Paracetamol-Hemofarm - instructions for use, dose, side effects, contraindications

Excipients: citric acid, anhydrous - 900.00 mg, sodium sulfate, anhydrous - 500.0 mg, lactose monohydrate - 251.30 mg, sodium hydrogen carbonate - 835.0 mg, povidone To 25 - 20.00 mg, silicone emulsion SE 4 (simethicone - 30%, methylcellulose 2.5%, sorbic acid 0.1%, purified water 67.4% **) 0.70 mg, sodium saccharinate 8.00 mg, flavoring lemon - 10,00 mg, macrogol 6000 - 75,00 mg.

** - removed during production

Description:

Round tablets of flat-cylindrical shape with a facet on both sides, from white to white with a yellowish hue of color.

Pharmacotherapeutic group:analgesic non-narcotic remedy

ATX: & nbsp

N.02.B.E Anilides

N.02.B.E.01 Paracetamol

Pharmacodynamics:

Paracetamol is an analgesic non-narcotic agent, the mechanism of action is associated with inhibition of prostaglandin synthesis and a predominant effect on the thermoregulatory center in the hypothalamus. It blocks cyclooxygenase 1 and 2 mainly in the central nervous system. In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on cyclooxygenase, which explains the almost complete absence of anti-inflammatory effect. The absence of a blocking effect 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.

Pharmacokinetics:

Paracetamol is characterized by high absorption, the time to reach the maximum concentration (TCmax) after 0.5-2 h; the maximum concentration (Cmax) is 5-20 μg / ml. Relationship with plasma proteins -15%. Penetrates through the blood-brain barrier. Less than 1% of the dose of paracetamol taken by the lactating mother penetrates into breast milk. The therapeutically effective concentration of paracetamol in plasma is achieved when it is administered at a dose of 10-15 mg / kg.

Metabolised in the liver (90-95%): 80% enters the conjugation reaction with glucuronic acid and sulfates with the formation of inactive metabolites; 17% undergoes hydroxylation with the formation of 8 active metabolites, which are conjugated with glutathione with the formation of already inactive metabolites. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. In the metabolism of the drug is also involved isoenzyme CYP2E1. The half-life (T1 / 2) is 1-4 hours. It is excreted by the kidneys in the form of metabolites, mainly conjugates, only 3% in unchanged form. In elderly patients, the clearance of the drug decreases and T1 / 2 increases.

Indications:

Pain syndrome of mild or moderate intensity (arthralgia, myalgia, neuralgia, dental and headache, algodismenorea).

To reduce the elevated body temperature in infectious and inflammatory diseases.

Contraindications:

Hypersensitivity to the components of the drug;

Renal and hepatic impairment;

Pregnancy (I and III trimester) and lactation;

Lactose intolerance;

Deficiency of lactase;

Glucose-galactose malabsorption;

Children under 12 years.

Carefully:

Benign hyperbilirubinemia (including Gilbert syndrome), kidney disease, liver (including alcoholic liver damage), viral hepatitis, alcoholism, pregnancy (II period), advanced age.

During therapy with Paracetamol-Hemofarm, do not use other medicines containing paracetamol.

Dosing and Administration:

The effervescent tablet of Paracetamol-Hemofarm completely dissolve in a glass of water, and the resulting solution is immediately drunk. It is better to take medicine between meals.

If the doctor is not recommended otherwise, then the following dosages should be observed when using the drug.

Adults: a single dose is from 500 to 1000 mg (1 - 2 effervescent tablets), the drug is taken 3-4 times a day. The maximum daily dose of paracetamol should not exceed 4 g.

Children: dosage by body weight of the baby implies dose 10-15 mg / kg of body weight of the child. A convenient dosage regimen is given in the table:

Application of the drug children over the age of 12

Body weight (kg)	Single dose (mg)	The maximum daily dose (g)
up to 40	1 spike. tab. (500 mg)	4 spines. tab. (2 g)
more than 40	1-2 spines. tab.(500-1000 mg)	4-8 spines. tab. (2-4 g)

Acceptance of recommended doses can be repeated every 6-8 hours. The interval between receptions should be at least 4 hours.

