Influnet^® AIR Stop Tos (Tablets) Instructions for Use

Marketing Authorization Holder

AnviLab, LLC (Russia)

Manufactured By

Vitale-XD, Ltd. (Estonia)

ATC Code

R05DA20 (Opium alkaloids and their derivatives in combination)

Active Substances

Paracetamol (Rec.INN registered by WHO)

Dextromethorphan (Rec.INN registered by WHO)

Dosage Form

Influnet® AIR Stop Tos

Effervescent tablets 7.5 mg+300 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Effervescent tablets white with a creamy tint, flat-cylindrical, with a bevel, with an orange-lemon smell.

Excipients: dextrose – 1927.5 mg, sodium bicarbonate – 800 mg, anhydrous citric acid – 800 mg, aspartame (contains phenylalanine) – 40 mg, macrogol 6000 – 25 mg, orange flavor – 80 mg, lemon flavor – 20 mg.

2 pcs. – non-cell contour packs (5) – cardboard boxes.
2 pcs. – non-cell contour packs (10) – cardboard boxes.
10 pcs. – polypropylene jars (1) – cardboard boxes.
20 pcs. – polypropylene jars (1) – cardboard boxes.

Clinical-Pharmacological Group

Combination analgesic-antipyretic

Pharmacotherapeutic Group

Acute respiratory diseases and “common cold” symptoms elimination agent (non-narcotic analgesic agent + opioid antitussive agent)

Pharmacological Action

Combined preparation. Paracetamol is an analgesic, antipyretic agent; it relieves fever, reduces temperature, and also effectively relieves headache, muscle and joint pain, which often accompany influenza. It inhibits the synthesis of prostaglandins.

Dextromethorphan is an antitussive agent that suppresses the cough center in the brain and thereby relieves dry cough.

Dextromethorphan reduces the excitability of the cough center. The mechanism of action is to increase the sensitivity threshold of central receptors, which leads to suppression of the cough reflex.

Pharmacokinetics

Paracetamol is well absorbed from the gastrointestinal tract, C_max in plasma is reached within 10…60 minutes after administration. Paracetamol is distributed evenly in tissues and is poorly bound to plasma proteins. Paracetamol is metabolized mainly in the liver and excreted by the kidneys. T_1/2 of the drug is 1…3 hours. Complete elimination occurs within 24 hours. Dextromethorphan is rapidly absorbed from the gastrointestinal tract, metabolized in the liver, and excreted by the kidneys both unchanged and in the form of metabolites, which also have antitussive activity.

Indications

The drug Influnet AIR is used as an antipyretic for influenza and acute respiratory diseases accompanied by cough.

ICD codes

Dosage Regimen

Adults are prescribed 1-2 tablets every 4 hours, but not more than 8 tablets per day. Children from 6 to 12 years old – 1 tablet 4 times a day, with an interval between doses of at least 4 hours. The duration of treatment is not more than 3 days.

In the absence of sufficient therapeutic effect, high temperature that persists during treatment for more than 3 days, cough, as well as the appearance of new symptoms, the possibility of a more serious disease should be considered and it is necessary to consult a doctor immediately.

Adverse Reactions

From the central nervous system drowsiness, sleep disorders, increased nervous excitability (especially in children).

From the gastrointestinal tract epigastric pain, nausea, vomiting. With prolonged use of the drug in combination with alcohol, the development of a hepatotoxic effect (liver dysfunction) is possible.

Allergic reactions skin rash, itching, angioedema.

From the hematopoietic system anemia, thrombocytopenia.

Contraindications

Hypersensitivity to the components of the drug. Severe liver and/or kidney dysfunction, glucose-6-phosphate dehydrogenase deficiency, phenylketonuria, blood diseases, bronchial asthma, bronchitis, simultaneous use of mucolytic agents, children under 6 years of age.

With caution. Renal and hepatic insufficiency, benign hyperbilirubinemia (including Gilbert’s syndrome), viral hepatitis, alcoholic liver disease, alcoholism, old age.

Use in Pregnancy and Lactation

It is not recommended to take the drug during pregnancy and lactation.

Use in Hepatic Impairment

Contraindicated in severe liver dysfunction.

With caution hepatic insufficiency, viral hepatitis, alcoholic liver disease.

Use in Renal Impairment

Contraindicated in severe kidney dysfunction.

With caution: renal insufficiency.

Pediatric Use

Contraindicated in children under 6 years of age.

Geriatric Use

With caution old age.

Special Precautions

When taking the drug, it is necessary to monitor the state of the hematopoietic system. During treatment with the drug, it is not recommended to consume alcohol.

When using the drug, one should refrain from driving vehicles and working with potentially dangerous mechanisms.

Overdose

SymptomsParacetamol – pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may appear 12-48 hours after overdose. Impaired glucose metabolism and metabolic acidosis may occur. In severe poisoning, liver failure may progress to encephalopathy, hemorrhage, hypoglycemia, coma and death. Acute renal failure with acute tubular necrosis may present with severe low back pain, hematuria, proteinuria and develop even in the absence of severe liver damage. Cardiac arrhythmia and pancreatitis have also been reported.

Dextromethorphan – nausea, vomiting, dizziness, drowsiness, visual impairment, lethargy, impaired coordination of movements, difficulty breathing. First aid: gastric lavage, take activated charcoal and consult a doctor immediately.

Drug Interactions

Do not take together with other drugs containing Paracetamol. When prescribing to patients with diabetes, it should be taken into account that the preparation contains glucose.

With simultaneous administration of barbiturates, anticonvulsants, rifampicin, the risk of hepatotoxic effects is significantly increased.

Long-term use of barbiturates reduces the effectiveness of paracetamol.

Concomitant use of paracetamol in high doses enhances the effect of anticoagulant drugs.

Long-term combined use of paracetamol and other non-steroidal anti-inflammatory drugs increases the risk of analgesic nephropathy and renal papillary necrosis, and the onset of end-stage renal failure.

Simultaneous long-term use of paracetamol in high doses and salicylates increases the risk of kidney or bladder cancer.

Dextromethorphan enhances the effect of narcotic antitussive drugs and other drugs that depress the central nervous system. Interaction with monoamine oxidase inhibitors is potentially possible (it is advisable to avoid taking dextromethorphan during the course of monoamine oxidase inhibitors).

Monoamine oxidase inhibitors (including furazolidone, procarbazine, selegiline) when used simultaneously can cause adrenergic crisis, collapse, coma, dizziness, agitation, increased blood pressure, hyperpyrexia, intracranial bleeding, lethargy, nausea, cramps, tremor.

Storage Conditions

Store in the original packaging in a dry place at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life. 2 years. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.