Antiflu powder for oral solution in bags of 17 g 5 pcs.

Pharmacodynamics. Paracetamol has analgesic, antipyretic and weak anti-inflammatory effects. Its mechanism of action is to inhibit the synthesis of prostaglandins and affect the thermoregulation center in the hypothalamus.

Phenylephrine hydrochloride is an α-adrenomimetic, which, due to its vasoconstrictor effect, reduces edema and hyperemia of the mucous membrane of the upper respiratory tract and paranasal sinuses.

Chlorpheniramine maleate is an antihistamine of the alkylamine class, a blocker of H ₁ -histamine receptors. It has antiallergic action, eliminates rhinorrhea, lacrimation and itching in the eyes and nose. The therapeutic effect develops within 1 hour after oral administration and lasts for 24 hours.

The components of the drug are metabolized independently of each other.

Pharmacokinetics. After oral administration, paracetamol is rapidly absorbed, mainly in the upper digestive tract. It is rapidly distributed in tissues. Binding to blood proteins is less than 10%. Paracetamol is metabolized in the liver: most of it is bound to glucuronic acid, less to sulfuric acid. The half-life of paracetamol is 2-2.5 hours. It increases in people with liver diseases.

Paracetamol is excreted in the urine (85% of a single dose of paracetamol is excreted within 24 hours). Excretion is significantly impaired in cases of impaired renal excretory function, which can lead to the accumulation of paracetamol and its metabolites in the body. T _½ of chlorpheniramine maleate is 8 hours. Metabolism products and the unchanged part of the drug are excreted in the urine.

Phenylephrine hydrochloride is partially excreted in the urine unchanged, the rest is inactivated by MAO in the blood, liver and other tissues. Inactive products are partially excreted by the kidneys, the rest by the liver in the form of glucuronides.

Symptomatic treatment of influenza, acute respiratory viral infections and colds to reduce body temperature, eliminate headache, muscle and joint pain, and swelling of the respiratory tract mucosa.

Take orally. Before use, dissolve the contents of the packet in a glass of hot water.

Single dose for adults and children over 12 years old – 1 packet. If necessary, repeat every 4 hours. The maximum daily dose – 4 packets during the day – should not be exceeded. The maximum period of use without consulting a doctor is 3 days. Further use is possible only under the supervision of a doctor.

Children: Do not use in children under 12 years of age.

The maximum dose for children is up to 100 mg/kg/day, or 4000 mg/day.

• Hypersensitivity to the components of the drug; severe liver and kidney dysfunction; congenital deficiency of glucose-6-phosphate dehydrogenase (as evidenced by hemolytic anemia); Gilbert’s syndrome (intermittent benign jaundice, resulting from glucuronyltransferase deficiency); hematopoietic disorders; blood diseases; severe leukopenia; anemia; severe cardiac conduction disorders; decompensated heart failure; severe atherosclerosis of the coronary arteries; severe coronary artery disease; severe ag; ba; emphysema; chronic obstructive pulmonary disease; congenital hyperbilirubinemia; Dubin-Johnson syndrome; diabetes mellitus; hyperthyroidism; angle-closure glaucoma; bladder neck obstruction; pyloroduodenal obstruction; gastric ulcer in the acute stage; alcoholism; arrhythmias; prostatic adenoma with difficulty urinating; acute pancreatitis; increased excitability; sleep disorders; pheochromocytoma; epilepsy; advanced age; patients at risk of respiratory failure.

Do not use simultaneously with MAO inhibitors and within 2 weeks after discontinuation of MAO inhibitors; with tricyclic antidepressants, β-adrenergic blockers.

In most cases, the drug is well tolerated.

In rare cases, the following side effects may occur after prolonged use in amounts exceeding the recommended daily doses:

