NUROFEN FOR CHILDREN ORANGE FLAVOURED

Posology For oral administration and short term use only. 4). In children ibuprofen is dosed depending on body weight, as a rule with 5 to 10 mg/kg body weight as a single dose. The maximum daily dosage of Nurofen for Children is 20-30 mg/kg bodyweight.

The recommended daily dose can be achieved as follows:

Child Body Weight (kg) Age (Years) Single dose Maximum daily dose 20-29 7-9 200 mg ibuprofen (corresponding to 2 capsules) 600 mg ibuprofen (corresponding to 6 capsules) 30-40 10-12 300 mg ibuprofen (corresponding to 3 capsules) 900 mg ibuprofen (corresponding to 9 capsules) Doses should be given approximately every 6 to 8 hours (or with a minimum of 6 hours between each dose) if required.

Do not use in children under 7 years of age or in children weighing less than 20 kg. If in children this medicinal product is required for more than 3 days, or if symptoms worsen, a doctor should be consulted. 3). 3). Method of administration For oral administration.

The product should be chewed before swallowing. No water needed

The list of the following undesirable effects comprises all undesirable effects that have become known under treatment with ibuprofen, also those under high-dose long- term therapy in rheumatism patients. The stated frequencies, which extend beyond very rare reports, refer to the short-term use of daily doses up to a maximum of 1200 mg ibuprofen for oral dosage forms and a maximum of 1800 mg for suppositories.

With the following adverse drug reactions, it must be accounted for that they are predominantly dose-dependent and vary inter-individually. Adverse events which have been associated with Ibuprofen are given below, listed by system organ class and frequency.

Frequencies are defined as:

Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

The adverse events observed most often are gastrointestinal in nature. Adverse events are mostly dose-dependent, in particular the risk of occurrence of gastrointestinal bleeding which is dependent on the dosage range and duration of treatment.

4). 4) have been reported following administration. Less frequently, gastritis has been observed. Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. 4). g. development of necrotising fasciitis) coinciding with the use of nonsteroidal anti-inflammatory drugs has been described.

This is possibly associated with the mechanism of action of the nonsteroidal anti-inflammatory drugs. If signs of an infection occur or get worse during use of Nurofen for Children, the patient is therefore recommended to go to a doctor without delay.

It is to be investigated whether there is an indication for an antimicrobial/antibiotic therapy. The blood count should be checked regularly in long-term therapy. The patient is to be instructed to inform a doctor at once and no longer to take Nurofen for Children if one of the symptoms of hypersensitivity reactions occurs, which can happen even on first use, the immediate assistance of a doctor is required.

The patient is to be instructed to withdraw the medicinal product and to go to a doctor immediately if severe pain in the upper abdomen or melaena or haematemesis occurs. g. development of necrotising fasciitis), in exceptional cases, severe skin infections and soft-tissue complications may occur during a varicella infection Blood and Lymphatic System Disorders Very rare Haematopoietic disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranuloctosis).

The first signs may be fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding and bruising. In such cases, the patient should be advised to discontinue this medicinal product, to avoid any self-medication with analgesics or antipyretics and to consult a physician.

Symptoms could be: facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension (anaophylaxis, angioedema or severe shock). Exacerbation of asthma Immune System Disorders Not Known Respiratory tract reactivity comprising asthma, bronchospasm or dyspnoea Psychiatric disorders Very rare Psychotic reactions, depression Uncommon Central nervous disturbances such as headache, dizziness, sleeplessness, agitation, irritability or tiredness Nervous System Disorders Very rare Aseptic meningitis3 Eye disorders Uncommon Visual disturbances Ear and labyrinth disorders Rare Tinnitus Cardiac Disorders Very rare Not known Cardiac failure, palpitations and oedema myocardial infarction Kounis syndrome System Organ Class Frequency Adverse Events Vascular Disorders Very rare Hypertension, vasculitis Common Gastrointestinal complaints such as abdominal pain, nausea and dyspepsia.

Diarrhoea, flatulence, constipation, heartburn, vomiting and slight gastro-intestinal blood losses that may cause anaemia in exceptional cases. 4), gastritis Gastrointestinal Disorders Very rare Oesophagitis, formation of intestinal diaphragm-like strictures, pancreatitis.

Hepatobiliary Disorders Very rare Hepatic dysfunction, hepatic damage, particularly in long-term therapy, hepatic failure, acute hepatitis Uncommon Various skin rashes Very rare Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, Stevens- Johnson syndrome, and toxic epidermal necrolysis) Alopecia Skin and Subcutaneous Tissue Disorders Not known Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome).

Acute generalised exanthematous pustulosis (AGEP) Photosensitivity reactions Renal and Urinary Disorders Rare Not known Kidney-tissue damage (papillary necrosis) and elevated urea concentrations in the blood may also occur rarely; elevated uric acid concentrations in the blood.

Ureteric colic, dysuria System Organ Class Frequency Adverse Events Renal tubular acidosis* Very rare Formation of […]

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). 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. 5). g. 8) There is a risk of renal impairment in dehydrated children. Renal tubular acidosis and hypokalaemia may occur following acute overdose and in patients taking ibuprofen products over long periods at high doses (typically greater than 4 weeks), including doses exceeding the recommended daily dose.

In general terms, the habitual intake of painkillers, particularly on combination of several pain-relieving active substances, may lead to permanent renal damage with the risk of renal failure (analgesic nephropathy). 8) Surgery: Caution is required directly after major surgery.

Allergy:

Caution is required in patients who react allergically to other substances, as an increased risk of hypersensitivity reactions occurring also exists for them on use of Nurofen for Children. In patients who suffer from hayfever, nasal polyps or chronic obstructive respiratory disorders as an increased risk exists for them of allergic reactions occurring.

These may present as asthma attacks (so-called analgesic asthma), Quincke’s oedema or urticaria. Severe acute hypersensitivity reactions (for example anaphylactic shock) are observed very rarely. At the first signs of hypersensitivity reaction after using Nurofen for Children therapy must be stopped.

Medically required measures, in line with the symptoms, must be initiated by specialist personnel.

Cardiovascular and cerebrovascular effects:

Cases of Kounis syndrome have been reported in patients treated with Nurofen for Children Orange Flavoured 100mg Chewable Capsule, Soft. Kounis syndrome has been defined as cardiovascular symptoms secondary to an allergic or hypersensitive reaction associated with constriction of coronary arteries and potentially leading to myocardial infarction.

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.

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). g. ≤ 1200 mg/day) is associated with an increased risk of arterial thrombotic events.

Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided.

g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required 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. 8). GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events.

3), and in the elderly. These patients should commence treatment on the lowest dose available. g. 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.

5). When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn.

Severe cutaneous adverse reactions (SCARs):

Severe cutaneous adverse reactions (SCARs), including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis […]

1. g. asthma, rhinitis, angioedema or urticaria) in response to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs). Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).

History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. 4). 6). This medicinal product contains soya lecithin. If you are allergic to peanuts or soya do not use this medicinal product. Cerebrovascular or other active bleeding.

Unclarified blood-formation disturbances. Severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).