Bi-Profenid 150 mg - 20 Scored Tablet

Nonsteroidal Anti-inflammatory Drug (NSAID) used in the treatment of ankylosing spondylitis, rheumatoid arthritis, osteoarthritis and dysmenorrhea.

-Administer with food to reduce gastrointestinal upset. Do not crush or break ER capsules or tablets. -Rectal suppository: Insert suppository rectally. -Tablets and capsules: to be taken by mouth with sufficient amount of water. -Syrup: To be taken by mouth, use a calibrated measuring device (not a household teaspoon or tablespoon). -Ampoules: Intramuscular injection: The injections should be made in a strictly aseptic manner in the outer part of the upper outer quadrant of the buttock, deeply and slowly. When repeated, it is recommended to switch sides with each injection.

flatulence, nausea, stomatitis, vomiting, urinary tract irritation, abnormal dreams, depression, dizziness, drowsiness, headache, insomnia, malaise, nervousness, visual disturbance, tinnitus, renal insufficiency, acute myocardial infarction, cardiac arrhythmia, cardiac failure, edema, facial edema, hypertension, palpitations, peripheral vascular disease, shock, tachycardia, vasodilation, alopecia, bullous rash, diaphoresis, eczema, erythema multiforme, exfoliative dermatitis, onycholysis, pruritus, skin discoloration, skin photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, change in libido, exacerbation of diabetes mellitus, gynecomastia, hyponatremia, increased thirst, microvesicular steatosis, weight gain, weight loss, buccal necrosis, dysgeusia, eructation, gastritis, gastrointestinal hemorrhage, gastrointestinal perforation, gastrointestinal ulcer, hematemesis, increased appetite, melena, occult blood in stools, pancreatitis, peptic ulcer, salivation, ulcerative colitis, xerostomia, hematuria, impotence, nephrotic syndrome, uterine hemorrhage, agranulocytosis, anemia, disorder of hemostatic components of blood, hemolysis, purpuric disease, purpuric rash, rectal hemorrhage, thrombocytopenia, cholestatic hepatitis, hepatitis, jaundice, anaphylaxis, hypersensitivity reaction, amnesia, aseptic meningitis, chills, confusion, dysphoria, hallucination, migraine, nightmares, paresthesia, personality disorder, vertigo, conjunctivitis, dry eye syndrome, eye pain, retinal hemorrhage, retinal pigment changes, auditory impairment, acute renal tubular disease, interstitial nephritis, renal failure syndrome, bronchospasm, dyspnea, epistaxis, hemoptysis, laryngeal edema, pharyngitis and rhinitis.

-Should not be given to patients suffering from hypersensitivity to ketoprofen. -Should not be given to patients suffering from active peptic ulcer or active inflammatory disease of the gastrointestinal tract; inflammatory lesions or recent bleeding of the rectum or anus. -Contraindicated in patients who experience bronchospasm, asthma, rhinitis, or urticaria with nonsteroidal anti-inflammatory drug (NSAID) or aspirin therapy. -NSAIDs cause an increased risk of serious (and potentially fatal) adverse cardiovascular thrombotic events, including MI and stroke. -May cause drowsiness, dizziness, blurred vision, and other neurologic effects which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving). -NSAIDs cause increased risk of serious GI inflammation, ulceration, bleeding, and perforation (may be fatal); elderly patients and patients with history of peptic ulcer disease and/or GI bleeding are at greater risk of serious GI events. -Platelet adhesion and aggregation may be decreased; may prolong bleeding time. -May cause anemia. -May cause elevations in transaminase. -NSAID use may increase the risk of hyperkalemia. -May cause blurred/diminished vision. -NSAIDs may cause potentially fatal serious skin adverse events including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). -May increase the risk of aseptic meningitis, especially in patients with systemic lupus erythematosus (SLE). -Use with caution in patients with hepatic impairment. -Avoid use in patients with advanced renal disease. -Do not take a double dose to make up for the single dose that you missed. -In case of over dose be ready to tell or show what was taken, how much and when it happened, and seek immediate medical attention. For additional information call us on 16676. Always tell your physician your detailed medical history.

Store at room temperature.

-Acemetacin: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. -May enhance the antiplatelet effect of the agents with antiplatelet properties. -Alcohol (Ethyl): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. -Aminoglycosides: Nonsteroidal Anti-Inflammatory Agents may decrease the excretion of Aminoglycosides. -Angiotensin II Receptor Blockers: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. -Angiotensin-Converting Enzyme Inhibitors: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. -Beta-Blockers: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Beta-Blockers. -Bisphosphonate Derivatives: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Bisphosphonate Derivatives. -Corticosteroids (Systemic): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. -Deoxycholic Acid: May enhance the adverse/toxic effect of Deoxycholic Acid. -Digoxin: Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Digoxin. -Lithium: Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Lithium. -Loop Diuretics: Nonsteroidal Anti-Inflammatory Agents may diminish the diuretic effect of Loop Diuretics. -Metformin: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Metformin. -Methotrexate: Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Methotrexate. -Multivitamins/Minerals (containing vitamins ADEK, Folate, Iron): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. -Omega-3 Fatty Acids: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. -For the rest of interactions refer to Pregnancy and lactation.

Not safe in pregnancy-Ketoprofen crosses the placenta, maternal use of NSAIDs should be avoided beginning at 20 weeks' gestation. If NSAID use is necessary between 20 and 30 weeks' gestation, limit use to the lowest effective dose and shortest duration possible. Based on available information, NSAIDs can be continued during the first 2 trimesters of pregnancy in patients with rheumatic and musculoskeletal diseases; use in the third trimester is not recommended. -Ketoprofen is present in breast milk. NSAIDs are considered compatible for the treatment of rheumatic and musculoskeletal diseases in lactating patients, maternal use of NSAIDs should be avoided if the breastfeeding infant has platelet dysfunction, thrombocytopenia, or a ductal-dependent cardiac lesion. -Ask you physician before taking any medication during pregnancy or lactation. -Interactions (continue): -Potassium Salts: Nonsteroidal Anti-Inflammatory Agents may enhance the hyperkalemic effect of Potassium Salts. -Quinolones: Nonsteroidal Anti-Inflammatory Agents may enhance the neuroexcitatory and/or seizure-potentiating effect of Quinolones. -Thiazide and Thiazide-Like Diuretics: May enhance the nephrotoxic effect of Nonsteroidal Anti-Inflammatory Agents. -Vancomycin: Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Vancomycin. -Vitamin E (Systemic): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. -Vitamin K Antagonists (eg, warfarin): Nonsteroidal Anti-Inflammatory Agents (Nonselective) may enhance the anticoagulant effect of Vitamin K Antagonists.

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