Special Warning : אזהרת שימוש

Warnings
Ibuprofen should be administered under close supervision to patients with a history of upper gastrointestinal tract disease.
If symptoms persist, worsen, or new symptoms develop, the physician should be referred to.
If, following the administration of Nurofen for Children Suspension, symptoms persist for more than 3 days, the physician should be referred to.
Nurofen for Children Suspension is not suitable for children with stomach ulcer or other stomach disorder”.

Use in Pregnancy
Administration of ibuprofen is not recommended during pregnancy.
The onset of labor may be delayed and duration of labor increased.

NUROFEN ,   24. 1. 2005, ,RH
Children under 12 years are unlikely to become pregnant. However, whist no teratogenic effects have been demonstrated in animal studies, the use of Nurofen for Children should if possible be avoided during pregnancy.

Use in Breastfeeding
Ibuprofen appears in breast milk in very low concentrations and is unlikely to affect the breastfed infant adversely.
Children under 12 years are unlikely to breastfeed.

Use in Pediatrics
Nurofen Tablets/Liquid Capsules and Nurofen Forte Tablets are not to be used in children under 12 years of age.
Nurofen for Children Suspension is not recommended for children under 3 months of age, unless advised by the physician.

Adverse Reactions
Gastrointestinal
Epigastric pain, heartburn, diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of gastrointestinal tract, dyspepsia, gastrointestinal bleeding, peptic ulceration,.

Central Nervous System
Dizziness, severe headache, nervousness, convulsions, pain in the spinal column.

Dermatological
Rash (including maculopapular type), pruritus, photosensitivity, skin peeling.
Rarely exfoliative dermatitis and epidermal necrolysis have been reported with ibuprofen.

Special Senses
Hearing disturbance.

Metabolic/Endocrine
Decreased appetite.
Cardiovascular
Edema, fluid retention (generally responds to drug discontinuation, see Precautions).

Hematological
Neutropenia,    agranulocytosis, aplastic   anemia,            hemolytic     anemia, thrombocytopenia, decreased hemoglobin and hematocrit.

Allergic
Fever.
Bronchospasm may be precipitated in patients with a history of aspirin-sensitive asthma

Other Hypersensitivity Reactions:
Rarely hypersensitivity reactions with cutaneous eruptions, urticaria and pruritus, as well as attacks of asthma, with or without drop in blood pressure, have been observed. In single cases, severe hypersensitivity reactions, manifesting as facial edema, swelling of the tongue, swelling of the larynx, dyspnea, tachycardia, hypotension or severe shock have been reported. If these symptoms occur, immediate medical attention is necessary.

NUROFEN ,    24. 1. 2005, ,RH
In single cases, serious forms of skin reactions such as erythema multiforme can occur.
In patients with existing auto-immune disorders (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.

Other
Stiffness, sudden decrease in the amount of urine, black stools.
Renal papillary necrosis which can lead to renal failure.

Precautions
Note
Patients sensitive to one of the non-steroidal anti-inflammatory agents (NSAIAs) may be sensitive to any of the other NSAIAs also.

Blurred and/or diminished vision, scotomata, and changes in color vision have been reported. If a patient develops such complaints while receiving ibuprofen, the drug should be discontinued and the patient should have an ophthalmological examination which includes central visual fields and color vision testing.
As with other NSAIAs, patients should be cautioned about engaging in activities requiring mental alertness and motor coordination, such as driving a car.
Physicians should be consulted if patients taking ibuprofen exhibit signs or symptoms of gastrointestinal ulceration or bleeding, blurred vision or other eye symptoms, skin rash, weight gain, or edema.
Fluid retention and edema have been reported in association with ibuprofen.
Therefore, the drug should be used with caution in patients with a history of cardiac decompensation or hypertension.
Since ibuprofen is eliminated primarily by the kidneys, patients with significantly impaired renal function should be closely monitored, and a reduction in dosage should be anticipated to avoid drug accumulation.
Ibuprofen should be used with caution in individuals with intrinsic coagulation defects, and those on anticoagulant therapy.
Caution should be exercised when this product is administered to asthma sufferers since bronchospasm may be precipitated in patients suffering from, or with a previous history of bronchial asthma or allergic disease.
The elderly are at increased risk of the consequence of adverse reactions.
Monitoring of blood urea nitrogen (BUN), serum creatinine concentrations and/or serum potassium concentrations may be required at periodic intervals during therapy, especially in patients with documented hepatic or renal function impairment.
The same monitoring may also be required in patients known or suspected to be at risk for renal function impairment, patients taking diuretics concurrently, and in patients in whom signs of possible renal toxicity occur, such as substantial increases in blood pressure, fluid retention, or rapid weight gain.
In order to avoid exacerbation of disease or adrenal insufficiency, patients who have been on prolonged corticosteroid therapy should have their therapy reduced slowly, rather than discontinued abruptly, when ibuprofen is added to the treatment regimen.
As with other non-steroidal anti-inflammatory agents, borderline elevations of one or more liver tests may occur in up to 15% of patients. These abnormalities may progress, remain essentially unchanged, or be transient with continued therapy.
Because serious gastrointestinal tract ulcerations and bleeding can occur without warning symptoms, physicians should follow chronically treated patients for the signs and symptoms of ulcerations and bleeding and should inform them (in case of children, the child’s parent/guardian) of importance of this follow-up.

NUROFEN ,   24. 1. 2005, ,RH
Patients with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of more severe hepatic reactions while on therapy with ibuprofen.
Severe hepatic reactions, including jaundice and cases of fatal hepatitis, have been reported with ibuprofen as with other non-steroidal anti-inflammatory agents.
Although such reactions are rare, if abnormal liver tests persist or worsen, or clinical signs and symptoms consistent with liver disease develop, or systemic manifestations occur (e.g., eosinophilia, rash, etc.), ibuprofen should be discontinued.
In cross-study comparisons with doses ranging from 1200-3200 mg daily for several weeks, a slight dose-response decrease in hemoglobin/hematocrit was noted.
Aseptic meningitis with fever and coma has been observed on rare occasions in patients on ibuprofen therapy. Although it is probably more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has been reported in patients who do not have an underlying chronic disease. If signs or symptoms of meningitis develop in a patient on ibuprofen, the possibility of its being related to ibuprofen should be considered.

Patients Who Require Surgery (Including Dental Surgery)
Caution is recommended in patients who require surgery. Most of the Nonsteroidal anti-inflammatory agents inhibit platelet aggregation and may prolong bleeding time, which may increase intra-and postoperative bleeding. Consideration should therefore be given to discontinuing NSAIAs treatment for an appropriate length of time prior to elective surgery, depending on the potency and duration of effect of the individual agent on platelet aggregability.
In case of patients requiring dental surgery, nonsteroidal anti-inflammatory agents may cause soreness, irritation, or ulceration of the oral mucosa. Most of the nonsteroidal anti-inflammatory agents may rarely cause leukopenia and/or thrombocytopenia, which may result in an increased incidence of microbial infection, delayed healing, and gingival bleeding. If leukopenia or thrombocytopenia occurs, dental work should be deferred until blood counts return to normal, and patients should be instructed in proper oral hygiene.


Each 5 ml of Nurofen For Children Suspension contains 10 mg of sodium saccharin. A quantity of 5 mg/kg body weight/day sodium saccharin should not be exceeded.

Effects on Driving