País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PREGABALIN
DCH AURIGA (MALAYSIA) SDN. BHD.
PREGABALIN
6x10 Capsules
Balkanpharma Dupnitsa AD
_Consumer Medication Information Leaflet (RiMUP)_ BRIEKA CAPSULES Pregabalin (50mg, 75mg, 150mg) 1 WHAT IS IN THIS LEAFLET 1. What Brieka is used for 2. How Brieka works 3. Before you use Brieka 4. How to take Brieka 5. While you are using Brieka 6. Side Effects 7. Storage and Disposal of Brieka 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT BRIEKA IS USED FOR Pregabalin is indicated for the treatment of peripheral and central neuropathic pain in adults. Pregabalin is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Pregabalin is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults. Pregabalin is indicated for the management of fibromyalgia. HOW BRIEKA WORKS Pregabalin helps decrease the number of nerve signals, and as a result calms down overly sensitive nerve cells. BEFORE YOU USE BRIEKA _-When you must not take it _ Do not start taking if you are allergic to pregabalin or any of the ingredients in Brieka. Symptoms of an allergic reaction to pregabalin may include swelling of the face, lips, tongue, and throat, shortness of breath, wheezing as well as skin rashes. _-Before you start to take it _ Talk to your doctor or pharmacist before you take Brieka: - have or had depression, mood problems or suicidal thoughts or behaviour - have kidney problems or get kidney dialysis - have heart problems including heart failure - have a bleeding problem or a low blood platelet count - have abused prescription medicines, street drugs, or alcohol in the past - have ever had swellings in your face, mouth, tongue, lips, gums, neck or throat (angioedema) - have eye problems. Pregabalin may cause blurring or loss of vision, or other changes in eyesight, many of which are temporary. You should immediately tell your doctor if you experience any changes in your vision. - are pregnant or plan to become pregnant. It is not known if pregabalin will harm your unborn baby. You and your doctor will have to deci Llegiu el document complet
PRODUCT NAME BRIEKA capsules 50mg BRIEKA capsules 75mg BRIEKA capsules 150mg COMPOSITION _Name and Strength of Active Substance(s) _ 50mg: Each capsule contains Pregabalin 50mg 75mg: Each capsule contains Pregabalin 75mg 150mg: Each capsule contains Pregabalin 150mg PRODUCT DESCRIPTION 50mg: White cap and white body, hard gelatine capsules size 3. Markings in black ink on body: “PGB 50“ with a black band. 75mg: Orange cap and white body, hard gelatine capsules size 4. Markings in black ink on body: “PGB 75“. 150mg: White cap and white body, hard gelatine capsules size 2. Markings in black ink on body: “PGB 150“. PHARMACOLOGY Pharmacotherapeutic group: Antiepileptics, other antiepileptics ATC code: N03AX16 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, potently displacing [ 3 H]-gabapentin. PHARMACOKINETICS Pregabalin steady-state pharmacokinetics is similar in healthy volunteers, patients with epilepsy receiving antiepileptic 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 C max by approximately 25-30% and a delay in t max to approximately 2.5 hours. However, administration of pregabalin with food has no clinically significant effect on the extent of pregabalin absorption. Distribution The apparent volume of distribution of pregabalin following oral administration is approximately 0.56 l/kg. Pregabalin is not bound to plasma proteins. Biotransformati Llegiu el document complet