Antigrippin-ORVI (Capsules) Instructions for Use

Marketing Authorization Holder

Antiviral NPO, CJSC (Russia)

Manufactured By

Valenta Pharm, JSC (Russia)

ATC Code

R05X (Other remedies for the treatment of colds)

Dosage Form

Antigrippin-ORVI

Capsules (combined packaging with two types of capsules), including: caps. A yellow: 10 pcs.; caps. B white: 10 pcs.

Dosage Form, Packaging, and Composition

Combined packaging (contains 1 blister with capsules A and 1 blister with capsules B).

Capsules A yellow (10 pcs. in a blister).

Capsules B white (10 pcs. in a blister).

10 pcs. – blisters (2) – carton packs.

Clinical-Pharmacological Group

Drug for symptomatic therapy of acute respiratory diseases

Pharmacotherapeutic Group

ARI and “common cold” symptoms relieving agent

Pharmacological Action

A combined drug. The action is due to the components that make up the drug.

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

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

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

Diphenhydramine (dimedrol) has antiallergic, anti-edema, and local anesthetic effects (reduces vascular permeability, eliminates swelling and hyperemia of the nasal mucosa, sore throat, allergic reactions from the upper respiratory tract).

Calcium gluconate is a regulator of calcium and phosphorus metabolism, has an antiallergic effect (mechanism is unclear), and reduces vascular permeability. For the treatment of allergic diseases or complications, its combined use with antihistamines is recommended.

Indications

• Symptomatic treatment in adults and children over 15 years of age for “common colds”, influenza, acute respiratory viral infections (ARVI).

ICD codes

Dosage Regimen

Take orally, after meals, with a sufficient amount of water.

For adults and children over 15 years of age, take two capsules per single dose: one yellow capsule (from blister A) and one white capsule (from blister B).

Administer the drug 2 to 3 times per day.

The typical treatment duration is 3 to 5 days, or until the symptoms of the disease resolve.

Do not exceed the recommended daily dosage or duration of treatment.

If there is no improvement in well-being after starting treatment, discontinue use and consult a physician.

Monitor for signs of adverse reactions, especially with prolonged use beyond one week.

Inform your physician prior to any scheduled surgery about taking this medication due to its antiplatelet effects.

Refrain from consuming alcoholic beverages during treatment to avoid an increased risk of gastrointestinal bleeding.

Avoid activities requiring increased concentration and rapid psychomotor reactions while using this drug.

Adverse Reactions

Anorexia, nausea, vomiting, gastralgia, diarrhea, erosive and ulcerative lesions of the gastrointestinal tract, gastrointestinal bleeding, hepatic and/or renal failure, increased blood pressure, tachycardia. Allergic reactions: skin rash, angioedema, bronchospasm. With long-term use (more than 7 days) – dizziness, headache, visual disturbances, tinnitus, leukopenia, thrombocytopenia, agranulocytosis; in patients prone to bronchospasm, an attack may be provoked; decreased platelet aggregation, hypocoagulation, hemorrhagic syndrome (nosebleed, bleeding gums, purpura, etc.), kidney damage with papillary necrosis; deafness; anaphylactic shock, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), Reye’s syndrome in children (hyperpyrexia, metabolic acidosis, disorders of the nervous system and psyche, vomiting, impaired liver function). Impaired renal function, oliguria, anuria, proteinuria, interstitial nephritis, red staining of urine due to the excretion of a metabolite are possible.

All side (unusual) effects, including those not listed above, should be reported to the attending physician and the drug should be discontinued.

Contraindications

• Erosive and ulcerative lesions (in the acute phase) of the gastrointestinal tract;
• Gastrointestinal bleeding;
• Increased tendency to bleeding;
• Bronchial asthma, diseases accompanied by bronchospasm, “aspirin asthma”;
• Inhibition of hematopoiesis (agranulocytosis, neutropenia, leukopenia);
• Severe impairment of liver or kidney function;
• Hereditary hemolytic anemia associated with glucose-6-phosphate dehydrogenase deficiency;
• Hemorrhagic diatheses (hemophilia, von Willebrand disease, telangiectasia, hypoprothrombinemia, thrombocytopenia, thrombocytopenic purpura);
• Dissecting aortic aneurysm;
• Portal hypertension;
• Hypercalcemia (the concentration of calcium ions should not exceed 12 mg% or 6 mEq/l);
• Hypercalciuria;
• Nephrolithiasis (calcium);
• Sarcoidosis;
• Intoxication with cardiac glycosides (risk of arrhythmia);
• Vitamin K deficiency;
• Glucose-6-phosphate dehydrogenase deficiency;
• Pregnancy and breastfeeding period;
• Children under 15 years of age;
• Hypersensitivity to the components of the drug.

