Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
gabapentin
Upjohn Australia Pty Ltd
Registered
GANTIN ® (GAN-TIN) _gabapentin (gab-a-pen-tin)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Gantin. 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 Gantin 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 GANTIN IS USED FOR _WHAT GANTIN DOES_ Gantin 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. Gantin 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 GANTIN WORKS_ This medicine is thought to work by controlling brain chemicals which send signals to nerves to help control seizures or neuropathic pain. Gantin also has pain relieving effects. Your doctor may have prescribed Gantin 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 Gantin for another reason. Gantin may lead to dependence on this medicine. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE 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 GANTIN _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE GANTIN IF YOU HAVE AN ALLERGY TO: • any medicine containing gabapentin, the active ingredient in Gantin • any of the ingredients listed at the end of this leaflet. Some of the s Read the complete document
Version: pfpganta10118 Supersedes: pfpganta10817 Page 1 of 18 PRODUCT INFORMATION GANTIN ® (GABAPENTIN) NAME OF THE MEDICINE GANTIN (gabapentin) 100 mg, 300 mg and 400 mg capsules. GANTIN (gabapentin) 800 mg tablets. GANTIN contains the active ingredient gabapentin. The structural formula of gabapentin is shown below: CH 2 NH 2 CH 2 C O 2 H Chemical name: 1-(aminomethyl) cyclohexaneacetic acid Molecular formula: C 9 H 17 NO 2 Molecular weight: 171.24 CAS Registry Number: 60142-96-3. DESCRIPTION Gabapentin is a white to off-white crystalline solid. It is freely soluble in water and both basic and acidic aqueous solutions. GANTIN capsules also contain the following inactive ingredients: lactose monohydrate, purified talc, maize starch, gelatin and titanium dioxide. The 300 mg capsule also contains iron oxide yellow and the 400 mg capsule also contains both iron oxide yellow and iron oxide red. GANTIN tablets also contain the following inactive ingredients: poloxamer, copovidone, maize starch, magnesium stearate, candelilla wax and Opadry white YS-1-18111. PHARMACOLOGY PHARMACODYNAMICS The mechanism by which gabapentin exerts its anticonvulsant action is unknown. Gabapentin is structurally related to the neurotransmitter GABA (gamma-aminobutyric acid) but its mechanism of action is different from that of several other drugs that interact with GABA synapses including valproate, barbiturates, benzodiazepines, GABA transaminase inhibitors, GABA uptake inhibitors, GABA agonists, and GABA prodrugs. _In _ _vitro_ studies with radiolabelled gabapentin have characterised a novel peptide binding site in rat brain tissues including neocortex and hippocampus that may relate to anticonvulsant activity of gabapentin and its structural derivatives. However, the identification and function of the gabapentin binding site remains to be elucidated. Gabapentin at relevant clinical concentrations does not bind to other common drug or neurotransmitter receptors of Version: pfpganta10118 Supersedes: pfpganta10817 Page 2 of 18 the brain Read the complete document