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Reckitt Benckiser Ireland Limited

7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 468 9200
Fax: +353 1 468 9299

Summary of Product Characteristics last updated on medicines.ie: 11/08/2015
SPC Nurofen for Children 60mg Suppositories Age 3 months - 2 years

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Nurofen for Children 60 mg Suppositories Age 3 months to 2 years

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Each suppository contains: Ibuprofen 60mg

For the full list of excipients see section 6.1

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White or yellowy-white cylindrical suppositories

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4.1 Therapeutic indications

Reduction of fever and relief of mild to moderate pain, such as teething pain, toothache, headache, sprains and strains and to ease the pain of sore throats and earache.

Relief of pain and fever associated with colds and influenza.

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4.2 Posology and method of administration


For short term use only.

Do not use in children under 3 months of age without medical advice.

The maximum total daily dose of Nurofen for Children 60 mg Suppositories Age 3 months to 2 years is 20-30 mg/Kg of body weight, administered in three to four single doses. This can be achieved as follows:

Age (weight)

Single dose

Daily dose

3-9 months (6.0–8.0 Kg)

1 suppository

3 times a day, leaving 6-8 hours between doses

9 months -2 years (8.0–12.0 Kg)

1 suppository

4 times a day, leaving 6 hours between doses

Do not use this product in children weighing less than 6kg .

For children aged 3 – 5 months medical advice should be sought if symptoms worsen or not later than 24 hours if symptoms persist. If in children aged from 6 months this medicinal product is required for 3 days, or if symptoms worsen a doctor should be consulted.

Method of administration

For rectal use only.

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4.3 Contraindications

Patients with severe hepatic failure, severe renal failure or severe heart failure (see section 4.4).

History of gastrointestinal bleeding or perforation related to previous NSAIDs therapy. Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding or other gastrointestinal disorders).

Hypersensitivity to ibuprofen or to any of the excipients listed in section 6.1.

Patients with a history of hypersensitivity reactions (e.g. bronchospasm, asthma, rhinitis, angioedema or urticaria), associated with acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs).

During the last trimester of pregnancy (see section 4.6)

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4.4 Special warnings and precautions for use

The use of Nurofen for Children 60mg Suppositories Age 3 months to 2 years with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5).

Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms (See section 4.2, and GI and cardiovascular risks below).

Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.

Gastrointestinal bleeding, ulceration and perforation: GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without any 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 (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk (see below and 4.5).

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 acetylsalicylic acid (aspirin) (see section 4.5).

When GI bleeding or ulceration occurs in patients receiving Nurofen for Children 60mg Suppositories Age 3 months to 2 years, the treatment should be withdrawn.

NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's Disease) as their condition may be exacerbated (see section 4.8 – undesirable effects).

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.

Caution is required in patients with renal impairment (see section 4.3) since renal function may deteriorate. In patients with renal impairment, renal function should be monitored as it may deteriorate following the use of NSAIDs.

Caution is required in patients with hepatic impairment (see section 4.3 and 4.8)

Elderly patients are particularly susceptible to the adverse effects of NSAIDs. Prolonged use of NSAIDs in the elderly is not recommended. Where prolonged therapy is required, patients should be reviewed regularly.

As NSAIDs can interfere with platelet function, they should be used with caution in patients with idiopathic thrombocytopenic purpura (ITP), intracranial haemorrhage and bleeding diathesis.

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 (see 4.8). Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Nurofen for Children 60mg Suppositories Age 3 months to 2 years should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

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.

Bronchospasm may be precipitated in patients suffering from, or with a history of, bronchial asthma or allergic disease.

Caution is advised in patients with systemic lupus erythematosus as well as those with connective tissue disease (see section 4.8)

Caution is also required in patients with disorders of the anus or rectum.

There is a risk of renal impairment in dehydrated children.

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4.5 Interaction with other medicinal products and other forms of interaction

Ibuprofen should be avoided in combination with:

Acetylsalicylic Acid (Aspirin): unless low-dose Acetylsalicylic Acid (Aspirin) (not above 75 mg daily) has been advised by a doctor, as this may increase the risk of adverse reactions (see section 4.4). Experimental data suggest that ibuprofen may inhibit the effect of low dose acetylsalicylic acid (aspirin) on platelets aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding the extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional use (see section 5.1)

Other NSAIDs including cyclo-oxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse effects (see section 4.4).

