Influnet^® (Capsules) Instructions for Use

Marketing Authorization Holder

Rapharma, JSC (Russia)

Manufactured By

PharmVILAR NPO, LLC (Russia)

Or

Pharmproekt, JSC (Russia)

Contact Information

PharmFirma Sotex ZAO (Russia)

ATC Code

R05X (Other remedies for the treatment of colds)

Dosage Forms

	Influnet®	Capsules: 10, 20 or 40 pcs.
		Powder for preparation of oral solution[cranberry, lime, forest berries, raspberry, mint]: sachet 5 g 3, 5, 6, 10, 16, 50 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 0, blue body, blue cap; capsule contents – a mixture of powder and/or granules of yellow with a greenish tint; the presence of lumps is allowed, which, when pressed with a glass rod, easily turn into powder.

Excipients: hypromellose – 4.5 mg, colloidal silicon dioxide – 2.5 mg, lactose monohydrate – 21.3 mg, magnesium stearate – 4.2 mg.

Composition of the hard gelatin capsule: gelatin, indigo carmine (E132), brilliant blue dye (E133), titanium dioxide (E171).

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.

Powder for preparation of oral solution[cranberry, lime, forest berries, raspberry, mint] in the form of a mixture of powder and/or granules from light yellow to yellow with a greenish tint, with the smell of cranberry or lime, or forest berries, or raspberry, or mint; prepared solution* – cloudy with a yellowish-greenish tint, with the smell of cranberry or lime, or forest berries, or raspberry, or mint; the presence of undissolved yellow particles is allowed.

Excipients: cranberry flavor or lime flavor, or forest berries flavor, or raspberry flavor, or mint flavor – 60 mg, aspartame – 30 mg, hypromellose – 30 mg, colloidal silicon dioxide – 10 mg, lactose monohydrate – 4075 mg.

5 g – thermowelded sachets made of combined material (3) – cardboard packs.
5 g – thermowelded sachets made of combined material (5) – cardboard packs.
5 g – thermowelded sachets made of combined material (6) – cardboard packs.
5 g – thermowelded sachets made of combined material (10) – cardboard packs.
5 g – thermowelded sachets made of combined material (16) – cardboard packs.
5 g – thermowelded sachets made of combined material (50) – cardboard packs.

* after dissolving the contents of 1 sachet in 200 ml of water.

Clinical-Pharmacological Group

Drug for symptomatic therapy of acute respiratory diseases

Pharmacotherapeutic Group

Remedy for the relief of acute respiratory disease and “common cold” symptoms (non-narcotic analgesic + decongestant + vitamin)

Pharmacological Action

A combined drug with antipyretic, analgesic, angioprotective, and decongestant action.

Paracetamol has antipyretic and analgesic effects.

Ascorbic acid (vitamin C) is involved in the regulation of carbohydrate metabolism, redox processes, synthesis of steroid hormones, tissue regeneration, activates immune responses, reduces capillary permeability, enhances the detoxification function of the liver, and regulates blood clotting processes. It replenishes vitamin C deficiency in “cold” diseases.

Succinic acid enhances biochemical and physiological recovery processes. It has hepatoprotective, immunomodulatory, and antioxidant effects. It activates energy processes in mitochondria, normalizes the permeability of cell membranes, and is an intermediate of the Krebs cycle. In combination with drugs, it enhances their positive effects and reduces the manifestations of toxic effects.

Rutoside reduces capillary permeability, relieves swelling and inflammation, strengthens the vascular wall, inhibits aggregation, and increases the degree of erythrocyte deformation.

Phenylephrine stimulates postsynaptic α-adrenergic receptors, reduces swelling and hyperemia of the nasal mucosa, restores free breathing, and reduces pressure in the paranasal sinuses and middle ear.

Pharmacokinetics

Data on the pharmacokinetics of the drug Influnet^® are not provided.

Indications

• Symptomatic treatment of “cold” diseases and influenza, accompanied by fever, headache, chills, nasal congestion, sore throat, and sinus pain.

ICD codes

Dosage Regimen

The drug is administered orally, after meals.

Capsules are taken with plenty of water.

The contents of 1 sachet should be dissolved in a glass of boiled hot water and taken hot. Stir before use.

The recommended dose is 2 capsules or 1 sachet with an interval of 4-6 hours, but not more than 4 times/day, for 3 days. The maximum daily dose is 8 capsules or 4 sachets.

If no improvement in well-being occurs within 3 days after starting treatment, the patient should stop taking the drug and consult a doctor.

