Medicinal Products

ALGISEDAL

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

Compressed
box of 16
All forms

Indication

Reserved for adults and children over 15 years old.

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

Dosage ALGISEDAL tablet box of 16

Reserved for adults and children over 15 years old.

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

Against indications

· Children under 15 years old.

· Hypersensitivity to any of the excipients.

Related to paracetamol:

· Hypersensitivity to paracetamol.

· Hepatocellular insufficiency.

Linked 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.

· Hypersensitivity to codeine.

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.

Algodiesal side effects

· A few rare cases of allergic accidents are most often manifested by simple rashes with erythema or urticaria and require discontinuation of treatment.

· Very exceptional cases of thrombocytopenia have been reported.

Linked to codeine:

· The adverse effects of codeine are comparable to those of other opiates but, at therapeutic doses, more rare and moderate, possibility of:

o constipation,

o sleepiness,

o vertiginous states,

o nausea, vomiting,

o bronchospasm, allergic skin reactions,

o respiratory depression.

Risk of dependence and abrupt cessation syndrome that has been observed in the user and the newborn of a drug addict mother.

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