Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PREGABALIN
Macleods Pharmaceuticals Sdn. Bhd.
PREGABALIN
3X10 Capsules
Macleods Pharmaceuticals Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ NEUROGAB 75 Pregabalin Capsules 75mg Page 1 of 4 WHAT IS IN THIS LEAFLET 1. What Neurogab 75 is used for 2. How Neurogab 75 works 3. Before you use Neurogab75 4. How to use Neurogab 75 5. While you are using Neurogab 75 6. Side effects 7. Storage and Disposal of Neurogab 75 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT NEUROGAB 75 IS USED FOR: Neurogab 75 belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults. PERIPHERAL AND CENTRAL NEUROPATHIC PAIN: Neurogab 75 is used to treat long lasting pain caused by damage to the nerves. A variety of diseases can cause peripheral neuropathic pain, such as diabetes or shingles. Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins and needles. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbance, fatigue (tiredness), and can have an impact on physical and social functioning and overall quality of life. EPILEPSY: Neurogab 75 is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults. Your doctor will prescribe Neurogab 75 for you to help treat your epilepsy when your current treatment is not controlling your condition. You should take Neurogab 75 in addition to your current treatment. Neurogab 75 is not intended to be used alone, but should always be used in combination with other anti- epileptic treatment. GENERALISED ANXIETY DISORDER: Neurogab 75 is used to treat Generalised Anxiety Disorder (GAD). The symptoms of GAD are prolonged excessive anxiety and worry that are difficult to control. GAD can also cause restlessness or feeling keyed up or on edge, being easily fatigued (tired), having difficulty concentrating or mind going blank, feeling irritable, having muscle tension or sleep disturbance. This is different Baca dokumen lengkap
1 FOR THE USE ONLY OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR A LABORATORY NEUROGAB75 (Pregabalin Capsules 75mg) COMPOSITION Each capsule contains: Pregabalin USP…………….75mg DESCRIPTION Orange/White size ‘4’ hard gelatin capsules imprinted with ‘M3’ on cap and ‘75mg’ on body containing white coloured powder. PHARMACODYNAMICS Pharmacotherapeutic group: Antiepileptics, ATC code: N03A (proposed). The active substance, pregabalin, is a gamma-aminobutyric acid analogue ((S)-3- (aminomethyl)-5-methylhexanoic acid). _MECHANISM OF ACTION: _ Pregabalin binds to an auxiliary subunit (α 2 -δ protein) of voltage-gated calcium channels in the central nervous system._ _ Although the mechanism of action of pregabalin has not been fully elucidated, results with genetically modified mice and with compounds structurally related to pregabalin (such as gabapentin) suggest that binding to the alpha 2 -delta subunit may be involved in pregabalin's anti-nociceptive and antiseizure effects in animals. In animal models of nerve damage, pregabalin has been shown to reduce calcium-dependent release of pro-nociceptive neurotransmitters in the spinal cord, possibly by disrupting alpha2-delta containing-calcium channel trafficking and/or reducing calcium currents. Evidence from other animal models of nerve damage and persistent pain suggest the anti-nociceptive activities of pregabalin may also be mediated through interactions with descending noradrenergic and serotonergic pathways originating from the brainstem that modulate pain transmission in the spinal cord. While pregabalin is a structural derivative of the inhibitory neurotransmitter gammaaminobutyric acid (GABA), it does not bind directly to GABAA, GABAB, or benzodiazepine receptors, does not augment GABAA responses in cultured neurons, does not alter rat brain GABA concentration or have acute effects on GABA uptake or degradation. However, in cultured neurons prolonged application of pregabalin increases the density of GABA transporter protein and in Baca dokumen lengkap