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

Composition:1 effervescent tablet contains active ingredients: paracetamol -330 mg, ascorbic acid - 200 mg; auxiliary substances: sodium bicarbonate, sodium carbonate, citric acid, lactose monohydrate, docusate sodium, sodium saccharinate, sodium benzoate, povidone.

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 combined (analgesic non-narcotic remedy + vitamin).

ATX: & nbsp

N.02.B.E Anilides

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

Pharmacodynamics:Paracetamol-C-Hemofarm is a combination of paracetamol and ascorbic acid (vitamin C).
Paracetamol - an analgetic non-narcotic remedy, the mechanism of action is associated with inhibition of prostaglandin synthesis and a predominant influence on the thermoregulatory center in the hypothalamus.
Ascorbic acid (vitamin C) plays an important role in the regulation of oxidation-reduction processes, carbohydrate metabolism, blood coagulation, tissue regeneration; participates in the synthesis of glucocorticosteroids, collagen and procollagen; normalizes the permeability of capillaries. Particularly important is the ability to increase the body's resistance, which is probably due to the antioxidant properties of ascorbic acid and the stimulation of the immune system.

Pharmacokinetics:Paracetamol - characterized by high absorption, time to reach the maximum concentration (TC_max) in 0.5-2 hours; maximum concentration (C_max) -5-20 μg / ml. Connection 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 glu-choronic 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. The isozyme CYP2E1 also participates in the metabolism of the drug. T1 / 2 1-4 h. It is excreted by the kidneys in the form of metabolites, mainly conjugates, only 3% unchanged. In elderly patients, the clearance of the drug decreases and the half-life (T1 / 2) increases. Ascorbic acid absorbed in the gastrointestinal tract (GIT) - mainly in the jejunum. With an increase in the dose up to 200 mg, up to 140 mg (70%) is absorbed; with a further increase in the dose, the absorption decreases (50-20%). Connection with plasma proteins - 25%. Diseases of the gastrointestinal tract (peptic ulcer of stomach and duodenum, constipation or diarrhea, helminthic invasion, giardiasis), the use of fresh fruit and vegetable juices,Alkaline drink reduces the absorption of ascorbate in the intestine.
The concentration of ascorbic acid in the plasma is normally about 10-20 μg / ml, the reserves in the body are about 1.5 g when taking daily recommended doses and 2.5 g when taking 200 mg / day. the time to reach the maximum concentration after ingestion for 4 hours.
Easily penetrates into leukocytes, platelets, and then into all tissues; the greatest concentration is achieved in glandular organs, leukocytes, liver and lens of the eye; deposited in the posterior lobe of the pituitary gland, adrenal cortex, ocular epithelium, interstitial cells of the seminal glands, ovaries, liver, spleen, pancreas, lungs, kidneys, wall of the intestine, heart, muscles, thyroid gland; penetrates the placenta. The concentration of ascorbic acid in leukocytes and platelets is higher than in erythrocytes and in plasma. With deficient states, the concentration in leukocytes decreases later and more slowly and is considered as the best criterion for assessing the deficit than the concentration in the plasma. Metabolised mainly in the liver in desoxyascorbic and then in oxaloacetic and diketogulonovoy acid.
It is excreted by the kidneys, through the intestines, with sweat, breast milk in the form of unchanged ascorbate and metabolites.
At the appointment of high doses, the rate of excretion increases sharply. Smoking and the use of ethanol accelerate the destruction of ascorbic acid (conversion into inactive metabolites), sharply reducing the reserves in the body.
It is in hemodialysis.

Indications:Pain syndrome of mild or moderate intensity (headache, neuralgia, myalgia, arthralgia, algodismenorea, toothache).
To reduce the elevated body temperature with infectious inflammatory diseases (including "colds") and the flu.

Contraindications:Hypersensitivity to the components of the drug; bronhoobstruktsiya, rhinitis, urticaria, provoked by the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including in the anamnesis); severe renal insufficiency (creatinine clearance less than 30 ml / min), acute liver disease or severe hepatic insufficiency in the exacerbation phase, condition after aortocoronary bypass surgery; confirmed hyperkalemia; gastrointestinal bleeding, inflammatory bowel disease,erosive and ulcerative changes in the mucous membrane of the stomach and duodenum in the phase of exacerbation; portal hypertension; pregnancy (I and III trimesters) and lactation; deficiency of glucose-6-phosphate dehydrogenase, children under 6 years.

