Država: Malezija
Jezik: angleščina
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PREGABALIN
DUOPHARMA (M) SDN. BHD.
PREGABALIN
30capsule Capsules; 100capsule Capsules; 60 Capsules Capsules
DUOPHARMA (M) SDN. BHD.
1 PRELICA CAPSULE _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ Pregabaline (75mg, 150mg) WHAT IS IN THE LEAFLET 1. What PRELICA is used for 2. How PRELICA works 3. Before you use PRELICA 4. How to use PRELICA 5. While you are using it 6. Side effects 7. Storage and Disposal of PRELICA Capsule 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT PRELICA IS USED FOR PRELICA is used to treat following: NEUROPATHIC PAIN. For the treatment of peripheral and central neuropathic pain in adults. EPILEPSY As adjunctive t h e r a p y in adults wi t h partial seizures with or without secondary generalization. GENERALIZED ANXIETY DISORDER For the treatment of Generalized Anxiety Disorder (GAD) in adults. FIBROMYALGIA For the management of fibromyalgia HOW PRELICA WORKS PRELICA helps decrease the number of nerve signals, and as a result calms down overly sensitive nerve cells. Your doctor ma y have prescribed this medicine for another reason. Ask your doctor if you have any questions about why it has been prescribed for you. BEFORE YOU USE PRELICA _When you must not use it _ Do not start taking PRELICA if you are allergic to: • Pregabalin, the active ingredient • Any of the other ingredients in PRELICA. Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal. If you are not sure whether you should start taking this medicine, talk to your doctor or pharmacist. - _Before you start use it _ _ _ Tell your healthcare provider about all your medical condition including if you: • have or had depression, mood problems or suicidal thoughts or behaviour. • have kidney problems or get kidney dialysis • have heart problem or a low blood platelet count • have abused prescription medicines, street drugs, or alcohol in the past • have ever had swelling in your face, mouth, tongue, lips, gums, neck or throat (angioedema) • are pregnant Preberite celoten dokument
[DUOPHARMA (M) SDN BHD] Page 1 of 4 [Revision Date: (09.05.2019)] PRELICA CAPSULE COMPOSITION: Prelica 75mg Capsule : Each capsule contain 75mg Pregabalin Prelica 150mg Capsule : Each capsule contain 150mg Pregabalin DECLARATION OF CAPSULE SOURCE: Bovine source. PRODUCT DESCRIPTION: Prelica 75mg Capsule : A size #4 capsule, with white body and brown cap printed with PRE/75, contains white to off white granules Prelica 150mg Capsule : A size #2 capsule, with opaque white body and cap printed with PRE/150, contains white to off white granules PHARMACODYNAMIC / PHARMACOLOGY: Mechanism of action Pregabalin binds to an auxiliary subunit (α2-δ protein) of voltage-gated calcium channels in the central nervous system PHARMACOKINETIC: Pregabalin steady-state pharmacokinetics are similar in healthy volunteers, patients with epilepsy receiving anti-epileptic drugs and patients with chronic pain. Absorption Pregabalin is rapidly absorbed when administered in the fasted state, with peak plasma concentrations occurring within 1 hour following both single and multiple dose administration. Pregabalin oral bioavailability is estimated to be ≥ 90% and is independent of dose. Following repeated administration, steady state is achieved within 24 to 48 hours. The rate of pregabalin absorption is decreased when given with food resulting in a decrease in Cmax by approximately 25-30% and a delay in tmax to approximately 2.5 hours. However, administration of pregabalin with food has no clinically significant effect on the extent of pregabalin absorption. Distribution Pregabalin has been shown to cross the placenta in rats and is present in the milk of lactating rats. In humans, the apparent volume of distribution of pregabalin following oral administration is approximately 0.56 l/kg. Pregabalin is not bound to plasma proteins. Biotransformation Pregabalin undergoes negligible metabolism in humans. Following a dose of radiolabelled pregabalin, approximately 98% of the radioactivity recovered in the urine was unchanged pregabalin. The Preberite celoten dokument