BOOTS PERIOD PAIN RELIEVER

Posology Adolescents (post puberty) and adult females between the ages of 15 and 50: 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 in any one cycle (period) is 3 days. Method of administration For oral use, to be taken preferably with or after food swallowed whole with water.

Not to be broken or crushed.

The following adverse events have been reported with NSAIDs and with naproxen.

Blood and lymphatic system disorders:

Neutropenia, thrombocytopenia, agranulocytosis, 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, angioedema and, more rarely, exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).

Metabolism and nutrition disorders:

Hyperkalaemia.

Psychiatric disorders:

Insomnia, dream abnormalities, depression, confusion and hallucinations.

Nervous system disorders:

Convulsions, dizziness, retrobulbar, optic neuritis, headaches, light-headedness, drowsiness, paraesthesia, inability to concentrate and cognitive dysfunction have been reported. 4).

Eye disorders:

Visual disturbances, corneal opacity, papillitis and papilloedema.

Ear and labyrinth disorders:

Tinnitus, hearing disturbances including impairment and vertigo.

Cardiac disorders:

Oedema, palpitations, hypertension, 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.

Gastrointestinal disorders:

The most commonly observed adverse events are gastrointestinal in nature. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, heartburn and epigastric distress. 4) and oesophagitis have been reported following administration.

Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.

Hepatobiliary disorders:

Jaundice, fatal hepatitis and abnormal liver function tests.

Skin and subcutaneous tissue disorders:

Bullous reactions including Stevens- Johnson syndrome and toxic epidermal necrolysis (very rare). 4). Skin rashes including fixed drug eruption, itching (pruritus), urticaria, ecchymoses, purpura, sweating. Alopecia, erythema multiforme, erythema nodosum, lichen planus, pustular reaction, SLE, 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.

Musculoskeletal and connective tissue disorders:

Myalgia and muscle weakness.

Renal and urinary disorders:

Nephrotoxicity in various forms, including glomerular nephritis, tubulointerstitial nephritis (with possible progression to renal failure), 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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Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see warnings on GI and cardiovascular risks below). Patients treated with NSAIDs long-term should undergo regular medical supervision to monitor for adverse events.

The anti-inflammatory and antipyretic activities of naproxen may reduce inflammation and fever, thereby diminishing their utility as diagnostic signs. 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 nonsteroidal 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.

Combination with other NSAIDs The combination of naproxen-containing products and other NSAIDs including cyclooxygenase-2 selective inhibitors or aspirin is not recommended, because of the cumulative risks of inducing serious NSAID- related adverse events.

2). Prolonged use of NSAIDs in these patients is not recommended. Where prolonged therapy is required, patients should be reviewed regularly. Respiratory disorders Caution is required if administered to patients suffering from, or with a history of, bronchial asthma or allergic disease, since administration of naproxen or other NSAIDs may elicit bronchospasm.

Cardiovascular, Hepatic Impairment and 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 and the elderly.

3) Cardiovascular and cerebrovascular effects Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.

Clinical trial and epidemiological data suggest that use of coxibs and some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).

Although data suggest that the use of naproxen (1000 mg daily) may be associated with a lower risk, some risk cannot be excluded. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with naproxen after careful consideration.

g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). 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.

8). Acute tubulointerstitial nephritis can progress to renal failure. Naproxen should be discontinued in case of suspected TIN, and appropriate treatment should be promptly initiated. 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.

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. Gastrointestinal effects 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 the elderly. These patients should […]

1. Naproxen is contraindicated in patients with a history of, or active, peptic ulceration and active gastrointestinal bleeding (two or more distinct episodes of proven ulceration or bleeding). Naproxen is contraindicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.

Naproxen should not be given to patients in whom aspirin or other non- steroidal anti-inflammatory/analgesic drugs induce the syndrome of asthma, rhinitis, nasal polyps, angioedema or urticaria, as the potential exists for cross- sensitivity reactions.

These reactions have the potential of being fatal. Severe anaphylactic-like reactions to naproxen have been reported in such patients. 4). 6 – Pregnancy and lactation).