Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
VALPROIC ACID USP; SODIUM VALPROATE BP
LABORATORIES TORRENT (MALAYSIA) SDN. BHD.
VALPROIC ACID USP; SODIUM VALPROATE BP
30Tablet Tablets; 100 Tablet Tablets; 10 Tablet Tablets
TORRENT PHARMACEUTICALS LTD
VALPARIN XR 500 TABLET _ _ Sodium valproate (500mg) _ _ _ _ 1 _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ WHAT IS IN THIS LEAFLET 1. What is Valparin XR used for 2. How Valparin XR works 3. Before you use Valparin XR 4. How to use Valparin XR 5. While you are using it 6. Side effects 7. Storage and disposal of Valparin XR 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT VALPARIN XR IS USED FOR Valparin XR is used for: • The treatment of generalised or partial epilepsy, particularly with the following patterns of seizures: - Absence (short period of “blanking out” or staring into space). - Myoclonic (brief shock-like jerks of a muscle). - Atonic (abrupt loss of muscle tone). - Tonic-clonic (loss of consciousness and violent muscle contractions) - Mixed seizures. • Partial epilepsy: - Simple (not affecting awareness or memory). - Complex seizures. - Secondary generalised seizures (start in one area and spread to both sides of the brain). - Specific syndromes (West, Lennox-Gastaut). HOW VALPARIN XR WORKS Valparin XR contains sodium valproate. It belongs to a group of medicines called anti-convulsants or anti-epileptic agents. These medicines are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen. BEFORE YOU USE VALPARIN XR WARNING FOR WOMEN AND GIRLS BEFORE YOU START TO USE IT: This medicine can seriously harm an unborn baby. Always use effective contraception during treatment with sodium valproate. If you are thinking about becoming pregnant, or if you are pregnant, contact your doctor immediately. You must CONTINUE taking sodium valproate unless your doctor tell you to stop. - _When you must not use it _ Do not take Valparin XR: • If you are allergic (hypersensitive) to sodium valproate or any of the other ingredients. • If you are having liver problems or you or your family have a history of liver problems. • If you are having a rare illness called porphyria (a rare hereditary disease in w Olvassa el a teljes dokumentumot
PRODUCT NAME : ITEM / PACK : DESIGN STYLE : CODE : DIMENSIONS (MM) : ART WORK SIZE : DATE : Reviewed By NO. OF COLORS: 1 COUNTRY : Malaysia Front/Back Valparin XR 500 mg Tablet Insert S/S 180 x 420 xxxxxxxxx-5253 Black 25-05-2021 PANTONE SHADE NOS.: ACTIVITIES DEPARTMENT NAME SIGNATURE DATE Prepared By PKG.DEV PKG.DEV LOCATION : Chhatral QUALITY Approved By PANCREATITIS: CASES OF LIFE-THREATENING PANCREATITIS HAVE BEEN REPORTED IN BOTH CHILDREN AND ADULTS RECEIVING VALPROATE. SOME OF THE CASES HAVE BEEN DESCRIBED AS HEMORRHAGIC WITH A RAPID PROGRESSION FROM INITIAL SYMPTOMS TO DEATH. CASES HAVE BEEN REPORTED SHORTLY AFTER INITIAL USE AS WELL AS AFTER SEVERAL YEARS OF USE. PATIENTS AND GUARDIANS SHOULD BE WARNED THAT ABDOMINAL PAIN, NAUSEA, VOMITING AND/OR ANOREXIA CAN BE SYMPTOMS OF PANCREATITIS THAT REQUIRE PROMPT MEDICAL EVALUATION. IF PANCREATITIS IS DIAGNOSED; VALPROATE SHOULD BE DISCONTINUED _WARNING AND PRECAUTIONS:_ Potential for an increase of suicidal thoughts or behaviours. - Liver function tests should be carried out before therapy (see “contraindications”), and periodically during the first 6 months especially in patients at risk (see “warnings”) As with most antiepileptic drugs, mild increased liver enzymes may be noted, particularly at the beginning of the therapy; they are transient and isolated, without clinical sign. More extensive biological investigations (including prothrombin rate) are recommended in those patients; an adjustment of dosage may be considered when appropriate and tests should be repeated as necessary. - Monotherapy is recommended in children under the age of 3 years when prescribing Valparin XR 500 mg Tablet, but the potential benefit of Valparin XR 500 mg Tablet should be weighed against the risk of liver damage in such patients prior to initiation of therapy (see “warnings”). The concomitant use of salicylates should be avoided in those children under 3 due to the risk of liver toxicity. - Blood tests (blood cell count, including platelet count, bleeding time and Olvassa el a teljes dokumentumot