1. Name Of The Medicinal Product
Nurofen Extra Strength 400 mg Tablets
2. Qualitative And Quantitative Composition
Ibuprofen 400 mg. For excipients, see 6.1
3. Pharmaceutical Form
Coated Tablet
A white to off-white, biconvex, round, sugar coated tablet printed with an identifying logo in red on one face.
4. Clinical Particulars
4.1 Therapeutic Indications
For the relief of migraine-headaches, backache, dental pain, neuralgia and period pains as well as rheumatic and muscular pains, and pain of non-serious arthritic conditions.
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.
4.2 Posology And Method Of Administration
For oral administration and short-term use only.
Adults and children over 12 years: Initial dose one tablet taken with water, then if necessary, one tablet every four hours. Do not exceed three 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.
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 symptoms persist or worsen, the patient should consult a doctor.
Leave at least four hours between doses and do not take more than 1200 mg in any 24 hour period.
4.3 Contraindications
Hypersensitivity to ibuprofen or any of the constituents in the product.
Patients who have previously shown hypersensitivity reactions (eg asthma, rhinitis, angioedema or urticaria) in response to aspirin or other NSAIDs. Active or previous peptic ulcer. History of upper gastrointestinal bleeding or perforation, related to previous NSAID therapy.
Use with concomitant NSAIDS including cycloxygenase-2 specific inhibitors (see section 4.5 Interactions). Severe hepatic failure, renal failure or heart failure (see section 4.4, Special Warnings and Precautions for Use). Last trimester of pregnancy (see section 4.6 Pregnancy and Lactation).
4.4 Special Warnings And Precautions For Use
Bronchospasm may be precipitated in patients suffering from, or with a previous history of, bronchial asthma or allergic disease.
Undesirable effects may be minimised by using the minimum effective dose for the shortest possible duration.
The elderly are at increased risk of serious consequences of adverse reactions.
Systemic lupus erythematosus and mixed connective tissue disease – increased risk of aseptic meningitis (see section 4.8 Undesirable Effects).
Chronic inflammatory intestinal disease (ulcerative colitis, Crohn's disease)- as these conditions may be exacerbated (see section 4.8 Undesirable effects).
Hypertension and/or cardiac impairment since renal function may deteriorate and/or fluid retention occur.
Renal impairment as renal function may further deteriorate (see section 4.3 Contraindications and section 4.8 Undesirable effects).
Hepatic dysfunction (see section 4.3 Contraindications and section 4.8 Undesirable effects).
There is limited evidence that drugs which inhibit cyclo-oxygenase/prostaglandins synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment.
Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAID's at anytime during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.
Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal 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 Interactions).
Where gastrointestinal bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn.
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 or are allergic to ibuprofen or any of the ingredients of the product, aspirin or other related painkillers are taking other NSAID painkillers, or aspirin with a daily dose above 75 mg are in the last 3 months of pregnancy
Speak to your doctor or pharmacist before taking this product if you have asthma, liver, heart, kidney or bowel problems are in the first 6 months of pregnancy
If symptoms persist or worsen consult your doctor.
Do not exceed the stated dose. Keep out of the reach and sight of children.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Ibuprofen (like other NSAIDs) should not be used in combination with:
aspirin unless low-dose aspirin (not above 75 mg daily) has been advised by a doctor, as this may increase the risk of adverse reactions (see section 4.3 Contraindications).
Other NSAIDs. This may result in an increased incidence of adverse reactions (see section 4.3 Contraindications). Ibuprofen should be used with caution in combination with:
Antihypertensives and diuretics: NSAIDs may diminish the effects of these drugs. Anti-coagulants. NSAIDs may enhance the effects of anticoagulants such as warfarin (see section 4.4 Special warnings).
Corticosteriods may increase the risk of adverse reactions in the gastrointestinal tract (see section 4.4 Special warnings). Lithium: there is evidence for potential increases in plasma levels of lithium.
Methotrexate. There is a potential for an increase in plasma levels methotrexate. Zidovudine: There is evidence of an increased risk of haemarthroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.
4.6 Pregnancy And Lactation
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.
During the 3rd trimester, ibuprofen is contraindicated as there is a risk of premature closure of the foetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and duration of labour increased with an increased bleeding tendency in both mother and child (see section 4.3 Contraindications).
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.
4.7 Effects On Ability To Drive And Use Machines
None expected at recommended doses and duration of therapy.
4.8 Undesirable Effects
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.
Hypersensitivity Uncommon: Hypersensitivity reactions with Reactions urticaria and 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.
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4.9 Overdose
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.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
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.
ATC Code: M01A E01
5.2 Pharmacokinetic Properties
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.
5.3 Preclinical Safety Data
There are no preclinical safety data of relevance to the consumer.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Tablet Core Croscarmellose Sodium Sodium Laurilsulfate Sodium Citrate Stearic Acid Colloidal Anhydrous Silica Sugar Coat Ingredients Carmellose Sodium Calcium Sulphate Dihydrate Acacia Spray Dried Sucrose Titanium Dioxide Carnauba Wax Powder Purified Water Tablet Printing Ink Opacode S-1-9460 HV Brown (solids)1 Industrial Methylated Spirit 1 Opacode S-1-8152 HV Brown contains the following residual materials after application:
Shellac USNF 28.877%
Iron oxide red (E172) 25.000%
Soya lecithin 1.000%
Simethicone 0.005%
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
24 months.
6.4 Special Precautions For Storage
PVC blister pack only – Do not store above 30°C.
Store in the original pack. PVC/PVDC Blister:
Store in the original pack. HDPE bottle: Store in the original pack.
6.5 Nature And Contents Of Container
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, 8, 10, 12, 15, 16, 18, 20, 24, 28, 32 or 48 tablets. Not all packs will be marketed.
Or
High density polyethylene bottle with a child resistant cap that is internally wadded with expanded polyethylene. 96 tablets. Not all packs will be marketed.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
Crookes Healthcare Limited
1 Thane Road
West Nottingham
NG2 3AA
8. Marketing Authorisation Number(S)
PL 00327/0184
9. Date Of First Authorisation/Renewal Of The Authorisation
20/02/2007
10. Date Of Revision Of The Text
20/02/2007
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