Šalis: Malaizija
kalba: anglų
Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
NAPROXEN
SUNWARD PHARMACEUTICAL SDN. BHD.
NAPROXEN
1000Tablet Tablets; 500Tablet Tablets; 100Tablet Tablets; 500 Tablets
SUNWARD PHARMACEUTICAL SDN. BHD.
1 _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ SUNPROX 275MG TABLET Naproxen ( 275 mg ) WHAT IS IN THIS LEAFLET 1.What Sunprox 275mg Tablet is used for 2. How Sunprox 275mg Tablet works 3. Before you use Sunprox 275mg Tablet 4. How to use Sunprox 275mg Tablet 5. While you are using Sunprox 275mg Tablet 6. Side Effects 7. Storage and Disposable of Sunprox 275mg Tablet 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT SUNPROX 275MG TABLET IS USED FOR It is used for relief of mild to moderate pain and for the treatment of primary dysmenorrhea (period paid). It also indicate for the treament of rheumatoid arthritis (systemic inflammatory disorder that affects joints), osteoarthritis (degenerative joint disease)ankylosing spondylitis (chronic inflammatory disease of the skeleton), tendinitis (inflammation of the tendon), bursitis (Inflammation of the bursa) and acute gout. HOW SUNPROX 275MG TABLET WORKS Sunprox 275mg tablet contains a substance called Naproxen. It belongs to a group of medicines called non steroidal anti- inflammatory agents (NSAIDs) which reduces fever and pain. BEFORE YOU USE SUNPROX 275MG TABLET _- When you must not use it _ Do not use Sunprox 275mg tablet: If you have active peptic ulceration If you are allergic to Naproxen, Aspirin, other NSAIDs or other ingredients of this medicine (listed in Product Description). If you have had asthma, rhinitis (Inflammation of the nasal mucous membrane) , urticaria (itching or hives), nasal polyps and the symptoms become worsen caused by Aspirin or NSAIDs. _ _ _- Before you start to use it _ You should check with your doctor:- if you have heart problem or stroke. if you have hypertension (high blood pressure). Naproxen may cause severe skin reactions, e.g. exfoliative dermatitis, toxic epidermal necrolysis, Steven-Johnson Syndrome. Symptoms may include skin rash, blisters and peel off. These could be signs of a serious condition. If these reactions occur, stop use and seek medical as Perskaitykite visą dokumentą
WARNINGS AND PRECAUTIONS: Cardiovascular Thrombotic Events Observational studies have indicated that non-selective NSAIDs may be associated with an increased risk of serious cardiovascular events, principally myocardial infarction, which may increase with dose or duration of use. Patients with cardiovascular disease or cardiovascular risk of an adverse cardiovascular event in patient taking NSAID, especially in those with cardiovascular risk factors, the lowest effective dose should be used for the shortest possible duration. There is no consistent evidence that the concurrent use of aspirin mitigates the possible increased risk of serious cardiovascular thrombotic events associated with NSAID use. Hypertension NSAIDs may lead to the onset of new hypertension or worsening the pre-existing hypertension and patients taking antihypertensive with NSAIDs may have an impaired anti-hypertensive response. Caution is advised when prescribing NSAIDs to patients with hypertension. Blood pressure should be monitored closely during initiation of NSAID treatment and at regular intervals thereafter. Heart Failure Fluid retention and oedema have been observed in some patients taking NSAIDs, therefore caution is advised in patients with fluid retention or heart failure. Severe Skin Reactions NSAIDs may very rarely cause serious cutaneous adverse events such as exfoliative dermatitis, toxic epidermal necrolysis (TEN) and Stevens - Johnson Syndrome (SJS), which can be fatal and occur without warning. These serious adverse events are idiosyncratic and are independent of dose or duration of use. Patients should be advised of the signs and symptoms of serious skin reactions and to consult their doctor at the first appearance of a skin rash or any other sign of hypersensitivity. Measures such as the use of physical therapy and mild analgesic like paracetamol (when inflammation is not a major factor) should be instituted prior to initiation of therapy with NSAID. NSAIDs should only be used after proper appraisal of potential risks to p Perskaitykite visą dokumentą