Medicinal Products

PARACETAMOL CODEINE BIOGARAN 500 mg / 30 mg

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

Sparkling effervescent tablet
pillbox of 16
All forms

Indication

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

Dosage PARACETAMOL CODEINE BIOGARAN 500 mg / 30 mg tablet effervescent breakable pillbox of 16

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

Against indications

This medicine is contraindicated in the following cases:

· Child under 15 kg,

Hypersensitivity to any of the components of this medication,

· Hepatocellular insufficiency,

· Asthma and respiratory failure (due to the presence of codeine)

· Apart from a punctual intake during breastfeeding (see section on 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 Biogaran

RELATED TO PARACETAMOL

Some rare cases of allergic accidents are manifested by simple skin rashes with erythema or urticaria and require stopping treatment.

Very exceptional cases of thrombocytopenia have been reported.

RELATED TO CODEINE

At therapeutic doses:

The side effects of codeine are moderate.

Possibility of constipation, nausea, vomiting, drowsiness, dizziness, allergic skin reactions, bronchospasm, respiratory depression (see section 4.3 ).

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

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