Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
pregabalin, Quantity: 75 mg
Accord Healthcare Pty Ltd
Pregabalin
Capsule, hard
Excipient Ingredients: Gelatin; purified water; sodium lauryl sulfate; titanium dioxide; pregelatinised maize starch; iron oxide red; purified talc; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
14 capsules in HDPE bottle, 30 capsules in HDPE bottle, 56 capsules in HDPE bottle, 20 capsules in HDPE bottle, 200 capsules in HDPE bottle, 60 capsules in HDPE bottle, 500 capsules in HDPE bottle
(S4) Prescription Only Medicine
PREGABALIN INTAS (pregabalin) is indicated for the treatment of neuropathic pain in adults.,PREGABALIN INTAS (pregabalin) is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Visual Identification: Red opaque/White opaque, size 4 hard gelatin capsules imprinted with PG on cap and 75 on body containing white to off white powder.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2016-03-23
PREGABALIN INTAS CONSUMER MEDICINE INFORMATION Version: 2.0 PREGABALIN INTAS (PREGABALIN CAPSULES 25 MG, 75 MG, 150 MG AND 300 MG) _Pregabalin _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Pregabalin Intas. 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 Pregabalin Intas against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING PREGABALIN INTAS ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT PREGABALIN INTAS IS USED FOR Pregabalin Intas is used to treat neuropathic pain, which is pain caused by an abnormality of, or damage to, the nerves. Pregabalin Intas is also 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. Pregabalin Intas belongs to a group of medicines called anticonvulsants. These medicines are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen. Pregabalin Intas also has pain relieving effects. Pregabalin Intas _ _ may be used alone, or in combination with other medicines, to treat your condition. Your doctor may prescribe Pregabalin Intas _ _ 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 PREGABALIN INTAS_ _HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. 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 18 years. BEFORE YOU TAKE PREGABALIN INTAS _WHEN YOU MUST NOT USE IT _ DO NOT USE PREGABALIN INTAS_ _IF YOU HAVE AN ALLERGY TO: • pregabalin, the active Les hele dokumentet
Pregabalin Intas (Pregabalin Capsules 25 mg, 75 mg, 150 mg and 300 mg) Version 2.0 PRODUCT INFORMATION PREGABALIN INTAS (PREGABALIN CAPSULES 25 MG, 75 MG, 150 MG AND 300 MG) NAME OF THE MEDICINE Pregabalin Intas (Pregabalin Capsules 25 mg, 75 mg, 150 mg and 300 mg). Pregabalin Intas contains the active ingredient pregabalin. Pregabalin is an analogue of the neurotransmitter gamma-aminobutyric acid (GABA). It has analgesic and anticonvulsant activity. The structural formula of pregabalin is shown below: Chemical name: ( _S_ )-3-(aminomethyl)-5-methylhexanoic acid Molecular formula: C 8 H 17 NO 2 Molecular weight: 159.23 CAS number: 148553-50-8. DESCRIPTION Pregabalin is a white to off-white solid. It is freely soluble in water and basic and acidic aqueous solutions. Pregabalin Intas capsules contain 25 mg, 75 mg, 150 mg or 300 mg of pregabalin and the following inactive ingredients: pregelatinised maize starch, purified talc, gelatin, sodium lauryl sulfate, titanium dioxide. The capsules also have a trace of TekPrint SW-9008 black ink. PHARMACOLOGY MECHANISM OF ACTION _In vitro _ studies show that pregabalin binds to an auxiliary subunit (α 2 -δ protein) of voltage- gated calcium channels in the central nervous system, potently displacing [ 3 H]-gabapentin. Two lines of evidence indicate that binding of pregabalin to the α 2 -δ site is required for -2016- Page 1 of 22 Pregabalin Intas (Pregabalin Capsules 25 mg, 75 mg, 150 mg and 300 mg) Version 2.0 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 α 2 -δ 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 se Les hele dokumentet