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Antigrippin (Tablets, Powder) Instructions for Use

ATC Code

N02BE51 (Paracetamol in combination with other drugs, excluding psycholeptics)

Active Substances

Ascorbic acid (Rec.INN registered by WHO)

Paracetamol (Rec.INN registered by WHO)

Chlorphenamine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug for symptomatic therapy of acute respiratory diseases

Pharmacotherapeutic Group

Remedy for the relief of symptoms of acute respiratory infections and the "common cold" (non-narcotic analgesic agent + H1-histamine receptor blocker + vitamin)

Pharmacological Action

A combined drug.

Paracetamol has analgesic and antipyretic effects; it relieves headache and other types of pain, and reduces elevated temperature.

Chlorphenamine is a blocker of histamine H1 receptors, has an antiallergic effect, facilitates nasal breathing, reduces the feeling of nasal congestion, sneezing, lacrimation, itching and redness of the eyes.

Ascorbic acid (vitamin C) is involved in the regulation of redox processes, carbohydrate metabolism, and increases the body’s resistance.

Indications

  • Infectious and inflammatory diseases (ARVI, influenza), accompanied by elevated temperature, chills, headache, pain in the joints and muscles, nasal congestion, and pain in the throat and nasal sinuses.

ICD codes

ICD-10 code Indication
J00 Acute nasopharyngitis (common cold)
J01 Acute sinusitis
J06.9 Acute upper respiratory infection, unspecified
J11 Influenza, virus not identified
M25.5 Pain in joint
M79.1 Myalgia
R07.0 Pain in throat
R50.8 Other specified fever (including fever with chills)
R51 Headache

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Powder

The drug is taken orally. The contents of the sachet should be completely dissolved in a glass (200 ml) of warm water (50-60°C (122-140°F)) and the resulting solution should be drunk immediately. It is better to take the drug between meals.

For adults and children over 15 years of age – 1 sachet 2-3 times/day. The interval between doses of the drug should be at least 4 hours. The maximum daily dose is 3 sachets.

In patients with impaired liver or kidney function and elderly patients, the interval between doses of the drug should be at least 8 hours.

The duration of use of the drug without consulting a doctor is no more than 5 days when prescribed as an analgesic and 3 days as an antipyretic.

Tablets

The drug is taken orally. The tablet should be completely dissolved in a glass (200 ml) of warm water (50-60°C (122-140°F)), and the resulting solution should be drunk immediately. It is better to take the drug between meals. The interval between doses of the drug should be at least 4 hours.

Children aged 3 to 5 years are prescribed 1/2 tablet 2 times/day; children aged 5 to 10 years – 1 tablet 2 times/day; children aged 10 to 15 years – 1 tablet 2-3 times/day.

In patients with impaired liver or kidney function, the interval between doses of the drug should be at least 8 hours.

The duration of use of the drug without consulting a doctor is no more than 5 days when prescribed as an analgesic and 3 days as an antipyretic.

Adverse Reactions

The drug is well tolerated at recommended doses.

From the nervous system in isolated cases – headache, feeling of fatigue.

From the digestive system in isolated cases – nausea, pain in the epigastric region.

From the endocrine system in isolated cases – hypoglycemia (up to the development of coma).

From the hematopoietic system in isolated cases – anemia, hemolytic anemia (especially in patients with glucose-6-phosphate dehydrogenase deficiency); extremely rarely – thrombocytopenia.

Allergic reactions in isolated cases – skin rash, itching, urticaria, angioedema, anaphylactoid reactions (including anaphylactic shock), multiform exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome).

Other in isolated cases – hypervitaminosis C, metabolic disorder, feeling of heat, dry mouth, accommodation paresis, urinary retention, drowsiness.

All side effects of the drug should be reported to the doctor.

Contraindications

  • Hypersensitivity to paracetamol, ascorbic acid, chlorphenamine or any other component of the drug;
  • Erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase);
  • Severe renal and/or hepatic impairment;
  • Alcoholism;
  • Closed-angle glaucoma;
  • Phenylketonuria;
  • Prostatic hyperplasia;
  • Pregnancy;
  • Breastfeeding period;
  • Children under 15 years of age.

With caution renal and/or hepatic impairment, glucose-6-phosphate dehydrogenase deficiency, congenital hyperbilirubinemias (Gilbert’s, Dubin-Johnson and Rotor syndromes), viral hepatitis, alcoholic hepatitis, old age.

Use in Pregnancy and Lactation

The use of the drug is contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

The use of the drug is contraindicated in severe hepatic impairment.

The drug should be used with caution in hepatic impairment.

Use in Renal Impairment

The use of the drug is contraindicated in severe renal impairment.

The drug should be used with caution in renal impairment.

Pediatric Use

The use of the drug is contraindicated in children under 15 years of age.

Geriatric Use

The drug should be used with caution in elderly patients.

Special Precautions

When taking metoclopramide, domperidone or cholestyramine, it is also necessary to consult a doctor.

With long-term use in doses significantly exceeding the recommended ones, the likelihood of impaired liver and kidney function increases; monitoring of the peripheral blood picture is necessary.

