NUROFEN BACK PAIN

During short-term use, if symptoms persist or worsen the patient should be advised to consult a doctor. 4).

Adults, the elderly and children and adolescents between 12 and 18 years:

If in children and adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted. If in adults the product is required for more than 10 days, or if the symptoms worsen, the patient should consult a doctor.

For oral administration.

Children and Adolescents between 12 and 18 years:

One or two capsules taken twice daily.

Adults:

One or two capsules taken twice daily. The capsules should be taken together with water and swallowed whole. Do not chew or suck the capsules. Do not take more than 4 capsules in 24 hours. There should be at least 8 hours between doses.

Adverse events which have been associated with Ibuprofen are given below, listed by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

Within each frequency grouping, adverse events are presented in order of decreasing seriousness. The list of the following adverse events 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 events may occur.

The adverse events observed most often are gastrointestinal in nature. Adverse events are mostly dose-dependent, in particular the risk of occurrence of gastrointestinal bleeding is dependent on the dosage range and duration of treatment.

4). System Organ Class Frequency Adverse Event Blood and Lymphatic System Disorders Very rare: Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.

Immune System Disorders Uncommon Very rare Not Known Hypersensitivity reactions consisting of1: Urticaria and pruritus Severe hypersensitivity reactions. Symptoms could be facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock).

Respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea. Nervous System Disorders Uncommon Very rare Headache Aseptic meningitis2 Cardiac Disorders Not known Not known Cardiac failure and oedema Kounis syndrome Vascular Disorders Not known Hypertension Gastrointestinal Disorders Uncommon Rare Very rare Not known Abdominal pain, nausea, dyspepsia Diarrhoea, flatulence, constipation and vomiting Peptic ulcer, perforation or gastrointestinal haemorrhage, sometimes fatal, particularly in the elderly.

Melaena, haematemesis, ulcerative stomatitis, gastritis. 4). Hepatobiliary Disorders Very rare Liver disorders Skin and Subcutaneous Tissue Disorders Uncommon Very rare Not known Various skin rashes Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis).

Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) Acute generalised exanthematous pustulosis (AGEP) Photosensitivity reactions Metabolism and Nutrition Disorders Not known Not known Decreased Appetite Hypokalaemia* Renal and Urinary Disorders Very rare Not known Not known Not known Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema.

Renal insufficiency Ureteric colic, dysuria Renal tubular acidosis* Investigations Very rare Decreased haemoglobin levels Description of Selected Adverse Reactions 1 Hypersensitivity reactions have been reported following treatment with ibuprofen.

These may consist of (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract activity comprising asthma, aggravated asthma, bronchospasm, 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).

2The pathogenic mechanism of drug-Induced aseptic meningitis is not fully understood. However, the available data on NSAID-related aseptic meningitis points to a hypersensitivity reaction (due to a temporal relationship with drug intake, and disappearance of symptoms after drug discontinuation).

Of note, single cases of symptoms of aseptic meningitis (such as stiff neck, headache, nausea, vomiting, fever or disorientation) have been observed during treatment with ibuprofen, in patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease).

*Renal tubular acidosis and hypokalaemia have been reported in the post-marketing setting typically following prolonged use of the ibuprofen component at higher than recommended doses. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

2, and GI and cardiovascular risks below). The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.

Respiratory:

Bronchospasm may be precipitated in patients suffering from, or with a history of, bronchial asthma or allergic disease. 8) There is a risk of renal impairment in dehydrated children and adolescents Renal tubular acidosis and hypokalaemia may occur following acute overdose and in patients taking ibuprofen products over long periods at high doses (typically greater than 4 weeks), including doses exceeding the recommended daily dose.

8) Cardiovascular and cerebrovascular effects: Cases of Kounis syndrome have been reported in patients treated with Nurofen Back Pain 300mg Sustained Release Capsules/Nurofen Long Lasting Pain Relief 300mg Prolonged Release Capsules.

Kounis syndrome has been defined as cardiovascular symptoms secondary to an allergic or hypersensitive reaction associated with constriction of coronary arteries and potentially leading to myocardial infarction. 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 Clinical studies suggest that use of ibuprofen, particularly at high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).

g. ≤1200mg/day) is associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided.

g. hypertension, hyperlipidaemia, diabetes mellitus and smoking), particularly if high doses of ibuprofen (2400 mg/day) are required.

Impaired female fertility:

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

3), and in the elderly. These patients should commence treatment on the lowest dose available. 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.

5). When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn. 8). Most of these reactions occurred within the first month. If signs and symptoms suggestive of these reactions appear ibuprofen should be withdrawn immediately and an alternative treatment considered (as appropriate).

Masking of symptoms of underlying infections This medicinal product can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection. This has been observed in bacterial community acquired pneumonia and bacterial complications to varicella.

When this medicine is administered for pain or fever in relation to infection, monitoring of infection is advised. In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen. Excipients • Sucrose - Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

The leaflet will include:

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

The label will include:

Read the enclosed leaflet before taking this product Do not take if you: o have (or have had two or more episodes […]

Patients with a known hypersensitivity to ibuprofen or any other constituent of the medicinal product. g. asthma, rhinitis, angiodema, or urticaria) in response to aspirin or other non-steroidal anti- inflammatory drugs. Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding.

History of gastrointestinal bleeding or perforation, related to previous NSAIDS therapy. Patients with severe hepatic failure, severe renal failure or severe heart failure (NYHA Class IV). 4)During the last trimester of pregnancy as there is a risk of premature closure of the fetal ductus arteriosus with possible persistent pulmonary hypertension.

6). Severe heart failure.