Nurofena For Children Sugar Free 100 mg / 5 ml Suspension

For the relief of symptoms of fever, pain and inflammation, associated with cold and flu, a sore throat, earache, headache, dental pain and minor aches and sprains.

Use the lowest effective dose for the shortest possible duration of treatment. The dosage of NUROFENu00ae for Children SUGAR FREE is 20 mg/kg of body weight per day given in divided doses. Do not give to children under 12 months of age unless on prescription from a doctor.

Children:

Pain: Initial dose 5mg/kg body weight. A second dose of 5 mg/kg may be given after 2 hours if pain is not controlled, thereafter 5 mg/kg every 6 hours. DO NOT EXCEED 20 mg/kg of body weight per day.

Fever: 5 mg/kg of body weight every 6 hours. DO NOT EXCEED 20 mg/kg of body weight per day. If fever persists for more than 3 days, a doctor should be consulted.

• Hypersensitivity to any of the ingredients of NUROFENu00ae for Children SUGAR FREE, including excipients (see COMPOSITION).
• Use of NUROFENu00ae for Children SUGAR FREE is contra-indicated in patients with heart failure.
• History of gastrointestinal perforation, ulceration or bleeding (PUBs) related to previous NSAIDs including NUROFENu00ae for Children SUGAR FREE.
• Active or history of recurrent ulcer/haemorrhage/perforations.
• Severe impairment of liver and renal function.
• Pregnancy in the third trimester (see HUMAN REPRODUCTION).
• Hypersensitivity to Ibuprofen, aspirin or any other non-steroidal anti-inflammatory agent. Because of the possibility of cross-sensitivity due to structural relationships which exist among non-steroidal anti-inflammatory medicines, acute allergic reactions may be more likely to occur in patients who have exhibited allergic reactions to these compounds.
• Aspirin-induced nasal polyps associated with bronchospasm.
• Uncontrolled asthma.
• Children under the age of one year.
• Porphyria.
• Concomitant treatment with lithium (see INTERACTIONS).
• Concomitant treatment with digoxin (see INTERACTIONS).

Caution is required in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with NUROFENu00ae for Children SUGAR FREE therapy. In view of the NUROFENu00ae for Children SUGAR FREEu2019s inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.

Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs including NUROFENu00ae for Children SUGAR FREE, especially gastrointestinal perforation, ulceration and bleeding (PUBs) which may be fatal. The risk of gastrointestinal perforation, ulceration or bleeding (PUBs) is higher with increasing doses of NUROFENu00ae for Children SUGAR FREE, in patients with a history of ulcers, and the elderly (see CONTRAINDICATIONS). When gastrointestinal bleeding or ulceration occurs in patients receiving NUROFENu00ae for Children SUGAR FREE, treatment with NUROFENu00ae for Children SUGAR FREE should be stopped.

NUROFENu00ae for Children SUGAR FREE should be given with caution to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohnu2019s disease, hiatus hernia, gastro-oesophageal reflux disease, angiodysplasia) as the condition may be exacerbated.

DRESS: Drug Reaction with Eosinophillia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such NUROFENu00ae for Children SUGAR FREE. Some of these events have been fatal or life threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, haematological abnormalities, myocarditis, or myositis. Sometimes symptoms of DRESS may resemble an acute viral infection. Eosinophillia is often present. Because this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, discontinue NUROFENu00ae for Children SUGAR FREE and evaluate the patient immediately.

Dermatological effects: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. 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. Acute generalised exanthematous pustulosis (AGEP) has been reported in relation to NUROFENu00ae for Children SUGAR FREE. NUROFENu00ae for Children SUGAR FREE should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Regular use of NSAIDs such as NUROFENu00ae for Children SUGAR FREE during the third trimester of pregnancy, may result in premature closure of the foetal ductus arteriosus in utero, and possibly, in persistent pulmonary hypertension of the new-born. The onset of labour may be delayed and its duration increased.

Pregnancy: NUROFENu00ae for Children SUGAR FREE should be avoided during the first and second trimesters of pregnancy. During the third trimester, the use of NUROFENu00ae for Children SUGAR FREE is contraindicated (see CONTRAINDICATIONS).

Lactation: NUROFENu00ae for Children SUGAR FREE is not recommended during breastfeeding as ibuprofen is excreted in breastmilk.

Fertility: NUROFENu00ae for Children SUGAR FREE may impair female fertility by an effect of ovulation. This is reversible upon withdrawal of treatment.

The following side-effects have been reported:

System organ class Frequencies Adverse event

• Blood and lymphatic system disorders: Less frequent - Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, neutropenia, pancytopenia, eosinophilia and agranulocytosis). First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.
• Immune system disorders: Less frequent - Hypersensitivity reactions with urticaria and pruritus. Severe hypersensitivity reactions, including facial tongue and throat swelling, dyspnoea, tachycardia and hypotension (anaphylaxis, angioedema or severe shock). Not known - DRESS reaction.
• Nervous system disorders: Less frequent - Headache, aseptic meningitis, dizziness, nervousness, tinnitus, depression, drowsiness, insomnia.
• Eye disorders: Less frequent - Blurred vision, changes in visual colour perception, toxic amblyopia.
• Cardiac disorders: Not known - Cardiac failure and oedema.
• Vascular disorders: Not known - Hypertension.
• Respiratory, thoracic and mediastinal disorders: Not known - Exacerbation of asthma and bronchospasm or dyspnoea.
• Gastrointestinal disorders: Less frequent - Abdominal discomfort or pain, nausea, diarrhoea, flatulence, constipation, vomiting, GI ulcers (sometimes with bleeding), GI perforation or gastritis. Not known - Exacerbation of colitis and Crohn's disease.
• Hepatobiliary disorders: Less frequent - Hepatotoxicity, abnormalities in liver function tests, hepatitis.
• Skin and subcutaneous tissue disorders: Less frequent - Skin rashes, bullous reactions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis. Not known - Acute generalised exanthematous pustulosis (AGEP), photosensitivity reactions.
• Renal and urinary disorders: Less frequent - Acute renal failure, cystitis, haematuria, interstitial nephritis, nephrotic syndrome.

Symptoms: In children, the ingestion of more than 400 mg/kg of ibuprofen may cause symptoms. In adults, the dose response effect is less clear cut. The half-life in overdose is 1.5 u2013 3 hours. The most likely symptoms of over dosage are pain in upper, middle region of the stomach and nausea, vomiting and dizziness. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasional 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.

Management: Management should be symptomatic and supportive and include the maintenance of clear airway and monitoring of cardiac and vital signs until stable. If recently taken, washing out the stomach will remove any unabsorbed ibuprofen. Electrolytes may be corrected by intravenous infusions, if necessary. There is no specific antidote for ibuprofen. 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 bronchospasm.