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Essential information

Nurofen for Children 3 months to 9 years Strawberry PL00063/0667
Active Ingredients: Ibuprofen 100mg/5ml (2.0%w/v).
Indications: For the fast and effective reduction of fever, including post immunisation pyrexia and the fast and effective relief of the symptoms of colds and influenza and mild to moderate pain, such as a sor e throat, teething pain, toothache, headache, minor aches and sprains.
Dosage and Administration: The lowest effective dose should be used f or the shortest duration necessary to relieve symptoms (see section 4.4). For short term use only.
The recommended daily dose of the product is 20 – 30 mg per k g of body weight, divided into equal doses, with dosing intervals of 6 to 8 hours. Leave at least 4 hours between doses and do not tak e more than the recommended dose in 24 hours. The recommended dose should not be exceeded.
Not suitable for children under 3 months of age.
Do not use this product in children weighing less than 5 kg.
For infants aged 3-6 months medical advice should be sought if sy mptoms worsen or not later than 24 hours if symptoms persist.
If in children aged from 6 months this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.
Special patient groups:

• For children with Juvenile Rheumatoid Arthritis: The usual daily dose of up t o 30 to 40 mg per kg of body weight, in three to four divided doses may be taken.
• For post-immunisation pyrexia: One 2.5 ml dose followed by one further 2.5 ml dose 6 hours lat er if necessary. Do not exceed two 2.5ml doses in 24 hours. If the fever is not reduced, consult a doctor.

Method of administration
For oral administration.
For patients with sensitive stomachs the product can be taken with or after food
Contraindications: Hypersensitivity to ibuprofen or to any of the excipients. History of hypersensitivity reactions in response to ibuprofen, acetylsalicylic acid or other NSAIDs. Active or a history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Hist ory of gastrointestinal bleeding or per foration, related to previous NSAIDs therapy. Severe hepatic failure, renal failure or heart failure. Last trimester of pregnancy. Special Warnings and Precautions for use: Do not give this product if the child is under 3 mont hs old or weighs less than 5 kg; has (or has had two or more episodes of) a stomach ulcer, perforation or bleeding; is allergic to ibuprofen or any other ingredient of the product, aspirin or other related painkillers, or fructose; is taking other NSAID painkillers, or aspirin w ith a daily dose above 75mg. Consult a doctor or pharmacist before use for someone who has or had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems; is dehydrated; has chicken pox; smokers; elderly. Acute generalised exanthematous pustulosis (AGEP) has been reported in relation to ibuprofen-containing products. This medicine can mask sy mptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection. This has been obser ved in bacterial community acquired pneumonia and bacterial complications to varicella. You must consult a doct or if symptoms persist or worsen, or if the medicine is needed for more than 24h for a child of 3 to 6 months, or for more than 3 days for a child over 6 months. Contains Maltitol Liquid.
Fertility, Pregnancy and Lactation:
Pregnancy
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of car diac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5 %. The risk is believed to increase with dose and duration of therapy. In animals, administration o f a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryofoetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimest er of pregnancy, Nurofen for Children should not be given unless clearly necessary. If Nurofen for Children is used by a woman attempting to conceive, or during the first and second trimest er of pregnancy, the dose should be kept as low and duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:
- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
- renal dysfunction, which may progress to renal failure with oligo-hydroamniosis; the mother and the neonate, at the end of pregnancy, to:
- possible prolongation of bleeding time, an anti-aggr egating effect which may occur even at very low doses.
- inhibition of uterine contractions resulting in delayed or prolonged labour.
Consequently, Nurofen for Children is contraindicated during the third trimester of pregnancy.
Breast-feeding
In limited studies, ibuprofen appears in the breast milk in very low concentration and is unlikely to affect the breast fed infant adversely.
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.
Side effects:
The following list of adverse effects relates to those experienced with ibuprofen at OTC doses (maximum 1200 mg ibupr ofen per day), in short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse events may occur.
Adverse events which have been associated with ibuprofen are given below, tabulated by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and

Description of Selected Adverse Reactions

¹ 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 aller gic reactions and anaphylaxis, (b) respiratory tract reactivity, including asthma, aggravated asthma, bronchospasm, and dyspnoea, or (c) various skin reactions, including pruritus, ur ticaria, purpura, angioedema and, more rarely, exfoliative and bullous dermatoses, including toxic epidermal necrolysis, Stevens-Johnson Syndrome and erythema multiforme.
³ The pathogenic mechanism of drug-Induced aseptic meningitis is not ful ly 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 sy mptoms after drug discontinuation). 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 epidemiolo gical data suggest that use of ibuprofen (particularly at high doses 2400 mg daily) and in long-term treatment may be associated with a small increased risk of ar terial thrombotic events (e.g. myocardial infarction or stroke), (see section 4.4).
⁵ The adverse events observed most often are gastrointestinal in nature.
⁶ Sometimes fatal.
⁷ See section 4.4.
⁸ Especially in long-term use, associated with increased serum urea and oedema. Also includes papillary necrosis.
Legal Classification: GSL.
Licence Number: PL 00063/0667.
Licence Holder: Reckitt Benckiser Healthcare (UK) Limited HU8 7DS.
Price: £3.99 x100 ml
Last Revised: 30/April/2021.
For full information refer to: https://www.medicines.org.uk/emc/product/8137/smpc

Adverse events should be recorded using the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.