Generic drug of the therapeutic class: Analgesics
Active ingredients: Lysine acetylsalicylate, Codeine
laboratory: Sanofi Synthelabo Otc
Powder for oral solution
Box of 16 sachets-dose
Symptomatic treatment of pain of moderate to intense or not responding to peripheral analgesics used alone, in adults.
Dosage ASPEGIC CODEINE 500 mg / 25 mg Powder for oral solution Box of 16 Sachets-dose
RESERVED FOR THE ADULT.
Administration mode :
Drink immediately after completely dissolving the contents of the sachet in a large glass of water.
- Adult :
The maximum recommended daily dosage is 3 g of acetylsalicylic acid, which is 6 sachets per day.
The usual dosage is 1 sachet to be renewed if necessary after 4 hours minimum. In case of more intense pain, 2 sachets, to renew if necessary after 4 hours minimum, without exceeding 6 sachets per day .
- Elderly people:
The maximum recommended daily dosage is 2 g of acetylsalicylic acid, 4 sachets per day.
The usual dosage is 1 sachet to be renewed if necessary after 4 hours minimum. In case of more intense pain, 2 sachets, to renew if necessary after 4 hours minimum, without exceeding 4 sachets per day .
This medicine is CONTRAINDICATED in the following situations:
. child under 15,
. phenylketonuria (due to the presence of aspartame).
- Due to the presence of acetylsalicylic acid :
. hypersensitivity to acetylsalicylic acid or to any of the excipients,
. a history of asthma caused by the administration of salicylates or substances of similar activity, including nonsteroidal anti-inflammatory drugs,
. peptic ulcer in evolution,
. any constitutional or acquired hemorrhagic disease,
. hemorrhagic risk,
. severe hepatic insufficiency,
. severe renal insufficiency,
. severe uncontrolled heart failure,
. combination with methotrexate at doses greater than or equal to 15 mg / week (see interactions),
. combination with oral anticoagulants when salicylates are used in high doses (see interactions), especially in the treatment of rheumatic diseases,
. from the 6th month of pregnancy, when analgesic, antipyretic or anti-inflammatory doses are administered (> = 500 mg per day and taken): starting from the 6th month of pregnancy, aspirin with analgesic doses, antipyretic or anti-inflammatory drugs (> = 500 mg per day and per dose), like all prostaglandin synthesis inhibitors, may expose the fetus to cardiopulmonary toxicity with premature closure of the ductus arteriosus and pulmonary hypertension; renal dysfunction up to renal failure with oligohydramnios; the mother and the child, at the end of pregnancy, to a longer bleeding time. This anti-aggregating effect can occur even at very low doses. Consequently, from the 6th month of pregnancy, apart from extremely limited cardiological or obstetrical uses, which warrant specialized surveillance, any aspirin-based medication is CONTRAINDICATED as of the 6th month.
- Due to the presence of codeine :
. known hypersensitivity to codeine,
. asthma and respiratory insufficiency whatever its degree (depressant effect of codeine on the respiratory centers),
. combination with a morphine agonist-antagonist: nalbuphine, buprenorphine, pentazocine (see interactions),
. during breastfeeding without punctual intake: aspirin 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.
NOT RECOMMENDED :
- Taking alcoholic drinks and drugs containing alcohol during treatment is not recommended (see interactions).
- Associations advised against : oral anticoagulants; other nonsteroidal anti-inflammatory drugs; heparins (parenteral route); uricosurics: benzbromarone, probenecid.
Adverse Reactions Aspegic Codeine
- Related to acetylsalicylic acid :
. Gastrointestinal effects:
. abdominal pain,
. overt digestive haemorrhages, (hematemesis, melaena, ...) or occult, responsible for iron deficiency anemia. These haemorrhages are all the more frequent as the dosage is higher,
. gastric ulcers and perforations.
. Effects on the central nervous system:
. headache, dizziness,
. feeling of loss of hearing,
. ear buzzing,
which are usually the mark of an overdose.
. Hematological effects:
Hemorrhagic syndromes (epistaxis, gingivorragies, purpura ...) with increased bleeding time. This action persists for 4 to 8 days after stopping acetylsalicylic acid. It can create a hemorrhagic risk, in case of surgical intervention.
. Hypersensitivity reaction:
Urticaria, skin reactions, anaphylactic reactions, asthma, Quincke's edema.
- Linked to codeine :
. At therapeutic doses: the adverse effects of codeine are comparable to those of other opiates but they are rarer and more moderate: possibility of constipation, drowsiness, dizziness, nausea, vomiting, bronchospasm, hypersensitivity reactions (pruritus, urticaria and in rare cases rash), respiratory depression.
. At supratherapeutic doses: there is a risk of dependence and sudden withdrawal syndrome, which has been observed in the user and the newborn of a mother poisoned with codeine.
. Acute biliary or pancreatic abdominal pain syndrome, suggestive of an Oddi sphincter spasm, occurring particularly in cholecystectomized patients.