Страна: Малайзія
мова: англійська
Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DICLOFENAC SODIUM
IMEKS PHARMA SDN. BHD.
DICLOFENAC SODIUM
100Tablet Tablets; 10Tablet Tablets; 20Tablet Tablets; 50Tablet Tablets
Salutas pharma GmbH
1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ DICLAC ® 150 ID MODIFIED RELEASE TABLET Diclofenac Sodium (150mg) WHAT IS IN THIS LEAFLET 1. What Diclac ® 150 ID is used for 2. How Diclac ® 150 ID works 3. Before you use Diclac ® 150 ID 4. How to use Diclac ® 150 ID 5. While you are using it 6. Side effects 7. Storage and Disposal of Diclac ® 150 ID 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT DICLAC ® 150 ID IS USED FOR Diclac ® 150 ID contains the active ingredient diclofenac sodium. It is indicated for the treatments of: • Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis (systemic inflammatory disorder that affects joints), Juvenile arthritis (inflammation of the joint in children), ankylosing spondylitis (chronic inflammatory disease of the skeleton), osteoarthritis (degenerative joint disease), spondylarthritis (inflammation of the joint), painful syndromes of the vertebral column, non-articular rheumatism (musculoskeletal aches and pains which do not arise from joints) • Acute attack of gout • Post-traumatic and post-operative pain, inflammation and swelling • Primary dysmenorrhoea (period pain) HOW DICLAC ® 150 ID WORKS Diclofenac sodium belongs to a group of medicines called non-steroidal anti- inflammatory drug (NSAIDs). It works to reduce pain and inflammation (swelling and redness). BEFORE YOU USE DICLAC ® 150 ID - _When you must not use it_ Do not take Diclac ® 150 ID if you: • Have ever had a reaction or been told that you are allergic to diclofenac sodium or to any of the excipients. • Any other similar medicines, such as aspirin or other NSAIDs • Have asthma or have had a skin rash, facial swelling or runny nose after taking other NSAIDs • Had or have stomach and intestinal ulcers or bleeding in the digestive tract (including fresh blood in the faeces or blood in vomit) • Have severe heart, kidney or liver problems • Have blood cells disorder (anaemia) or blood clotting defects • During t Прочитайте повний документ
DIRECTIONS FOR USE PLEASE READ CAREFULLY! _ _ _ _ DICLAC ® 150 ID MODIFIED RELEASE TABLETS CONTENT One modified-release tablet (bi-layer tablet) contains 150 mg diclofenac sodium: 25 mg diclofenac sodium, immediate release, and 125 mg diclofenac sodium, slow release. DESCRIPTION Round, bi-layer tablets, white-pink coloured, flat with facet, plain surface. 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 After oral administration of the usual gastro-resistant pharmaceutical forms, diclofenac is completely absorbed after passage through the stomach. Maximum plasma levels are achieved after 1-16 hours depending on the duration of the gastric passage, on average after 2-3 hours. Maximum plasma levels are achieved after 10-20 minutes following intramuscular administration and approximat Прочитайте повний документ