Medicinal Products

PARACETAMOL CODEINE GNR 500 mg / 30 mg

Generic drug of the therapeutic class: Analgesics
active ingredients: Paracetamol, Codeine
laboratory: Sandoz

Sparkling effervescent tablet
Pill box 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 GNR 500 mg / 30 mg Tablets effervescent breakable Pill box of 16

Reserved for adults and children from 15 kg (approximately 3 years).
Administration mode :
Oral way.
The tablets should be dissolved in a little liquid before being administered.
Dosage:
- In adults:
1 tablet, to be renewed if necessary after 6 hours, or possibly 2 tablets in case of intense pain without exceeding 6 tablets per day.
The maximum daily dosage of paracetamol is 3 g.
The catches should be spaced preferably 6 hours and at least 4 hours.
- Elderly : The initial dosage will be halved compared to the recommended dosage in adults, and may be increased depending on tolerance and needs .
- In case of severe renal insufficiency (creatinine clearance less than 10 ml / min ), the interval between two doses will be at least 8 hours.
- In children:
In children, it is imperative to respect the dosages defined according to the weight of the child . Approximate ages by weight are given for information.
The recommended daily dose of paracetamol is approximately 60 mg / kg / day, divided into 4 or 6 doses.
The recommended daily dose of codeine is approximately 3 mg / kg / day, to be divided into 4 or 6 doses.
. For children weighing 15 to 22 kg (approximately 3 to 6 years), the dosage is one half-tablet per dose, to be renewed if necessary after 6 hours, without exceeding 4 half-tablets per day .
. For children weighing 23 to 30 kg (approximately 7 to 10 years), the dosage is one half-tablet per dose, to be renewed if necessary after 4 hours, not exceeding 6 half-tablets per day .
. For children weighing 31 to 44 kg (approximately 11 to 14 years), the dosage is 1 tablet per dose, to be renewed if necessary after 6 hours, without exceeding 4 tablets per day.
. For children weighing 45 to 50 kg (approximately 14 to 15 years), the dosage is 1 tablet per dose, to be renewed if necessary after 4 hours, without exceeding 6 tablets per day.
. In children over 50 kg (from about 15 years), the dosage is one tablet, to be renewed if necessary after 4 hours, or possibly 2 tablets in case of severe pain, without exceeding 6 tablets a day.
Maximum recommended doses:
The dose of codeine not to be exceeded in children is 1 mg / kg per dose and 6 mg / kg per day.
The total dose of paracetamol should not exceed 80 mg / kg in children under 37 kg and 3 g per day in adults or grandchildren over 38 kg.
Frequency of administration:
Systematic catches prevent pain oscillations:
in children, they should be regularly spaced preferably 6 hours, and at least 4 hours.
Renal failure :
In renal failure, there is a risk of accumulation of codeine and paracetamol, as a result:
- the interval between two shots will be at least 8 hours,
- a reduction of the dose will be considered,
- and close supervision of the child will be put in place.

Against indications

CONTRAINDICATED:
This medicine is contraindicated in the following cases:
- hypersensitivity to any of the components of this medication,
- hepatocellular insufficiency,
- asthma and respiratory failure (due to the presence of codeine),
- child under 15 kg,
- apart from a punctual intake during breastfeeding: paracetamol and codeine pass into breast milk. A few cases of hypotonia and respiratory pauses have been reported in infants after mothers have taken codeine doses at supratherapeutic doses. As a result, apart from a punctual intake, this medication is contraindicated during breastfeeding.
Due to the presence of sorbitol, this drug is contraindicated in cases of fructose intolerance.
NOT RECOMMENDED :
Associations advised against : morphine agonists-antagonists: buprenorphine, nalbuphine, pentazocine; alcohol; naltrexone.

Paracetamol Codeine Gnr side effects

- Paracetamol-related :
. Some rare cases of allergic accidents are manifested by simple skin rashes with erythema or urticaria and require stopping treatment.
. Very exceptional cases of thrombocytopenia have been reported.
- Linked to codeine :
. At therapeutic doses:
the adverse effects of codeine are moderate.
Possibility of constipation, nausea, vomiting, drowsiness, dizziness, allergic skin reactions, bronchospasm, respiratory depression (see contraindications).
. At supratherapeutic doses:
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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