• from the blood system: anemia, sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, heart pain), thrombocytosis, thrombocytopenia, leukopenia, agranulocytosis, hemolytic anemia, bruising or bleeding;
• from the digestive tract: heartburn, nausea, vomiting, dry mouth, discomfort and pain in the epigastrium, hypersalivation, decreased appetite, constipation, diarrhea, flatulence;
• Liver: impaired liver function, increased activity of liver enzymes, usually without the development of jaundice; hepatonecrosis (dose-dependent effect);
• from the endocrine system: hypoglycemia up to hypoglycemic coma;
• Immune system disorders: hypersensitivity reactions (including allergic reactions), anaphylactic reactions and anaphylactic shock;
• from the nervous system: headache, weakness, dizziness, psychomotor agitation and disorientation, anxiety, feelings of fear, sleep disorders, drowsiness, insomnia, dyskinesia, behavior changes, irritability or nervousness, tremor, confusion, depressive states, tingling and heaviness in the limbs, tinnitus, epileptic seizures, coma;
• from the urinary system: renal colic and interstitial nephritis, urinary retention and difficulty urinating, aseptic pyuria;
• on the part of the organs of vision: impaired vision and accommodation, dry eyes, mydriasis;
• Skin and subcutaneous tissue disorders: itching, skin and mucous membrane rashes (usually generalized rash, erythema, urticaria), allergic and angioedema, acute generalized exanthematous pustulosis, local drug dermatitis, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), including fatal outcome;
• Cardiovascular system: tachycardia, reflex bradycardia, shortness of breath, heart pain, increased blood pressure, arrhythmia; with prolonged use in high doses, myocardial dystrophy is possible;
• Respiratory system: bronchospasm in patients sensitive to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs.

Concomitant use with other drugs intended for the symptomatic treatment of colds and flu, or drugs containing paracetamol, should be avoided.

This medicine is not recommended for use concurrently with sedatives, hypnotics or medicines containing alcohol due to the increased risk of hepatotoxicity.

The drug contains paracetamol, which due to hepatotoxicity should not be used for longer periods and in doses higher than those recommended in the USAGE section. Long-term use may lead to serious liver complications, such as cirrhosis. Acute or chronic overdose may lead to severe liver damage and in rare cases, death.

Long-term use of paracetamol, especially in combination with other analgesics, can lead to irreversible kidney damage and the risk of developing kidney failure (analgesic nephropathy).

Prolonged use of paracetamol in high doses can lead to liver and kidney damage. A large number of medications used simultaneously, alcoholism, alcoholic liver disease, sepsis or diabetes mellitus can increase the risk of hepatotoxicity of paracetamol in therapeutic doses. The risk of overdose occurs in patients with non-cirrhotic alcoholic liver disease.

If, on the recommendation of a doctor, the drug is used for a long period, it is necessary to monitor the functional state of the liver and the peripheral blood picture.

In patients with severe infections, such as sepsis, accompanied by decreased glutathione levels, the risk of metabolic acidosis may be increased when taking paracetamol (see Conditions and shelf life).

Before using the drug, consultation with a doctor is necessary:

• if the patient is taking warfarin or similar drugs that have an anticoagulant effect;
• if the patient has breathing problems, chronic lung disease, emphysema, or chronic bronchitis;
• a patient with liver disease or infectious liver lesions, such as viral hepatitis;
• in a patient with kidney disease, as dose adjustment may be necessary.

In case of renal insufficiency, the doctor should assess the risk/benefit ratio before starting the drug. Dose adjustment is necessary, constant monitoring should be ensured:

• with hypertension;
• with daily use of analgesics for mild arthritis.

Use with caution in patients with:

• the presence of chronic malnutrition and dehydration;
• mild to moderate hepatic insufficiency (9 points on the Child-Pugh scale);
• Raynaud’s disease;
• thyroid diseases, except hyperthyroidism, which is listed in the Side Effects section;
• glaucoma, except for glaucoma, which is listed in the Side Effects section.

You should consult a doctor:

• if symptoms persist and/or are accompanied by a high body temperature that lasts more than 3 days;
• if the headache becomes constant.

Severe skin reactions have been reported very rarely. If you experience redness, rash, blistering or peeling of the skin, stop using paracetamol and seek medical attention immediately.

When prescribing paracetamol in therapeutic doses, an increase in ALT is possible.

Paracetamol may affect the results of laboratory tests for blood glucose and uric acid.

Do not exceed the recommended dose.

The excipient, yellow dye “Sunset”, may cause allergic reactions.

Warning regarding sugar and sucrose content: if the patient has an intolerance to some sugars, consult a doctor before taking this medicine; the medicine may be harmful to the teeth.

Use during pregnancy and breastfeeding. The drug is not recommended for use during pregnancy. Women should stop breastfeeding while taking the drug.

Fertility: There is limited evidence of a possible impairment of female fertility due to the effect on ovulation of drugs that inhibit cyclooxygenase/prostaglandin synthesis, which is reversible and disappears after discontinuation of treatment. Since paracetamol is believed to inhibit prostaglandin synthesis, it may adversely affect fertility, although no such cases have been reported.

The ability to influence the reaction speed when driving or working with other mechanisms.

Due to the possibility of drowsiness, you should refrain from driving vehicles or operating machinery for 4 hours after using the drug.

