Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
gabapentin, Quantity: 400 mg
MedTAS Pty Ltd
Gabapentin
Capsule, hard
Excipient Ingredients: maize starch; purified talc; titanium dioxide; purified water; iron oxide red; iron oxide yellow; Gelatin; sodium lauryl sulfate
Oral
PVC/ PVDC-Aluminium blister pack of 100 capsules (10x10C in carton)
(S4) Prescription Only Medicine
Gabapentin is indicated for the treatment of partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults and children age 3 years and above who have not achieved adequate control with standard anti-epileptic drugs.,Gabapentin is indicated for the treatment of neuropathic pain.
Visual Identification: Orange-Orange colour size'0' hard gelatin capsule contains free flowing white crystalline powder.; 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
2017-04-28
WP GABAPENTIN 1 CONSUMER MEDICINE INFORMATION (CMI) SUMMARY 1. WHY AM I USING WP GABAPENTIN? 2. WHAT SHOULD I KNOW BEFORE I USE WP GABAPENTIN? 3. WHAT IF I AM TAKING OTHER MEDICINES? 4. HOW DO I USE WP GABAPENTIN? 5. WHAT SHOULD I KNOW WHILE USING WP GABAPENTIN? WP GABAPENTIN The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. WP Gabapentin contains the active ingredient gabapentin. WP Gabapentin is used to control epilepsy. For more information, see Section 1. Why am I using WP Gabapentin? in the full CMI. Do not use if you have ever had an allergic reaction to WP Gabapentin 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 WP Gabapentin? in the full CMI. Some medicines may interfere with WP Gabapentin 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. • Your doctor will decide what dose of WP Gabapentin you will receive. The dosage will depend on your condition. More instructions can be found in Section 4. How do I use WP Gabapentin? in the full CMI. THINGS YOU SHOULD DO • If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Gabapentin WP GABAPENTIN 2 B&B. THINGS YOU SHOULD NOT DO • Do not take WP Gabapentin to treat any other complaints unless your doctor tells you to. • Do not give WP Gabapentin to anyone else, even if their symptoms seem similar to yours or they have the same condition as you. • Do not stop taking WP Gabapentin or lower the dose without checking with your doctor. DRIVING OR USING MACHINES • Be careful driving or operating machinery until you know how WP Gabapentin affects you. DRINKING ALCOHOL • Be careful when drinking alcohol while you are taking WP Gaba Perskaitykite visą dokumentą
AUSTRALIAN PRODUCT INFORMATION – GABAPENTIN B&B (GABAPENTIN) 1. NAME OF THE MEDICINE Gabapentin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Gabapentin B&B 100 mg capsules contains 100 mg, of gabapentin. Gabapentin B&B 300 mg capsules contains 300 mg, of gabapentin Gabapentin B&B 400 mg capsules contains 400 mg, of gabapentin For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM GABAPENTIN CAPSULES, 100MG: Size ‘3’ hard gelatin capsule with white body and white cap, containing 100 mg of gabapentin. GABAPENTIN CAPSULES, 300MG: Size ‘1’ hard gelatin capsule with yellow body and yellow cap, containing 300 mg of gabapentin. GABAPENTIN CAPSULES, 400MG: Size ‘0’ hard gelatin capsule with orange body and orange cap, containing 400 mg of gabapentin. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gabapentin is indicated for the treatment of partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults and children age 3 years and above who have not achieved adequate control with standard anti-epileptic drugs. Gabapentin is indicated for the treatment of neuropathic pain. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE _EPILEPSY DOSAGE FOR ADULTS AND CHILDREN OLDER THAN 12 YEARS OF AGE _ Initiation of treatment should be as add-on therapy. Gabapentin B&B can be given orally with or without food. In controlled clinical trials, the effective dose range was 900 mg/day to 1800 mg/day given in divided doses (three times a day). Therapy may be initiated by administering 300 mg of Gabapentin B&B three times a day on Day 1, as 300 mg capsules, or by titrating the dose as described below. Titration to an effective dose can take place rapidly, over a few days, giving 300 mg Gabapentin B&B on Day 1, 300 mg Gabapentin B&B twice a day on Day 2, 300 mg Gabapentin B&B three times a day on Day 3, as 300 mg capsules. Titration may be preferable for patients with renal impairment, patients with encephalopathy, patients on more than 2 othe Perskaitykite visą dokumentą