Medicinal Products

PARACETAMOL CODEINE CRISTERS 500 mg / 30 mg

Generic drug of the therapeutic class: Analgesics
active ingredients: Paracetamol + Codeine
laboratory: Cristers

Sparkling effervescent tablet
pillbox of 16
All forms

Indication

Symptomatic treatment of pain of moderate or intense intensity or not responding to the use of peripheral analgesics used alone.

Dosage PARACETAMOL CODEINE CRISTERS 500 mg / 30 mg tablet effervescent breakable pill box of 16

Symptomatic treatment of pain of moderate or intense intensity or not responding to the use of peripheral analgesics used alone.

Against indications

· Child under 15 kg.

RELATED TO PARACETAMOL

· Hypersensitivity to paracetamol or other components.

· Hepatocellular insufficiency.

RELATED TO CODEINE

· Codeine is contraindicated in patients with respiratory insufficiency regardless of the degree of respiratory failure, due to the depressant effect of codeine on respiratory centers.

· Asthma.

· Hypersensitivity to codeine.

· During breastfeeding apart from a punctual intake (see section Pregnancy and breastfeeding ).


OPINION AND RECOMMENDATION OF PRAC of 12/04/2013

The PRAC initiated in November 2012 a re-evaluation of codeine-based medicines used as analgesics in children 5. Codeine is transformed into morphine in the body by a liver enzyme called cytochrome P450 CYP2D6. However, the activity of this enzyme can vary depending on the individual; some patients have a profile of CYP2D6 rapid metabolizers, which results in a faster conversion of codeine to morphine. In these patients, blood levels of morphine are higher, posing a toxic risk, including a risk of respiratory failure.

The observation in the United States of an increased risk in children who received codeine after surgery (tonsillectomy and adenoidectomy) is the cause of the alert. A very small number of serious or even fatal cases of respiratory depression have been reported in children with "rapid metabolisers".

Without waiting for the final decision of the risk minimization measures announced, the ANSM already recommends: to use codeine in children over 12 years old only after failure of paracetamol and / or NSAIDs.

- no longer use this product in children under 12 years;

- no longer use this product after tonsillectomy or adenoidectomy;

- no longer use this product in breastfeeding women

ANSM alert of 12/05/2015:


The CMDH also endorsed the PRAC recommendation to contraindicate codeine in patients known to be ultra-fast metabolisers of CYP2D6 substrates. In addition, the CMDH recommends extending the contraindication during breastfeeding to all adult codeine-containing specialties, regardless of indication.

Pending the modification of the marketing authorizations concerned, the ANSM recommends taking into account these restrictions of use right now.

Side effects Paracetamol Codeine Cristers

RELATED TO PARACETAMOL

· 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.

RELATED 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:

o sedation, euphoria, dysphoria,

o miosis, urinary retention,

o hypersensitivity reactions (pruritus, urticaria and rash),

o constipation, nausea, vomiting,

o drowsiness, dizziness,

o bronchospasm, respiratory depression (see section 4.3 ),

o Acute biliary or pancreatic abdominal pain syndrome, suggestive of Oddi sphincter spasm, occurring particularly in cholecystectomized patients.

There is a risk of dependence and abrupt cessation syndrome, which can be observed in the user and the newborn of a mother poisoned with codeine.

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