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.

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.

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.