Flamotal     Film Coated Tablets

Ibuprofen   400, 600 & 800mg

 

Usage and indications:

Flamotal tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.

Flamotal tablets are indicated for relief of mild to moderate pain.

Flamotal tablets are also indicated for the treatment of primary dysmenorrhea.

Dose and method of administration:

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

Adults and children over 12 years of age: The recommended dosage of Flamotal is 1200-1800 mg daily in divided doses. Some patients can be maintained on 600-1200 mg daily.

In severe or acute conditions, it can be advantageous to increase the dosage until the acute phase is brought under control, provided that the total daily dose does not exceed 2400 mg in divided dose.

Not recommended for children weighing less than 7 kg.

Elderly: The elderly are at increased risk of serious consequences of adverse reactions.

If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy. If renal or hepatic function is impaired, dosage should be assessed individually.

For oral administration. It is recommended that patients with sensitive stomachs take Flamotal with food. If taken shortly after eating, the onset of action of Flamotal may be delayed. To be taken preferably with or after food, with plenty of fluid. Flamotal tablets should be swallowed whole and not chewed, broken, crushed or sucked on to avoid oral discomfort and throat irritation.

Undesirable effects:

Incidence greater than 1% (but less than 3%):

Gastrointestinal:

Nausea*, epigastric pain, heartburn, diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of GI tract (bloating and flatulence).

Central nervous system:

Dizziness, headache, nervousness.

Dermatologic:

Rash*, (including maculopapular type), pruritus.

Special senses: 

Tinnitus.

Metabolic/endocrine:

Decreased appetite.

Cardiovascular:

Edema, fluid retention (generally responds promptly to drug discontinuation)

Precise incidence unknown (but less than 1%)

Probable Causal Relationship

Gastrointestinal: 

Gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal hemorrhage, melena, gastritis, hepatitis, jaundice, abnormal liver function tests, pancreatitis.

Central nervous system:

Depression, insomnia, confusion, emotional liability, somnolence, aseptic meningitis with fever and coma.

Dermatologic:

vesiculobullous eruptions, urticarial, erythema multiforme, stevens-johnson syndrome, alopecia.

Special senses:

hearing loss, amblyopia (blurred and/or diminished vision, scotomata and/or changes in color vision).

Hematologic: 

Neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (sometimes Coombs positive), thrombocytopenia with or without purpura, eosinophilia, decreases in hemoglobin and hematocrite.

Cardiovascular:  

Congestive heart failure in patients with marginal cardiac function, elevated blood pressure, palpitations.

Allergic:

syndrome of abdominal pain, fever, chills, nausea and vomiting, anaphylaxis, bronchospasm.

Renal:

acute renal failure, decreased creatinine clearance, polyuria, azotemia, cystitis, hematuria.

Miscellaneous:

dry eyes and mouth, gingival ulcer, rhinitis

Precise incidence unknown (but less than 1%)

(Causal relationship unknown)

Central nervous system:

paraesthesias, hallucinations, dream abnormalities, pseudotumor cerebri.

Dermatologic:

toxic epidermal necrolysis, photoallergic skin reactions.

Special senses:

conjunctivitis, diplopia, optic neuritis, cataracts, hearing loss, amblyopia (blurred and/or diminished vision, scotomata and/or changes in color

Hematologic:

bleeding episodes (e.g. epistaxis, menorrhagia).

Metabolic/endocrine:

Gynecomastia, hypoglycemic reaction, acidosis.

Cardiovascular:

Arrhythmias (sinus tachycardia, sinus bradycardia)

Allergic:

serum sickness, lupus erythematosus syndrome, Henoch-Schonlein vasculitis, angioedema.

Renal:

Renal papillary necrosis.

Warnings and precautions:

Cardiovascular risk

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction and stroke which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. NSAIDs are contraindicated for the treatment of pre-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal risk 

NSAIDs cause an increased risk of serious gastrointestinal adverse events including inflammation, bleeding, ulceration and perforation of the stomach or intestine, which can be fatal. These events can occur at any time during use and without warning symptoms.

Elderly patients are at greater risk for serious gastrointestinal events.

General

Ibuprofen tablets cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids. The pharmacological activity of Ibuprofen tablets in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.

Ophthalmological effects

Blurred and/or diminished vision, scotomata, and/or changes in color vision have been reported. If a patient develops such complaints while receiving ibuprofen tablets, the drug should be discontinued, and the patient should have an ophthalmologic examination which includes central visual fields and color vision testing.

Pack:

Flamotal 400mg tablet: A carton box containing 1 or 3 strips each of 10 tablets.

Flamotal 600mg tablet: A carton box containing 1 or 2 strips each of 10 tablets.

Flamotal 800mg tablet: A carton box containing 1 strip each of 10 tablets.

 

 

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