Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DICLOFENAC SODIUM
AIPHARMA HEALTHCARE SDN BHD
DICLOFENAC SODIUM
10x10tablet Tablets
Troikaa Pharmaceuticals Ltd
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ DICLOTROY EC TABLETS Diclofenac Sodium BP 50 mg WHAT IS IN THIS LEAFLET 1. What Diclotroy EC tablets is used for 2. How Diclotroy EC tablets works 3. Before you use Diclotroy EC tablets 4. How to use Diclotroy EC tablets 5. While you are using it 6. Side effects 7. Storage and Disposal of Diclotroy EC tablets 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT DICLOTROY EC TABLETS IS USED FOR Diclotroy EC relieves pain, reduce swelling and ease inflammation in conditions affecting the joints, muscles, tendons, teeth and minor surgery. HOW DICLOTROY EC TABLETS WORKS Diclotroy EC, is nonsteroidal anti- inflammatory drugs (NSAIDs), works by blocking a specific enzyme known as cyclooxygenase (COX), inhibiting the production of various inflammatory substances in the body. This action helps to treat pain and inflammation. BEFORE YOU USE DICLOTROY EC TABLETS - _When you must not use it_ Do not take Diclotroy EC tablets if: If you think you may be allergic to Diclofenac Sodium, Aspirin, Ibuprofen or any other NSAID, or to any of the other ingredients of Diclotroy EC. Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing problems, runny nose, skin rash or any other allergic type reaction. If you have now, or have ever had, a stomach (gastric) or duodenal (peptic) ulcer, or bleeding in the digestive tract (this can include blood in vomit, bleeding when emptying bowels, fresh blood in faeces or black, tarry faeces). If you have severe heart, kidney or liver failure. If you are more than six months pregnant. - _Before you start use it_ Tell your pharmacist or doctor if you are using any other painkillers. Tell your doctor if you recently had or you are going to have a surgery of the stomach or intestinal tract before receiving / taking/ using Diclotroy EC tablets, as Diclotroy EC Tablets can sometimes worsen wound healing in your gut after surgery. PREGNANCY AND LACT Soma hati kamili
Prescribing Information For the use of Registered Medical Practitioner, Hospital or a Laboratory Only. Diclofenac Tablets BP Brown colored, round, biconvex, enteric coated tablet. Metabolism : Roughly half of the active substance is metabolised during its first passage through the liver (first pass effect); consequently, the areas under the concentration curves (AUCs) after an oral dose are only about one-half as large as after a parenteral dose of the same size. The biotransformation of diclofenac involves partly-glucuronidation of the intact molecule but mainly single and multiple hydroxylation followed by glucuronidation. Approx. 60% of the dose administered is excreted in the urine than 1% as unchanged substance. The remainder of the dose is eliminated as metabolites through the bile in the faeces. No relevant age-dependent differences in the drug's absorption, metabolism, or excretion have been observed. Elimination : The total systemic clearance of diclofenac in plasma is 263±56 mL/min (x ± SD). The terminal half-life in plasma is 1-2 hours. Kinetics in special clinical situations In patients suffering from renal impairment, no accumulation of the unchanged active substance can be inferred from the singled-ose kinetics when applying the usual dosage schedule. At a creatinine clearance of less than 10 mL/ min, the theoretical steady-state plasma level of metabolites is about four Each enteric coated tablet contains : ACTION AND CLINICAL PHARMACOLOGY : DESCRIPTION : PHARMACOKINETICS : Although diclofenac sodium does not alter the course of the underlying disease, it has been found to relieve pain, reduce fever, swelling and tenderness, and increase mobility in patients with rheumatic disorders of the types listed. COMPOSITION : Absorption : Diclofenac is rapidly and completely absorbed from the coated tablets. When the tablets are taken with a meal, the quantity of active substance absorbed is not diminished, although the speed of its absorption may possibly be reduced. Distribution Following ingestion of o Soma hati kamili