Indications:

Used in the treatment of moderate to severe pain.
Used as a cough suppressant.

Dosage

The dosage should be adjusted to the intensity of the pain; the lowest effective dose should generally be used, for the shortest possible duration. If long-term treatment is necessary, taking into account the nature and severity of the disease, careful and regular monitoring should be carried out (by inserting, if necessary, therapeutic breaks) in order to check whether, and the extent to which further treatment is necessary.

Adults (from 15 years old):

1 prolonged-release tablet of 60 mg, to be renewed if necessary after 12 hours, without exceeding 2 tablets per day (maximum dosage).
1 tablet of 30 mg to be renewed every 6 hours at least (for forms associated with paracetamol or NSAIDs).
Caution: Consider all medications to avoid opioid overdose, including over-the-counter medications.

Child (from 12 years old):

Used as an antitussive in children, the doses in syrup or tablets must be spaced at least 6 hours apart without exceeding the total dose of 1 mg/kg/d. This treatment should be of short duration.

Special populations: elderly, renal and/or hepatic impairment:

In these patients, codeine requires dosage adjustment (start of treatment at a reduced dosage with subsequent adjustment depending on the clinic).

Contraindications:

This medicine should never be used in the following cases:
– Hypersensitivity to the active substance or to any of the excipients mentioned in the Composition section.
– Respiratory insufficiency regardless of the degree of insufficiency, due to the depressant effect of codeine on the respiratory centers.
– Severe hepatocellular and/or renal failure.
– Child under 15 years old for adult forms and under 12 years old for antitussive drugs (do not exceed 1 mg/kg per day).

Warnings and precautions for use:

Warnings :

Cases of addiction have been described with codeine.
With prolonged use, the patient may develop drug tolerance and need to gradually increase doses to maintain analgesia.
Prolonged use of this medication may lead to physical dependence and a withdrawal syndrome may appear when treatment is abruptly stopped.
When stopping treatment, it is advisable to gradually reduce the doses to prevent the appearance of this withdrawal syndrome.

Codeine poses a risk of abuse and dependence. Codeine can give rise to misuse (misuse) and abuse by people with a latent or manifest risk of addictive disorders. Psychological dependence may appear after the administration of opioid analgesics, including codeine.
Codeine should be used with caution in patients with a history of drug abuse or alcoholism.

Codeine is not suitable for replacement therapy in patients with opioid dependence.

Precautions for use:

Codeine requires special monitoring:
– in cholecystectomized patients (removal of the gallbladder). Indeed, codeine can cause an acute abdominal pain syndrome of the biliary or pancreatic type, most often associated with biological abnormalities, suggestive of a spasm of the sphincter of Oddi (sphincter controlling the evacuation of bile in the intestine );
– in patients with constipation: it is important to look for and manage constipation or an occlusive syndrome before and during treatment;
– in patients with chronic respiratory disease (asthma, emphysema, chronic obstructive bronchitis, etc.)

Interactions:

Drugs interactions :

It must be taken into account that many drugs or substances can add up their depressant effects on the central nervous system and contribute to reducing alertness and/or causing a respiratory problem.
Beware of all drugs or substances causing drowsiness or potential respiratory problems.

Not recommended:

– Morphinics
– Alcohol consumption: increase by alcohol of the sedative effect of morphine analgesics.
Impaired alertness can make driving vehicles and using machines dangerous. Avoid taking alcoholic beverages and medications containing alcohol.

To consider :

– Other morphine analgesics
– Morphine cough suppressants
– Benzodiazepines and related.
– Barbiturates: increased risk of respiratory depression, which can be fatal in case of overdose.
– Other sedative drugs: increased central depression. Impaired alertness can make driving vehicles and using machines dangerous.

Pregnancy and breast feeding :

Pregnancy :

Codeine is not recommended during pregnancy.
If administered in late pregnancy, consider neonatal monitoring:
– risk of withdrawal syndrome in the newborn in the event of prolonged administration at the end of pregnancy, whatever the dose;
– theoretical risk of respiratory depression in the newborn after high doses, even in brief treatment, before or during delivery.

Feeding with milk :

The passage of codeine into breast milk is not known. Given the risks of respiratory depression in the newborn, it is preferable to avoid the use of codeine during breastfeeding.

Driving and using machines:

Due to possible reduced alertness Codeine may have minor or moderate influence on the ability to drive and use machines.
Caution, in sensitive subjects, or, when codeine is taken at the same time as other treatments that may alter alertness, or alcohol.

Side effects :

The most common side effects at usual doses are: constipation, abdominal pain, dry mouth, nausea and vomiting, headache, drowsiness.
The incidence of adverse reactions, classified by system organ class, is presented below. The definition of the categories of frequency of occurrence are as follows: very common (≥ 1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000, <1/1000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Immune System Disorders:

-Not known: angioedema.

Psychiatric conditions:

– Common: Hallucinations.
– Not known: confusional state, drug dependence, dysphoria.

Nervous System Disorders:

– Very common: somnolence, headache.
– Common: dizziness.
– Not known: convulsions, sedation.

Vascular conditions:

– Not known: hypotension.

Respiratory, Thoracic and Mediastinal Conditions:

– Not known: respiratory depression, bronchospasm.

Gastrointestinal Disorders:

– Very common: abdominal pain, constipation, dry mouth, nausea, vomiting.
– Not known: diarrhoea, paralytic ileus (related to constipation).

Hepatobiliary Disorders:

– Not known: spasm of the sphincter of Oddi (closing of the end of the bile duct).

Skin and Subcutaneous Tissue Disorders:

– Common: hyperhidrosis (profuse sweating).
– Frequency not known: itching, urticaria, rash.

Kidney and Urinary Tract Disorder:

– Not known: urinary retention.

General Disorders and Injection Site Conditions:

– Frequent: tiredness.
– Not known: withdrawal syndrome, neonatal withdrawal syndrome.

At supratherapeutic doses:

Risk of dependence and withdrawal syndrome on sudden cessation that can be observed in users and newborns of drug-addicted mothers.

Overdose:

Symptoms :

Signs of a codeine overdose are:
– drowsiness that can progress to a coma,
– a miosis,
– vomitings,
– hypotension,
– hypothermia,
– signs of histamino-release,
– acute depression of the respiratory centers (cyanosis, bradypnoea), which can be fatal in the most serious cases.

Emergency driving:

Ensure a clear airway (aspiration), maintain ventilation and circulation symptomatically. In case of overdose, naloxone may be administered.

Precaution:

In subjects dependent on morphinomimetics, an injection of high dose naloxone can cause a withdrawal syndrome. In these subjects, naloxone must be injected in progressive doses.