Flamex Duo^®

Flamex Duo is a combination of Paracetamol and Ibuprofen. Paracetamol is a para-aminophenol derivative with analgesic and antipyretic properties and weak
anti-inflammatory activity, It's analgesic effect may include inhibition of central prostaglandin synthesis and modulation of inhibitory descending serotonergic pathways while its
antipyretic property may be due to reduced production of prostaglandin in the hypothalamus. Ibuprofen is an NSAID which has analgesic, anti-inflammatory and antipyretic properties. It inhibits COX-I and -2 enzymes, thereby also inhibiting prostaglandin synthesis.

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Flamex Duo is indicated for the temporary relief of mild to moderate pain which has not been relieved by ibuprofen or paracetamol individually (such as migraine, headache,
backache, menstrual pain, dental pain, rheumatic and joint pain. muscular pain. cold and flu symptoms, sore throat and fever).

Route Of administration:

Flamex Duo should be taken in oral route with food. The recommended dose is one Flamex Duo 200/500 tablet three times daily (every 8 hours). If necessary, maximum two Flamex Duo 200/500 tablets may be taken three times daily. Leave at least six hours between doses, Do not take more than 3000 mg paracetamol and 1200 mg ibuprofen in any 24 hour period,

Pregnancy: There are no well controlled studies of pregnant women exposed to this combination of a drug-associated risk of major birth defects, miscarriage or adverse
maternal or fetal outcomes. The use of this combination should be avoided in the first six months of pregnancy and contraindicated in the last three months of pregnancy.

Lactation: Paracetamol is excreted in breast milk but not in a clinically significant amount. It is not necessary to interrupt breastfeeding for short-term treatment with the recommended

Use in children and adolescents
Safety and effectiveness have not been established in children and adolescents below 18
years of age.

Caution should be taken in patient with existing or history of bronchial asthma or allergic disease, hypertension, mild to moderate CHF, mixed connective tissue disorder, SLE,
non-cirrhotic alcoholic liver disease, G6PD deficiency, chronic malnutrition, anorexia, bulimia, cachexia, dehydration, hypovolemia and elderly patients. The patient should be
monitored regularly for gastrointestinal bleeding. Renal function should be monitored with renal, cardiac, liver impairment, those taking diuretics and the elderly.

The most common side effects are abdominal pain and discomfort, vomiting, diarrhoea, nausea, dyspepsia, hyperhidrosis, increased serum creatinine and blood urea and abnormal
liver function tests.

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In case of overdose, pallor, nausea, vomiting, abdominal pain, dizziness, convulsions and hepatic or renal damage may occur. Symptomatic treatment should be given. Treatment
with activated charcoal should be considered within I hour and with N-acetylcysteine up to 24 hours after overdose.

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Flamex Duo 200/500 Tablet: Each coated tablet contains Ibuprofen BP 200 mg and
Paracetamol BP 500 mg.

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

Packing
Flamex Duo 200/500 Tablet Carton of 200 tablets in blister pack.