; lactose; lactose monohydrate; croscarmellose sodium; betadex; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350
Oral
14 tablets, 168 tablets, 100 tablets, 56 tablets
(S4) Prescription Only Medicine
Briviact tablets are indicated as add-on therapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 4 years of age with epilepsy
Visual Identification: White to off white, round, film-coated tablet, debossed with "u10" on one side; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2016-08-04
_May 2016: – Briviact Tablets& Oral Solution _ _Reference documents: EU SmPC, Brivaracetam PI _ 1 BRIVIACT _ _tablets & oral solution (pronounced "BREE-vee-act") _Contains the active ingredient brivaracetam (pronounced "BREE-va-RA-se-tam")_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Briviact. 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 Briviact 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 BRIVIACT IS USED FOR Briviact tablets and oral solution are used 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 Briviact is addictive. This medicine is available only with a doctor’s prescription. Briviact is not recommended for use in children under the age of 16 years as its safety and effectiveness has not been established in this age group. BEFORE YOU TAKE BRIVIACT _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE BRIVIACT 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 Read the complete document
Briviact Tablets & OS PI g2016-263 Page 1 PRODUCT INFORMATION BRIVIACT (BRIVARACETAM) FILM-COATED TABLETS AND ORAL SOLUTION NAME OF THE MEDICINE Non-proprietary name: Brivaracetam Chemical name: (2 _S_ )-2-[(4 _R_ )-2-oxo-4-propyltetrahydro-1H-pyrrol-1-yl]butanamide Chemical structure: Molecular formula: C 11 H 20 N 2 O 2 MW: 212.29 CAS number: [357336-20-0] DESCRIPTION The active ingredient brivaracetam is a white to off-white crystalline powder. It is very soluble in water, buffer (pH 1.2, 4.5 and 7.4), ethanol, methanol, and glacial acetic acid. It is freely soluble in acetonitrile and acetone and soluble in toluene. It is very slightly soluble in n-hexane. _ _ BRIVIACT FILM-COATED TABLETS contain the following excipients: croscarmellose sodium, lactose, betadex, lactose anhydrous, magnesium stearate and the proprietary film coating agents specified below: 10 mg tablets: Opadry II complete film coating system 85F18422 White (ARTG No: 11376) 25 mg tablets: Opadry II complete film coating system 85F275014 Grey (ARTG No: 110507) 50 mg tablets: Opadry II complete film coating system 85F38197 (ARTG No: Yellow 110509) 75 mg tablets: Opadry II complete film coating system 85F200021 Purple (ARTG No: 110513) 100 mg tablets: Opadry II complete film coating system 85F270000 Tan (ARTG No: 110508) BRIVIACT ORAL SOLUTION contains the following excipients: sodium citrate, citric acid anhydrous, methyl hydroxybenzoate, carmellose sodium, sucralose, sorbitol solution (70 percent)(crystallising), glycerol, Raspberry Flavour 7557-A (ARTG No: 110532) and purified water. PHARMACOLOGY Briviact Tablets & OS PI g2016-263 Page 2 MECHANISM OF ACTION Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain. Binding to SV2A is considered to be the primary mechanism for brivaracetam anticonvulsant activity, however, the precise mechanism by which brivaracetam exerts is anticonvulsant activity has not been fully elucidated. Effects on QT interval The effect of brivaracetam on QTc prolongation Read the complete document