With caution – hyperuricemia, urate nephrolithiasis, gout, gastric and/or duodenal ulcer (in history), decompensated heart failure.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Acetylsalicylic acid has a teratogenic effect: when used in the first trimester of pregnancy, it leads to a developmental defect – cleft palate; in the third trimester – inhibition of labor (inhibition of prostaglandin synthesis), closure of the arterial duct in the fetus, which causes hyperplasia of the pulmonary vessels and hypertension in the vessels of the pulmonary circulation. Acetylsalicylic acid is excreted in breast milk, which increases the risk of bleeding in the child due to impaired platelet function.

Use in Hepatic Impairment

Contraindicated in severe liver dysfunction.

Use in Renal Impairment

Contraindicated in severe renal impairment. With caution – urate nephrolithiasis.

Pediatric Use

Contraindicated in children under 15 years of age.

Special Precautions

The drug is not prescribed as an antipyretic for children under 15 years of age with acute respiratory diseases caused by viral infections due to the danger of developing Reye’s syndrome (encephalopathy and acute fatty liver degeneration with acute development of liver failure).

With prolonged use of the drug, monitoring of peripheral blood and the functional state of the liver is necessary. Since Acetylsalicylic acid has an antiplatelet effect, the patient, if he is to undergo surgery, should inform the doctor in advance about taking the drug. Acetylsalicylic acid in low doses reduces the excretion of uric acid. This may in some cases provoke an attack of gout.

During treatment, one should refrain from consuming alcoholic beverages (increased risk of gastrointestinal bleeding).

Acetylsalicylic acid has a teratogenic effect: when used in the first trimester of pregnancy, it leads to a developmental defect – cleft palate; in the third trimester – inhibition of labor (inhibition of prostaglandin synthesis), closure of the arterial duct in the fetus, which causes hyperplasia of the pulmonary vessels and hypertension in the vessels of the pulmonary circulation. Acetylsalicylic acid is excreted in breast milk, which increases the risk of bleeding in the child due to impaired platelet function.

Due to the stimulating effect of ascorbic acid on the synthesis of corticosteroid hormones, it is necessary to monitor kidney function and blood pressure. The appointment of ascorbic acid to patients with rapidly proliferating and intensively metastasizing tumors may exacerbate the course of the process. Ascorbic acid, as a reducing agent, can distort the results of various laboratory tests (blood glucose content, bilirubin, activity of “liver” transaminases, LDH).

In patients suffering from bronchial asthma and hay fever, the development of hypersensitivity reactions is possible.

During the use of the drug, one should refrain from active activities that require concentration of attention and increased speed of psychomotor reactions.

Overdose

Symptoms nausea, vomiting, stomach pain, sweating, pale skin, tachycardia. In mild intoxications – ringing in the ears; severe intoxication – drowsiness, collapse, convulsions, bronchospasm, difficulty breathing, anuria, bleeding, progressive respiratory paralysis and uncoupling of oxidative phosphorylation causing respiratory acidosis. If poisoning is suspected, it is necessary to immediately seek medical help.

Treatment induce vomiting, perform gastric lavage, take saline laxatives, activated charcoal. In a medical institution – forced diuresis, hemodialysis, with the development of a convulsive syndrome – intravenous administration of diazepam and barbiturates.

Drug Interactions

If it is necessary to take it concomitantly with other medicines, consult a doctor in advance.

It enhances the effect of heparin, oral anticoagulants, reserpine, steroid hormones, and hypoglycemic agents. It reduces the effectiveness of spironolactone, furosemide, antihypertensive drugs, anti-gout agents that promote the excretion of uric acid.

It enhances the side effects of glucocorticosteroids, sulfonylurea derivatives, methotrexate, non-narcotic analgesics and non-steroidal anti-inflammatory drugs.

The combination of the drug with barbiturates, antiepileptic drugs, zidovudine, rifampicin and alcoholic beverages should be avoided (the risk of hepatotoxic effect increases).

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. Metamizole enhances the effects of alcoholic beverages.

Radiocontrast agents, colloidal blood substitutes and penicillin should not be used during treatment with metamizole.

Simultaneous use of metamizole with cyclosporine reduces the level of the latter in the blood. Thiamazole and sarcolysin increase the risk of leukopenia.

Sedatives and tranquilizers enhance the analgesic effect of metamizole.

Storage Conditions

In a dry, light-protected place, out of the reach of children, at a temperature of 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

By 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.