Nurofen Gel

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For cutaneous use.
Adults, the elderly and children over 14 years: Squeeze 50 to 125 mg (4 to 10 cm) of the gel from the tube and lightly rub into the affected area until absorbed.
The dose should not be repeated more frequently than every four hours and no more than 4 times in any 24 hour period.
Wash hands after every application. Do not exceed the stated dose. Review treatment after 7 days, especially if the symptoms worsen or persist.
Children under 14 years: Do not use on children under 14 years of age except on the advice of a doctor.

Topical analgesic and anti-inflammatory for backache, rheumatic and muscular pain, sprains, strains, sports injuries.

– Hypersensitivity to the active substance(s) or to any of the excipients. In patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis or urticarial) in response to ibuprofen, Acetylsalicylic acid (aspirin), or other non-steroidal anti-inflammatory drugs.
– Do not use in third trimester of pregnancy.
– Not to be used on broken or damaged skin.

Discontinue immediately if rash develops.
Apply with gentle massage only. Avoid contact with eyes, mucous membranes and inflamed or broken skin.
Hands should be washed immediately after use.
Not for use with occlusive dressings.
Speak to a pharmacist or doctor before using this product if:
You are taking aspirin or any other pain relieving medication.
You are pregnant.
You have asthma
Not to be used in children under 14 years.
Oral NSAIDs, including ibuprofen, can sometimes be associated with renal
impairment, aggravation of active peptic ulcers, and can induce allergic bronchial reactions in susceptible asthmatic patients. Although the systemic absorption of topically applied ibuprofen is less than for oral dosage forms, these complications can occur in rare cases. For these reasons, patients with an active peptic ulcer, impaired hepatic function, a history of kidney problems or asthma should seek medical advice before using Ibuprofen gel as should patients already taking other painkillers.
If symptoms persist for more than 7 days, or worsen at any time, consult your doctor or pharmacist.
Patients should be advised against excessive exposure to sunlight of area treated in order to avoid possibility of photosensitivity.
Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
Excipients:
• This medicine contains 1.25 mg benzyl alcohol in each dose.
Benzyl alcohol may cause allergic reactions and mild local irritation.

Systemic availability of topical ibuprofen is very low compared to orally administered NSAIDs. Adverse events, particularly those affecting the gastrointestinal tract, are less common with the use of topical ibuprofen.
See prescribing information for full details.

Non-steroidal anti-inflammatory drugs may interact with blood pressure lowering drugs, and may possibly enhance the effects of anticoagulants, although the chance of either of these occurring with a topically administered preparation is extremely remote.
Concurrent aspirin or other NSAIDS may result in an increased incidence of adverse reactions.

Not to be used during pregnancy or lactation.
Pregnancy: Although no teratogenic effects have been demonstrated in animal experiments, ibuprofen should be avoided during pregnancy. During the last trimester of pregnancy there is a risk of premature closure of the fetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration of labour increased.
Lactation: Ibuprofen appears in breast milk in very low concentrations but is unlikely to affect breast fed infants adversely.

Overdosage with a topical presentation is unlikely.
Symptoms of severe ibuprofen overdosage (e.g. following accidental oral ingestion) include headache, vomiting, drowsiness and hypotension. Correction of severe electrolyte abnormalities should be considered.
In children ingestion of more than 400 mg/kg may cause symptoms. In adults the dose response effect is less clear cut. The half-life in overdose is 1.5-3 hours.
Symptoms: Symptoms of Ibuprofen overdose include headache, vomiting, drowsiness and hypotension. 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.
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.