Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
gabapentin, Quantity: 300 mg
Apotex Pty Ltd
Capsule
Excipient Ingredients: lactose monohydrate; maize starch; purified talc; Gelatin; purified water; sodium lauryl sulfate; titanium dioxide; iron oxide yellow
Oral
100, 50, 30, 20, 10, 1000, 500, 300, 150
(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: 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.; 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
Registered
2018-09-20
GABAPENTIN APOTEX – Consumer Medicine Information Page 1 of 5 WARNING: Before taking Gabapentin, tell your doctor if you have a history of drug abuse. Gabapentin poses risks of abuse and dependence. Using Gabapentin with other medicines that can make you feel drowsy such as sleeping tablets and other pain relievers (e.g., benzodiazepines and opioids), antihistamines, antidepressants, antipsychotics, cannabis, and alcohol may result in severe drowsiness, decreased awareness, breathing problems, coma and death. If you have any concern about taking this medicine, speak to your doctor. GABAPENTIN APOTEX CAPSULES _Contains the active ingredient gabapentin _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about gabapentin. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is Gabapentin APOTEX capsules. It contains the active ingredient, gabapentin. • control epilepsy, a condition that causes repeated seizures (fits). There are many different types of seizures, ranging from mild to severe • treat neuropathic pain (pain due to nerves being damaged or affected). Ask your do Belgenin tamamını okuyun
1 AUSTRALIAN PRODUCT INFORMATION – GABAPENTIN APOTEX (GABAPENTIN) 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). 1 NAME OF THE MEDICINE Gabapentin. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100 mg, 300 mg or 400 mg of gabapentin. EXCIPIENTS WITH KNOWN EFFECT Lactose monohydrate For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 100 MG CAPSULES: White/White coloured size ‘3’ hard gelatin capsules, filled with white to off-white blend. 300 MG CAPSULES: Yellow/Yellow coloured 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 coloured 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 antiepileptic drugs. Gabapentin is indicated for the treatment of neuropathic pain. 2 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE Epilepsy Dosage for Adults and Children Over 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 900mg/day to 1800mg/day given in divided dose Belgenin tamamını okuyun