Antigrippin Pharmaceutical (Capsules) Instructions for Use

Marketing Authorization Holder

Pharmfirma Sotex, CJSC (Russia)

Manufactured By

PharmVILAR NPO, LLC (Russia)

ATC Code

R05X (Other remedies for the treatment of colds)

Dosage Form

Antigrippin Pharmaceutical

Capsule set (two types): 20 pcs.

Dosage Form, Packaging, and Composition

Capsule set of two types.

Capsules A are hard gelatin capsules, size No. 0, green in color; the capsule contents are a mixture of crystalline and amorphous powder ranging from light yellow to yellow with a greenish tint; the presence of lumps and single inclusions of a darker color is allowed (10 pcs. in a blister pack).

Excipients: calcium stearate – 1 mg, potato starch – 9 mg.

Composition of the hard gelatin capsules: gelatin – 90.723 mg, azorubine colorant (E122) – 0.003 mg, brilliant black colorant (E151) – 0.184 mg, patent blue colorant (E131) or brilliant blue colorant (E133) – 0.315 mg, quinoline yellow colorant (E104) – 2.207 mg, titanium dioxide (E171) – 2.56 mg.

Capsules B are hard gelatin capsules, size No. 0, white in color; the capsule contents are a mixture of powder and granules, white or white with a yellowish tint; the presence of lumps is allowed (10 pcs. in a blister pack).

Excipients: calcium stearate – 3.8 mg, potato starch – 6.2 mg.

Composition of the hard gelatin capsules: gelatin – 91.944 mg, titanium dioxide (E171) – 4.055 mg.

20 pcs.* – blister packs (2) – cardboard packs.

* capsule set: 10 pcs. of green Capsules A in one pack and 10 pcs. of white Capsules B in the second pack.

Clinical-Pharmacological Group

Drug for symptomatic therapy of acute respiratory diseases

Pharmacotherapeutic Group

Drugs used for cough and colds; other drugs used for colds

Pharmacological Action

A combined medicinal product. It has analgesic, antipyretic, anti-inflammatory, anti-allergic, and angioprotective actions.

Acetylsalicylic acid has analgesic, antipyretic, and anti-inflammatory effects; it inhibits platelet aggregation.

Metamizole sodium has analgesic, antipyretic, and weak anti-inflammatory effects, the mechanism of which is associated with the inhibition of prostaglandin synthesis.

Ascorbic acid (vitamin C) plays an important role in the regulation of redox processes, carbohydrate metabolism, blood clotting, tissue regeneration, and helps to increase the body’s resistance.

Diphenhydramine has anti-allergic and anti-edema effects. It reduces vascular permeability, eliminates swelling and hyperemia of the nasal mucosa, and reduces throat irritation and manifestations of allergic reactions from the upper respiratory tract.

Calcium gluconate is a regulator of calcium and phosphorus metabolism, reduces vascular permeability. In allergic diseases or conditions, its combined use with antihistamines is recommended.

Rutoside (rutin) is an angioprotector. It reduces capillary permeability, reduces swelling and inflammation, and strengthens the vascular wall. It inhibits aggregation and increases the degree of erythrocyte deformation.

Indications

Symptomatic treatment of influenza, acute respiratory viral infections (ARVI), common cold in adults and adolescents over 15 years of age.

ICD codes

Dosage Regimen

Take the two different capsule types separately and together as a single dose.

Administer the medication 2 to 3 times per day strictly after meals to minimize gastrointestinal irritation.

Swallow the capsules whole with a sufficient amount of water; do not chew or crush.

The standard treatment duration is 3 to 5 days.

Discontinue use upon the disappearance of influenza or cold symptoms (fever, headache, muscle aches).

Do not exceed the maximum daily dosage or extend the treatment course beyond 5 days without medical supervision.

If symptoms persist after 3 days of therapy, consult a physician for re-evaluation.

This regimen is indicated for adults and adolescents over 15 years of age only.

Adverse Reactions

From the digestive system: anorexia, nausea, vomiting, epigastric pain, diarrhea, erosive and ulcerative lesions of the gastrointestinal tract, gastrointestinal bleeding, hepatic failure.

From the cardiovascular system: increased blood pressure, tachycardia.

Allergic reactions: skin rash, angioedema, bronchospasm (in individuals prone to bronchospasm, an attack may be provoked).

Other: renal failure.

Side effects noted with long-term use of the drug (more than 7 days)

From the hematopoietic system: thrombocytopenia, agranulocytosis, leukopenia.

From the central nervous system: dizziness, headache.

From the sensory organs: visual disturbances, tinnitus, deafness.

