Brufen Tablets (Generic Ibuprofen Tablets)

1. Brufen Tablets (Generic Ibuprofen Tablets) © The Swiss Pharmacy

2. Brufen Tablets (Generic Ibuprofen Tablets) Brufen (Generic Ibuprofen Tablets) is used for its analgesic and anti- inflammatory effects in the treatment of Rheumatoid arthritis (including Juvenile rheumatoid arthritis or Still's disease), Osteoarthritis, other non-rheumatoid (seronegative) arthropathies, ankylosing spondylitis, Primary dysmenorrhoea, and Pyrexia. This medicine is also used in the treatment of non-articular rheumatic conditions, Brufen is indicated in periarticular conditions such as frozen shoulder (capsulitis), bursitis, tendonitis, tenosynovitis and low back pain; Brufen can also be used in soft tissue injuries such as sprains and strains. Brufen is also indicated for its analgesic effect in the relief of mild to moderate pain, dental and post-operative pain and for symptomatic relief of headache, including migraine headache. © The Swiss Pharmacy

3. Brufen Tablets (Generic Ibuprofen Tablets) © The Swiss Pharmacy

4. Brufen Tablets (Generic Ibuprofen Tablets) Brufen (Generic Ibuprofen Tablets) are manufactured by Abbott India Limited in the strength of 200 mg, 400 mg and 600 mg. © The Swiss Pharmacy

5. Brufen Tablets (Generic Ibuprofen Tablets) Chemical Structure © The Swiss Pharmacy

6. Brufen Tablets (Generic Ibuprofen Tablets) The active pharmaceutical ingredient present in Brufen Tablets is Ibuprofen. Each Brufen Tablet contains 200 mg, 400 mg or 600 mg of Ibuprofen. © The Swiss Pharmacy

7. Brufen Tablets (Generic Ibuprofen Tablets) Uses of Brufen 200 mg, 400 mg and 600 mg Tablets: Brufen (Generic Ibuprofen Tablets) is a nonsteroidal anti- inflammatory drug (NSAID) used to treat mild to moderate pain, and helps to relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, or juvenile arthritis), such as inflammation, swelling, stiffness, and joint pain. This medicine does not cure arthritis and will help you only as long as you continue to take it. In addition, Ibuprofen can be used to treat fever, menstrual cramps, and other conditions as determined by your doctor . URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html © The Swiss Pharmacy

8. Brufen Tablets (Generic Ibuprofen Tablets) Recommended Adult Dosage The recommended initial dosage of Brufen Tablets Ibuprofen Tablets) is 1200 mg to 1800 mg daily in divided doses. Some patients can be maintained on 600 to 1200 mg daily. In severe or acute conditions it can be advantageous to increase the dosage until the acute phase is brought under control, providing that the total daily dosage does not exceed 2400 mg in divided doses. Brufen Tablets (Generic URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html © The Swiss Pharmacy

9. Brufen Tablets (Generic Ibuprofen Tablets) Recommended Adult Dosage Primary Dysmenorrhoea: For the treatment of dysmenorrhea, beginning with the earliest onset of such pain or menstrual bleeding, Ibuprofen tablets should be given in a dose of 400 mg every 4 to 6 hours as necessary with a maximum total daily dose of 1,600 mg. Maintenance Dose: In all indications the dose should be adjusted for each patient and the smallest dose that results in acceptable control of the symptoms employed. In general, patients with Rheumatoid Arthritis and Osteoarthritis tend to require higher doses than patients with other conditions. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html © The Swiss Pharmacy

10. Brufen Tablets (Generic Ibuprofen Tablets) Recommended Adult Dosage Paediatric Dosage: The daily dosage of Brufen tablets (Ibuprofen) is 20 mg per kg of body weight in divided doses. In Juvenile Rheumatoid Arthritis up to 40 mg per kg of body weight in divided doses may be given. In children weighing less than 30 kg the total dose should not exceed 500 mg in a 24 hour period. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html © The Swiss Pharmacy

11. Brufen Tablets (Generic Ibuprofen Tablets) Recommended Adult Dosage Mild to Moderate Pain: The recommended adult dosage is 400 mg every 4 to 6 hours as necessary for relief of pain. It is recommended that patients with sensitive stomachs take Brufen with food. If taken shortly after eating, the onset of action of Brufen may be delayed. To be taken preferably with or after food, with plenty of fluid. Brufen tablets should be swallowed whole and not chewed, broken, crushed or sucked on to avoid oral discomfort and throat irritation. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html © The Swiss Pharmacy