Paracetamol and Ascorbic acid may distort laboratory test results (quantitative determination of glucose and uric acid in blood plasma, bilirubin, activity of liver transaminases, LDH).

To avoid toxic liver damage, Paracetamol should not be combined with the intake of alcoholic beverages, and should not be taken by persons prone to chronic alcohol consumption. The risk of liver damage increases in patients with alcoholic hepatosis.

The prescription of ascorbic acid to patients with rapidly proliferating and intensively metastasizing tumors may exacerbate the course of the process.

In patients with increased iron content in the body, ascorbic acid should be used in minimal doses.

One honey-lemon and lemon sachet contains 1.793 g and 1.738 g of sugar, which corresponds to approximately 0.15 XE.

One chamomile and blackcurrant sachet contains 2.058 g and 1.993 g of sugar, which corresponds to approximately 0.17 XE.

Overdose

Symptoms of drug overdose are due to the substances included in its composition. The clinical picture of acute paracetamol intoxication develops within 6-14 hours after its intake. Symptoms of chronic intoxication appear 2-4 days after overdose.

Symptoms of acute paracetamol intoxication diarrhea, loss of appetite, nausea and vomiting, abdominal discomfort and/or abdominal pain, increased sweating.

Symptoms of chlorphenamine intoxication dizziness, agitation, sleep disturbances, depression, convulsions.

Treatment is symptomatic.

Drug Interactions

Ascorbic acid

Increases the concentration of benzylpenicillin and tetracyclines in the blood.

Improves the absorption of iron preparations in the intestine (converts ferric iron to ferrous); may increase iron excretion when used concomitantly with deferoxamine.

Increases the risk of crystalluria during treatment with salicylates and short-acting sulfonamides, slows down the renal excretion of acids, increases the excretion of drugs with an alkaline reaction (including alkaloids), reduces the concentration of oral contraceptives in the blood.

Increases the total clearance of ethanol.

With simultaneous use, it reduces the chronotropic effect of isoprenaline.

May either increase or decrease the effect of anticoagulant drugs.

Reduces the therapeutic effect of antipsychotic drugs (neuroleptics) – phenothiazine derivatives, tubular reabsorption of amphetamine and tricyclic antidepressants.

Simultaneous intake of barbiturates increases the excretion of ascorbic acid in the urine.

Chlorphenamine maleate

Chlorphenamine maleate enhances the effect of hypnotic drugs.

Antidepressants, antiparkinsonian drugs, antipsychotic drugs (phenothiazine derivatives) increase the risk of side effects (urinary retention, dry mouth, constipation).

Glucocorticoids increase the risk of glaucoma.

Ethanol enhances the sedative effect of chlorphenamine maleate.

Paracetamol

When paracetamol interacts with inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), the production of hydroxylated active metabolites increases, which causes the possibility of severe intoxication with small overdoses.

Against the background of paracetamol intake, ethanol contributes to the development of acute pancreatitis.

Inhibitors of microsomal oxidation (including cimetidine) reduce the risk of hepatotoxic action.

Simultaneous intake of diflunisal and paracetamol increases the plasma concentration of the latter by 50%, increasing hepatotoxicity.

Simultaneous intake of barbiturates reduces the effectiveness of paracetamol.

Paracetamol reduces the effectiveness of uricosuric drugs.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years. Do not use after the expiration date.

Dispensing Status

The drug is dispensed without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Bausch Health, LLC (Russia)

Manufactured By

Natur Produkt Pharma, Sp. z o.o. (Poland)

Contact Information

BAUSH HEALTH LLC (Russia)

Dosage Forms

Bottle OTC Icon Antigrippin Powder for oral solution (honey-lemon) 500 mg+10 mg+200 mg/1 sachet: sachet 5 g 3 or 10 pcs.
Powder for oral solution chamomile 500 mg+10 mg+200 mg/5 g: sachet 3 or 10 pcs.
Powder for oral solution (lemon) 500 mg+10 mg+200 mg/1 sachet: sachet 5 g 3 or 10 pcs.

Dosage Form, Packaging, and Composition

Powder for oral solution honey-lemon of varying degrees of granulation, consisting of particles from white to grayish-beige in color, with a characteristic odor; dark brown inclusions are allowed.

1 sachet
Paracetamol 500 mg
Chlorphenamine maleate 10 mg
Ascorbic acid 200 mg

Excipients : sodium bicarbonate, citric acid, sorbitol, povidone K30, sucrose, sodium cyclamate, aspartame, acesulfame potassium, lemon flavor, caramel color, honey flavor.

5 g – sachets (3) – cardboard packs.
5 g – sachets (10) – cardboard packs.

Powder for oral solution chamomile of varying degrees of granulation, consisting of particles from white to beige and light brown in color, with a characteristic odor; brown inclusions are allowed.

1 sachet
Paracetamol 500 mg
Chlorphenamine maleate 10 mg
Ascorbic acid 200 mg

Excipients : sodium bicarbonate, citric acid, sorbitol, povidone K30, sucrose, sodium cyclamate, aspartame, acesulfame potassium, chamomile extract.

5 g – sachets (3) – cardboard packs.
5 g – sachets (10) – cardboard packs.

