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NAPROXEN EC is a brand name for Naproxen. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Naproxen EC is indicated in adults for the treatment of rheumatoid arthritis, osteoarthrosis (degenerative arthritis), ankylosing spondylitis, acute musculoskeletal disorders (such as sprains and strains, direct trauma, lumbosacral pain, cervical spondylitis, tenosynovitis and fibrositis) and dysmenorrhoea.
Verbatim from this product's MHRA label. Tap a section to expand.
4). Adults Naproxen EC tablets should be swallowed whole and not broken or crushed. Therapy should be started at the lowest recommended dose, especially in older people. Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis The usual dose is 500 mg to 1 g daily taken in 2 doses at 12-hour intervals.
Where 1 g per day is needed either one 500 mg tablet twice daily or two 500 mg tablets in a single administration (morning or evening) is recommended. In the following cases a loading dose of 750 mg or 1 g per day for the acute phase is recommended: a) In patients reporting severe night-time pain/or morning stiffness.
b) In patients being switched to Naproxen from a high dose of another anti- rheumatic compound. c) In osteoarthrosis where pain is the predominant symptom. Acute musculoskeletal disorders and dysmenorrhoea 500 mg initially followed by 250 mg at 6 – 8 hours intervals as needed, with a maximum daily dose after the first day of 1250 mg.
Older people Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in older people. The implication of this finding for Naproxen EC dosing is unknown.
As with other drugs used in older people it is prudent to use the lowest effective dose and for the shortest possible duration as older people are more prone to adverse events. The patient should be monitored regularly for GI bleeding during NSAID therapy.
For the effect of reduced elimination in older people see section
The following adverse events have been reported with NSAIDs and with naproxen.
Gastrointestinal disorders:
The most commonly observed adverse events are gastrointestinal in nature. Heartburn, nausea, vomiting, constipation, diarrhoea, flatulence, dyspepsia, abdominal discomfort and epigastric distress. 4), oesophagitis, gastritis and pancreatitis.
Blood and lymphatic system disorders:
Neutropenia, thrombocytopenia, granulocytopenia including agranulocytosis, eosinophilia, leucopenia, aplastic anaemia and haemolytic anaemia.
Immune system disorders:
Hypersensitivity reactions have been reported following treatment with NSAIDs in patients with, or without, a history of previous hypersensitivity reactions to NSAIDs. These may consist of (a) non- specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angio-oedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
Metabolic and nutrition disorders: hyperkalaemia.
Psychiatric disorders:
Insomnia, dream abnormalities, depression, confusion and hallucinations.
Nervous system disorders:
Convulsions, dizziness, headache, lightheadedness, drowsiness, paraesthesia, retrobulbar optic neuritis, inability to concentrate and cognitive dysfunction have been reported. 4), Eye disorders: Visual disturbances, corneal opacity, papillitis, and papilloedema.
4. Paediatric population Naproxen EC is not recommended for use in children under 16 years of age. Renal/hepatic impairment A lower dose should be considered in patients with renal or hepatic impairment. 3). Treatment should be reviewed at regular intervals and discontinued if no benefit is seen.
Method of administration For oral administration. To be taken preferably with or after food. 3 Contraindications Active or history of peptic ulceration or active gastrointestinal bleeding, (two or moredistinct episodes of proven ulceration or bleeding).
History of gastrointestinal bleeding or perforation related to previous NSAIDs therapy. Hypersensitivity to naproxen, naproxen sodium or any of the excipients. Since the potential exists for cross-sensitivity reactions, Naproxen EC should not be given to patients in whom aspirin or other non-steroidal anti- inflammatory/analgesic drugs induce asthma, rhinitis, nasal polyps or urticaria.
These reactions have the potential of being fatal. Severe anaphylactic-like reactions to naproxen have been reported in such patients. Severe renal, hepatic or heart failure. 6). 2 and GI and cardiovascular risks below). Patients treated with NSAIDs long-term should undergo regular medical supervision to monitor for adverse events.
