Nurofen 200 mg Caplets

Ibuprofen 200 mg For excipients, see 6.1.

Coated Tablet

A white to off-white, biconvex, round, sugar coated tablet printed 'Nurofen' in black on one face.

For the relief of migraine-headaches, backache, dental pain, neuralgia and period pains as well as rheumatic and muscular pains.

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.

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 taken with water, 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.

Elderly: No special dosage modifications are required. (See Section 4.4)

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.

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. (See Section 4.4)

Patients with severe hepatic failure, severe renal failure or severe heart failure. See also Section 4.4

Use with concomitant NSAIDs, including cyclo-oxygenase-2 specific inhibitors – increased risk of adverse reactions (see section 4.5).

During the last trimester of pregnancy as there is a risk of premature closure of the fetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child (see Section 4.6).

Severe heart failure.

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 (see Section 4.5).

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.

The label will include: 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.

Ibuprofen (like other NSAIDs) should be used with caution in combination with:

Aspirin unless low-dose aspirin (not above 75mg daily) has been advised by a doctor as this may increase the risk of adverse reactions (see Section 4.3). Other NSAIDs as these may increase the risk of adverse effects (see Section 4.3)

Ibuprofen should be used in caution in combination with:

Corticosteroids as these may increase the risk of adverse reactions, especially of the gastrointestinal tract. (see Section 4.3) Antihypertensives and diuretics since NSAIDs may diminish the effects of these drugs. Anticoagulants. There is limited evidence of enhancement of oral anticoagulant effects. Lithium. There is evidence for potential increase in plasma levels of lithium. Methotrexate. There is evidence for the potential increase in plasma levels of methotrexate. Zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

Whilst no teratogenic effects have been demonstrated in animal experiments, the use of Nurofen during pregnancy should, if possible, be avoided during the first 6 months of pregnancy. It should not be used for the last trimester of pregnancy. The onset of labour may be delayed and duration of labour increased. (See Section 4.3)

In limited studies, ibuprofen appears in the breast milk in very low concentration and is unlikely to affect the breast-fed infant adversely.

See section 4.4 regarding female fertility.

None expected at recommended dose and duration of therapy.

Hypersensitivity reactions have been reported and these may consist of non-specific allergic reactions and anaphylaxis respiratory tract reactivity e.g. asthma, aggravated asthma, bronchospasm, dyspnoea various skin reactions e.g. pruritus, urticaria, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme)

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 (see section 4.4) Exacerbation of ulcerative colitis and Crohn's disease (See section 4.4)

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) (see section 4.4).

In children ingestion of more than 400 mg/kg may cause symptoms. In adults the dose response effect is less clear cut. The half-life in overdose is 1.5-3 hours.

Symptoms – Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning metabolic acidosis may occur and the prothrombin time/ INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.

Management – Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.

Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans, ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation.

Ibuprofen is well absorbed from the gastrointestinal tract. Ibuprofen is extensively bound to plasma proteins.

Peak serum concentration occurs approximately 1-2 hours after administration.

Ibuprofen is metabolised in the liver to two major metabolites with primary excretion via the kidneys, either as such or as major conjugates, together with a negligible amount of unchanged ibuprofen. Excretion by the kidney is both rapid and complete.

Elimination half-life is approximately 2 hours.

No significant differences in pharmacokinetic profile are observed in the elderly.

No relevant information, additional to that contained elsewhere in the SPC.

Tablet Core

Croscarmellose Sodium

Sodium Laurilsulfate

Sodium Citrate Stearic Acid

Colloidal Anhydrous Silica

Sugar coat ingredients

Carmellose Sodium French

Chalk for Tablets (Talc) Acacia

Spray Dried Sucrose Titanium

Dioxide Macrogol 6000

Tablet printing

Opacode S-1-8152 HV Black (solids)¹

¹ Opacode S-1-8152 HV black contains the following residual materials after application

Shellac USNF 53.504% Iron oxide

black (E172) 44.699% Soya

lecithin 1.788% Antifoam DC1510

0.009%

Not applicable.

24 months.

Do not store above 25ºC.

Store in the original pack.

The tablets will be packed in blisters consisting of:

Push through laminate consisting of opaque, white 250 micron PVC heat-sealed to 20 micron aluminium foil or Push through laminate consisting of opaque, white 250 micron PVC with 40 gsm PVdC, heat-sealed to 20 micron aluminium foil.

The blisters are contained in a cardboard carton

2, 3, 4, 5, 6, 8, 10, 12, 15, 16 tablets.

Not all packs will be marketed.

Not applicable

Crookes Healthcare Limited 1

Thane Road West

Nottingham NG2 3AA

PL 00327/0145

15^th July 2004

21/03/2007