BRUPAL FORTE Tablet

For the relief of mild to moderate pain associated with inflammation.

Dosage and directions for use

Adults: 1-2 tablets 3 times a day. Tablets are to be taken with food or after meals with sufficient water.

Not more than 6 tablets must be taken daily.

Not recommended for children under 12 years.

In patients with the following conditions:

- History of severe allergic reaction such as anaphylaxis or angioedema, induced by aspirin or other NSAIDs. Because of the possibility of cross-sensitivity due to structural relationships which exist among NSAIDs, acute allergic reactions are likely to occur in patients who have exhibited allergic reactions to these compounds.

- Patients sensitive to any of the ingredients.

- Aspirin induced nasal polyps associated with bronchospasm. (High risk of severe allergic reactions because of cross sensitivity).

- Children under the age of 2 years.

- Active peptic ulceration.

- Safety in pregnancy and lactation has not been established.

- Severe renal function impairment.

Ibuprofen

Cardio vascular system: Tachycardia, flushing, increase in blood pressure

Central nervous system: Confusion, hallucinations, mental depression, peripheral neuropathy, tinnitus, drowsiness, insomnia.

Gastrointestinal system: Epigastric pain or discomfort, gastritis, hematemesis, gastrointestinal perforation, gastrointestinal ulceration.

Dermatological: Allergic dermatitis, erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis.

Renal: Hematuria, cystitis, renal impairment or failure, polyuria, fluid retention/oedema, acute renal failure, interstitial nephritis, nephrotic syndrome.

Hematological: Agranulocytosis, anaemia, aplastic anaemia, eosinophilia, hemolytic anaemia, leukopenia, thrombocytopenia.

Hypersensitivity reactions: Angiitis, angioedema, bronchospastic allergic reactions, allergic rhinitis, serum sickness like reaction, systemic lupus erythematosus, aseptic meningitis.

Ophthalmic: Amblyopia, blurred or double vision, conjunctivitis, dry irritated or swollen eyes, scotoma.

Oral: Aphthous stomatitis, gingival ulcerations.

Ear, Nose and Throat: Decreased hearing or any change in hearing, epistaxis.

Hepatic effects: Hepatitis

Pancreatic effects: Pancreatitis

Paracetamol

Gastrointestinal system: Nausea, vomiting, stomach pain or cramps, diarrhoea, loss of appetite, hepatotoxicity, hepatic failure, hepatic encephalopathy, gastrointestinal tract bleeding, pancreatitis

Central nervous system: Convulsions, respiratory depression, cerebral oedema, coma

Haematological: Leucopenia, thrombocytopenia, neutropenia, pancytopenia, agranulocytosis, disseminated intravascular coagulation

Metabolic: Hypoglycaemia, metabolic acidosis

Cardiovascular system: Cardiac arrhythmias, cardiovascular collapse

Renal System: Renal tubular necrosis, renal failure

Dermatological: Skin rashes and other allergic reactions. The rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by fever and mucosal lesions.

See the package insert about the details below:

Paracetamol

- Alcohol or corticosteroids or chronic therapeutic use of corticotrophin or potassium supplements

- Anticoagulants (coumarin or indandione derivative) or heparin or thrombolytic agents

- Oral antidiabetic agents or insulin

- Antihypertensives or diuretics

- Other NSAIDs (used concurrently with Ibuprofen)

- Bone marrow depressants

- Digoxin

- Cefamandole or cefoperazone or cefatetan or plicamycin or valproic acid

- Cyclosporine or Gold Compounds and other nephrotoxic compounds

- Lithium

- Methotrexate

- Laboratory Value Alterations.

Safety in pregnancy and lactation has not been established.

Dosage in excess of those recommended by the Physician cause severe liver function damage. Patients suffering from liver or kidney disease should take Paracetamol only under medical supervision. Consult a doctor if no relief is obtained from the recommended dosage. Do not use continuously for more than 10 days without consulting a doctor.

Cross-sensitivity and/or related problems.

Patients sensitive to one of the NSAIDs, may be sensitive to any of the other NSAIDs also. NSAIDs may cause bronchoconstriction or anaphylaxis in aspirin sensitive asthmatics, especially those with aspirin induced nasal polyps, asthma and other allergic reactions.

Geriatrics

NSAID-induced gastrointestinal ulceration and/or bleeding may be more likely to cause serious consequences, including fatalities, in geriatric patients than in younger adults. In addition, elderly patients are more likely to have age-related renal function impairment, which may increase the risk of NSAID-induced hepatic and renal toxicity and may also require dosage reduction to prevent accumulation of the medication. Also, careful monitoring of the patient is recommended.

Dental

NSAIDs may cause soreness, irritation, or ulceration of oral mucosa. Ibuprofen may rarely cause leukopenia and/or thrombocytopenia, which may result in an increased incidence of microbial infection, delayed healing, and gingival bleeding. If leucopenia or thrombocytopenia occurs, dental work should be deferred until blood counts have returned to normal, and patients should be instructed in proper oral hygiene, including caution in use of regular tooth brushes, dental floss and toothpicks.

Surgical

Caution is recommended in patients who require surgery. Most NSAIDs inhibit platelet aggregation and may prolong bleeding time, which may increase intra- and postoperative bleeding. Recovery of platelet function may occur within one day after discontinuation of Ibuprofen. Consideration should be given to discontinuing NSAID 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.

Special Precautions

- Mild allergic reaction such as allergic rhinitis, urticaria or skin rash induced by aspirin or other NSAIDs

- Anemia

- Asthma

- Conditions such as compromised cardiac function, congestive heart disease, pre-existing edema, renal function impairment.

- Conditions predisposing to gastro-intestinal toxicity, such as active alcoholism, inflammatory or ulcerative disease of upper or lower gastrointestinal tract, including Crohn’s disease diverticulitis, peptic ulcer disease, or ulcerative colitis and recent history of tobacco use.

- Hemophilia or other bleeding problems including coagulation or platelet function disorders.

- Hepatic cirrhosis or hepatic function impairment

- Renal function impairment

- Stomatitis

- Systemic lupus erythematosus.

Analgesic combinations