Χώρα: Μαλαισία
Γλώσσα: Αγγλικά
Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DICLOFENAC SODIUM
IMEKS PHARMA SDN. BHD.
DICLOFENAC SODIUM
20Tablet Tablets; 50Tablet Tablets; 100Tablet Tablets
Salutas pharma GmbH
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ 1 DICLAC ® RETARD TABLET Diclofenac sodium (100mg) WHAT IS IN THIS LEAFLET 1. What DICLAC ® RETARD TABLET is used for 2. How DICLAC ® RETARD TABLET works 3. Before you use DICLAC ® RETARD TABLET 4. How to use DICLAC ® RETARD TABLET 5. While you are using it 6. Side effects 7. Storage and Disposal of DICLAC ® RETARD TABLET 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT DICLAC ® RETARD TABLET IS USED FOR DICLAC ® RETARD TABLET is used for intense pain with: 1. Rheumatism (joint/tissue disease) that causes forms of inflammation and degeneration (e.g. rheumatoid arthritis, ankylosing spondylitis (Bechterew’s disease), osteoarthritis (degenerative joint disease), and spondylarthritis (inflammation of the joint), painful conditions in the vertebral column (spine) and non-articular rheumatism (musculoskeletal aches and pains which do not arise from joints) 2. Pain, inflammation and swelling due to trauma and /or operations. 3. Menstrual pain HOW DICLAC ® RETARD TABLET WORKS DICLAC ® RETARD TABLET contains the active ingredient diclofenac sodium. It belongs to the group of medicines called non-steroidal anti-inflammatory drug (NSAIDs). It works to reduce pain and inflammation (swelling and redness). BEFORE YOU USE DICLAC ® RETARD TABLET _-_ _ _ _WHEN YOU MUST NOT USE IT_ Do not take this medicine if you have an allergy to: • diclofenac sodium, the active ingredient • any of the other ingredients listed at the end of this leaflet • any other similar medicines, such as aspirin or other NSAIDS Do not take DICLAC ® RETARD TABLET if: • you have had asthma, rhinitis (inflammation of the nasal mucous membrane), urticaria (itching or hives) and the symptoms become worsen caused by Aspirin or NSAIDs. • you have stomach and intestinal ulcers • you have blood cells disorder • you have severe heart, kidney or liver problems • you are children or adolescents _-_ _ _ _BEFORE YOU START TO USE IT_ Tell your d Διαβάστε το πλήρες έγγραφο
DIRECTIONS FOR USE PLEASE READ CAREFULLY! _ _ _ _ DICLAC ® RETARD 100MG TABLET MODIFIED RELEASE TABLETS COMPOSITION One modified-release tablet contains 100mg diclofenac sodium; lactose monohydrate; methylhydroxypropylcellulose; magnesium stearate. PRODUCT DESCRIPTION White, round and biconvex tablets. PHARMACODYNAMICS Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids, acetic acid derivatives and related substances. ATC code: M01AB05 Mechanism of action (MoA) Diclofenac sodium is a non-steroidal compound with pronounced antirheumatic, anti-inflammatory, analgesic and antipyretic properties. Inhibition of prostaglandin biosynthesis, which has been demonstrated in experiments, is considered to be fundamental to its mechanism of action. Prostaglandins play an important role in causing inflammation, pain and fever. Diclofenac sodium in vitro does not suppress proteoglycan biosynthesis in cartilage at concentrations equivalent to the concentrations reached in humans. Pharmacodynamics (PD) In rheumatic diseases, the anti-inflammatory and analgesic properties of diclofenac elicit a clinical response characterised by marked relief from signs and symptoms such as pain at rest, pain on movement, morning stiffness, and swelling of the joints, as well as by an improvement in function. In post-traumatic and post-operative inflammatory conditions, diclofenac rapidly relieves both spontaneous pain and pain on movement and reduces inflammatory swelling and wound oedema. Diclofenac also has beneficial effects on the symptoms of migraine attacks. PHARMACOKINETICS Absorption Judged by urinary recovery of unchanged diclofenac and its hydroxylated metabolites, the same amount of diclofenac is released and absorbed from diclofenac prolonged-release tablets as from gastro-resistant tablets. However, the systemic availability of diclofenac from diclofenac prolonged-release tablets is on average about 82% of that achieved with the same dose of diclofenac administered in the form of gastro-resistant ta Διαβάστε το πλήρες έγγραφο