Carefully:Erosive-ulcerative lesions of the gastrointestinal tract (in the anamnesis), presence of Helicobacter pylori; hepatic insufficiency of mild and moderate severity, renal insufficiency (creatinine clearance (CK) more than 30 ml / min, but less than 60 ml / min); ischemic heart disease (CHD), chronic heart failure (CHS), cerebrovascular disease; blood diseases (thrombocytopenia, leukopenia, agranulocytosis), constitutional hyperbilirubinemia (Gilbert syndrome), congenital hyperbilirubinemia (Dubin-Johnson syndrome and Rotor syndrome), dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial diseases, severe somatic diseases. Prolonged use of non-steroidal anti-inflammatory drugs, simultaneous administration of oral glucocorticosteroids (incl. prednisolone), anticoagulants (incl. warfarin), antiplatelet agents (incl. acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (incl. citalopram, fluoxetine, paroxetine, sertraline), smoking, alcoholism, old age.

Dosing and Administration:The effervescent tablet of the drug Paracetamol-S-Hemofarm is completely dissolved in a glass of water, and the resulting solution is immediately drunk. It is better to take medicine between meals.
If the doctor does not give other instructions, then when using the drug, the following dosages should be observed.
Adults and adolescents over 14 years of age are prescribed 1-2 tablets 1-3 times a day. The maximum daily dose of paracetamol is 4 g (12 effervescent tablets).
For children of primary school age (6-9 years), the drug is prescribed by 1/2 tablet 1-3 times a day. The maximum single dose is 1 tablet, the maximum daily dose is 3 tablets. For children 9-12 years old, 1 tablet 1-3 times a day. The maximum single dose is 2 tablets, the maximum daily dose is 6 tablets.
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.
With renal and / or liver failure, the daily dose is reduced by reducing the single dose and / or the frequency of reception.

Side effects:Allergic reactions - skin rash, itching, urticaria, Quincke's edema; nausea, epigastric pain; anemia, thrombocytopenia, agranulocytosis. With prolonged use in large doses - hepatotoxic effect, irritation of the mucous membrane of the gastrointestinal tract, nephrotoxic effect (renal colic, glucosuria, aseptic pyuria, interstitial nephritis, papillary necrosis), hyperprothrombinemia, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia. Very rarely there is a drop in blood pressure, dyspnea.
Long-term use of large doses of vitamin C can lead to the formation of oxalate stones in the kidneys.

Overdose:Symptoms (due to paracetamol): pallor of the skin, decreased appetite, nausea, vomiting; hepatonecrosis (the severity of necrosis due to intoxication directly depends on the degree of overdose). Toxic effect in adults is possible after taking more than 10-15 g of paracetamol: increased activity of "liver" transaminases,increased 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, administration of activated carbon, administration of SH-group donors and glutathione-methionine synthesis precursors - 8-9 hours after an overdose and N-acetylcysteine, after 12 hours.
The need for additional therapeutic measures (further introduction of methionine, intravenous injection of N-acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration.

Interaction:Stimulants of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants, estrogen-containing contraceptives) increase the production of hydroxylated active metabolites, which allows the development of severe intoxication with small overdoses. Ethanol promotes the development of acute pancreatitis. Inhibitors of microsomal oxidation (cimetidine) reduce the risk of hepatotoxic effects. Reduces the effectiveness of uricosuric drugs. Strengthens the effect of drugs that depress the central nervous system, ethanol. When slowing down the emptying of the stomach (propantheline bromide), a delayed onset of paracetamol action may occur. When accelerating the emptying of the stomach (metoclopramide) the drug starts to act faster. The toxicity of chloramphenicol is enhanced. Be careful with prolonged use of paracetamol and simultaneous therapy with oral medications that inhibit blood clotting.

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.
To avoid toxic damage to the liver paracetamol should not be combined with the reception of alcoholic beverages, but also to people prone to chronic alcohol consumption.
There is evidence that frequent use of drugs containing paracetamol, leads to a worsening of the symptoms of bronchial asthma.

Form release / dosage:The tablets are effervescent.

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

Storage conditions:Store in a dry, dark place at a temperature of 15 to 25 ° C. Keep out of the reach of children.

Shelf life:2 years.
Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N015050 / 01

Date of registration:10.09.2008

Expiration Date:Unlimited

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: & nbsp2016-12-15

Illustrated instructions

Instructions

Paracetamol-S-Hemofarm (Paracetamol-C-Hemofarm)