It is considered unsafe to take NSAIDs in combination with warfarin or heparin unless under direct medical supervision.

Care should be taken in patients treated with any of the following drugs as interactions have been reported:

Anti-hypertensives (ACE inhibitors and Angiotensin II Antagonists) and diuretics: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ace inhibitor or Angiotensin II antagonist and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking ibuprofen concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter. Diuretics can increase the risk of nephrotoxicity of NSAIDs.

Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4).

Anti-coagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin (see section 4.4).

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4).

Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma cardiac glycoside levels.

Lithium: decreased elimination of lithium.

Methotrexate: decreased elimination of methotrexate.

Cyclosporin: increased risk of nephrotoxicity with NSAIDs.

Aminoglycosides: reduction in renal function in susceptible individuals, decreased elimination of aminoglycoside and increased plasma concentrations.

Probenecid: reduction in metabolism and elimination of NSAID and metabolites.

Oral hypoglycemic agents: inhibition of metabolism of sulfonylurea drugs, prolonged half-life and increased risk of hypoglycaemia

Mifepristone: NSAIDs should not be used for 8-12 days after Mifepristone administration as NSAIDs can reduce the effect of Mifepristone.

Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with Tacrolimus.

Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with Zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with Quinolone antibiotics. Patients taking NSAIDs and Quinolones may have an increased risk of developing convulsions.

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4.6 Fertility, pregnancy and lactation


There is insufficient experience about the safety of use of ibuprofen in humans during pregnancy. As the influence of prostaglandin synthesis inhibition is unclear, it is recommended not to use ibuprofen during the first six months of pregnancy.

In the last trimester of pregnancy use of ibuprofen is contraindicated. Due to the mechanism of action, inhibition of uterine contractions, premature closure of ductus arteriosus and pulmonary hypertension of the neonate, an increased bleeding tendency in mother and child and increased formation of oedema in the mother could occur.


Ibuprofen and its metabolites can pass in very small concentrations (0.0008% of the maternal dose) into the breast milk. No harmful effects to infants are known, so it is not necessary to interrupt breast-feeding for short-term treatment with the recommended dose for mild to moderate pain and fever.


See section 4.4 on Special Warnings and Precautions for use regarding female fertility

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4.7 Effects on ability to drive and use machines

Nurofen for Children 60mg Suppositories Age 3 months to 2 years has no or negligible influence on the ability to drive and use machines.

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4.8 Undesirable effects

The list of the following adverse effects relates to those experienced with ibuprofen at OTC doses (maximum 1200mg ibuprofen per day), 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 are given below, tabulated by system organ class and frequency.

The frequencies are defined as follows:

Very common (≥1/10)

Common (≥1/100 to <1/10)

Uncommon (≥1/1000 to <1/100)

Rare (≥1/10000 to <1/1000)

Very Rare (<1/10000)

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


Adverse Events

Blood and Lymphatic System Disorders

Very rare

Haematopoietic disorders1

Immune System Disorders


Hypersensitivity reactions with urticaria and pruritus2

Very rare

Severe hypersensitivity reactions, including facial, tongue and throat swelling, dyspnoea, tachycardia and hypotension (anaphylaxis, angioedema or severe shock)2

Nervous System Disorders



Very rare

Aseptic meningits3

Cardiac Disorders

Very rare

Cardiac failure and oedema4

Vascular Disorders

Very rare


Respiratory, Thoracic and Mediastinal Disorders

Very rare

Respiratory and tract reactivity compromising asthma, aggravated asthma, bronchospasm or dyspnoea2

Gastrointestinal Disorders


Abdominal pain, nausea and dyspepsia5


Diarrhoea, flatulence, constipation and vomiting

Very rare

Peptic ulcer, gastrointestinal perforation or gastrointestinal haemorrhage, melaena and haematemesis6. Exacerbation of colitis and Crohn's disease7. Mouth ulceration and gastritis.

Hepatobiliary Disorders

Very rare

Liver disorder8

Cholestatic jaundice, hepatitis, elevation of serum enzymes.