Adverse Reactions

When used in recommended doses and duration, the drug is well tolerated, and side effects develop extremely rarely.

From the hematopoietic system: agranulocytosis, thrombocytopenia, thrombocytosis, hyperprothrombinemia, erythrocytopenia, neutrophilic leukocytosis, anemia.

From the cardiovascular system: increased blood pressure, bradycardia, arrhythmia, angina pectoris.

From the nervous system: headache, agitation, irritability, anxiety, weakness, dizziness, respiratory depression, tremor.

From the digestive system: nausea, vomiting, diarrhea.

From metabolism: metabolic disorders, inhibition of glycogen synthesis, excessive formation of corticosteroids, sodium and water retention, hypokalemia.

From the urinary system: increase or decrease in diuresis, damage to the glomerular apparatus of the kidneys, formation of oxalate urinary stones.

Allergic reactions: skin rash, hyperemia.

If any of the side effects listed in the instructions worsen or other side effects not listed in the instructions appear, the patient should inform the doctor.

Contraindications

• Hypersensitivity to one or more components included in the drug;
• Severe liver diseases (including acute hepatitis or exacerbation of chronic diseases);
• Severe kidney diseases (including acute pyelonephritis, acute glomerulonephritis or exacerbation of chronic diseases);
• Peptic ulcer of the stomach and duodenum;
• Glaucoma;
• Tendency to thrombosis;
• Diabetes mellitus;
• Arterial hypertension;
• Bradycardia;
• Ventricular tachycardia, conduction disorders, ventricular fibrillation;
• Heart failure;
• Severe atherosclerosis;
• Severe aortic stenosis;
• Acute myocardial infarction;
• Pheochromocytoma;
• Hyperthyroidism;
• Prostatic hyperplasia;
• Concomitant use of tricyclic antidepressants, beta-blockers, MAO inhibitors (including within 14 days after their withdrawal), other drugs containing Paracetamol;
• Lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome (due to the presence of lactose in the composition);
• Phenylketonuria (powder for preparation of oral solution – due to the presence of aspartame in the composition);
• Pregnancy;
• Lactation period (breastfeeding);
• Childhood and adolescence under 18 years.

With caution the drug should be used in patients with benign hyperbilirubinemia, congenital glucose-6-phosphate dehydrogenase deficiency.

Use in Pregnancy and Lactation

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

Use in Hepatic Impairment

The use of the drug is contraindicated in severe liver diseases (including acute hepatitis or exacerbation of chronic diseases).

Use in Renal Impairment

The use of the drug is contraindicated in severe kidney diseases (including acute pyelonephritis, acute glomerulonephritis or exacerbation of chronic diseases).

Pediatric Use

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

Special Precautions

The duration of use of the drug without consulting a doctor should not exceed 3 days.

When using the drug, distortion of the results of laboratory tests assessing the concentration of glucose and uric acid in plasma is possible.

Persons prone to alcohol consumption should consult a doctor before starting treatment with Influnet^®, since Paracetamol can have a damaging effect on the liver.

Overdose

Symptoms (overdose is mainly caused by paracetamol): pallor of the skin, anorexia, nausea, vomiting and abdominal pain, increased activity of liver transaminases, increased prothrombin time, hepatonecrosis, arrhythmia, ventricular tachycardia, increased blood pressure.

Treatment: at the prehospital stage – gastric lavage, administration of activated charcoal, symptomatic therapy. The antidote for paracetamol is acetylcysteine. In case of overdose, the patient should consult a doctor.

Drug Interactions

Stimulators of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites of paracetamol, which explains the possibility of severe intoxication with minor overdose.

Paracetamol enhances the effects of MAO inhibitors, sedative drugs, and ethanol.

Antidepressants, antiparkinsonian, antipsychotic drugs, phenothiazine derivatives increase the risk of urinary retention, dry mouth, and constipation.

Corticosteroids, when used concomitantly with the drug, increase the risk of developing glaucoma.

Phenylephrine reduces the hypotensive effect of guanethidine.

Guanethidine enhances the alpha-adrenergic stimulating effect, and tricyclic antidepressants enhance the sympathomimetic effect of phenylephrine.

If it is necessary to take the drug Influnet^® concomitantly with other drugs, the patient should consult the attending physician.

Storage Conditions

Capsules should be stored out of the reach of children, protected from light, at a temperature not exceeding 25°C (77°F); shelf life – 2 years.

Powder for preparation of oral solution should be stored out of the reach of children, in a dry place, at a temperature not exceeding 25°C (77°F); shelf life – 2 years.

Do not use the drug after the expiration date indicated on the packaging.

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.