Paracetamol Darnytsia tablets of 500 mg, 10 pcs

Paracetamol-Darnytsia is an analgesic and antipyretic.

Indications for use

Headache, including migraine and tension headache, toothache, back pain, rheumatic pain, muscle pain, periodic pain in women, moderate arthritic pain; relieving the symptoms of fever and pain in colds and flu.

Composition

• active substance: paracetamol;
• 1 tablet contains paracetamol 500 mg;
• excipients: pregelatinized starch, povidone, microcrystalline cellulose, croscarmellose sodium, calcium stearate.

Contraindication

Hypersensitivity to the components of the drug, severe liver and/or kidney dysfunction, congenital hyperbilirubinemia, glucose-6-phosphate dehydrogenase deficiency, alcoholism, blood diseases, Gilbert’s syndrome, severe anemia, leukopenia.

Adverse reactions

From the respiratory system: bronchospasm in patients sensitive to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs.

From the gastrointestinal tract: nausea, pain in the epigastrium.

From the side of the liver and biliary tract: impaired liver function, increased activity of liver enzymes, as a rule, without the development of jaundice.

From the endocrine system: hypoglycemia, up to hypoglycemic coma.

From the blood and lymphatic system: thrombocytopenia, agranulocytosis, anemia, sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, heart pain), hemolytic anemia, bruising or bleeding.

From the immune system: anaphylaxis, hypersensitivity reactions, including skin itching, rash on the skin and mucous membranes (usually generalized rash, erythematous rash, urticaria), angioedema, exudative erythema multiforme (including Stevens-Johnson syndrome) , toxic epidermal necrolysis (Lyell’s syndrome).

Method of application

The drug is intended for oral administration.

Adults and children over 12 years of age: 1-2 tablets 4 times a day if necessary. Do not take more than 8 tablets (4000 mg) within 24 hours.

Children (6-12 years): ½-1 tablet 3-4 times a day if necessary.

A single dose of paracetamol is 10-15 mg/kg of body weight, the maximum daily dose is 60 mg/kg of body weight. Do not take more than 4 doses in 24 hours.

The maximum period of use for children without consulting a doctor is 3 days.

The interval between receptions is at least 4 hours.

Do not exceed the recommended dose.

Do not take together with other medicines containing paracetamol.

Features of application

Use during pregnancy or breastfeeding

Pregnancy. Prescribing the drug during these periods is possible only if the expected benefit for the mother exceeds the potential risk for the fetus or child.

Breastfeeding period. Paracetamol penetrates into breast milk, but in clinically insignificant amounts. Available published data do not indicate any contraindications for breastfeeding.

Children

Do not use in children under 6 years of age.

The ability to influence the speed of reaction when driving vehicles or other mechanisms

Does not affect.

Overdose

An overdose of paracetamol can cause liver failure, which can lead to the need for a liver transplant or be fatal. Clinical signs of liver damage after an overdose of paracetamol usually appear 24-48 hours after the overdose and reach a maximum after 4-6 days.

There is an increased risk of paracetamol poisoning, particularly in elderly patients, children, patients with liver disease, chronic alcoholism and chronic malnutrition.

Liver damage is possible in adults who have taken 10 g or more of paracetamol, and in children who have taken more than 150 mg/kg of body weight. In patients with risk factors (long-term use of carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St. John’s wort or other drugs that induce liver enzymes; alcohol abuse; insufficiency of the glutathione system, for example: digestive disorders, cystic fibrosis, HIV infection, fasting, cachexia) taking 5 g or more of paracetamol can cause liver damage.

Treatment: in case of overdose, urgent medical assistance is required. The patient should be taken to the hospital immediately, even if there are no early symptoms of overdose, because liver damage may not develop immediately. Symptoms may be limited to nausea and vomiting and may not reflect the severity of the overdose or the risk of organ damage. Treatment with activated charcoal should be considered if an overdose of paracetamol has been taken within 1 hour. The concentration of paracetamol in blood plasma should be measured 4 hours or later after intake (earlier concentrations are unreliable). Treatment with N-acetylcysteine ​​can be used within 24 hours after taking paracetamol, but the maximum protective effect is obtained when it is used within 8 hours after taking it. The effectiveness of the antidote decreases sharply after this time. If necessary, N-acetylcysteine ​​should be administered intravenously to the patient according to current recommendations. In the absence of vomiting, oral methionine may be used as a suitable alternative in remote areas outside the hospital.

It is also necessary to carry out symptomatic treatment.

Interaction with other medicinal products and other types of interactions

The rate of absorption of paracetamol can increase with the use of metoclopramide and domperidone and decrease with the use of cholestyramine.

Paracetamol should be used 1 hour before or 4-6 hours after taking cholestyramine.

Anticoagulant effect of warfarin and other coumarins with increased risk of bleeding can be enhanced with simultaneous long-term use of paracetamol. Periodic reception does not have a significant effect.

Barbiturates reduce the antipyretic effect of paracetamol.

Anticonvulsant drugs (including phenytoin, barbiturates, carbamazepine), which stimulate the activity of microsomal liver enzymes, can increase the toxic effect of paracetamol on the liver due to an increase in the degree of transformation of the drug into hepatotoxic metabolites. The simultaneous use of paracetamol with hepatotoxic agents increases the toxic effect of the drugs on the liver. Simultaneous use of large doses of paracetamol with isoniazid increases the risk of developing hepatotoxic syndrome.

Probenecid halves the clearance of paracetamol by blocking its binding to glucuronic acid, therefore, in the case of combined therapy with probenecid, the dose of paracetamol should be reduced.

Paracetamol should be used with caution with chloramphenicol due to the prolongation of the half-life and the increase in the toxic effect of the latter.

Caution should be exercised when paracetamol is co-administered with flucloxacillin, as co-administration is associated with metabolic acidosis with a high anion gap, especially in patients with risk factors.

Paracetamol reduces the effectiveness of diuretics.

Do not use simultaneously with alcohol.

Storage conditions

Store in the original packaging at a temperature not higher than 25 °C.

Keep out of the reach of children.