Krajina: Malajzia
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PREGABALIN
LABORATORIES TORRENT (MALAYSIA) SDN. BHD.
PREGABALIN
30capsule Capsules; 10capsule Capsules; 60capsule Capsules; 100capsule Capsules
TORRENT PHARMACEUTICALS LTD.
PREGEB CAPSULES _ _ Pregabalin (75 mg, 150 mg) _ _ _ _ 1 _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What is Pregeb used for 2. How Pregeb works 3. Before you use Pregeb 4. How to use Pregeb 5. While you are using it 6. Side effects 7. Storage and Disposal of Pregeb 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT PREGEB IS USED FOR Pregabalin belongs to a group of medicines used to treat epilepsy, neuropathic pain, fibromyalgia and Generalised Anxiety Disorder (GAD) in adults. HOW PREGEB WORKS Pregeb corrects chemical imbalance in brain and provides relief in epilepsy, neuropathic pain, fibromyalgia and generalised anxiety disorder. BEFORE YOU USE PREGEB - _When you must not use it _ Talk to your doctor or pharmacist before taking Pregeb if you experience below symptoms: - Some patients taking Pregeb have reported symptoms suggesting an allergic reaction, these symptoms include swelling of the face, lips, tongue, and throat, as well as diffuse skin rash. Pregeb has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients. Therefore, you should be careful until you are used to any effect the medicine might have. Pregeb 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. Some patients with diabetes who gain weight while taking Pregabalin may need an alteration in their diabetic medicines. Certain side effects may be more common, such as sleepiness, because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity, that have similar side effects to Pregabalin and the severity of these effects may be increased when taken together. There have been reports of heart failure in some patients when taking Pregeb; these patients were mostly elderly with cardiovascular cond Prečítajte si celý dokument
Proposed Prescribing Information For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory only PREGEB CAPSULES 75 MG PREGEB CAPSULES 150 MG (Pregabalin Capsules) NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) PREGEB CAPSULES 75 MG Each hard gelatin capsules contains: Pregabalin …… 75 mg Approved colours used in hard capsules shells PREGEB CAPSULES 150 MG Each hard gelatin capsules contains: Pregabalin …… 150 mg Approved colours used in hard capsules shells DOSAGE FORM Hard gelatin capsules PRODUCT DESCRIPTION PREGEB CAPSULES 75 MG S i z e ‘ 4 ’ , h a r d g e l a t i n c a p s u l e h a v i n g o r a n g e o p a q u e c a p a n d w h i t e o p a q u e b o d y , imprinted ‘1360' on cap and '75’ on body with black ink containing white to off-white powder. PREGEB CAPSULES 150 MG Size ‘1’, hard gelatin capsule having white opaque cap and white opaque body, imprinted ‘1362' on cap and '150’ on body with black ink containing white to off-white powder. PHARMACODYNAMICS / PHARMACOKINETICS PHARMACODYNAMICS Pharmacotherapeutic group: Antiepileptics, other antiepileptics T h e a c t i v e s u b s t a n c e , p r e g a b a l i n , i s a g a m m a - a m i n o b u t y r i c a c i d a n a l o g u e ((S)-3- (aminomethyl)-5-methylhexanoic acid). _ _ _MECHANISM OF ACTION _ Pregabalin binds to an auxiliary subunit (α2-δ protein) of voltage-gated calcium channels in the central nervous system. PHARMACOKINETICS ABSORPTION Pregabalin is rapidly absorbed when administered in the fasted state, with peak plasma c o n c e n t r a t i o n s o c c u r r i n g w i t h i n 1 h o u r f o l l o w i n g b o t h s i n g l e a n d m u l t i p l e d o s e administration. Pregabalin oral bioavailability is reported 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 ho Prečítajte si celý dokument