Ibuprofen + Paracetamol

Indication

This combination tablet 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).

Pharmacology

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-1 and COX-2 enzymes, thereby also inhibiting prostaglandin synthesis.

Dosage

Route of administration: This tablet should be taken in oral route with food.

The recommended dose: One 200/500 tablet or two 125/250 tablets three times daily (every 8 hours). If necessary, maximum two 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.

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

Administration

Route of administration: This tablet should be taken in oral route with food.

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

Interaction

Concomitant use of this combination with other paracetamol containing products, acetylsalicylic acid and other NSAIDs including COX-2 selective inhibitors is contraindicated. Caution should be taken in concomitant use with cholestyramine, metoclopramide and domperidone, anticoagulants, antihypertensives, antiplatelet agents and SSRI, cardiac glycosides, ciclosporin, corticosteroid, mifepristone, quinolone, antibiotic, tacrolimus and zidovudine.

Contraindications

It is contraindicated in patients with history of known hypersensitivity to this combination or acetylsalicylic acid or other NSAIDs or any other components of this product. It is also contraindicated in patients with a history of or an existing gastrointestinal ulceration/perforation or bleeding, including that associated with NSAIDs, defects in coagulation, severe hepatic failure, severe renal failure or severe heart failure (NYHA Class IV).

Side Effects

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.

Pregnancy & Lactation

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 dose.

Precautions & Warnings

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.

Use in Special Populations

In case of overdose, pallor, nausea, vomiting, abdominal pain, drowsiness, convulsions and hepatic or renal damage may occur. Symptomatic treatment should be given. Treatment with activated charcoal should be considered within 1 hour and with N-acetylcysteine up to 24 hours after overdose.

Therapeutic Class

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Overdose Effects

Duration of treatment

Reconstitution

Storage Conditions

Store below 30°C in a dry place, protected from light. Keep away from the reach of children.