Skin and Subcutaneous Tissue Disorders


Skin rash2

Very rare

Severe forms of skin reactions such as erythema multiforme, epidermal necrolysis and Stevens-Johnson syndrome2

Renal and Urinary Disorders

Very rare

Acute renal failure9


Very rare

Haemoglobin decreased, urea renal clearance 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.

2Hypersensitivity reactions: These may consist of (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactivity, including asthma, aggravated asthma, bronchospasm, and dyspnoea, or (c) various skin reactions, including pruritus, urticaria, purpura, angioedema and, more rarely, exfoliative and bullous dermatoses, including toxic epidermal necrolysis, Stevens-Johnson Syndrome and erythema multiforme.

3The pathogenic mechanism of drug-induced aseptic meningitis is not fully understood. However, the available data on NSAID-related aseptic meningitis points to a hypersensitivity reaction (due to a temporal relationship with drug intake, and disappearance of symptoms after drug discontinuation). Of note, 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.

4Clinical 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 (e.g. myocardial infarction or stroke), (see section 4.4).

5The adverse events observed most often are gastrointestinal in nature.

6Sometimes fatal, particularly in the elderly (see section 4.4).

7See section 4.4.

8Especially in long-term treatment.

9Decrease of urea excretion and oedema can occur. Papillary necrosis, especially in long-term use, and increased serum urea concentrations have been reported.

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

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4.9 Overdose

A dose in excess of 200mg/kg carries a risk of causing toxicity.

Symptoms of Overdosing

Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, abdominal pain, or more rarely diarrhoea. Tinnitus, headache, nystagmus, blurred vision, hypotension and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as dizziness, drowsiness, loss of consciousness, 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.

Therapeutic Measure in Overdosing

Patients should be treated symptomatically as required. Use supportive care where appropriate. Management should include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam, Give bronchodilators for asthma, No specific antidote is available.

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5.1 Pharmacodynamic properties

Pharmacotherapeutic Group: Anti-inflammatory and anti-rheumatic products, non-steroids, propionic acid derivative; ATC Code: M01AE01

Ibuprofen is an NSAID that has demonstrated its efficacy in the common animal experimental inflammation models by inhibition of prostaglandin synthesis. In humans, ibuprofen reduces inflammatory pain, swelling and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation.

The clinical efficacy of ibuprofen has been demonstrated in fever and in pain associated with headache, toothache and dysmenorrhoea. Furthermore it has been demonstrated in patients with pain and fever associated with cold and flu and in pain models such as sore throat, muscular pain, soft tissue injury, backache.

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelets aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400mg was taken within 8 h before or within 30 min after immediate release aspirin (81mg), a decreased effect of ASA on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use.

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5.2 Pharmacokinetic properties

After rectal administration, ibuprofen is absorbed quickly and almost completely, and is rapidly distributed throughout the whole body.Median peak plasma concentrations are seen 0.75 hours after use of a 60 mg suppository.

Ibuprofen is extensively bound to plasma proteins.

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. The elimination half life is approximately 2 hours.

No special pharmacokinetic studies have been carried out in children. However, pharmacokinetic parameters of ibuprofen in children are comparable with those in adults.

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5.3 Preclinical safety data

The toxicity of ibuprofen in animal experiments was observed as lesions and ulcerations in the gastrointestinal tract. Ibuprofen did not show a mutagenic potential in vitro and was not carcinogenic in rats and mice. Experimental studies have demonstrated that ibuprofen crosses the placenta, but there is not evidence of any teratogenic action.

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6.1 List of excipient(s)

Hard Fat

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6.2 Incompatibilities

Not applicable.

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6.3 Shelf life

2 years

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6.4 Special precautions for storage

Do not store above 25°C.

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6.5 Nature and contents of container

PE 40g/m2/aluminium foil 45μm/lacquer 1.0 g/m2

Pack size: 10 or 20 Suppositories. Not all pack sizes may be marketed.

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6.6 Special precautions for disposal and other handling


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Reckitt Benckiser Ireland Ltd.,

7 Riverwalk,

Citywest Business Campus, dublin 24

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PA 979/32/7

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Date of first authorisation: 12th September 2008

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July 2015

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