국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DICLOFENAC SODIUM
Abio Marketing Sdn Bhd
DICLOFENAC SODIUM
100Tablet Tablets
SYNMOSA BIOPHARMA CORPORATION
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ AVONAC SR TABLET Diclofenac Sodium (100mg) 1 WHAT IS IN THIS LEAFLET 1. What Avonac is used for 2. How Avonac Works 3. Before you use Avonac 4. How to use Avonac 5. While you are using Avonac Tablets 6. Side Effects 7. Storage and disposal of Avonac 8. Product description 9. Manufacturer and Product registration Holder 10. Date of revision WHAT AVONAC IS USED FOR Avonac Tablets contain diclofenac and belong to a group of medicines called non-steroid anti- inflammatory drugs (NSAIDs). Avonac Tablets are used to treat rheumatoid Arthritis ( systemic inflammatory disorder that affects joints) & ankylosing spondylitis (chronic inflammatory disease of the skeleton) ; osteoarthrosis (degenerative joint disease) & spondylarthritis (inflammation of the joint) ; non-articular rheumatism (musculoskeletal aches and pains which do not arise from joints) ; painful, post- operative & post-traumatic inflammation & swelling; painful inflammatory conditions in gynecology (medical science that deals with the health maintenance and diseases of women, especially of the reproductive organs). HOW AVONAC WORKS Diclofenac Sodium slow release works by reducing hormones that cause inflammation and pain in the body. BEFORE YOU USE AVONAC _- When you must not use it _ • You know that you are allergic to Diclofenac Sodium or any of the ingredients in this medicine. • You have or previously have had a peptic ulcer bleeding or ruptured bowel (hole) in your stomach, or intestines. • You show any signs of allergy (such as asthma, hay fever or skin rash) to aspirin, ibuprofen or other NSAIDs (anti-inflammatory medicine) • You have heart disease, kidney or liver failure or bleeding in your brain • You have had stomach or bowel problems after taking other NSAIDs • You are in your last three months of pregnancy. _- Before you start to use it _ Be careful and check with doctor or pharmacist if: • You have had an ulcer or some other problem affecting your stomach, or intestines (ulcerati 전체 문서 읽기
COMPOSITION Each film-coated tablet contains: Diclofenac sodium ……………… 100mg DESCRIPTION Pink to pink-orange, round, biconvex, film-coated tablets INDICATIONS For rheumatoid arthritis & ankylosing spondylitis; osteoarthrosis & spondylarthritis; non-articular rheumatism; painful, post-operative & post-traumatic inflammation & swelling; painful inflammatory conditions in gynecology. PHARMACODYNAMIC Diclofenac sodium is a non-steroidal anti-inflammatory agent which has analgesic and antipyretic properties. It is a prostaglandin synthetase (cyclo-oxygenase) inhibitor. PHARMACOKINETICS Following ingestion, diclofenac sodium is completely absorbed from the intestinal tract but undergoes first pass metabolism and peak plasma concentrations occur in about 2 to 4 hours; at therapeutic concentrations it is more than 99% bound to plasma proteins. Diclofenac is almost entirely metabolized in the liver and the terminal plasma half-life is about 1-2 hours, with metabolic excretion mainly via the kidneys and also in the bile. DOSAGE AND ADMINISTRATION For oral administration. This is slow release tablet. It should be swallowed whole with liquid, and must not be divided or chewed. The recommended initial daily dosage is 100mg. As a general recommendation, the dose should be individually adjusted. Adverse effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section WARNINGS AND PRECAUTIONS) ESTABLISHED CARDIOVASCULAR DISEASE OR SIGNIFICANT CARDIOVASCULAR RISK FACTORS Treatment with diclofenac is generally not recommended in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension. If needed, patients with established cardiovascular disease, uncontrolled hypertension, or significant risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes melilitus and smoking) should be treated with diclofenac only after caref 전체 문서 읽기