Translation of the instruction Mose

PARACETAMOL of a tablet of 200 mg

Instruction

On medical use of medicine

Paracetamol

Ingredients:

Active ingredient: paracetamol;

1 tablet contains paracetamol 200 mg;

excipients: potato starch, calcium stearate, silicon dioxide colloidal anhydrous, hydroksipropilmetiltsellyuloza.

Dosage form.

Tablet.

Main physical and chemical properties: integral correct, round cylinders, upper and lower surfaces of which flat, edges of surfaces are slanted, with a hyphen for division, color, white or white with a cream shade.

Pharmacotherapeutic group.

and antipyretics. paracetamol.

ATX N02B E01 Code.

Pharmacological properties.

Pharmacodynamics.

Paracetamol represents 4 hydroxyacetanilide — non-narcotic, nesalitsilatny analgetik and antipyretic which analgetic activity is connected with the central and peripheral action. Raises a threshold of painful sensitivity, has weak anti-inflammatory effect as a result of oppression of synthesis of prostaglandins and blocks impulses on receptors, sensitive to bradykinin.

Pharmacokinetics.

after intake. The maximum concentration in blood plasma are registered in 15–60 minutes after its reception. Therapeutic effective concentration of paracetamol in blood plasma is reached at its appointment in a dose of 10-15 mg/kg. Paracetamol is metabolized in a liver generally by conjugation tests with sulfuric and glucuronic acids, with formation of a glucuronide and sulfate of paracetamol. Paracetamol is removed by kidneys, less than 5% are removed in not changed state. Elimination half-life after intake makes about 1-4 hours. In a heavy renal failure (the clearance of creatinine is lower than 10 ml/min.) the removal of paracetamol and its metabolites happens more slowly.

Clinical characteristics.

Indication.

Headache, including migraine and a headache of tension; neuralgia; toothache; relief of symptoms of cold and flu, such as fever, ache, pain.

Contraindication.

Hypersensitivity to medicament components. heavy abnormal liver functions and/or kidneys, congenital hyperbilirubinemia, deficit glyukozo-6-fosfatdegidrogenazy, alcoholism, blood diseases, profound anemia, leukopenia.

Interaction with other medicines and other types of interactions.

At co-administration of barbiturates, anticonvulsant (antiepileptic) means, rifampicin, alcohol intake the risk of hepatotoxic action considerably increases.

Paracetamol increases effect of indirect anticoagulants (coumarin derivatives). Metoclopramidum and domperidon raises, and holestiramin — reduces absorption speed. Paracetamol needs to be applied in 1 hour prior to or in 4–6 hours after reception of a holestiramin. Barbiturates reduce febrifugal activity.

at simultaneous prolonged daily use of paracetamol, with increase in risk of bleeding. Periodic reception has no considerable effect.

Anticonvulsant medicaments (including Phenytoinum, barbiturates, carbamazepine) stimulating activity of microsomal enzymes of a liver can strengthen toxic influence of paracetamol on a liver owing to increase in extent of transformation of medicament on hepatotoxic metabolites. At simultaneous use of paracetamol with hepatotoxic means the toxic influence of medicaments on a liver increases.

Simultaneous use of high doses of paracetamol with an isoniazid increases risk of development of a hepatotoxic syndrome. Paracetamol reduces efficiency of diuretics.

Probenetsid twice reduces clearance of paracetamol by blocking of its linking with glucuronic acid therefore at combination therapy with probenetsidy the dose of paracetamol has to be reduced.

Paracetamol needs to be applied with care with chloramphenicol because of lengthening of a half-life period and increase in toxic action of the last.

Feature of use.

needs to consult to the doctor concerning a possibility of use of drug:

• to patients, with renal failures and a liver;
• to patients who use warfarin or similar medicaments which have anticoagulating effect;
• to the patients accepting analgetik in arthritises of an easy form;
• at patients with heavy infections, such as sepsis which are followed by decrease in level of glutathione at intake of paracetamol the risk of developing of a metabolic acidosis increases. Symptoms of a metabolic acidosis is the deep, speeded-up or complicated breath, nausea, vomiting, loss of appetite. It is necessary to see immediately a doctor in case of these symptoms;
• in case the headache gains constant character.

that at patients with alcoholic damage of a liver the risk of hepatotoxic action of paracetamol increases; medicament can affect results of laboratory researches on content in blood of glucose and uric acid.

If symptoms do not disappear, to see a doctor.

Use during pregnancy or feeding by a breast.

in case the expected advantage for mother exceeds potential risk for a fruit or the child.

Paracetamol gets into breast milk, but in clinically insignificant quantities. The available published data do not contain contraindications concerning feeding by a breast.