12. Brufen Tablets (Generic Ibuprofen Tablets) Contraindications ➔Hypersensitivity to Ibuprofen, or any inactive component of this medication. ➔Ibuprofen should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. ➔Ibuprofen is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html © The Swiss Pharmacy

13. Brufen Tablets (Generic Ibuprofen Tablets) Contraindications ➔Brufen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Brufen should not be used in patients with active, or history of, recurrent peptic ulcer or gastrointestinal haemorrhage (two or more distinct episodes of proven ulceration or bleeding). ➔Brufen should not be given to patients with conditions involving an increased tendency to bleeding. ➔Brufen is contraindicated in patients with severe heart failure (NYHA Class IV), hepatic failure and renal failure. ➔Brufen is contraindicated during the last trimester of pregnancy. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html © The Swiss Pharmacy

14. Brufen Tablets (Generic Ibuprofen Tablets) Storage Instructions Brufen Tablets (Generic Ibuprofen Tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html © The Swiss Pharmacy

15. Brufen Tablets (Generic Ibuprofen Tablets) Warnings Cardiovascular Thrombotic Events: Increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Hypertension: NSAIDs, including Ibuprofen, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of cardiovascular events. Congestive Heart Failure and Edema: Fluid retention and edema have been observed in some patients taking NSAIDs. Ibuprofen should be used with caution in patients with fluid retention or heart failure. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html © The Swiss Pharmacy

16. Brufen Tablets (Generic Ibuprofen Tablets) Warnings Gastrointestinal Effects: NSAIDs, including Brufen (Ibuprofen tablets), can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. Renal Effects: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Advanced Renal Disease: Treatment with Ibuprofen tablets is not recommended in these patients with advanced renal disease. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html © The Swiss Pharmacy

17. Brufen Tablets (Generic Ibuprofen Tablets) Warnings Anaphylactic/Anaphylactoid Reactions: As with other NSAIDs, anaphylactic/anaphylactoid reactions may occur in patients without known prior exposure to Ibuprofen. Ibuprofen should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. Skin Reactions: NSAIDs, including Ibuprofen, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html © The Swiss Pharmacy

18. Brufen Tablets (Generic Ibuprofen Tablets) Warnings Infections and infestations: Exacerbation of skin infection-related inflammations (e.g. development of necrotising fasciitis) coinciding with the use of NSAIDs has been described. If signs of an infection occur or get worse during use of ibuprofen the patient is therefore recommended to go to a doctor without delay. Pregnancy: In late pregnancy, as with other NSAIDs, Brufen tablets should be avoided because it may cause premature closure of the ductus arteriosus. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html © The Swiss Pharmacy

19. Brufen Tablets (Generic Ibuprofen Tablets) Warnings Infections and infestations: Exacerbation of skin infection-related inflammations (e.g. development of necrotising fasciitis) coinciding with the use of NSAIDs has been described. If signs of an infection occur or get worse during use of Ibuprofen tablets the patient is therefore recommended to go to a doctor without delay. Respiratory disorder: Caution is required if Ibuprofen is administered to patients suffering from, or with a previous history of bronchial asthma, chronic rhinitis or allergic diseases since Ibuprofen has been reported to cause bronchospasm, urticarial or angioedema in such patients. Ophthalmological effects: Adverse ophthalmological effects have been observed with NSAIDs; accordingly, patients who develop visual disturbances during treatment with Ibuprofen should have an ophthalmological examination. © The Swiss Pharmacy

20. Brufen Tablets (Generic Ibuprofen Tablets) Effects On Ability To Drive And Use Machines Following treatment with Ibuprofen (Brufen tablets), the reaction time of patients may be affected. Care should be taken when driving or operating machinery as the activity may be affected by dizziness, drowsiness, fatigue and visual disturbance. This applies to a greater extent in combination with alcohol. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html © The Swiss Pharmacy

21. Brufen Tablets (Generic Ibuprofen Tablets) Brufen Tablets and Alcohol Most people can drink a small amount of alcohol if they've taken Brufen tablets (Generic Ibuprofen tablets). But if you heavily drink, you may have a higher risk of side effects. Serious side effects of mixing Ibuprofen and alcohol include GI bleeding, kidney or liver problems, and heart problems. Alcohol and Ibuprofen make a dangerous combination. The two contain substances that can irritate the lining of the stomach and intestines. Hence, taking them simultaneously time can cause side effects depending on the dose and how much alcohol you ingest. When alcohol is present inside your body, your stomach also tends to become more vulnerable, increasing the risks of ulcer and gastrointestinal bleeding. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html © The Swiss Pharmacy

