Name Brufen Flu Tablets & Suspension Description For the relief of the symptoms of colds and flu. Active Ingredients:

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1 Name Brufen Flu Tablets & Suspension Description For the relief of the symptoms of colds and flu Active Ingredients: Brufen Flu each tablet (Film-coated) contains: Ibuprofen 200 mg Pseudoephedrine hydrochloride 30 mg Brufen Flu suspension per 5 ml: Ibuprofen 100 mg Pseudoephedrine hydrochloride 15 mg Clinical Pharmacology Ibuprofen (analgesic, anti-inflammatory and anti-pyretic activity) Ibuprofen is a propionic acid derivative with analgesic, anti-inflammatory and anti-pyretic activity. The drugs therapeutic effects are thought to result from its inhibitory effect on the enzyme cyclooxygenase, which results in a marked reduction in prostaglandin synthesis. These properties provide symptomatic relief of inflammation and pain. Pseudoephedrine Hydrochloride (decongestant action). Pseudoephedrine Hydrochloride is an orally effective sympathomimetic amine that decongests swollen mucous membranes of the respiratory tract by vasoconstriction. While its vasoconstrictor action is similar to that of ephedrine, pseudoephedrine has been shown to have less pressor effect than ephedrine in normotensive adults. Indications Brufen Flu is indicated for the relief of the symptoms of colds and flu, including: Sore throat Runny or blocked nose and sinuses Aches and pains Headache Fever Contraindications Brufen Flu is contraindicated in patients with known hypersensitivity to any of its ingredients. Sympathomimetic amines are contraindicated in nursing mothers. Ibuprofen is contraindicated in patients with active peptic ulceration and those with a history of hypersensitivity reactions, including asthma, rhinitis or urticaria, in response to ibuprofen, aspirin or other NSAIDs. Warnings Do not exceed the recommended dosage. If nervousness, restlessness or sleeplessness occurs, reduce dosage. Sympathomimetic amines should be used with caution in patients with cardiovascular disease

2 such as ischemic heart disease, arrhythmia or tachycardia, occlusive vascular disorders including arteriosclerosis, hypertension, or aneurysms. Anginal pain may be precipitated in patients with angina pectoris. Care is required when sympathomimetic agents are given to patients with diabetes mellitus or closed-angle glaucoma. May cause excitability, especially in children. Elderly persons (approximately 60 years of age and older) are more likely to have adverse reactions to sympathomimetic amines. Persistent and severe pain or for fever for more than 3 days, could be signs of a serious condition that needs investigation and additional treatment. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, emphysema, or if cough is accompanied by excessive phlegm (mucus). Alcohol Warning: There is an increased overall relative risk for upper gastrointestinal bleeding with regular use of Ibuprofen among varying amounts of alcohol consumption. Precautions General Precautions: Ibuprofen should be given with care to patients with a history of gastrointestinal disease. Caution is required if ibuprofen is administered to patients suffering from, or with a previous history of bronchial asthma since ibuprofen has been reported to cause bronchospasm in such patients. Caution is required in patients with renal, hepatic or cardiac impairment since the use of NSAIDs may result in deterioration of renal function. The dose should be kept as low as possible and renal function should be monitored in these patients. Ibuprofen should be given with care to patients with a history of heart failure or hypertension since edema has been reported in association with ibuprofen administration. As with other NSAIDs, ibuprofen may mask the signs of infection. Renal Effects: Caution should be used when initiating treatment with ibuprofen in patients with considerable dehydration. As with other NSAIDs, long-term administration of ibuprofen has resulted in renal papillary necrosis and other renal pathologic changes. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a nonsteroidal antiinflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors and the elderly. Discontinuation of nonsteroidal anti-inflammatory drug therapy is usually followed by recovery to the pretreatment state. Hematologic Effects: Ibuprofen, like other NSAIDs, can inhibit platelet aggregation and has been shown to prolong bleeding time in normal subjects.

