Paracetamol ........................... 500 mg
Codeine phosphate ............... 30 mg
Excipients.q.s........................... 1 tablet
(Anhydrous citric acid, sodium hydrocarbonate, ludipress LCE, effersoda, lactose anhydrous, PVP, aspartame, PEG 6000, sodium benzoate, orange flavour, ethanol 96%).
Box of 4 blisters x 4 effervescent tablets. Box of 10 blisters x 4 effervescent tablets
Paracetamol has peripheral analgesic and antipyretic properties. Codeine has a central analgesic effect.
The combination of 500 mg of Paracetamol and 30 mg of Codeine phosphate not only gives the most effective treament of analgesic and but also relieves the adverse effects in case of increasing the dose and taking separately. Paracetamol also enhances the analgesic effect of codeine.
This combination does not show any mutual influence during the absorptive, distributive, or eliminative processes between paracetamol and codeine in the body after oral administration.
For treatment of moderate to severe symptoms of aches and pains, with or without fever, in some cases e.g headache, myalgia, ostalgia, arthralgia, backache, rachiodynia, toothache, dysmenorrhea, neuralgia, sprain, pains due to flu, pharyngitis or sinusitis, traumatic injuries, postoperative pains (excluding head and abdomen surgery), …
Hypersensitivity to any components of the drug. Phenylcetonuria (due to aspartame).
Patients with anemia, cardiopathy, pneumopathy, nephropathy, hepatocellular insufficiency, in cases of glucose-6-phosphate dehydrogenase deficiency (due to paracetamol).
Respiratory insufficiency, bronchial asthma (due to codeine).
Children under 15 years of age. Pregnant women and nursing mothers.
In patients suffered from respiratory tract diseases e.g. asthma, alveolar emphysema. Impaired renal function. Old and weakened patients.
Hypothyroidism. Addisonism and prostatauxe or urethrospasm. Drivers and machinery operators are warned of the possibility of doze and a decrease in nimbleness or alertness when taking Hapacol Codein. Patients on low-sodium or sodium-free diets are warned that the drug contains 195 mg of ion sodium.
Taking much alcoholic drinks may enhance hepatotoxicity from paracetamol; therefore, avoid or limit drinking alcohol. The finished product contains active ingredients that may give positive reactions in the anti-doping test (using stimulants).
* In concern with codeine: it reduces cyclosporin metabolism due to inhibition of cytochrome P450. Concurrent use of Hapacol Codein with analgesics; soporifics; antipsychotics; substances with anti-anxious or depressant effects (including alcoholic drinks) may cause an increase in the depression for CNS. Therefore, in case of applying the combinative therapy, the dose 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 be clearly enhanced 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, oligopnea, nausea, vomiting, skin allergic rashes, urticaria, brochospasm, constipation, colic, dyspepsia, doze, dryness of mouth, sweating. High doses of codeine may have all 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
Dissolve the effervescent tablet in 200 ml of fresh water until bubbling completely.
Orally taken every 5 - 6 hours. Do not take more than 8 tablets/ day.
Adults and children over 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: -Do not exceed the prescribed dose
-Consult a physician in case of 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 places; protected from light.