Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
pregabalin
Apotex Pty Ltd
Pregabalin
Registered
APO-PREGABALIN _Contains the active ingredient pregabalin_ 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 pregabalin. 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 this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • 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 THIS MEDICINE IS USED FOR The name of your medicine is APO- Pregabalin. It contains the active ingredient pregabalin. It is used to: • treat neuropathic pain, which is pain caused by an abnormality of, or damage to, the nerves • control epilepsy. Epilepsy is a condition where you have repeated seizures (fits). There are many different types of seizures, ranging from mild to severe. Pregabalin may be used alone, or in combination with other medicines, to treat your condition. Your doctor may prescribe pregabalin in addition to your current therapy when your current treatment is no longer working as well as before. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. _HOW IT WORKS_ Pregabalin belongs to a group of medicines called a Read the complete document
Product Information – Australia APO-Pregabalin capsules Page 1 APO-PREGABALIN CAPSULES NAME OF THE MEDICINE Pregabalin. Chemical Name: (S)-3-(aminomethyl)-5-methylhexanoic acid Structural Formula: Molecular Formula: C 8 H 17 NO 2 Molecular Weight: 159.23 CAS Registry Number: 148553-50-8 DESCRIPTION Pregabalin is an analogue of the neurotransmitter gamma-aminobutyric acid (GABA). It has analgesic and anticonvulsant activity. Pregabalin is a white to off-white solid. It is freely soluble in water and basic and acidic aqueous solutions. Each capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg of pregabalin, as the active ingredient. In addition, each capsule contains the following inactive ingredients: lactose monohydrate, maize starch, purified talc, gelatin, purified water, titanium dioxide, sodium lauryl sulfate and TekPrint SW 9008 black ink. The 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules also contain iron oxide red. PHARMACOLOGY PHARMACOLOGICAL ACTIONS _In vitro_ studies show that pregabalin binds to an auxiliary subunit (α2δ protein) of voltage-gated calcium channels in the central nervous system, potently displacing [3H]-gabapentin. Two lines of evidence indicate that binding of pregabalin to the α2δ site is required for analgesic and anticonvulsant activity in animal models: (1) Studies with the inactive _R_-enantiomer and other structural derivatives of pregabalin and (2) Studies of pregabalin in mutant mice with defective drug binding to the α2δ protein. In addition, pregabalin reduces the release of several neurotransmitters, including glutamate, noradrenaline and substance P. The significance of these effects for the clinical pharmacology of pregabalin is not known. Pregabalin does not show affinity for receptor sites or alter responses associated with the action of several common drugs for treating seizures or pain. Pregabalin does not interact with either GABA A or GABA B receptors; it is not converted metabolically into GABA or a GABA agonist; it is not an inh Read the complete document