Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
gabapentin, Quantity: 300 mg
Pharmacor Pty Ltd
Gabapentin
Capsule, hard
Excipient Ingredients: lactose; maize starch; purified talc; titanium dioxide; purified water; iron oxide yellow; Gelatin; sodium lauryl sulfate
Oral
One carton contins 100 capsules (10x10's capsules), one carton contains 20 capsules (2x10 capsules), one carton contains 4 capsules (1x4 capsules)
(S4) Prescription Only Medicine
ALKEM GABAPEN 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.,? Neuropathic pain.
Visual Identification: yellow hard gelatin capsule imprinted"215" on body with blue ink; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2014-02-06
ALKEM GABAPEN ( V- 06) PAGE 1 OF 7 ALKEM GABAPEN GABAPENTIN (GAB-A-PEN-TIN) ___________________________________________________________________________________________ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ALKEM GABAPEN. 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 ALKEM GABAPEN against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING ALKEM GABAPEN, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ALKEM GABAPEN IS USED FOR _WHAT ALKEM GABAPEN DOES _ ALKEM GABAPEN 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. ALKEM GABAPEN 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 ALKEM GABAPEN WORKS _ This medicine is thought to work by controlling brain chemicals which send signals to nerves to help control seizures or neuropathic pain. ALKEM GABAPEN also has pain relieving effects. Your doctor may have prescribed ALKEM GABAPEN 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 ALKEM GABAPEN for another reason. ALKEM GABAPEN may lead to dependence on this medicine. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ALKEM GABAPEN 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 ALKEM GABAPEN _WHEN YOU Læs hele dokumentet
ALKEM GABAPEN (V-06) Page 1 of 22 AUSTRALIAN PRODUCT INFORMATION - ALKEM GABAPEN ( GABAPENTIN) CAPSULES 1. NAME OF THE MEDICINE Gabapentin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ALKEM GABAPEN contains the active ingredient gabapentin. ALKEM GABAPEN 100 MG CAPSULES : Each capsule contains gabapentin 100 mg ALKEM GABAPEN 300 MG CAPSULES: Each capsule contains gabapentin 300 mg ALKEM GABAPEN 400 MG CAPSULES: Each capsule contains gabapentin 400 mg EXCIPIENT WITH KNOWN EFFECT: lactose For the full list of excipients, see SECTION 6.1 - LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Capsules, hard. ALKEM GABAPEN 100 MG CAPSULES : Size "4" white hard gelatin capsule imprinted "216" on body with blue ink. ALKEM GABAPEN 300 MG CAPSULES: Size "1" yellow hard gelatin capsule imprinted "215" on body with blue ink. 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). ALKEM GABAPEN (V-06) Page 2 of 22 ALKEM GABAPEN 400 MG CAPSULES: Size "0" orange hard gelatin capsule imprinted "214" on body with blue ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ALKEM GABAPEN is indicated for the treatment of partial seizures, including secondarily generalized 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. ALKEM GABAPEN is indicated for the treatment of neuropathic pain. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE EPILEPSY DOSAGE FOR ADULTS AND CHILDREN OLDER THAN 12 YEARS OF AGE Initiation of treatment should be as add-on therap Læs hele dokumentet