The maximum duration of treatment for children is 3 days.

The maximum duration of treatment for adults - no more than 5 days with an appointment as an anesthetic and no more than 3 days - as an antipyretic. After 5 days of treatment, peripheral blood is analyzed.

Side effects:

Allergic reactions: skin rash, itching, urticaria, Quincke's edema; multiforme exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome); nausea, pain in the epigastric region; dizziness, insomnia; anemia, thrombocytopenia, agranulocytosis. With long-term use in large doses - hepatotoxic effect, nephrotoxic effect (renal colic, aseptic pyuria, interstitial nephritis, papillary necrosis), hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia. Very rarely - lowering blood pressure, hypoglycemia, dyspnea, vasculitis.

Overdose:

Symptoms: during the first 24 hours after administration - pallor of the skin, nausea, vomiting, decreased appetite, abdominal pain; disturbance of glucose metabolism, metabolic acidosis. In severe overdose - liver failure with progressive encephalopathy, coma, death; acute renal failure with tubular necrosis (including in the absence of severe liver damage); arrhythmia, pancreatitis. Toxic effect in adults is possible after taking 10 g of paracetamol and more: increased activity of "liver" transaminases, an increase in prothrombin time (12-48 hours after administration); a detailed clinical picture of liver damage manifests itself after 1-6 days. Rarely, liver failure develops at a lightning speed and can be complicated by renal insufficiency (tubular necrosis).

Treatment: gastric lavage, the reception of activated carbon, the introduction of donators SH-groups and precursors of the synthesis of glutathione-methionine-8-9 hours after overdose and acetylcysteine-after 12 hours. The need for additional therapeutic measures (further introduction of methionine, intravenous administration acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration.

Interaction:

Reduces the effectiveness of uricosuric medicines (LS). The concomitant use of paracetamol in high doses increases the effect of anticoagulant drugs (a decrease in the synthesis of procoagulant factors in the liver). Inductors of microsomal oxidation in the liver (phenytoin, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), ethanol and hepatotoxic drugs increase the production of hydroxylated active metabolites, which allows the development of severe intoxication even with a slight overdose.

Long-term use of barbiturates reduces the effectiveness of paracetamol. Ethanol promotes the development of acute pancreatitis. Inhibitors of microsomal oxidation (incl. cimetidine) reduce the risk of hepatotoxic effects. Long-term combined use of paracetamol and non-steroidal anti-inflammatory drugs increases the risk of developing "analgesic" nephropathy and renal papillary necrosis, the onset of the terminal stage of renal failure.Simultaneous long-term administration of paracetamol in high doses and salicylates increases the risk of developing kidney or bladder cancer. Diflunisal increases the plasma concentration of paracetamol by 50% - the risk of developing hepatotoxicity.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Special instructions:

Simultaneous use with other medicines should be agreed with the doctor.

After 5 days of using the drug, control of the picture of peripheral blood and the functional state of the liver is necessary.

Distorts the indicators of laboratory studies in the quantitative determination of glucose and uric acid in plasma. To avoid toxic damage to the liver paracetamol should not be combined with the reception of drinks containing alcohol, and also to people who are prone to chronic alcohol consumption.

There is evidence that frequent use of drugs containing paracetamol, leads to a weighting of the symptoms of bronchial asthma.

Form release / dosage:

Tablets effervescent 500 mg.

Packaging:

For 10 or 20 tablets of effervescent in a plastic tube, ukuporennuyu plastic cover with silica gel and control the first opening.For 1 or 2 tubes together with instructions for use in a pack of cardboard.

Storage conditions:

Store in a dry place at a temperature of 15 to 25 ° C.

Keep out of the reach of children!

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N015337 / 01

Date of registration:09.04.2010

The owner of the registration certificate:Hemofarm ADHemofarm AD Serbia

Manufacturer: & nbsp

HEMOFARM, A.D. Serbia

Representation: & nbspHEMOFARM A.D. HEMOFARM A.D. Serbia

Information update date: & nbsp04.10.2015

Illustrated instructions

Instructions

Paracetamol-Hemofarm (Paracetamol-Hemofarm)