Medicinal Products

ANTARENE CODEINE 400 mg / 60 mg

Generic drug of the therapeutic class: Analgesics
active ingredients: Codeine + Ibuprofen
laboratory: Elerte

Coated tablet
box of 1 blister pack of 10
All forms

Indication

Treatment of short-term pain episodes in adults, of moderate to severe intensity or not responding to a non-opioid analgesic alone.

Dosage ANTARENE CODEINE 400 mg / 60 mg film-coated tablet box of 1 blister pack of 10

Treatment of short-term pain episodes in adults, of moderate to severe intensity or not responding to a non-opioid analgesic alone.

Against indications

This medicine is contraindicated in the following situations:

· Child under 15,

· Beyond 24 weeks of amenorrhea (5 months pregnant) (see section on Pregnancy and breastfeeding ),

· Hypersensitivity to ibuprofen or any of the excipients of the product,

· History of asthma triggered by ibuprofen or other substances of similar activity such as: other NSAIDs, acetylsalicylic acid,

· History of bleeding or digestive perforation during previous NSAID treatment,

· Gastrointestinal haemorrhage, cerebrovascular hemorrhage or other progressive haemorrhage,

· Progressive peptic ulcer, history of peptic ulcer or recurrent haemorrhage (2 or more episodes, or more, of haemorrhage or ulceration objectivized),

· Severe liver failure,

· Severe renal insufficiency,

· Severe heart failure,

· Systemic lupus erythematosus,

· Respiratory insufficiency regardless of the degree due to the depressant effect of codeine on the respiratory centers,

· During breastfeeding outside of a punctual intake.

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.

Antarene Codeine side effects

RELATED TO IBUPROFEN

Clinical studies and epidemiological data suggest that the use of ibuprofen, especially when used at high doses (2400 mg per day) over a long course of treatment, may be associated with a slight increase in the risk of arterial thrombotic event (eg, myocardial infarction or stroke) (see Warnings and Precautions for Use section ).

The most commonly observed side effects are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, can occur, especially in the elderly (see section Warnings and precautions for use ).

Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, ulcerative stomatitis, abdominal pain, melena, hematemesis, exacerbation of rectocolitis or Crohn's disease (see Warnings and Precautions for Use section ) reported following administration of NSAIDs. Less frequently, gastritis has been observed.

Edema, hypertension and heart failure have been reported in combination with NSAID therapy.

Gastrointestinal effects

Gastrointestinal disorders such as nausea, vomiting, gastralgia, dyspepsia, transit disorders, digestive ulcerations with or without haemorrhage, occult or non-occult haemorrhage have usually been reported. These are all the more frequent as the dosage used is high and the duration of treatment extended.

Hypersensitivity reactions

· Dermatological: rashes, rash, pruritus, edema, urticaria, aggravation of chronic urticaria.

· Respiratory: The onset of asthma attacks in some subjects may be related to an allergy to acetylsalicylic acid or a nonsteroidal anti-inflammatory drug (see section 4.3 ).

· General: anaphylactic shock, angioedema.

Skin effects

Very rarely bullous reactions (Stevens-Johnson syndrome, Lyell syndrome) have been observed.

Effects on the central nervous system

Ibuprofen may exceptionally be responsible for vertigo and headache.

Other

· Some rare cases of visual disturbances have been reported,

· Oliguria, renal failure,

· The discovery of aseptic meningitis with ibuprofen should result in systemic lupus erythematosus or connective tissue disease.

Some biological modifications could be observed

· Hepatic: rarely elevated transaminases, exceptional cases of hepatitis.

· Haematological: agranulocytosis, haemolytic anemia.

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:

· Sedation, euphoria, dysphoria,

· Miosis, urinary retention,

· Hypersensitivity reactions (pruritus, urticaria and rash),

· Constipation, nausea, vomiting,

· Drowsiness, dizziness,

· Bronchospasm, respiratory depression (see section 4.3 ),

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

At supra-therapeutic doses

Risk of dependence and sudden withdrawal syndrome, which can be observed in the user and the newborn of a mother poisoned with codeine.

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