Medicinal Products

DAFALGAN CODEINE 500 mg / 30 mg

Generic drug of the therapeutic class: Analgesics
active ingredients: Paracetamol, Codeine
laboratory: Bristol Myers Squibb

Coated tablet
Box of 100
All forms


Reserved for adults.
Moderate or intense pain or not responding to the use of peripheral analgesics.

Dosage DAFALGAN CODEINE 500 mg / 30 mg Film-coated tablet Box of 100

- Adult from 15 years old:
The dosage is 1 film-coated tablet, to be renewed if necessary after 6 hours, or possibly 2 film-coated tablets in case of severe pain, without exceeding 6 film-coated tablets per day . It is not usually necessary to exceed 6 film-coated tablets per day. However, in case of more severe pain, the maximum dosage can be increased up to 8 film-coated tablets per day. Always respect an interval of 4 hours between two shots.
- In cases of severe renal insufficiency (creatinine clearance less than 10 ml / min), the interval between 2 doses will be at least 8 hours.

Against indications

Child under 15 years old.
- Hypersensitivity to paracetamol or other constituents,
- hepatocellular insufficiency.
- codeine is contraindicated in patients with respiratory insufficiency whatever the degree of respiratory insufficiency, because of the depressant effect of codeine on the respiratory centers;
hypersensitivity to codeine;
- during breastfeeding apart from a punctual intake: paracetamol and codeine pass into breast milk. A few cases of hypotonia and respiratory pauses have been reported in infants after mothers have taken codeine doses at supratherapeutic doses. As a result, apart from a punctual intake, this medication is contraindicated during breastfeeding.
Associations advised against : morphine agonists-antagonists (buprenorphine, nalbuphine, pentazocine); alcohol; naltrexone.

Adverse effects Dafalgan Codeine

- Few cases of hypersensitivity reactions such as anaphylactic shock, angioedema, erythema, urticaria, skin rash have been reported. Their occurrence requires the definitive discontinuation of this drug and related drugs.
- Very exceptional cases of thrombocytopenia, leukopenia and neutropenia have been reported.
At therapeutic doses, the adverse effects of codeine are comparable to those of other opiates, but they are rarer and more moderate.
Possibility of :
. sedation, euphoria, dysphoria,
. myosis, urinary retention,
. hypersensitivity reactions (pruritus, urticaria and rash),
. constipation, nausea, vomiting,
. drowsiness, vertiginous states,
. bronchospasm, respiratory depression (see section contraindications),
. Acute biliary or pancreatic abdominal pain syndrome, suggestive of an Oddi sphincter spasm, occurring particularly in cholecystectomized patients.
- At supratherapeutic doses: there is a risk of dependence and sudden withdrawal syndrome, which can be observed in the user and the newborn of a mother poisoned by codeine.

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