22. Brufen Tablets (Generic Ibuprofen Tablets) Possible Side Effects The common side effects of Brufen Tablets (Ibuprofen) are nausea, epigastric pain, heartburn, diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of GI tract (bloating and flatulence), dizziness, headache, nervousness, rash (including maculopapular type), pruritus, tinnitus, decreased appetite, edema, and fluid retention. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html © The Swiss Pharmacy

23. Brufen Tablets (Generic Ibuprofen Tablets) Possible Side Effects The rare side effects of Brufen Tablets (Ibuprofen) include Gastic or duodenal ulcer with bleeding and/or perforation, gastrointestinal hemorrhage, melena, gastritis, hepatitis, jaundice, abnormal liver function tests; pancreatitis, Depression, insomina, confusion, emotional lability, somnolence, aseptic meningitis with fever and coma, vesiculobullous eruptions, urticaria, erythema multiforme, Stevens-Johnson syndrome, alopecia, hearing loss, amblyopia (blurred and/or diminished vision, scotomata and/or changes in color vision). URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html © The Swiss Pharmacy

24. Brufen Tablets (Generic Ibuprofen Tablets) Possible Side Effects The rare side effects of Brufen Tablets (Ibuprofen) include neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (sometimes Coombs Positive), thrombocytopenia with or without purpura, eosinophilia, decreases in hemoglobin and hematocrit, congestive heart failure in patients with marginal cardiac function, elevated blood pressure, palpitations, Syndrome of abdominal pain, fever, chills, nausea and vomiting; anaphylaxis; bronchospasm, acute renal failure, decreased creatinine clearance, polyuria, azotemia, cystitis, hematuria, dry eyes and mouth, gingival ulcer and rhinitis. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html © The Swiss Pharmacy

25. Brufen Tablets (Generic Ibuprofen Tablets) Brufen Tablets Overdosage The range of Ibuprofen (Brufen tablets) overdose symptoms observed has included nausea, vomiting, abdominal pain, drowsiness, nystagmus, diplopia, headache, tinnitus, impaired renal function, coma and hypotension lethargy, central nervous system depression, seizures, metabolic acidosis, coma, rhabdomyolysis, hypothermia, fulminant hepatic failure, apnea (primarily in very young children), cardiovascular toxicity including bradycardia, tachycardia and atrial fibrillation. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html © The Swiss Pharmacy

26. Brufen Tablets (Generic Ibuprofen Tablets) Treatment of Brufen Tablets Overdosage Appropriate interventions to decontaminate the gastrointestinal tract may be beneficial within the first four hours after ingestion. Routine symptomatic and supportive treatment is then recommended. In cases of acute overdose of Brufen (Ibuprofen tablets), the stomach should be emptied by vomiting or lavage, although little of the drug will be likely to be recovered if it is more than an hour since ingestion. Since the medication is acidic and excreted in the urine, it is theoretically beneficial to administer alkali and induce diuresis. In addition to supportive measures, the use of oral activated charcoal may help reduce the absorption and reabsorption of Ibuprofen. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html © The Swiss Pharmacy

27. Brufen Tablets (Generic Ibuprofen Tablets) Brufen Tablets During Pregnancy Ibuprofen (Brufen tablets) has been classified by the US FDA as Pregnancy Category C , Category D at 30 weeks or greater of gestation, due to the potential for premature closure of the ductus arteriosus. Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. However, animal reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies in pregnant women. Ibuprofen (Brufen tablets) should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the known effects of NSAIDs on the fetal cardiovascular system (closure of ductus arteriosus), use during late pregnancy should be avoided. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html © The Swiss Pharmacy

28. Brufen Tablets (Generic Ibuprofen Tablets) Brufen Tablets During Nursing In the limited studies so far available, Ibuprofen (Brufen tablets) appears in the breast milk in very low concentrations. Ibuprofen is not recommended for use in nursing mothers. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html © The Swiss Pharmacy

29. Brufen Tablets (Generic Ibuprofen Tablets) Brufen Tablets Brufen Tablets (Generic Ibuprofen Tablets) manufactured by Abbott India Limited URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9577_Ibuprofen-Tablets.html © The Swiss Pharmacy