From the blood coagulation system: decreased platelet aggregation, hypocoagulation, hemorrhagic syndrome (including nosebleeds, gum bleeding, purpura).

Allergic reactions: anaphylactic shock, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome).

From the urinary system: kidney damage with papillary necrosis, impaired renal function, oliguria, anuria, proteinuria, interstitial nephritis, red coloration of urine due to the excretion of a metabolite.

Other: in children – Reye’s syndrome (hyperpyrexia, metabolic acidosis, disorders of the nervous system and psyche, vomiting, impaired liver function).

The patient should be warned that all side effects, including those not listed above, should be reported to the attending physician and the drug should be discontinued.

Contraindications

Erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase); gastrointestinal bleeding; increased tendency to bleeding; bronchial asthma and diseases accompanied by bronchospasm (including “aspirin” asthma); bone marrow depression (agranulocytosis, neutropenia, leukopenia); hemorrhagic diatheses (hemophilia, von Willebrand disease, telangiectasia, hypoprothrombinemia, thrombocytopenia, thrombocytopenic purpura); vitamin K deficiency; severe liver dysfunction; portal hypertension; severe renal dysfunction; hereditary hemolytic anemia (including associated with glucose-6-phosphate dehydrogenase deficiency); dissecting aortic aneurysm; hypercalcemia (the concentration of calcium ions should not exceed 12 mg% or 6 mEq/l); hypercalciuria; nephrolithiasis (calcium); sarcoidosis; glycoside intoxication (risk of arrhythmia); glucose-6-phosphate dehydrogenase deficiency; pregnancy; lactation (breastfeeding); children and adolescents under 15 years of age; hypersensitivity to the components of the medicinal product.

With caution

Hyperuricemia, urate nephrolithiasis, gout, gastric and duodenal ulcer (in history), decompensated heart failure.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Contraindicated in severe liver dysfunction and portal hypertension.

Use in Renal Impairment

Contraindicated in severe renal dysfunction.

Pediatric Use

The drug is contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

With prolonged use, monitoring of the peripheral blood picture and laboratory parameters of the functional state of the liver is necessary.

Since Acetylsalicylic acid has an antiplatelet effect, a patient scheduled for surgery should inform the doctor in advance about taking the drug.

Acetylsalicylic acid in low doses reduces the excretion of uric acid, which in some cases may provoke a gout attack.

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

In patients with bronchial asthma and hay fever, hypersensitivity reactions may develop when taking the drug.

Due to the stimulating effect of ascorbic acid on the synthesis of corticosteroid hormones, it is necessary to monitor renal function and blood pressure.

It is not recommended to prescribe the drug with anticoagulants, glucocorticosteroids (GCS), ticlopidine, uricosuric and antihypertensive agents.

Ascorbic acid may distort the results of various laboratory tests (determination of glucose content, bilirubin and activity of liver transaminases, LDH in blood plasma).

Radiocontrast agents, colloidal blood substitutes, and penicillin should not be used during the use of metamizole sodium.

During the use of the drug, patients should avoid alcohol consumption due to an increased risk of gastrointestinal bleeding.

Use in pediatrics

Not used in children under 15 years of age with acute respiratory viral diseases due to the risk of developing Reye’s syndrome (encephalopathy and acute fatty liver degeneration with acute development of liver failure).

Effect on ability to drive vehicles and machinery

During the treatment period, one should refrain from engaging in potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Drug Interactions

With simultaneous use, it enhances the effect of heparin, indirect anticoagulants, reserpine, glucocorticosteroids (GCS), and hypoglycemic agents.

With simultaneous use, it reduces the effectiveness of spironolactone, furosemide, antihypertensive and uricosuric agents.

Enhances the adverse reactions of glucocorticosteroids (GCS), sulfonylurea derivatives, methotrexate, non-narcotic analgesics, and NSAIDs.

With simultaneous use with barbiturates, antiepileptic drugs, zidovudine, rifampicin, and ethanol-containing drugs, the risk of hepatotoxic effects increases. These combinations should be avoided.

Ascorbic acid improves the absorption of iron preparations in the intestine.

Tricyclic antidepressants, oral contraceptives, and allopurinol disrupt the metabolism of metamizole in the liver and increase its toxicity.

Simultaneous use of metamizole sodium with cyclosporine reduces the plasma level of the latter.

Sedatives and tranquilizers enhance the analgesic effect of metamizole sodium.

With simultaneous use with metamizole sodium, thiamazole and melphalan increase the risk of leukopenia.

Metamizole sodium enhances the effects of alcoholic beverages.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.