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NAPRALIEF is a brand name for Naproxen. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: This medicinal product is indicated in adults (18-50 years) for the short term relief of muscle or joint pain (such as sprains and strains, inflammation caused by sporting injuries, lower back pain, neck pain, or pain in the wrists or feet) and period pain.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology For oral administration and short-term use only. 4). If in adults the product is required for more than 3 days, or if the symptoms worsen the patient should consult a doctor. Adults (18-50 years) Therapy should be started at the lowest recommended dose, especially in older people.
Acute musculoskeletal disorders and dysmenorrhoea On the first day 2 tablets (500 mg) should be taken initially and then one tablet (250 mg) after 6 to 8 hours if needed. On the second and third day, if needed, one tablet (250mg) should be taken every 6 to 8 hours.
Not more than 3 tablets to be taken per day. The maximum duration of continuous treatment is 3 days 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 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.
This medicinal product is not recommended for use in those aged over 50 years. Paediatric Population This medicinal product is not recommended for use in children under 18 years of age. Renal/hepatic impairment A lower dose should be considered in patients with renal or hepatic impairment.
3). Method of Administration For oral administration. To be taken preferably with or after food. This medicinal product should be swallowed whole and not broken or crushed.
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:
2 and GI and cardiovascular risks below). This medicinal product is for short-term use only. Older people and/or debilitated patients are particularly susceptible to the adverse effects of NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal.
Prolonged use of NSAIDs in these patients is not recommended. This medicinal product is not recommended for use in those aged over 50 years The antipyretic and anti-inflammatory activities of naproxen 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. 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.
The product should not be taken, except on the advice of a doctor, by women who first experience period pain more than a year after starting menstruation Gastrointestinal bleeding, ulceration and perforation GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events.
3), and in older people. 5). When GI bleeding or ulceration occurs in patients receiving Naproxen, 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.
Active or history of peptic ulceration or active gastrointestinal bleeding (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Hypersensitivity to naproxen or any of the excipients.
Since the potential exists for cross-sensitivity reactions, this medicinal product should not be given to patients in whom aspirin or other non-steroidal antiinflammatory/ 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.
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Visual disturbances, corneal opacity, papillitis and papilloedema.
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).
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. Alopecia, erythema multiforme, Stevens Johnson syndrome, erythema nodosum, lichen planus, pustular reaction, SLE, epidermal necrolysis, very rarely toxic epidermal necrolysis, photosensitivity reactions (including cases in which skin resembles porphyria cutanea tarda “pseudoporphyria”) or epidermolysis bullosa-like reactions which may occur rarely.
If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued, and the patient monitored. 4) (Frequency: Not known) 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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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 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 binding. Certain patients, specifically those whose renal blood flow is compromised, such as in extracellular volume depletion, cirrhosis of the liver, sodium restriction, congestive heart failure, and pre-existing renal disease, should have renal function assessed before and during Naproxen therapy.
Some older people in whom impaired renal function may be expected, as well as patients using diuretics, may also fall within this category. A reduction in daily dosage should be considered to avoid the possibility of excessive accumulation of naproxen metabolites in these patients.
Use in patients with impaired liver function. Chronic alcoholic liver disease and probably also other forms of cirrhosis reduce the total plasma concentration of naproxen, but the plasma concentration of unbound naproxen is increased.
The implication of this finding for Naproxen dosing is unknown but it is prudent to use the lowest effective dose. Haematological Patients who have coagulation disorders or are receiving drug therapy that interferes with haemostasis should be carefully observed if naproxen- containing products are administered.
g. dicoumarol derivatives) may be at increased risk of bleeding if given naproxen containing products concurrently. Anaphylactic (anaphylactoid) reactions Hypersensitivity reactions may occur in susceptible individuals. Anaphylactic (anaphylactoid) reactions may occur both in patients with and without a history of hypersensitivity or exposure to aspirin, other non-steroidal anti- inflammatory drugs or naproxen-containing products.
g. asthma), rhinitis and nasal polyps. Anaphylactoid reactions, like anaphylaxis, may have a fatal outcome. Steroids Patients taking steroids should not take […]