देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
gabapentin, Quantity: 400 mg
Generic Health Pty Ltd
Gabapentin
Capsule
Excipient Ingredients: lactose monohydrate; maize starch; purified talc; Gelatin; purified water; sodium lauryl sulfate; titanium dioxide; iron oxide red; iron oxide yellow; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
30, 500, 20, 150, 50, 100, 1000, 10, 300
(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 colored size 0el with cap M and body 400 printed with black ink, hard gelatin capsules, filled with white to off-white blend; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2016-12-19
CONSUMER MEDICINE INFORMATION GABAPENTIN GENERICHEALTH (GABAPENTIN) CAPSULES WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Gabapentin generichealth. 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 Gabapentin generichealth 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 GABAPENTIN GENERICHEALTH IS USED FOR _WHAT GABAPENTIN _ _GENERICHEALTH DOES _ Gabapentin generichealth 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. Gabapentin generichealth 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 _ _GENERICHEALTH WORKS _ This medicine is thought to work by controlling brain chemicals which send signals to nerves to help control seizures or neuropathic pain. Gabapentin generichealth also has pain relieving effects. Your doctor may have prescribed Gabapentin generichealth 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 generichealth for another reason. Gabapentin generichealth may lead to dependence on this medicine. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY GABAPENTIN GENERICHEALTH 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 GABAPENTIN G पूरा दस्तावेज़ पढ़ें
AUSTRALIAN PRODUCT INFORMATION – GABAPENTIN GENERICHEALTH (GABAPENTIN) CAPSULES 1 NAME OF THE MEDICINE Gabapentin. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100 mg, 300 mg or 400 mg of gabapentin as the active ingredient. List of excipients with known effect: sugars as lactose monohydrate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Gabapentin generichealth capsules are intended for oral administration. 100 mg capsules: White/White coloured size ‘3’ hard gelatin capsules, filled with white to off-white blend. 300 mg capsules: Yellow/Yellow colored size ‘0’ with cap ‘M’ and body ‘300’ printed with black ink, hard gelatin capsules, filled with white to off-white blend. 400 mg capsules: Orange/Orange colored size ‘0el’ with cap ‘M’ and body ‘400’printed with black ink, hard gelatin capsules, filled with white to off-white blend. 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. WARNINGS: ABUSE POTENTIAL OR DEPENDENCE Gabapentin is a potential drug of abuse and dependence. Gabapentin 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). Gabapentin generichealth v6 Page 2 of 21 (gabapentin) capsules 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE Epilepsy Dosage for Adults and Children Older than 12 Years of Age Initiation पूरा दस्तावेज़ पढ़ें