Powder for oral solution lemon , consisting of granules of different sizes from white to white with a yellowish or brownish tint, without lumps, with a lemon smell.

1 sachet
Paracetamol 500 mg
Chlorphenamine maleate 10 mg
Ascorbic acid 200 mg

Excipients : sodium bicarbonate, citric acid, sorbitol, povidone K30, sucrose, sodium cyclamate, aspartame, acesulfame potassium, lemon flavor.

5 g – sachets (3) – cardboard packs.
5 g – sachets (10) – cardboard packs.

Marketing Authorization Holder

Bausch Health, LLC (Russia)

Manufactured By

Natur Produkt Pharma, Sp. z o.o. (Poland)

Contact Information

BAUSH HEALTH LLC (Russia)

Dosage Form

Bottle OTC Icon Antigrippin Effervescent tablets 500 mg+10 mg+200 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Effervescent tablets round, flat, with a beveled edge and a dividing line on one side, white or almost white, with a barely noticeable marbling, with a fruity smell.

1 tab.
Paracetamol 500 mg
Chlorphenamine maleate 10 mg
Ascorbic acid 200 mg

Excipients : sodium bicarbonate – 826.4 mg, citric acid – 950.4 mg, sorbitol – 700 mg, povidone – 25 mg, sodium saccharin – 30 mg, sodium carbonate – 93 mg, macrogol – 70 mg, sodium lauryl sulfate – 0.2 mg, lime flavor (lime flavor fruit additive) – 95 mg.

10 pcs. – plastic containers (1) – cardboard packs with internal partition.

Marketing Authorization Holder

Bausch Health, LLC (Russia)

Manufactured By

Natur Produkt Pharma, Sp. z o.o. (Poland)

Contact Information

BAUSH HEALTH LLC (Russia)

Dosage Forms

Bottle OTC Icon Antigrippin Effervescent tablets (grapefruit flavor) 500 mg+10 mg+200 mg: 10 pcs.
Effervescent tablets (orange flavor) 500 mg+10 mg+200 mg: 10 pcs.
Effervescent tablets (raspberry flavor) 500 mg+10 mg+200 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Effervescent tablets with raspberry flavor round, flat-cylindrical, with a bevel and a dividing line on one side, pink, pinkish-violet or violet in color, with lighter and darker inclusions, with a specific fruity smell.

1 tab.
Paracetamol 500 mg
Chlorphenamine maleate 10 mg
Ascorbic acid 200 mg

Excipients : sodium bicarbonate, citric acid, sorbitol, povidone K30, sodium saccharin, aspartame, sodium carbonate, macrogol, sodium lauryl sulfate, riboflavin-5-phosphate sodium, raspberry flavor (raspberry flavor fruit additive), taste corrector, red beet juice powder.

10 pcs. – plastic containers (1) – cardboard packs with internal partition.

Effervescent tablets with grapefruit flavor round, flat-cylindrical, with a bevel and a dividing line on one side, white, almost white or white with a brownish tint, with marbling, with a specific citrus smell.

1 tab.
Paracetamol 500 mg
Chlorphenamine maleate 10 mg
Ascorbic acid 200 mg

Excipients : sodium bicarbonate, citric acid, sorbitol, povidone K30, aspartame, sodium carbonate, macrogol, sodium lauryl sulfate, lemon flavor (lemon flavor fruit additive), grapefruit flavor (grapefruit flavor fruit additive), taste corrector.

10 pcs. – plastic containers (1) – cardboard packs with an internal partition.

Orange-flavored effervescent tablets round, flat-cylindrical, with a bevel and a score line on one side, from light orange to orange in color, with marbling, with an orange odor.

1 tab.
Paracetamol 500 mg
Chlorphenamine maleate 10 mg
Ascorbic acid 200 mg

Excipients: sodium bicarbonate, citric acid, sorbitol, povidone K30, sodium saccharin, aspartame, sodium carbonate, macrogol, sodium lauryl sulfate, beta-carotene 1%, orange flavor (aromatic fruit additive “Orange”), taste corrector.

10 pcs. – plastic containers (1) – cardboard packs with an internal partition

Marketing Authorization Holder

Bausch Health, LLC (Russia)

Manufactured By

Natur Produkt Pharma, Sp. z o.o. (Poland)

Contact Information

Bausch Health LLC (Russia)

Dosage Form

Bottle OTC Icon Antigrippin Effervescent tablets for children 250 mg+3 mg+50 mg: 10 or 30 pcs.

Dosage Form, Packaging, and Composition

Effervescent tablets for children round, flat, with a bevel on both sides and a score line on one side, light pink in color with lighter and darker specks, with a slight fruity odor.

1 tab.
Paracetamol 250 mg
Chlorphenamine maleate 3 mg
Ascorbic acid 50 mg

Excipients: sodium bicarbonate, citric acid, sorbitol, povidone, sodium saccharin, sodium carbonate, macrogol, silicon dioxide, fruit flavor (aromatic fruit additive “Red Fruits”).

6 pcs. – aluminum strips (5) – cardboard packs.
10 pcs. – plastic containers (1) – cardboard packs with an internal partition.

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