Flamex^®

Flamex is the preparation of Ibuprofen which is an NSAID, works by blocking the synthesis of prostaglandins and therefore reduces pain and inflammation. Flamex tablet is the immediate release formulation of Ibuprofen and Flamex SR capsule is a sustained release formulation of Ibuprofen. Flamex SR capsule provides more prolonged analgesic & anti-inflammatory effect than immediate release Ibu rofen.

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Flamex is indicated for:

• Relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis

• Treatment of primary dysmenorrhea

• Control of pain generally and particularly when pain is associated with inflammation

• Reduction of fever

Flamex SR is indicated for:

• Relief of backache

• Rheumatic pain

• Muscular pain

Route of administration: Flamex@can be taken orally.

Adults and children over 12 years:

Flamex

• Rheumatoid arthritis and osteoarthritis: Initially 300-400 mg 3-4 times daily; increased if necessary to maximum 2.4 g daily; maintenance dose of 0.6-1.2 g daily may be adequate.

• Analgesic and antipyretic: 200 to 400 mg every four to six hours as needed.

• Dysmenorrhea: 200 to 400 mg every four to six hours as needed. Dose should not exceed 3200 mg per day.

Flamex@ SR

Initially one (300 mg) or two (600 mg) capsules should be taken twice daily. Not more than 4 capsules are to be taken in 94 hours

In children:
Flamex

Mild to moderate pain, pain and inflammation of soft
tissue injuries, pyrexia with discomfort

Child 1-3 months: 5 mg/kg 3-4 times daily

Child 3-6 months: 50 mg 3 times daily (maximum 30
mg/kg daily in 3-4 divided doses)

Child 6 months-I year: 50 mg 3-4 times daily (maximum
30 mg/kg daily in 3-4 divided doses)

Child 1-4 years: 100 mg 3 times daily (maximum 30 mg/kg
daily in 3-4 divided doses)

Child 4-7 years: 150 mg 3 times daily (maximum 30 mg/kg
daily in 3-4 divided doses)

Child 7-10 years: 200 mg 3 times daily (up to 30 mg/kg
daily (maximum 2.4 g) in 3-4 divided doses)

Child 10-12 years: 300 mg 3 times daily (up to 30 mg/kg
daily (maximum 2.4 g) in 3-4 divided doses)

Rheumatic disease in children
Child 3 months-18 years: 30-40 mg/kg (maximum 2.4 g)
daily in 3-4 divided doses; in systemic juvenile idiopathic
arthritis up to 60 mg/kg (maximum 2.4 g) daily in 4-6
divided doses.

Post immunization pyrexia in infants
Child 2-3 months: 50 mg as a single dose repeated once
after 6 hours if necessary.

Flamex SR is not recommended for children under 12
years of age.

Elderly:
No special dosage modifications are required for elderly
patients unless there is an impairment of renal or hepatic
function. In case of such impairment, the dosage should
be assessed individually by the physician.

Pregnancy:

Although no teratogenic effects have been demonstrated in animal experiments, the use of ibuprofen during pregnancy should, if possible, be avoided.

Lactation:

In the limited studies so far available,
ibuprofen appears in the breast milk in very low
concentration and is unlikely to affect the breastfed infant
adversely.

Ibuprofen should be given with caution to patients with bleeding disorders, cardiovascular diseases, peptic ulceration or a history of such ulceration, in those receiving coumarin anticoagulants and in patients with renal or hepatic impairment.

The side effects of ibuprofen may include dyspepsia, gastro-intestinal intolerance and bleeding and skin rashes of various types. Less frequently, thrombocytopenia has occurred.

Ibuprofen is contraindicated to the patients with known hypersensitivity to this drug. It is also contraindicated in patients with a history of peptic ulceration. Bronchospasm may be precipitated in patients suffering from, or with a previous history of bronchial asthma or allergic disease. Ibuprofen should not be given to patients in whom aspirin or other NSAIDs induce the symptoms of asthma, rhinitis or urticaria.

Drug interaction with medication: In therapeutic doses there is no evidence of significant interactions with other
commonly used drugs. However, caution should be exercised in patients receiving oral anticoagulants and
thiazide diuretics.

Drug interaction with food and others: Not applicable

In case of overdose, gastric lavage and if necessary, correction of serum electrolytes have been recommended. There is no specific antidote for ibuprofen.

Store in a cool dry place. Protect from light.

Flamex 200 Tablet: Each coated tablet contains Ibuprofen BP 200 mg.

Flamex 400 Tablet: Each coated tablet contains Ibuprofen BP 400 mg.

Flamex Suspension: Each 5 ml contains Ibuprofen BP 100 mg.

Flamex SR Capsule: Each sustained release capsule contains Ibuprofen BP 300 mg.

Storage
Store below 300C in a dry place, protected from light.
Keep away from the reach of children.

Packing
Flamex 200 Tablet: Carton of 100 tablets in blister pack.
Flamex 400 Tablet: Carton of 100 tablets in blister pack.
Flamex Suspension: Bottle of 100 ml.
Flamex SR Capsule: Carton of 50 capsules in blister
pack.