Nurofen Meltlets Lemon 12

Nurofen relieves pain and reduces inflammation and temperature as well as relieving headaches and other types of pain. It also relieves cold and flu symptoms.

For oral administration and short-term use only.

Place tablet on the tongue and allow it to dissolve and then swallow. No water is required. Do not chew.

During short-term use, if symptoms persist or worsen the patient should be advised to consult a doctor

Adults and children over 12 years: Initial dose two tablets, then if necessary, one or two tablets every four hours. Do not exceed six tablets in any 24 hours. Not for use by children under 12 years of age without medical advice.

The minimum effective dose should be used for the shortest time necessary to relieve symptoms. If the product is required for more than 10 days, or if the symptoms worsen the patient should consult a doctor.

The list of the following adverse effects relates to those experienced with ibuprofen at OTC doses, for short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.

Gastrointestinal Uncommon: abdominal pain, dyspepsia and nausea.

Disorders Rare: diarrhoea, flatulence, constipation and vomiting

Very rare: Peptic ulcer, perforation or gastrointestinal haemorrhage, sometimes fatal, particularly in the elderly Exacerbation of ulcerative colitis and Crohn's disease

Nervous Uncommon: Headache System Very rare Aseptic meningitis - single cases have been reported very rarely

Kidney Very rare: Decrease of urea excretion and oedema can occur. Also, acute renal failure. Papillary necrosis, especially in long-term use, and increased serum urea concentrations have been reported.

Liver Very rare: liver disorders, especially in long-term treatment.

Blood Very rare: haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding.

Skin Very rare: severe forms of skin reactions such as erythema multiforme and epidermal necrolysis can occur.

Immune System Very rare: In patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic

meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed

Hypersensitivity Uncommon: Hypersensitivity reactions with urticaria and Reactions pruritus.

Very rare severe hypersensitivity reactions. Symptoms could be: facial, tongue and larynx swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock). Exacerbation of asthma and bronchospasm.

Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.

Clinical trial and epidemiological data suggest that use of ibuprofen (particularly at high doses 2400mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke)

Do not take if you suffer from the following:

Phenylketonuria

Patients with a known hypersensitivity to ibuprofen or any other constituent of the medicinal product.

Patients with a history of bronchospasm, asthma, rhinitis, or urticaria associated with aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).

Patients with a history of, or existing gastrointestinal ulceration/perforation or bleeding, including that associated with NSAIDs.

Patients with severe hepatic failure, severe renal failure or severe heart failure.

Use with concomitant NSAIDs, including cyclo-oxygenase-2 specific inhibitors - increased risk of adverse reactions

Severe heart failure.

Consult your doctor before use if you are pregnant, asthmatic, or are taking any other regular medical treatment.

Caution is required in patients with certain conditions, which may be made worse:

systemic lupus erythematosus as well as those with mixed connective tissue disease (see Section 4.8, Unwanted effects)

gastrointestinal disorders and chronic inflammatory intestinal disease (ulcerative colitis, Crohn's disease) (see Section 4.8, Unwanted effects)

hypertension and/or cardiac impairment (see Section 4.5, Interactions)

renal impairment (see Sections 4.3, Contraindications and 4.8, Unwanted effects)

hepatic dysfunction (see Sections 4.3, Contraindications and 4.8, Unwanted effects)

Bronchospasm may be precipitated in patients suffering from, or with a history of, bronchial asthma or allergic disease.

The elderly are at increased risk of the consequence of adverse reactions.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and cardiovascular risks below).

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 GI events.

Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of gastrotoxicity or bleeding, such as corticosteroids, or anticoagulants such as warfarin or anti-platelet agents such as aspirin.

When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn.

There is some evidence that drugs which inhibit cyclo-oxygenase/ prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment.

Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.

Cardiovascular and cerebrovascular effects

Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. 1200mg daily) is associated with an increased risk of myocardial infarction.

Read the enclosed leaflet before taking this product Do not take if you:

• have or have ever had a stomach ulcer, perforation or bleeding

• are allergic to ibuprofen, to any of the ingredients, or to aspirin or other painkillers

• are taking other NSAID pain killers or aspirin with a daily dose above 75mg

• are in the last 3 months of pregnancy

• or the patient is under 12 years of age.

Speak to your doctor or pharmacist before use if you

Have asthma , heart, liver, kidney or bowel problems, are in the first 6 months of pregnancy. If symptoms persist or worsen, or if new symptoms occur, consult your doctor or pharmacist.