In children ingestion of more than 400 mg/kg ibuprofen 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.
As with other sympathomimetics, Pseudoephedrine overdose may cause symptoms of central nervous system and cardiovascular stimulation, including:
Irritability, restlessness, tremor, palpitations, convulsions, urinary retention, hypertension, tachycardia and cardiac arrhythmias.
Difficulty in micturition, nausea, vomiting may also occur in Pseudoephedrine overdose.
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.
A rapidly-acting alpha blocker, such as phentolamine, may be given to reverse alpha1-mediated effects such as hypertension, while a beta blocker may be given for beta1-mediated effects such as cardiac arrhythmias. In severe hypertension, rapidly-acting vasodilators such as glyceryl trinitrate have also been used.
3 years.
Not applicable.
Tricalcium phosphate 118, microcrystalline cellulose, polyvidone, croscarmellose sodium, magnesium stearate, methylhydroxypropyl cellulose, talc, Opaspray Yellow M-1F-6168 or Mastercote Yellow FA 0156, black printing ink (contains shellac, iron oxide black and propylene glycol).
The most commonly observed adverse events are with ibuprofen are gastrointestinal in nature.
The following list of adverse effects relates to those experienced with ibuprofen at OTC doses (maximum 1200mg per day) and sympathomimetics including pseudoephedrine for short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.
Adverse events which have been associated with Ibuprofen and sympathomimetics including pseudoephedrine are given below, listed by system organ class and frequency. Frequencies are defined as: Very common (>1/10), Common (>1/100 and <1/10), Uncommon (>1/1000 and <1/100), Rare (>1/10,000 and <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.
|
System Organ Class |
Frequency |
Adverse Event |
|
Blood and Lymphatic System Disorders |
Very rare |
Haematopoietic disorders1 |
|
Immune System Disorders |
Uncommon |
Hypersensitivity with urticaria and pruritus2 |
|
Very rare |
Severe hypersensitivity reactions including facial, tongue and throat swelling, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock)2 | |
|
Psychiatric Disorders |
Not known |
Insomnia, anxiety, restlessness, agitation, hallucination. |
|
Nervous System Disorders |
Uncommon |
Headache, tremor |
|
Very rare |
Aseptic meningitis3, Muscular weakness | |
|
Cardiac Disorders |
Not known |
Cardiac failure and oedema4, tachycardia, arrhythmia, palpitations. |
|
Vascular Disorders |
Not known |
Hypertension4 |
|
Respiratory, Thoracic and Mediastinal Disorders |
Not known |
Respiratory tract reactivity including exacerbation of asthma, bronchospasm or dyspnoea2. |
|
Gastrointestinal Disorders |
Uncommon |
Abdominal pain, nausea and dyspepsia5 |
|
Rare |
Diarrhoea, flatulence, constipation and vomiting | |
|
Very rare |
Peptic ulcers, gastrointestinal perforation or gastrointestinal haemorrhage, melaena, haematemesis6. Mouth ulceration and gastritis. | |
|
Not known |
Dry mouth, exacerbation of colitis and Crohn's disease7 | |
|
Hepatobiliary Disorders |
Very rare |
Liver disorders |
|
Skin and Subcutaneous Tissue Disorders |
Not known |
Hyperhidrosis |
|
Uncommon |
Skin rashes2 | |
|
Very rare |
Bullous reactions, including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis2 | |
|
Musculoskeletal and connective tissue disorders |
Not known |
Muscular weakness |
|
Renal and Urinary Disorders |
Very rare |
Acute renal failure8 |
|
Not known |
Urinary retention | |
|
General and Administration Site Conditions |
Not known |
Chest pain, irritability, thirst, |
|
Metabolism and Nutrition Disorders |
Not known |
Decreased Appetite |
|
Investigations |
Very rare |
Haemoglobin decreased |
Description of Selected Adverse Reactions:
1 Examples include anaemia, leucopenia, thrombocytopenia, pancytopenia and agranulocytosis. First signs are fever, sore throat, superficial mouth ulcers, flu- like symptoms, severe exhaustion, unexplained bleeding and bruising.
2 Hypersensitivity reactions: These may consist of (a) non-specific allergic reaction and anaphylaxis, (b) respiratory tract reactivity including asthma, aggravated asthma, bronchospasm and dyspnoea, or (c) various skin reactions, including pruritis, urticaria, purpura, angioedema and, more rarely, severe forms of skin reactions such as exfoliative and bullous dermatoses (including toxic epidermal necrolysis can occur, Stevens-Johnson Syndrome and erythema multiforme).
3 The pathogenic mechanism of drug-induced aseptic meningitis is not fully understood. However, the available data suggest that NSAID-related meningitis develops in individuals rendered susceptible by an underlying autoimmune disorder who were previously sensitized or had a natural immunity to the drug. 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 and mixed connective tissue disease).
4 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),.