Older and/or debilitated patients are particularly susceptible to the adverse events of NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal. Prolonged use of NSAIDs in these patients is not recommended. Where prolonged therapy is required, patients should be reviewed regularly.
The antipyretic and anti-inflammatory activities of Naproxen EC may reduce fever and inflammation, thereby diminishing their utility as diagnostic signs. Bronchospasm may be precipitated in patients suffering from, or with a history of, bronchial asthma or allergic disease.
As with other non-steroidal anti-inflammatory drugs, elevations of one or more liver function tests may occur. Hepatic abnormalities may be the result of hypersensitivity rather than direct toxicity. Severe hepatic reactions, including jaundice and hepatitis (some cases of hepatitis have been fatal) have been reported with this drug as with other non-steroidal anti-inflammatory drugs.
Active or history of peptic ulceration or active gastrointestinal bleeding, (two or moredistinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation related to previous NSAIDs therapy. Hypersensitivity to naproxen, naproxen sodium or any of the excipients.
Since the potential exists for cross-sensitivity reactions, Naproxen EC should not be given to patients in whom aspirin or other non-steroidal anti- inflammatory/analgesic drugs induce asthma, rhinitis, nasal polyps or urticaria. These reactions have the potential of being fatal.
Severe anaphylactic-like reactions to naproxen have been reported in such patients. Severe renal, hepatic or heart failure. 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Naproxen in United Kingdom.
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Ear and labyrinth disorders:
Tinnitus, hearing disturbances including impairment and vertigo.
Cardiac disorders:
Oedema, palpitations, cardiac failure and congestive heart failure have been reported. 4).
Vascular disorders:
Hypertension, vasculitis.
Respiratory, thoracic and mediastinal disorders:
Dyspnoea, asthma, eosinophilic pneumonitis and pulmonary oedema.
Hepatobiliary disorders:
Jaundice, fatal hepatitis and abnormal liver function tests.
Skin and subcutaneous tissue disorders:
Skin rashes including fixed drug eruption, itching (pruritus), urticaria, ecchymoses, purpura, sweating. 4). If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored.
Musculoskeletal and connective tissue disorders:
Myalgia and muscle weakness.
Renal and urinary disorders:
Including but not limited to glomerular nephritis, interstitial nephritis, nephrotic syndrome, haematuria, raised serum creatinine, renal papillary necrosis and renal failure.
Reproductive system and breast disorders:
Female infertility.
General disorders and administration site conditions:
Thirst, pyrexia, fatigue and malaise. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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Cross reactivity has been reported. Naproxen decreases platelet aggregation and prolongs bleeding time. This effect should be kept in mind when bleeding times are determined. Although sodium retention has not been reported in metabolic studies, it is possible that patients with questionable or compromised cardiac function may be at a greater risk when taking Naproxen EC.
Gastrointestinal (GI) bleeding, ulceration and perforation GI bleeding, ulceration or perforation, which can be fatal has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.
3), and in older people. These patients should commence treatment on the lowest dose available. g. 5). Patients with a history of GI toxicity, particularly when older, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.
5). When GI bleeding or ulceration occurs in patients receiving Naproxen EC, the treatment should be withdrawn. 8). Renal Effects There have been reports of impaired renal function, renal failure, acute interstitial nephritis, haematuria, proteinuria, renal papillary necrosis and occasionally nephrotic syndrome associated with naproxen.
Renal failure linked to reduced prostaglandin production The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics, angiotensin converting enzyme inhibitors, angiotensin-II receptor antagonists and older people.
3) Use in patients with impaired renal function As naproxen is eliminated to a large extent (95%) by urinary excretion via glomerular filtration, it should be used with great caution in patients with impaired renal function and the monitoring of serum creatinine and/or creatinine clearance is advised and patients should be adequately hydrated.
Naproxen EC is contraindicated in patients having a baseline creatinine clearance of less than 30ml/minute. Haemodialysis does not decrease the plasma concentration of naproxen because of the high degree of protein […]