Antigrippin-ANVI^® (Capsules) Instructions for Use

Marketing Authorization Holder

Rapharma, JSC (Russia)

Manufactured By

ZiO-Health CJSC (Russia)

Or

Pharmproekt, JSC (Russia)

Contact Information

PharmFirma Sotex ZAO (Russia)

ATC Code

R05X (Other remedies for the treatment of colds)

Dosage Form

Antigrippin-ANVI®

Capsules (two types): 20 pcs.

Dosage Form, Packaging, and Composition

Capsules 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 from light yellow to yellow with a greenish tint, lumps are 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, dye azorubine (E122) – 0.003 mg, dye brilliant black (E151) – 0.184 mg, dye patent blue (E131) or dye brilliant blue (E133) – 0.315 mg, dye quinoline yellow (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 powder and/or granules white or white with a yellowish tint, lumps are 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. (10 caps. A green and 10 caps. B white) – blister packs (2) – cardboard packs.

Clinical-Pharmacological Group

Drug for symptomatic therapy of acute respiratory diseases

Pharmacotherapeutic Group

ARI and “common cold” symptoms relieving agent

Pharmacological Action

A drug of combined composition.

Acetylsalicylic acid has analgesic, antipyretic and anti-inflammatory effects; 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.

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.

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

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

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

Pharmacokinetics

Data on the pharmacokinetics of Antigrippin-ANVI^® are not provided.

Indications

• Symptomatic treatment of influenza, acute respiratory viral infections, “common cold” diseases in adults and adolescents over 15 years of age.

ICD codes

Dosage Regimen

The drug is taken orally, after meals, with water, 2-3 times/day for 3-5 days until the symptoms of the disease disappear.

Adults and adolescents over 15 years of age are prescribed 2 capsules per dose: 1 green capsule (from blister A) and 1 white capsule (from blister B).

The patient should be warned that if there is no improvement in well-being, the drug should be discontinued and a doctor should be consulted.

Adverse Reactions

Allergic reactions: skin rash, angioedema, bronchospasm.

From the urinary system: renal failure.

From the cardiovascular system: increased blood pressure, tachycardia.

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

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

From the central nervous system: dizziness, headache.

From the senses: visual disturbances, tinnitus, deafness.

From the hematopoietic system: leukopenia, thrombocytopenia, agranulocytosis.

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

From the respiratory system: in patients prone to bronchospasm, an attack may be provoked.

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

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

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);
• Hematopoiesis depression (agranulocytosis, neutropenia, leukopenia);
• Severe liver dysfunction;
• Severe renal dysfunction;
• Hereditary hemolytic anemia (including 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;
• Lactation period (breastfeeding);
• Childhood and adolescence up to 15 years;
• Hypersensitivity to the components of the drug.

With caution, the drug should be prescribed for hyperuricemia, urate nephrolithiasis, gout, gastric and duodenal ulcer (in history), decompensated heart failure.

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy. Acetylsalicylic acid has a teratogenic effect: when used in the first trimester of pregnancy, it leads to the development of cleft palate; in the third trimester – to premature closure of the arterial duct in the fetus, which causes hyperplasia of the pulmonary vessels and hypertension in the vessels of the pulmonary circulation, and to inhibition of labor (due to inhibition of prostaglandin synthesis).

Acetylsalicylic acid is excreted in breast milk, which increases the risk of bleeding in the child due to impaired platelet function. If it is necessary to prescribe during lactation, breastfeeding should be discontinued for the duration of drug use.

Use in Hepatic Impairment

Contraindicated in severe liver dysfunction and portal hypertension.

Use in Renal Impairment

Contraindicated in severe renal dysfunction, nephrolithiasis (calcium).

With caution, the drug should be prescribed for urate nephrolithiasis.

Pediatric Use

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

Special Precautions

With prolonged use of the drug, 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, 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, which in some cases may provoke an attack of gout.

While using the drug, patients should avoid consuming alcoholic beverages due to the increased risk of gastrointestinal bleeding.

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

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

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

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

Use in pediatrics

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

Effect on the ability to drive vehicles and mechanisms

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

Overdose

Symptoms: nausea, vomiting, stomach pain, sweating, pale skin, tachycardia; with minor overdose – ringing in the ears; with severe overdose – drowsiness, collapse, convulsions, bronchospasm, difficulty breathing, anuria, bleeding, progressive respiratory paralysis and respiratory acidosis (due to uncoupling of oxidative phosphorylation).

Treatment: artificial vomiting, gastric lavage, prescription of saline laxatives, activated charcoal; with the development of convulsive syndrome – intravenous administration of diazepam and barbiturates; if necessary – forced diuresis, hemodialysis.

Drug Interactions

When used simultaneously, Antigrippin-ANVI^® enhances the effect of heparin, indirect anticoagulants, reserpine, steroid hormones and hypoglycemic agents.

When used simultaneously, Antigrippin-ANVI^® reduces the effectiveness of spironolactone, furosemide, antihypertensive and uricosuric agents.

Antigrippin-ANVI^® enhances the side effects of glucocorticosteroids, sulfonylurea derivatives, methotrexate, non-narcotic analgesics and NSAIDs.

When the drug Antigrippin-ANVI^® is used simultaneously with barbiturates, antiepileptic drugs, zidovudine, rifampicin and alcohol-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.

Metamizole sodium enhances the effects of alcoholic beverages.

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

When used simultaneously with metamizole sodium, thiamazole and melphalan increase the risk of leukopenia.

Sedatives and tranquilizers enhance the analgesic effect of metamizole sodium.

X-ray contrast agents, colloidal blood substitutes and penicillin should not be used during the use of metamizole sodium.

Storage Conditions

The drug should be stored out of the reach of children, in a dry, light-protected place at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is available 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.