Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
gabapentin
Apotex Pty Ltd
Gabapentin
Registered
APO-GABAPENTIN CAPSULES _Contains the active ingredient gabapentin_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ 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 your medicine may be available. ASK YOUR DOCTOR OR PHARMACIST IF: • 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 IS THIS MEDICINE USED FOR The name of your medicine is APO- Gabapentin Capsules. It contains the active ingredient, gabapentin. It is used to: • 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 doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor's prescription. _HOW IT WORKS_ Gabapentin belongs to a group of medicines called anticonvulsants. It is thought to work by controlling brain chemicals which send signals to nerves to help control seizures or neuropathic pain. This medicine helps to relieve pain. Your doctor may prescribe gabapentin in addition to your current treatment when y Read the complete document
Product Information – Australia APO- Gabapentin Capsules Page 1 APO-GABAPENTIN CAPSULES NAME OF THE MEDICINE Gabapentin. Chemical Name: 1-(aminomethyl) cyclohexaneacetic acid. Structural formula: Chemical 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 in both basic and acidic aqueous solutions. Each capsule contains 100mg, 300mg or 400mg gabapentin, as the active ingredient. In addition, each capsule contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, purified talc (300mg & 400mg only), titanium dioxide, gelatin, iron oxide yellow (300mg & 400mg only), iron oxide red (400mg only) and black printing ink SW-9008/SW-9009. The black printing ink contains the following ingredients: shellac, ethanol, isopropyl alcohol, tert-Butyl alcohol, propylene glycol, ammonia, black iron oxide, potassium hydroxide and purified water. PHARMACOLOGY PHARMACOLOGICAL ACTIONS 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 medicines 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 medicine or neurotransmitter receptors of the brain including GABA A , GABA B , benzodiazepine, glutamate, glycine or N-methyl-d-aspartate receptors. Gabapentin does not inter Read the complete document