Ability to influence speed of response at control of motor transport or other mechanisms.

does not influence.

Route of administration and doses.

for oral administration.

to Adults and children since 12 years: on 2 tablets (400 mg) 3–4 times a day, with an interval between receptions is not less than 4 hours. It is no more than 4000 mg within 24 hours.

to Children (6–12 years): on 1–2 tablets (200–400 mg) each 4–6 hours.

should not take more than 20 pill (4000 mg) within 24 hours.

to Children of 3-6 years: on ½-1 tablets (100–200 mg) up to 4 times a day.

Interval between receptions makes not less than 4 hours.

Duration of treatment is defined by the doctor.

Maximum term of use without consultation of the doctor — 3 days.

not to exceed the specified dose.

together with other medicines containing paracetamol.

Children.

is not recommended to be applied to children up to 3 years.

Overdose.

at adults who accepted 10 g and more paracetamol, and at children who accepted more than 150 mg/kg of body weight. at patients with risk factors (long-term treatment by carbamazepine, Phenobarbitonum, Phenytoinum, Primidonum, rifampicin, a St. John's wort or other medicines inducing liver enzymes; regular reception of very large amount of ethanol; the glutationovy cachexia (digestive disturbance, a mucoviscidosis, HIV infection, hunger, a cachexia) can lead acceptance of 5 g or more paracetamol to damage of a liver.

overdose Symptoms in the first 24 hours: pallor, nausea, vomiting, anorexia and abdominal pain. Damage of a liver can become obvious in 12–48 hours after overdose. There can be a disturbance of metabolism of glucose and a metabolic acidosis. In a serious poisoning the liver failure can progress to encephalopathy, hemorrhage, a hypoglycemia, a coma and till a lethal outcome. The acute renal failure with acute necrosis of tubules can be shown by severe lumbar pain, a hamaturia, a proteinuria and to develop even in the absence of severe damage of a liver. Also cardiac arrhythmia and pancreatitis were noted.

At prolonged use of medicament in high doses from bodies of a krovoobrazovaniye the aplastic anemia, a pancytopenia, an agranulocytosis, a neutropenia, a leukopenia, thrombocytopenia can develop. At reception of high doses from the central nervous system — dizziness, psychomotor initiation and disturbance of orientation; from an urinary system — nephrotoxicity (renal colic, interstitial nephrite, capillary necrosis).

At overdose. The patient needs to be taken immediately to hospital even if there are no early symptoms of overdose. Symptoms can be limited to nausea and vomiting or can not display weights of overdose or risk of defeat of bodies. It is necessary to consider treatment by activated carbon if the overdose of paracetamol was accepted within 1 hour. Concentration of paracetamol should be measured in blood plasma in 4 hours or later after reception (earlier concentration are doubtful). Treatment by N-Acetylcysteinum can be performed for 24 hours after intake of paracetamol, but the maximum protective effect is gained at its use within 8 hours after reception. The efficiency of antidote sharply decreases after this time. If necessary to the patient intravenously enter N-Acetylcysteinum according to the established list of doses. In the absence of vomiting it is possible to apply methionine orally as the corresponding alternative in the remote areas outside hospital.

Side reactions.

to Stop use of medicament and to see immediately a doctor in case of side reactions.

Side reactions of paracetamol happen very seldom (

• allergic reactions: an anaphylaxis, a skin itching, rash on skin and mucous membranes (usually generalized rash, an erythematic small tortoiseshell), a Quincke's disease, a multiformny exudative erythema (including. Stephens-Johnson's syndrome), toxic epidermal necrolysis (Lyell's disease);
• from a digestive tract: nausea, pain in epigastriums, increase in activity of liver enzymes, as a rule, without development of jaundice;
• from an endocrine system: a hypoglycemia, up to a hypoglycemic coma;
• from the system of blood and lymphatic system: thrombocytopenia, agranulocytosis, anemia, sulfhemoglobinemia and methemoglobinemia (cyanosis, short wind, heartaches), hemolytic anemia, bruises or bleedings;
• disturbance from a respiratory system: a bronchospasm at the patients sensitive to acetylsalicylic acid (aspirin) and other non-steroidal anti-inflammatory drugs.

Expiration date.

3 years.

Storage conditions.

in original packing at a temperature not above 25 °C.

out of children's reach.

Packing.

Tablet No. 10 in blisters.

Category of release.

Without prescription.

Producer.

PJSC lubnyfarm.

Location of the producer and address of the venue of its activity.

Ukraine, 37500, Poltava Region, of a lubna, st. of a barvinkov, 16.