1. Name Of The Medicinal Product
Nurofen Migraine Pain
Nurofen Tension Headache
Nurofen Express 342mg Caplets
2. Qualitative And Quantitative Composition
Ibuprofen 200 mg ( as ibuprofen Lysine )
3. Pharmaceutical Form
Film-coated tablet. White, capsule - shaped tablet, printed with an identifying logo in black on one face.
4. Clinical Particulars
4.1 Therapeutic Indications
For the relief of headache and migraine pain.
4.2 Posology And Method Of Administration
Adults and children over 12 years: Initial dose, one or two tablets, then if necessary, one or two tablets every four hours. Do not exceed six tablets in any 24 hours. Leave at least 4 hours between doses.
For oral administration. To be taken with water.
Not recommended for children under 12 years of age.
Elderly: No special dosage modifications are required.
4.3 Contraindications
Hypersensitivity to any of the constituents, aspirin or other non steroidal anti-inflammatory drugs (NSAIDs).
Patients with existing, or a history of peptic ulceration.
Patients with a history of bronchospasm, rhinitis or urticaria associated with aspirin or other NSAIDs.
Severe heart failure.
4.4 Special Warnings And Precautions For Use
Caution is required in patients with renal, cardiac or hepatic impairment. In patients with renal impairment, renal function should be monitored since it may deteriorate following the use of any NSAID.
Bronchospasm may be precipitated in patients suffering from, or with a previous history of bronchial asthma or allergic disease.
The elderly are at increased risk of consequences of the serious 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).
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.
The label will state:
Do not use if you have ever had a stomach ulcer or are allergic to ibuprofen (or any of the ingredients of the product) or aspirin. If you are allergic to or are taking any other painkiller, pregnant, or suffer from asthma speak to your doctor before taking Nurofen Migraine Pain/Nurofen Tension Headache. Do not exceed the stated dose. Keep out of the reach of children. If symptoms persist, consult your doctor.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
The following drug interactions have been identified for ibuprofen acid:
Ibuprofen (like other NSAIDs) should not be used in combination with:
• Aspirin or other NSAIDS. This may result in an increased incidence of adverse reactions.
• Antihypertensives since NSAIDs may diminish the effects of these drugs. There is limited evidence of reduction of the effectiveness of diuretics.
• Anti-coagulants. There is limited evidence of enhancement of oral anticoagulant effects.
• Lithium and methotrexate. There is evidence for potential increase in plasma levels of both lithium and methotrexate.
4.6 Pregnancy And Lactation
No specific studies have been conducted with ibuprofen lysine.
No teratogenic effects have been demonstrated with ibuprofen acid in animal experiments. The use of Nurofen Migraine Pain/Nurofen Tension Headache during pregnancy should be avoided, if possible. The onset of labour may be delayed and the duration of labour increased.
In limited studies with ibuprofen acid, ibuprofen appears in breast milk in low concentrations and is unlikely to affect the breast fed infant adversely.
4.7 Effects On Ability To Drive And Use Machines
None
4.8 Undesirable Effects
Possible side effects are those experienced with ibuprofen acid. These may include:
Hypersensitivity reactions have been reported following treatment with ibuprofen. These may consist of (a) non-specific allergic reaction and anaphylaxis, (b) respiratory tract activity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritis, urticaria, purpura, angioedema and, more rarely, bullous dermatoses (including epidermal necrolysis and erythema multiforme).
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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).
4.9 Overdose
Symptoms include nausea, vomiting, dizziness, hypotension and, rarely, loss of consciousness. Large overdoses are generally well tolerated when no other drugs are involved. No specific antidote is available and supportive therapy is indicated. Treatment consists of gastric lavage and if necessary correction of serum electrolytes.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Ibuprofen lysine is the lysine salt of ibuprofen, a propionic acid derivative, having analgesic, anti-inflammatory and antipyretic activity. The therapeutic effects of ibuprofen lysine as a non steroidal anti-inflammatory drug are thought to result from inhibitory activity on prostaglandin synthesis.
Following oral administration, ibuprofen lysine dissociates to ibuprofen acid and lysine. Lysine has no recognised pharmacological activity. The pharmacological properties of ibuprofen lysine, therefore, are the same as those of ibuprofen acid.
5.2 Pharmacokinetic Properties
Most pharmacokinetic data obtained following the administration of ibuprofen acid also apply to ibuprofen lysine.
Peak plasma concentrations occur 1-2 hours after administrations of ibuprofen acid. However, ibuprofen is more rapidly absorbed from the gastrointestinal tract following the administration of Nurofen Migraine Pain tablets/Nurofen Tension headache, with peak plasma concentrations occurring approximately 35 minutes after administration in the fasting state.
The elimination half-life of ibuprofen acid is approximately 2 hours.
The drug is extensively bound to plasma proteins.
Ibuprofen is metabolised in the liver to two inactive metabolites and these, together with unchanged ibuprofen, are excreted by the kidney either as such or as conjugates. Excretion by the kidney is both rapid and complete.
No specific difference in pharmacokinetic profile is observed in the elderly.
5.3 Preclinical Safety Data
No relevant information additional to that contained elsewhere within the SmPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Povidone, sodium starch glycollate Type A, magnesium stearate, hypromellose, talc, Opaspray White M-1-7111B (contains hypromellose and titanium dioxide (E171) and Black Ink (contains, shellac, Iron oxide black (E172) and propylene Glycol).
6.2 Incompatibilities
Not applicable
6.3 Shelf Life
36 months
6.4 Special Precautions For Storage
Do not store above 30ºC . Store in the original container.
6.5 Nature And Contents Of Container
A blister pack consisting of opaque, white 250μm polyvinyl chloride (PVC)/23μm polychlorotrifluoroethylene (Aclar) laminate heat sealed to 20μm aluminium foil. The blisters are packed in cardboard cartons.
Or
A blister pack consisting of opaque, white 250μm polyvinyl chloride (PVC)/40gsm polyvinylidene chloride (PVdC) laminate heat sealed to 20μm aluminium foil. The blisters are packed in cardboard cartons.
Pack sizes: 2, 4, 6, 8, 10, 12, 16 tablets
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
United Kingdom
8. Marketing Authorisation Number(S)
PL 00327/0125
9. Date Of First Authorisation/Renewal Of The Authorisation
27 July 2000
10. Date Of Revision Of The Text
25/06/2007
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