AntiFlu^® (Tablets, Powder) Instructions for Use

ATC Code

N02BE51 (Paracetamol in combination with other drugs, excluding psycholeptics)

Active Substances

Paracetamol (Rec.INN registered by WHO)

Phenylephrine (Rec.INN registered by WHO)

Chlorphenamine (Rec.INN registered by WHO)

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

Combined drug. Paracetamol has analgesic, antipyretic and mild anti-inflammatory effects.

Phenylephrine Hydrochloride – an alpha-adrenergic agonist – has a vasoconstrictive effect, reduces swelling and hyperemia of the nasal mucosa and paranasal sinuses.

Chlorphenamine maleate – a histamine H₁-receptor blocker. It has an antiallergic effect, reduces the severity of local exudative manifestations, eliminates lacrimation, itching in the eyes and nose.

Indications

Symptomatic treatment of colds, influenza, acute respiratory viral infections (ARVI)

• Febrile syndrome;
• Pain syndrome;
• Rhinorrhea.

ICD codes

Dosage Regimen

Tablets

Adults and children over 12 years of age are prescribed 1 tablet orally every 4 hours, but not more than 8 tablets/day.

The single dose for children depends on body weight (10-15 mg of paracetamol per 1 kg of the child’s weight) and the child’s age and is approximately: children from 6 to 12 years – 1 tablet 2 times/day, with an interval between doses of at least 6 hours.

The duration of treatment is no more than 3 days.

The patient should be warned that in the absence of sufficient therapeutic effect, high fever that persists during treatment for more than 3 days, as well as the appearance of new symptoms, the possibility of a more serious disease should be considered and a doctor should be consulted urgently.

Powder

Orally. Adults and children over 12 years of age are prescribed 1 sachet every 4 hours, but not more than 4 sachets per day.

Before use, the contents of 1 sachet should be dissolved in a glass of hot water.

The duration of treatment is no more than 3 days.

The patient must be warned that in the absence of sufficient therapeutic effect, the presence of high fever that persists during treatment for more than 3 days, as well as the appearance of new symptoms, a doctor should be consulted urgently.

Adverse Reactions

Possible allergic reactions (rash, itching, urticaria, angioedema), increased excitability (especially in children), sleep disturbance, drowsiness, decreased speed of psychomotor reactions, feeling of fatigue, nausea, vomiting, stomach pain, palpitations, increased blood pressure, dizziness, mydriasis, accommodation paresis, increased intraocular pressure, dry mouth, urinary retention.

Considering the presence of paracetamol : rarely – disorders of the hematopoietic system (anemia, thrombocytopenia, leukopenia, agranulocytosis); with long-term use of high doses, hepatotoxic and nephrotoxic effects, hemolytic anemia, methemoglobinemia, pancytopenia are possible.

Contraindications

• Hypersensitivity to individual components of the drug;
• Pregnancy;
• Breastfeeding period;
• Portal hypertension;
• Alcoholism;
• Renal failure;
• Glucose-6-phosphate dehydrogenase deficiency.

Do not use in children under 6 years of age.

Use with caution in arterial hypertension, severe cardiovascular diseases, diabetes mellitus, bronchial asthma, chronic obstructive pulmonary disease, thyrotoxicosis, pheochromocytoma, angle-closure glaucoma, severe liver or kidney diseases, difficulty urinating due to prostate adenoma, blood diseases, congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes).

Use in Pregnancy and Lactation

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

Use in Hepatic Impairment

Contraindicated: portal hypertension. Use with caution in severe liver diseases.

Use in Renal Impairment

Contraindicated: renal failure.

Pediatric Use

Do not use in children under 6 years of age.

Children over 12 years of age are prescribed 1 tablet orally every 4 hours, but not more than 8 tablets/day.

Single doses for children depend on body weight (10-15 mg of paracetamol per 1 kg of the child’s weight) and the child’s age and are approximately: children from 6 to 12 years 1 tablet 2 times/day, with an interval between doses of at least 6 hours.

Special Precautions

During treatment, you should refrain from drinking alcohol, sleeping pills and anxiolytic (tranquilizer) medications.

Do not take together with other medicines containing Paracetamol.

If the symptoms of the disease do not go away within 3-5 days, consult a doctor.

Effect on ability to drive vehicles and operate machinery

During treatment, you should avoid driving vehicles, working with machinery and other potentially hazardous activities.

Overdose

Caused, as a rule, by paracetamol, manifests itself after taking more than 10-15 g of the latter.

Possible : pale skin, anorexia, nausea, vomiting, pain in the epigastric region, increased activity of liver transaminases, increased prothrombin time, hepatotoxic and nephrotoxic effects; in severe cases, liver failure, encephalopathy and coma develop.

Treatment : gastric lavage, intake of activated charcoal within the first 6 hours, administration of SH-group donors and precursors of glutathione synthesis – methionine 8-9 hours after overdose and N-acetylcysteine – after 12 hours.

Drug Interactions

It is recommended to refrain from taking the drug when taking MAO inhibitors.

The risk of hepatotoxic effects of paracetamol increases with simultaneous use of barbiturates, diphenyl, carbamazepine, rifampicin, zidovudine and other inducers of liver microsomal enzymes.

It enhances the effect of sedatives and ethanol. Ethanol enhances the sedative effect of chlorphenamine.

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

Storage Conditions

Store in a dry place, out of the reach of children, at a temperature of 15 to 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

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.