Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
gabapentin, Quantity: 300 mg
Sandoz Pty Ltd
Gabapentin
Capsule
Excipient Ingredients: maize starch; colloidal anhydrous silica; purified talc; pregelatinised maize starch; titanium dioxide; purified water; iron oxide yellow; Gelatin; sodium lauryl sulfate
Oral
100 capsules
(S4) Prescription Only Medicine
Gabapentin Sandoz 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 antiepileptic medicines..,Gabapentin Sandoz is indicated for the treatment of neuropathic pain.
Visual Identification: Size 1 capsules with yellow body; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered
2010-02-22
GABAPENTIN SANDOZ ® 1 GABAPENTIN SANDOZ ® _gabapentin capsules _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Gabapentin Sandoz. 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 risk of you taking this medicine 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 GABAPENTIN SANDOZ IS USED FOR _WHAT GABAPENTIN SANDOZ _ _DOES_ This medicine 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. This medicine 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 GABAPENTIN SANDOZ _ _WORKS_ This medicine is thought to work by controlling brain chemicals which send signals to nerves to help control seizures or neuropathic pain. Gabapentin Sandoz also has pain relieving effects. Your doctor may have prescribed Gabapentin Sandoz 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 Gabapentin Sandoz for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY GABAPENTIN SANDOZ 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 for the treatment of neuropathic pain. BEFORE YOU TAKE GABAPENTIN SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • any medicine containing gabapenti Lugege kogu dokumenti
210416-gabapentin sandoz-pi Page 1 of 21 AUSTRALIAN PRODUCT INFORMATION GABAPENTIN SANDOZ ® (GABAPENTIN) CAPSULES 1 NAME OF THE MEDICINE Gabapentin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Gabapentin Sandoz 100 mg capsule contains 100 mg of gabapentin. Each Gabapentin Sandoz 300 mg capsule contains 300 mg of gabapentin. Each Gabapentin Sandoz 400 mg capsule contains 400 mg of gabapentin. For the full list of excipients, see Section 6.1 List of excipients 3 PHARMACEUTICAL FORM Gabapentin Sandoz 100 mg* capsules: Size 3 hard gelatin capsules with white body and cap. _ _ Gabapentin Sandoz 300 mg capsules: Size 1 hard gelatin capsules with yellow body and cap. _ _ Gabapentin Sandoz 400 mg capsules: Size 0 hard gelatin capsules with brown body and cap. _* Gabapentin Sandoz 100mg capsules are not marketed in Australia. _ 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Gabapentin Sandoz 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 antiepileptic medicines. Gabapentin Sandoz is indicated for the treatment of neuropathic pain. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE _EPILEPSY _ _Adults and children over 12 years of age _ Initiation of treatment should be as add-on therapy. WARNINGS ABUSE POTENTIAL OR DEPENDENCE Gabapentin Sandoz is a potential drug of abuse and dependence. Gabapentin Sandoz poses risks of abuse and dependence which can lead to overdose and death especially when used concomitantly with opioids and other CNS depressants. Assess the patient’s risk of abuse or dependence before prescribing and monitor the patient regularly during treatment, particularly amongst patients with current or past abuse or dependence of opioids and/or benzodiazepines (see Section 4.4 Special warnings and precautions for use). 210416-gabapentin sandoz-pi Page 2 of 21 In controlled clinical trials, the effective dose range was 90 Lugege kogu dokumenti