Codeine + Paracetamol - instructions for use, dose, side effects, contraindications

Active substanceCodeine + ParacetamolCodeine + Paracetamol

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Codeine + Paracetamol

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MOSCOW ENDOCRINE FACTORY, FSUE Russia

Kodelmikst®

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Roushan Pharma Co., Ltd. India

Dosage form: & nbsppills

Composition:

For one tablet:

Active substances:

Paracetamol - 0.500 grams

Codeine or - 0.008 g

Codeine phosphate - 0.01 g

(in terms of codeine) (0.008 g)

Excipients: potato starch, low molecular weight polyvinylpyrrolidone (povidone), talc, magnesium stearate, citric acid - sufficient amount to prepare a tablet with a mass - 0.60 g.

Description:

Tablets are white or white with a light yellowish hue of color, a flat-cylindrical shape with a facet and a risk.

Pharmacotherapeutic group:Analgesic agent (analgesic opioid + analgesic non-narcotic agent)

ATX: & nbsp

N.02.B.E.51 Paracetamol in combination with other drugs, excluding psycholeptics

Pharmacodynamics:

Paracetamol is an analgesic and antipyretic. It blocks the synthesis of prostaglandins in the central nervous system by inhibiting cyclooxygenase 1 and cyclooxygenase 2, acting on pain centers and thermoregulation. Does not show anti-inflammatory effect.The lack of influence on the synthesis of prostaglandins in peripheral tissues determines the absence of a negative effect on the water-salt metabolism (sodium and water retention) and the mucosa of the gastrointestinal tract.

Codeine, being a natural analgesic from the group of opiate receptor agonists, significantly enhances the analgesic effect of paracetamol. The antitussive effect of codeine is associated with the suppression of the excitability of the cough center.

Pharmacokinetics:

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Paracetamol penetrates the blood-brain barrier. The half-life is 1-4 hours.

Codeine is metabolized in the liver; is excreted by the kidneys in an unchanged form and in the form of metabolites.

Indications:

Pains of mild and moderate intensity (headache and toothache, migraine, back pain, arthralgia, myalgia, neuralgia, algodismenorea, traumas of the musculoskeletal system), colds, flu.

Contraindications:

Hypersensitivity to the components of the drug, severe violations of the liver and kidneys, age to 12 years, violation of hemopoiesis, respiratory depression due to respiratory center depression,pulmonary insufficiency, pregnancy, lactation, genetically caused by a deficiency of glucose-6-phosphate dehydrogenase.

Dosing and Administration:Adults take 1-2 tablets every 4 hours (up to 4 times a day). The maximum daily dose is 8 tablets. As an antipyretic drug is not recommended without taking consultations of the doctor more than 3 days, and as an analgesic - more than 5 days.

Children aged 12 years are prescribed 1/2 to 1 tablet up to 4 times a day. The interval between doses should be at least 4 hours.

Side effects:Nausea, vomiting, pain in the epigastric region. Allergic reactions (skin rash, urticaria, pruritus, angioedema), very rarely - thrombocytopenia, hemolytic anemia, methemoglobinemia and impaired liver and kidney function.

Overdose:

Symptoms: agitation, a feeling of discomfort in the epigastrium, functional disorders of the gastrointestinal tract, heaviness in the head, insomnia, hypoglycemia, cyanosis, bronchospasm. May accelerate the development of severe respiratory failure

Treatment: gastric lavage, Activated carbon.

Interaction:

Increases the effect of antiaggregants, which can lead to the occurrence of adverse reactions.

Codeine enhances the effect of ethanol on the psychomotor function.

Inductors of microsomal oxidation (barbiturates, antiepileptic drugs, rifampicin and ethanol) increase the risk of hepatotoxicity.

Simultaneous reception with monoamine oxidase inhibitors causes ataxia, hypotension, paresthesia, accommodation disruption.

Drugs that depress the central nervous system, enhance the sedative effect and depressant effect on the respiratory center.

Oral contraceptives reduce the metabolic rate of paracetamol by 20-30%. Prolonged use of anticonvulsants may decrease the activity of paracetamol.

Special instructions:

Avoid joint intake with other medicines containing paracetamol, as well as with expectorants.

The recommended dose should be strictly observed. In the absence of therapeutic effect, a doctor's consultation is necessary. Because the drug contains codeine, should be borne in mind the possibility of developing addiction.

Effect on the ability to drive transp. cf. and fur:

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Pills.

Packaging:For 10 tablets in a planar cell package. For 1 or 2 contour mesh packages together with instructions for use in a cardboard bundle.

Storage conditions:

In a dry place protected from light. Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-004677/07

Date of registration:11.12.2007

Expiration Date:Unlimited

The owner of the registration certificate:MOSCOW ENDOCRINE FACTORY, FSUE MOSCOW ENDOCRINE FACTORY, FSUE Russia

Manufacturer: & nbsp

MOSCOW ENDOCRINE FACTORY, FSUE Russia

Information update date: & nbsp13.01.2018

Illustrated instructions

Instructions

Codeine + Paracetamol (Codeine + Paracetamol)