Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
gabapentin
Alphapharm Pty Ltd
Gabapentin
Registered
NUPENTIN _gabapentin_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Nupentin. 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 Nupentin against the benefits it is expected to 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 NUPENTIN IS USED FOR _WHAT NUPENTIN DOES_ Nupentin is used to control epilepsy. Epilepsy is a condition where you have repeated seizures (fits). There are many different types of seizures, ranging from mild to severe. Nupentin is also used to treat neuropathic pain, a type of pain caused by damage to the nerves. This medicine belongs to a group of medicines called anticonvulsants. _HOW NUPENTIN WORKS_ This medicine is thought to work by controlling brain chemicals which send signals to nerves to help control seizures or neuropathic pain. Nupentin also has pain relieving effects. Your doctor may have prescribed Nupentin in addition to other medicines that you may be taking. This may be necessary if your current treatment is no longer working as well. Your doctor may have prescribed Nupentin for another reason. Nupentin may lead to dependence on this medicine. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY NUPENTIN HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. _USE IN CHILDREN_ There is not enough information to recommend the use of this medicine in children: • under the age of 3 years to control epilepsy, or • under the age of 18 years to treat neuropathic pain. BEFORE YOU TAKE NUPENTIN _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE NUPENTIN IF YOU HAVE AN ALLERGY TO: • any medicine containing gabapentin, the active ingredient in Nupentin • any of the ingredients listed at the end of this leaflet. Some of the sympt Citiți documentul complet
AUSTRALIAN PRODUCT INFORMATION NUPENTIN _Gabapentin capsule _ 1 NAME OF THE MEDICINE Gabapentin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Gabapentin is a white to off-white crystalline solid. It is freely soluble in water and both basic and acidic aqueous solutions. Each NUPENTIN capsule contains gabapentin 100 mg, 300 mg or 400 mg as the active ingredient. NUPENTIN also contains: lactose monohydrate and sulfites (present in trace amounts). For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM NUPENTIN 100: Each 100 mg capsule contains gabapentin as the active ingredient, presented as a size 3 capsule with white body and white cap, “GP100” printed in black ink on the body and “G” on the cap. NUPENTIN 300: Each 300 mg capsule contains gabapentin as the active ingredient, presented as a size 1 capsule with yellow body and yellow cap, “GP300” printed in black ink on the body and “G” on the cap. NUPENTIN 400: Each 400 mg capsule contains gabapentin as the active ingredient, presented as a size 0 capsule with orange body and orange cap, “GP400” printed in black ink on the body and “G” on the cap. 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 EPILEPSY DOSAGE FOR ADULTS AND CHILDREN OLDER THAN 12 YEARS OF AGE Initiation of treatment should be as add-on therapy. Gabapentin 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 Nupentin three times a day on Day 1, or by titrating the dose as described below. Titration to an ef Citiți documentul complet