Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
gabapentin, Quantity: 400 mg
Pharmacor Pty Ltd
Gabapentin
Capsule, hard
Excipient Ingredients: maize starch; lactose; purified talc; titanium dioxide; purified water; iron oxide yellow; iron oxide red; Gelatin; sodium lauryl sulfate
Oral
One carton contins 100 capsules (10x10's capsules)
(S4) Prescription Only Medicine
PHARMAGABAPENTIN 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: orange hard gelatin capsule imprinted "214" 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
Registered
2014-02-06
PHARMAGABAPENTIN ( V- 06) PAGE 1 OF 7 PHARMAGABAPENTIN GABAPENTIN (GAB-A-PEN-TIN) ___________________________________________________________________________________________ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PHARMAGABAPENTIN. 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 PHARMAGABAPENTIN against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING PHARMAGABAPENTIN, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT PHARMAGABAPENTIN IS USED FOR _WHAT _ _PHARMAGABAPENTIN _ _DOES _ PHARMAGABAPENTIN 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. PHARMAGABAPENTIN 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 _ _PHARMAGABAPENTIN _ _WORKS _ This medicine is thought to work by controlling brain chemicals which send signals to nerves to help control seizures or neuropathic pain. PHARMAGABAPENTIN also has pain relieving effects. Your doctor may have prescribed PHARMAGABAPENTIN 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 PHARMAGABAPENTIN for another reason. PHARMAGABAPENTIN may lead to dependence on this medicine. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY PHARMAGABAPENTIN 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 n Read the complete document
PHARMAGABAPENTIN (V-06) Page 1 of 22 AUSTRALIAN PRODUCT INFORMATION - PHARMAGABAPENTIN ( GABAPENTIN) CAPSULES 1. NAME OF THE MEDICINE Gabapentin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PHARMAGABAPENTIN contains the active ingredient gabapentin. PHARMAGABAPENTIN 100 MG CAPSULES : Each capsule contains gabapentin 100 mg PHARMAGABAPENTIN 300 MG CAPSULES: Each capsule contains gabapentin 300 mg PHARMAGABAPENTIN 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. PHARMAGABAPENTIN 100 MG CAPSULES : Size "4" white hard gelatin capsule imprinted "216" on body with blue ink. PHARMAGABAPENTIN 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). PHARMAGABAPENTIN (V-06) Page 2 of 22 PHARMAGABAPENTIN 400 MG CAPSULES: Size "0" orange hard gelatin capsule imprinted "214" on body with blue ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PHARMAGABAPENTIN 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. PHARMAGABAPENTIN 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 Read the complete document