Pain of medium and high intensity, of various origins: headache, pain after tooth extraction, osteoarticular pain, also post traumatic, traumatic pain of soft tissues, menstrual pain.
Composition:
1 tabl contains 500 mg of Paracetamol and 15 mg of codeine phosphate.
Action:
The preparation combines the action of paracetamol and codeine. Paracetamol has an analgesic and antipyretic effect by inhibiting prostaglandin synthesis. Well absorbed from the gastrointestinal tract, the maximum concentration in the blood reaches after about 0.5-1 h. In about 25% bound to plasma proteins. It is metabolized in the liver, excreted in the urine in the form of glucuronides and sulphates. T0,5 is 3-4 hours. Codeine has analgesic effect. It is quickly absorbed from the digestive tract. It is metabolised in the liver for morphine and norectodeine, it is excreted in the urine mainly in the form of glucuronide derivatives. T0,5 codeine is 3.5-4 h.
Contraindications:
Hypersensitivity to the components of the preparation. Severe hepatic and renal failure. Alcoholic disease. The use of MAO inhibitors and up to 2 weeks after they have been discontinued. Congenital G-6-PD deficiency and methemoglobin reductase. Children under 12 years. Children and adolescents undergoing palatal and / or pharyngeal tonsillectomy as part of the treatment of obstructive sleep apnea syndrome due to the increased risk of serious and life-threatening side effects. Breast-feeding. Patients with very rapid metabolism with the CYP2D6 enzyme.
Precautions:
Special care should be taken in patients with severe hepatic and renal impairment. Particularly cautiously used in patients with Addison's disease, hyperthyroidism, prostatic hypertrophy and impaired urine outflow, in the elderly with hepatic and renal failure, head injuries due to the possibility of increased respiratory inhibition and increasing intracranial pressure, and in alcohol addicts with attention to the special risk of liver damage. Codeine is metabolized to morphine. Use with caution in patients with rapid CYP2D6 metabolism due to the increased risk of adverse reactions of opioid toxicity, even at the usual recommended doses. It has been reported that codeine used postoperatively in children after palatal and / or throat tonsillary surgery in obstructive sleep apnea leads to rare but life-threatening adverse events, including death - these children very quickly or rapidly metabolize codeine to morphine. Codeine is not recommended for use in children whose respiratory function may be impaired, including children with neuromuscular disorders, severe cardiac or respiratory disorders, upper respiratory or lung infections, multiple organ trauma or extensive surgical procedures. These factors may increase the symptoms of morphine toxicity.
Pregnancy and lactation:
The preparation can be used during pregnancy only if clearly necessary. During breast-feeding, the use of the drug is contraindicated.
Side effects:
Codeine can cause constipation, and long-term intake can lead to addiction, anxiety, headaches, and in the case of discontinuation to increase irritability. Rarely after the use of the preparation may occur allergic reactions with rash, occasionally thrombocytopenia and agranulocytosis.
Dosage:
Orally. Adults and children over 12 years of age: 1-2 tabl. up to 4 times a day, every 4-6 h (up to 8 tables a day). In patients with impaired liver or kidney function, it may be necessary to reduce the dose of the drug. The preparation should be taken after a meal, abundantly washed down with liquid.
(C)
