COMPOSITION:

Acetaminophen (Paracetamol) 500 mg

Codeine phosphate 30 mg

Per each film coated caplet.

INDICATIONS:

Acetaminophen and Codeine combination is used to relief of moderate to severe pain, such as: cancer pain, bone pain, headache, body ache, myalgias, neuralgias, toothache, low back

ADMINISTRATION AND DOSAGE:

Adults and children over the age of 12 years:

• 1-2 caplets, 1-3 times daily according to the degree of pain.

Children 6 to 12 years old:

• Half of the adult dose.

Minimum dosing interval: 4 hours.

CONTRAINDICATIONS:

• Allergic to components of this product.
• Respiratory depression, anemia, cardiac disease, pulmonary disease, G6PD deficiency.
• Severe liver failure and/or renal failure.
• Pregnancy and lactation.

WARNINGS AND PRECAUTIONS:

• Do not use this product for children under 6 years.
• Should not be used with other products containing Acetaminophen.
• Prolonged use and high dose of Acetaminophen may cause hepatocellular impairment.
• When driving vehicle or operating machinery because this product may cause drowsiness.
• Caution for respiratory disease such as bronchial asthma. People with a history of drug.

SIDE EFFECTS:

• Frequently: Nausea, vomiting, constipation, drowsiness, vertigo, palpitations, orthostatic hypotension.
• Rarely: Allergy, leukopenia, anemia, respiratory depression.

INTERACTIONS:

• Antacids can delay and decrease the oral absorption of Acetaminophen.
• The activity of this product is influenced by concurrent administration of Barbiturate, depressants, Carbamazepine and Phenytoin.
• Concomitant use of this medicine with other opiate derivatives (e.g. cough suppression, pain relief) may cause respiratory depression.

PRESENTATION:

Box of 10 blisters x 10 film coated caplets.