Medicinal Products

PARACETAMOL CODEINE ARROW 500 mg / 30 mg

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

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 ARROW 500 mg / 30 mg tablet effervescent breakable pill box 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),

· Breastfeeding (see section on Pregnancy and lactation )

· Combination with morphine agonists-antagonists; buprenorphine, nalbuphine, pentazocine (see section 4.5. Interactions with other medicinal products and other forms of interaction ).

This drug is generally not recommended in combination with alcohol or drugs containing alcohol.

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 Arrow

RELATED TO PARACETAMOL

A few rare hypersensitivity reactions such as anaphylactic shock, angioedema, erythema, urticaria, rash, have been reported. Their occurrence requires the definitive discontinuation of this drug and related drugs.

Very exceptional cases of thrombocytopenia have been reported.

RELATED TO CODEINE

At therapeutic doses

The adverse effects of codeine are of the same type as those of other opiates but they are more rare and moderate.

Possibility of:

· Constipation, nausea, vomiting,

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

· Drowsiness, dizziness,

· Hypersensitivity reactions (pruritus, urticaria and, in rare cases, rash), 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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