Paracetamol ................... 500 mg
Codeine phosphate ... 8 mg (eight milligrams) (
Lactose, wheat starch, PVP, nipagin, sodium starch glycolate, green color, talc powder, magnesium stearate).
Box of 10 blisters x 10 tablets.
Box of 1 bottle x 100 tablets.
Paracetamol has peripheral analgesic and antipyretic actions.
Codeine has a central analgesic effect.
Treatment of the symptoms of pains and aches with or without fever in some cases e.g headache, myalgia, ostalgia, sprain, arthralgia, pain, backache, toothache, dysmenorrhea, traumatic injuries, neuralgia, cold, flu,…
Hypersensitivity to any components of the drug. Hepatocellular insufficiency. Respiratory insufficiency.
Children under 15 years of age. Pregnant women and breast-feeding mothers.
In patients suffered from respiratory tract diseases e.g. asthma, alveolar emphysema. Impaired renal function. In old and weakened patients. Hypothyroidism. Addison disease and prostatauxe or urethrospasm.
Drivers and machinery operators are warned of the possibility of doze and the decrease in nimbleness or alertness when taking Hapacol Codein.
* In concern with codeine: it reduces cyclosporin metabolism due to the inhibition of cytochrome P450. Concurrent use of Hapacol Codein with analgesics; soporifics; antipsychotics; substances with anti-anxious or depressant effects (including alcohol drinks) may increase the depression on CNS. Therefore, in case of applying the combinative therapy, the doses of these substances should be reduced. In case of head injury, the effect of respiratory insufficiency and increase in cerebrospinal fluid pressure by soporifics may clearly enhance as well as may hide the clinical process in patients with head injury. Concurrent use of anticholinergics with codeine may cause adynamic ileus.
* In concern with Paracetamol: concomitant administration with anticoagulants (warfarin) may enhance the effect of anticoagulants.
* In concern with codeine: dizziness, shallow breath, nausea, vomiting, skin allergic rashes, urticaria, brochospasm, constipation, colic, gastrointestinal disturbances, doze, dryness of mouth, sweating. High doses of codeine may cause all the adverse effects of morphine, including respiratory insufficiency and drug dependence.
* In concern with Paracetamol: allergic reactions, thrombocytopenia have been rarely reported.
High doses and prolonged use of the drug may cause hepatic impairment (due to hepatolysis).
Inform your physician about any adverse effects occur during the treatment.
DOSAGE & ADMINISTRATION
Orally taken every 6 hours. Do not take more than 8 tablets daily.
Adults and children > 15 years of age: oral dose of 1 - 2 tablets.
Severe renal impairment: the interval between oral doses should be more than 8 hours.
Or as directed by the physician.
Notes: Consult a physician if taking overdosage or prolonged use of Hapacol Codein over 5 days.
Read the directions carefully before use
Consult the physician for more information
24 months from the manufacturing date.
Store in cool, dry place, protected from light.