Symptomatic treatment of pain from moderate to severe intensity or not responding to the use of analgesics, peripheral devices used alone

RESERVED FOR THE ADULT

1 tablet, to be renewed in case of need after 4 hours, or possibly 2, tablets in case of severe pain, without exceeding 6 tablets per day.
The maximum daily dose is 3 g of paracetamol and 120 mg of codeine.


In case of renal insufficiency, severe (creatinine clearance, less than 10 ml / min), the interval between two catches will be at least 8 hours. >
ANTALGIC central and device

(N. Central nervous system)

Combination of two active ingredients

· Paracetamol: analgesic, antipyretic

· Codeine phosphate · hemihydrate: central analgesic

The combination of paracetamol and codeine phosphate has significantly greater analgesic activity than its individual components, with a distinctly prolonged effect over time

Attention is drawn in particular to the risk of drowsiness associated with the use of this medicinal product in vehicle operators and users of machinery.
This medication is contraindicated during breast-feeding (see section Pregnancy and lactation).


· Related to paracetamol

O allergy to paracetamol

O insufficiency, hepatocellular

· Related to codeine

O respiratory insufficiency

O allergy to codeine.

Relative contraindication

· Combination with the morphine agonist-antagonists (buprenorphine, nalbuphine, pentazocine).
Warnings, special

Prolonged treatment of codeine may lead to a state of dependence.

· Pains due to disaffection (pain, neurogenic) do not respond to codeine / paracetamol association

· The attention of athletes will be drawn to the fact that this specialty contains an active ingredient which can induce a positive reaction from the tests performed during the doping controls.
Precautions for use

Elderly / Hepatic impairment The initial dosage will be halved by the recommended dosage in adults and may be increased depending on tolerance and need.
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Caution should be taken in cases of intracranial hypertension which may be increased.

The use of alcoholic beverages and medicines containing alcohol (see section Interactions with other medicinal products and other forms of interactions) during treatment is discouraged.
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Related to codeine

Associations, deprecated

+ Alcohol

Increase by alcohol of the sedative effect of central antitussives. The alteration of vigilance may render dangerous the driving of vehicles and the use of machines.

Avoid drinking alcoholic beverages and medicines containing alcohol

+ Agonists-antagonists, morphinics (buprenorphine, nalbuphine, pentazocine), reduction of the antalgic effect by competitive blockade of the receptors
Associations to be taken into account

+ Other CNS depressants, morphine analgesics, certain antidepressants, antihistamines H 1 sedative, barbiturates, benzodiazepines, clonidine and related, hypnotics, neuroleptics, anxiolytics other than benzodiazepines. >
Increased depression, central. The alteration of alertness can make dangerous the driving of vehicles and the use of machines.

+ Other derivatives, morphine (analgesic or cough suppressant)

Respiratory depression (synergy, potentiating) of the depressant effects of morphine, especially in the elderly

Related to paracetamol

Interaction with paraclinic tests Paracetamol intake may distort the determination of blood uric acid by the phosphotungstic acid method and the measurement of blood glucose by the glucose oxidase-peroxidase method.

Not applicable.

Codeine overdose

Signs in adults

· Acute depression · respiratory centers (cyanosis, bradypnea)

· Drowsiness, rash, vomiting

· Pruritus

· Ataxia

· Pulmonary edema (more rare)

Signs in children

(Toxic Threshold: 2 mg / kg in single dose)

· Bradypnea, breaks, breathing

· Myosis

· Convulsions

· Flush and edema of the face

· Urticarial eruption, collapse

· Retention of urine.

Emergency treatment

· Respiratory assistance

· Naloxone

Overdose of paracetamol

Poisoning is to be feared in elderly and especially in young children (therapeutic overdose or accidental and frequent poisoning) where it can be fatal

Symptoms: nausea, vomiting, anorexia, pallor, abdominal pain usually occur within the first 24 hours An overdose, starting with 10 g paracetamol and 150 mg / kg body weight in children, causes Cytolysis, liver disease, complete and irreversible necrosis, resulting in hepatocellular insufficiency, acidosis, metabolism, encephalopathy, comatose and death, and an increase in transaminases , Liverworts, lactic dehydrogenase, bilirubin and decreased prothrombin levels that may appear 12 to 48 hours after ingestion.



· Driving emergency

O Immediate transfer to hospital

O Quick evacuation of the product, ingested, by gastric lavage

O Before starting the treatment, take a blood tube to make the paracetamol plasma dosage.

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O Symptomatic treatment will be instituted

Pregnancy

The punctual use of this medication may be considered during pregnancy if needed regardless of the term, but its chronic use should be avoided.

In the event of administration at the end of pregnancy, take into account the morphinomimetic properties of this drug (risk of theoretical respiratory depression in the newborn after high doses before delivery, risk of withdrawal, Chronic end-of-pregnancy administration.
Data on paracetamol

In clinical studies, epidemiological studies have not revealed any malformative or foetotoxic effect related to use at the usual dosages of paracetamol. >
Codeine data

In clinical practice, although a few case-control studies show an increased risk of cardiac malformations, most epidemiological studies exclude malformative risk.
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Studies carried out in animal have demonstrated a teratogenic effect.

Breastfeeding

Paracetamol and Codeine pass into breast milk

A few cases of hypotonia and respiratory pauses have been described in infants after ingestion by the mothers of codeine at supra-therapeutic doses.
Therefore, apart from a single dose, this medication is contraindicated during breast-feeding (see section Contraindications).


At therapeutic doses the undesirable effects of codeine are comparable to those of other opiates but are more rare and moderate. >
O, constipation, nausea, vomiting

O, drowsiness, dizzy states

O allergic skin reactions

O bronchospasm, respiratory depression (see section Contraindications)

· There is a risk of dependence and. Of withdrawal syndrome, abrupt discontinuation, which can be observed, in the user and in the newborn of the mother, intoxicated with codeine.
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Related to paracetamol

A few rare cases of allergic symptoms are manifested by simple skin rashes with erythema or urticaria and require cessation of treatment.

Very rare cases of thrombocytopenia have been reported.

Symptomatic treatment of pain from moderate to severe intensity or not responding to the use of analgesics, peripheral devices used alone