Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Vigabatrin 500mg;
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Vigabatrin 500 mg
500 mg
Film coated tablet
Active: Vigabatrin 500mg Excipient: Magnesium stearate Microcrystalline cellulose Opadry white OY-S-7298 Povidone Sodium starch glycolate
Blister pack, PVC/Al, 100 tablets, 100 tablets
Prescription
Prescription
Huvepharma Italia SrL
For the treatment of epilepsy which is not satisfactorily controlled by other antiepileptic medicines. For the management of infantile spasms (West Syndrome). Monotherapy for the treatment of partial seizure.
Package - Contents - Shelf Life: Blister pack, PVC/Al - 100 tablets - 36 months from date of manufacture stored at or below 30°C
1993-02-18
SABRIL® 1 SABRIL ® 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 SABRIL? Sabril contains the active ingredient vigabatrin. Sabril is used in addition to other medicines to treat epilepsy. For more information, see Section 1. Why am I using Sabril? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE SABRIL? Do not take if you have ever had an allergic reaction to Sabril 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 take Sabril? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Sabril 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 TAKE SABRIL? • Sabril tablets and sachets are taken by mouth either once or twice a day. • Take Sabril at about the same time each day. More instructions can be found in Section 4. How do I take Sabril? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING SABRIL? THINGS YOU SHOULD DO • Tell all the doctors, dentists and pharmacists that are treating you that you are taking Sabril. • Tell your Doctor immediately or go to the Accident and Emergency department of your nearest hospital if you have any thoughts of harming yourself or committing suicide. THINGS YOU SHOULD NOT DO • Do not stop using this medicine suddenly. DRIVING OR USING MACHINES • Be careful before you drive or use any machines or tools until you know how Sabril affects you. LOOKING AFTER YOUR MEDICINE • Keep your tablets or sachets in the container until it is time to take them. • Keep Sabril in a cool dry place where the temperature stays below 30°C. For more information, see Section 5. What should I know while us Read the complete document
sabril-ccdsv14-dsv15-21sep23 Page 1 NEW ZEALAND DATA SHEET 1 PRODUCT NAME Sabril 500 mg tablets Sabril 500 mg oral powder 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg vigabatrin Each oral powder contains 500 mg vigabatrin For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Sabril tablets 500 mg (white to off-white, oval biconvex film-coated tablets with a break-mark on one side and "SABRIL" or "SABRILEX" engraved on the other side). Oral powder: White to off-white granular powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of epilepsy which is not satisfactorily controlled by other antiepileptic medicines. For the management of infantile spasms (West Syndrome). Monotherapy for the treatment of partial seizures and secondarily generalised tonic-clonic seizures. sabril-ccdsv14-dsv15-21sep23 Page 2 4.2 DOSE AND METHOD OF ADMINISTRATION Adults Vigabatrin is intended for oral administration once or twice daily. Initiation of treatment should be as add-on therapy in epilepsy which is not satisfactorily controlled by other drugs. Thus, the starting dose of 1 g (2 tablets) should be added on to the patient's current antiepileptic drug regimen. If necessary, the daily dose may be increased or decreased in 0.5 g or 1.0 g increments at weekly or greater intervals depending on clinical response and tolerability. Maximum efficacy usually occurs in the range of 2 to 4 g daily; slight increases in efficacy have been seen at higher doses up to 6g daily but are associated with increased incidence of adverse events. Vigabatrin may be taken before or after meals. The tablets should be swallowed with a little water. When administering the oral powder, the contents of the sachet should be dissolved in half a glass of water, juice or soft drink immediately prior to oral administration. Children The recommended starting dose is 40 mg/kg/day, increasing to 80 to 100 mg/kg per day, depending on response. For maintenance dosing, the recommendations are: Bodyweight: 10 Read the complete document