5 The adverse events observed most often are gastrointestinal in nature.
6 Sometimes fatal, particularly in elderly.
7
8 Especially in long-term use, associated with increased serum urea and oedema. Also includes papillary necrosis.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card scheme at: www.mhra.gov.uk/yellowcard
No data is available which is of relevance to the consumer.
Pharmacotherapeutic Group: Anti-inflammatory and antirheumatic products, propionic acid derivatives. Ibuprofen combinations. ATC Code: M01AE51
Ibuprofen is a propionic acid derivative, having analgesic, anti-pyretic and anti-inflammatory activity. The drug's therapeutic effects as a non-steroidal anti-inflammatory drug are thought to result from inhibitory activity on prostaglandin synthesis. Furthermore, ibuprofen reversibly inhibits platelet aggregation.
Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose aspirin (acetylsalicylic acid) on platelet aggregation when they are dosed concomitantly. Some pharmacodynamics studies show that when single doses of ibuprofen 400mg were taken with 8 h before or within 30 min after immediate release aspirin (acetylsalicylic acid) dosing (81mg), a decreased effect of ASA (acetylsalicylic acid) on the formation of thromboxane or platelet aggregation occurred. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No relevant effect is considered to be likely for occasional use.
Pseudoephedrine hydrochloride is used as a nasal and bronchial decongestant which acts by vasoconstriction to reduce oedema and nasal swelling. It is a stereoisomer of Ephedrine and has a similar action. It is a sympathomimetic agent with direct and indirect effects on adrenergic receptors. It has alpha- and beta-adrenergic activities and has stimulating effects on the central nervous system. It has a more prolonged, though less potent action than adrenaline. However, pseudoephedrine has been stated to have less pressor activity and central nervous system effects than ephedrine.
Ibuprofen is rapidly absorbed from the gastrointestinal tract, peak serum concentrations occurring 1-2 hours after administration. The elimination half- life is approximately two hours.
Ibuprofen is metabolised in the liver to two major 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.
Ibuprofen is extensively bound to plasma proteins.
Pseudoephedrine is absorbed from the gastrointestinal tract and is largely excreted in the urine unchanged, together with small amounts of a hepatic metabolite. It has an elimination half-life of several hours, which may be reduced by acidifying the urine.
12/09/2017
Reckitt Benckiser Healthcare (UK) Ltd
Slough
SL1 4AQ
Store in a dry place.
A strip pack consisting of a blister tray of white pigmented 250 µm PVC/40 gsm PVDC laminate heat-sealed to lacquered 20 µm aluminium foil containing 12 tablets. One or two trays packed in a cardboard carton (12 or 24 tablets).
PL 00063/0375
Undesirable effects may be minimised by using the lowest effective dose for the shortest possible duration necessary to control symptoms (see 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 previous history of, bronchial asthma or allergic disease.
Other NSAIDs:
The use of Nurofen Cold & Flu with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided.
SLE and mixed connective tissue disease:
Systemic lupus erythematosus and mixed connective tissue disease - increased risk of aseptic meningitis.
Renal:
Moderate to severe renal impairment as renal function may further deteriorate, especially in dehydrated children and adolescents.
Hepatic:
Hepatic dysfunction
Cerebrovascular effects:
Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of occlusive vascular disease, hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in associated with NSAID therapy.
Clinical trial and epidemiological data suggest that the 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.
Impaired female fertility:
There is limited evidence that drugs which inhibit cyclo-oxygenase/prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible upon withdrawal of treatment.
Gastrointestinal:
NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated.
GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.
The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation , and the elderly. These patients should commence treatment on the lowest dose available.
Patients with a history of GI toxicity, particularly when 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 ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin.
When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn.
Dermatological:
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases with the first month of treatment. Nurofen Cold & Flu should be discontinued at the first appearance of a skin rash, mucosal lesions, or any other signs of hypersensitivity.
To be used with caution in patients with cardiovascular disease, tachycardia, hypertension, angina pectoris, hyperthyroidism, diabetes, phaeochromocytoma, closed angle glaucoma or elevated intraocular pressure, prostatic enlargement, hyperexcitability.
To be used with caution in combination with antihypertensives including adrenergic neurone blockers & Beta blockers. The effects of a single dose on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment.
To be used with caution with other sympathomimetic agents such as decongestants, appetite suppressants and amphetamine-like psycho-stimulants.
If hallucinations, restlessness, or sleep disturbances are experienced whilst taking the product, use of the product should be discontinued.
The label will include:
Read the enclosed leaflet before taking this product
Do not take if you:
- Have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding
- Are allergic to ibuprofen or any other ingredient of the product, aspirin or other related painkillers
- Are taking other NSAID painkillers, or aspirin with a daily dose above 75mg
Speak to a pharmacist or your doctor before taking if you:
- Have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems
- Are a smoker
- Are pregnant
If symptoms persist, consult your doctor.
None expected at recommended doses and duration of therapy.
Not applicable.
24/11/1993 / 29/04/2009
