Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
gabapentin, Quantity: 600 mg
Pharmacor Pty Ltd
Gabapentin
Tablet, film coated
Excipient Ingredients: hyprolose; purified talc; poloxamer; copovidone; magnesium stearate; maize starch
Oral
100s
(S4) Prescription Only Medicine
Treatment of partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults who have not achieved adequate control with standard antiepileptic drugs. Treatment of neuropathic pain.
Visual Identification: White to off white, oval shaped, film coated tablets plain on both sides.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2010-06-03
Pharmacor Gabapentin (V 04) 1 PHARMACOR GABAPENTIN _Gabapentin_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PHARMACOR GABAPENTIN. 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 PHARMACOR GABAPENTIN 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 PHARMACOR GABAPENTIN IS USED FOR _WHAT _ _PHARMACOR _ _GABAPENTIN DOES _ PHARMACOR GABAPENTIN 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. PHARMACOR GABAPENTIN is also used to treat neuropathic pain, a type of pain caused by damage to the nerves. PHARMACOR GABAPENTIN belongs to a group of medicines called anticonvulsants. _HOW PHARMACOR _ _GABAPENTIN WORKS _ This medicine is thought to work by controlling brain chemicals, which send signals to nerves to help control seizures or neuropathic pain. PHARMACOR GABAPENTIN also has pain relieving effects. Your doctor may have prescribed PHARMACOR GABAPENTIN 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 PHARMACOR GABAPENTIN for another reason. PHARMACOR GABAPENTIN may lead to dependence on this medicine. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY PHARMACOR GABAPENTIN 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 PHARMACOR GABAPENTIN _WHE Прочитайте повний документ
Pharmacor Gabapentin (V 06) 1 AUSTRALIAN PRODUCT INFORMATION PHARMACOR GABAPENTIN (GABAPENTIN) TABLETS 1 NAME OF THE MEDICINE Gabapentin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: Each tablet contains 600mg or 800mg gabapentin. For the full list of excipients, see Section 6.1 List of excipients 3 PHARMACEUTICAL FORM 600 mg Tablets: White to off white, oval shaped, film-coated tablets plain on both sides 800 mg Tablets: White to off white, capsule shaped, film-coated tablets plain on both sides 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS • Treatment of partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults who have not achieved adequate control with standard antiepileptic drugs. • Treatment of neuropathic pain. 4.2 D OSE AND METHOD OF ADMINISTRATION Note : Pharmacor Gabapentin is available as 600mg and 800 mg unscored tablets and should not be broken into half to achieve gabapentin dosages of 300mg or 400 mg. WARNINGS Abuse Potential or Dependence Pharmacor Gabapentin is a potential drug of abuse and dependence. Pharmacor 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). Pharmacor Gabapentin (V 06) 2 Pharmacor Gabapentin 600 unscored tablets and Pharmacor Gabapentin 800 unscored Tablets cannot be used for initiation of treatment, dose titration or to achieve lower daily dose regimens. Pharmacor Gabapentin can only be used in stabilised patients. Adults and Children Older than 12 Years of Age with Epilepsy Pharmacor Gabapentin can be only used in stabilised patients. Alternative brands of gabapentin must be used for initiation of treatment Прочитайте повний документ