3 Aseptic Meningitis: Aseptic meningitis 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. Drug-Drug Interactions: Care should be taken in patients with any of the following drugs as interactions have been reported in some patients: * Anti-hypertensives, such as ACE inhibitors, and diuretics (reduced effect); * Lithium salts and methotrexate (decreased elimination). * Anticoagulants (enhanced anticoagulant effect). Aspirin - As with other products containing NSAIDs, concomitant administration of ibuprofen and aspirin is not generally recommended because of the potential of increased adverse effects. Cardiac Glycosides - NSAIDS may exacerbate cardiac failure, reduce glomerular filteration rate and increase plasma cardiac glycoside levels. Cyclosporin - increased risk of nephrotoxicity with NSAIDS. Corticosteroids - Increased risk of gastrointestinal bleeding with NSAIDS. The effects of sympathomimetics are increased with MAO inhibitors and beta-adrenergic blockers. Sympathomimetic amines may reduce the antihypertensive effects of reserpine, veratrum alkaloids, methyldopa and mecamylamine. Sympathomimetic agents should be avoided or used with caution in patients undergoing anesthesia with cyclopropane, halothane, or other halogenated anesthetics, as they may induce ventricular fibrillation. An increased risk of arrhythmias may occur if sympathomimetic agents are given to patients receiving cardiac glycosides, quinidine, or tricyclic antidepressants. Pregnancy Safety for use during pregnancy has not been established. While no teratogenic effects have been demonstrated in animal toxicology studies, the use of ibuprofen during pregnancy should, if possible, be avoided. Congenital abnormalities have been reported in association with ibuprofen administration in man; however, these are low in frequency and do not appear to follow any discernible pattern. In view of the known effects of NSAIDs on the fetal cardiovascular system (closure of ductus arteriosus), use in late pregnancy should be avoided.

4 Labor and Delivery: Administration of ibuprofen is not recommended during labor and delivery. Nursing Mothers: In the limited studies so far available, ibuprofen appears in the breast milk in very low concentrations. Ibuprofen is not recommended for use in nursing mothers. Ability to Drive and to Use Machines: No adverse effects known. Adverse Events Adverse Reactions to Ibuprofen: The pattern of adverse events reported for ibuprofen is similar to that for other NSAIDs. Gastrointestinal: The most commonly observed adverse events are gastrointestinal in nature. Nausea, vomiting, diarrhea, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis and gastrointestinal hemorrhage have been reported following ibuprofen administration. Less frequently, gastritis, duodenal ulcer and gastric ulcer have been observed. Epidemiological data indicate that of the seven most widely used oral, non-aspirin NSAIDs, ibuprofen presents the lowest risk of upper gastrointestinal toxicity. Hypersensitivity: Hypersensitivity reactions have been reported following treatment with ibuprofen. These may consist of: (a) non-specific allergic reaction and anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, less commonly, bullous dermatoses (including epidermal necrolysis and erythema multiform. Cardiovascular: Edema has been reported in association with ibuprofen treatment. Other adverse events reported less commonly and for which causality has not necessarily been established include: Dermatological: Photosensitivity Hematological:

5 Thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia and hemolytic anemia Hepatic: Hepatitis, jaundice Neurological: Disturbances of vision, optic neuritis, headache, paresthesia, vertigo, dizziness, drowsiness. Psychiatric: Depression, confusion Renal: Renal nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome and renal failure. Special Senses: Tinnitus Dosage and Administration Brufen Flu Tablets: Adults and children over 12 years: The recommended dose is: Two tablets 3 times a day. Brufen Flu Suspension: Children: Age Dose Frequency 2 to 6 years: 5 ml (3 to 4 times a day) 6 to 12 years 10 ml (3 to 4 times a day) Shake well before use. Storage Protect from heat, light and moisture. Store below 25 degrees C. Keep out of reach of children. How Supplied Brufen Flu Tablet: film-coated tablets, one strip X 10 tablets. (list # 00N890) Brufen Flu suspension: 60 ml bottle in banana-pineapple flavoured syrupy base (list # 00N548) Company Manufactured in Egypt by:

6 Kahira Pharm. & Chem. Ind. Co. Under Licence of: Abbott Laboratories

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