Universal reference book for medicines
Name of the preparation: PARACETAMOL-S-CHEMOPHARM (PARACETAMOL-C-HEMOFARM)

Active substance: ascorbic acid, paracetamol

Type: Analgesic-antipyretic

Manufacturer: HEMOFARM (Serbia)
Composition, form of production and packaging
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The tablets are effervescent from white to white with a yellowish hue of color, round, flat-cylindrical, with a bevel on both sides.
1 tab.

paracetamol 330 mg

ascorbic acid 200 mg

Excipients: sodium bicarbonate, sodium carbonate, citric acid, lactose monohydrate, docusate sodium, sodium saccharinate, sodium benzoate, povidone.

10 pieces.
- Plastic tubes (1) - packs of cardboard.
10 pieces.
- Plastic tubes (2) - packs cardboard.
20 pcs.
- Plastic tubes (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

Paracetamol-C-Hemofarm is a combination of paracetamol and ascorbic acid (vitamin C).

Paracetamol is an analgetic non-narcotic remedy, the mechanism of action is associated with inhibition of prostaglandin synthesis and a predominant effect on the thermoregulatory center in the hypothalamus.

Ascorbic acid (vitamin C) plays an important role in regulating redox processes, carbohydrate metabolism, blood coagulation, tissue regeneration;
participates in the synthesis of glucocorticosteroids, collagen and procollagen; normalizes the permeability of capillaries. Especially important is the ability to increase the resistance of the body, which is probably due to the anti-oxidant property of ascorbic acid and the stimulation of the immune system.
PHARMACOKINETICS

Paracetamol - characterized by high absorption, T max - 0.5-2 h;
With 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 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. The isozyme CYP2E1 also participates in the metabolism of the drug. T 1/2 - 1-4 hours. 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 T 1/2 increases.
Ascorbic acid is absorbed in the digestive tract, 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 the stomach and duodenum, constipation or diarrhea, helminthic invasion, giardiasis), the use of fresh fruit and vegetable juices, alkaline drink reduce the absorption of ascorbate in the intestine.
The concentration of ascorbic acid in the plasma is normally around 10-20 μg / ml, the reserves in the body are about 1.5 g with daily recommended doses and 2.5 g with 200 mg / day T max after ingestion - 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, intestinal wall, 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.

With 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 elevated body temperature in case of infectious and inflammatory diseases (including colds) and influenza.

DOSING MODE

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 / day. The maximum daily dose of paracetamol is 4 g (12 effervescent tablets).
Children of primary school age (6-9 years), the drug is prescribed to 1/2 tab.
1-3 times / day. The maximum single dose is 1 tablet, the maximum daily dose is 3 tablets.
For children 9-12 years - 1 tab.
1-3 times / day. The maximum single dose is 2 tablets, the maximum daily dose is 6 tablets.
The interval between doses 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 EFFECT

Allergic reactions: skin rash, itching, urticaria, angioedema.

From the digestive system: nausea, epigastric pain.

On the part of the hematopoiesis system: 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 decrease in blood pressure, dyspnea.

Long-term use of large doses of vitamin C can lead to the formation of oxalate stones in the kidneys.

CONTRAINDICATIONS

- bronchial obstruction;

- rhinitis;

- urticaria, provoked by the use of acetylsalicylic acid or other NSAIDs (including in the anamnesis);

- severe renal failure (creatinine clearance (CK) less than 30 ml / min);

- Acute liver disease or severe hepatic insufficiency in the exacerbation phase;

- condition after aortocoronary shunting, confirmed hyperkalemia;

- gastrointestinal hemorrhage;

- 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);

- lactation period;

- deficiency of glucose-6-phosphate dehydrogenase;

- children's age till 6 years;

- Hypersensitivity to the components of the drug.

With caution: erosive-ulcerative lesions of the gastrointestinal tract (in the anamnesis), the 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); IHD, chronic heart failure; cerebrovascular diseases; 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 NSAIDs, simultaneous administration oral GKSv (including prednisolone), anticoagulants (including warfarin), antiaggregants (including acetylsalicylic acid, clopidogrel), selective inhibitors of reverse capture and serotonin (including citalopram, fluoxetine, paroxetine, sertraline), smoking, alcoholism, old age.
PREGNANCY AND LACTATION

Contraindicated in pregnancy (I and III trimesters) and during lactation.

APPLICATION FOR FUNCTIONS OF THE LIVER

With renal failure, the daily dose is reduced by reducing the single dose and / or the frequency of reception.

With caution: renal failure (creatinine clearance (CC) more than 30 ml / min, but less than 60 ml / min).

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With liver failure, the daily dose is reduced by reducing the single dose and / or the frequency of administration.

With caution: liver failure of mild to moderate severity.

APPLICATION FOR CHILDREN

Children of primary school age (6-9 years), the drug is prescribed to 1/2 tab.
1-3 times / day. The maximum single dose is 1 tablet, the maximum daily dose is 3 tablets.
For children 9-12 years - 1 tab.
1-3 times / day. The maximum single dose is 2 tablets, the maximum daily dose is 6 tablets.
The interval between doses should be at least 4 hours. The maximum duration of treatment for children is 3 days.

Contraindicated:

- Children under 6 years.

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 intake of alcoholic beverages, and should also be taken to persons 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.

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 hepatic 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, reception of activated carbon, administration of SH-group donors and glutathione-methionine synthesis precursors - 8-9 hours after 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.

DRUG INTERACTION

Stimulants of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, gricyclic 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 begins 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.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

Keep out of the reach of children, dry, protected from light, at a temperature of 15 ° to 25 ° C.
Shelf life - 2 years.
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