When used simultaneously with paracetamol, the following types of interactions may occur:

• The rate of absorption of paracetamol may increase when used simultaneously with metoclopramide and domperidone, and decrease with cholestyramine;
• the elimination of antibiotics from the body may be slowed down;
• barbiturates and alcohol can increase the hepato- and nephrotoxicity of acetaminophen, barbiturates reduce the antipyretic effect;
• anticonvulsants (phenytoin, barbiturates, carbamazepine), isoniazid and rifampicin may enhance the hepatotoxic effects of paracetamol;
• tetracycline increases the risk of developing anemia and methemoglobinemia caused by paracetamol;
• The effect of indirect anticoagulants may be enhanced with an increased risk of bleeding with prolonged regular use of paracetamol;
• may reduce the effectiveness of diuretics;
• Antacids and food reduce the absorption of paracetamol.

With the simultaneous use of paracetamol with hepatotoxic drugs, the toxic effect of the drugs on the liver increases.

The drug is not recommended for use simultaneously with sedatives, hypnotics, or medications containing alcohol due to the increased risk of hepatotoxicity.

It is not recommended to use simultaneously with vasoconstrictors.

The simultaneous use of Antiflu with the following drugs may significantly increase the suppressive effect of chlorpheniramine maleate:

• sleeping pills;
• barbiturates;
• sedatives;
• neuroleptics;
• tranquilizers;
• anesthetics;
• narcotic analgesics;
• ethanol-containing products.

Chlorpheniramine enhances the anticholinergic effect of atropine, antispasmodics, tricyclic antidepressants, and antiparkinsonian drugs.

Chlorphenamine may inhibit the action of anticoagulants.

Phenylephrine hydrochloride can cause the development of hypertensive crisis or arrhythmia when used simultaneously with other adrenomimetics or MAO inhibitors, and cause severe hypertension when combined with indomethacin and bromocriptine.

Concomitant use of phenylephrine with other sympathomimetic agents or tricyclic antidepressants (e.g. amitriptyline) may increase the risk of cardiovascular side effects. Rauwolfia alkaloids reduce the therapeutic effect of phenylephrine hydrochloride.

Phenylephrine may reduce the effectiveness of β-blockers and antihypertensive drugs (e.g. debrisoquine, guanethidine, reserpine, methyldopa). The risk of developing hypertension and other cardiovascular side effects may increase.

Concomitant use of phenylephrine with digoxin and cardiac glycosides may increase the risk of heart rhythm disturbances or heart attack.

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

Concomitant use with ergot alkaloids (ergotamine, methysergide) increases the risk of ergotism.

Symptoms of overdose due to the action of paracetamol in the first 24 hours are pallor of the skin, nausea, vomiting, anorexia and abdominal pain. When taken in high doses, disorientation, psychomotor agitation or depression of the central nervous system, increased sweating, dizziness and sleep disturbances may also occur. Cardiac arrhythmias and pancreatitis have also been noted.

In rare cases, after paracetamol overdose, acute renal failure with acute tubular necrosis has been reported, which may manifest as severe lower back pain, hematuria, proteinuria and may develop even in the absence of severe liver damage; nephrotoxicity (renal colic, interstitial nephritis, papillary necrosis).

In severe cases, especially in the presence of alcohol, liver damage (hepatocellular necrosis) and deterioration of liver function may occur, which may progress to hepatic encephalopathy, hepatic coma, cerebral edema and death. Clinical signs of liver damage may not appear for 12-48 hours after overdose. Glucose metabolism disorders, hypokalemia and metabolic acidosis (including lactic acidosis), increased hepatic transaminase activity and increased prothrombin index, hemorrhage may occur. Liver damage in adults may develop after the use of 10 g or more of paracetamol and more than 150 mg / kg of body weight in children.

Common clinical manifestations that occur after 3-5 days include jaundice, fever, hemorrhagic diathesis, hypoglycemia, hepatic halitosis, and liver failure.

The use of 5 g or more of paracetamol can lead to liver damage in patients with risk factors (long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John’s wort or other drugs that induce liver enzymes, regular intake of excessive amounts of ethanol; glutathione cachexia (digestive disorders, cystic fibrosis, HIV infection, starvation, cachexia)).

With prolonged use in high doses, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, and thrombocytopenia are possible.

Emergency care. The patient should be taken to the clinic immediately, even if there are no early symptoms of overdose. Symptoms may be limited to nausea and vomiting or may not reflect the severity of the overdose or may lead to organ damage. Treatment with activated charcoal should be considered if an overdose of paracetamol has been taken within 1 hour. The concentration of paracetamol in the blood plasma should be measured 4 hours or later after ingestion (earlier concentrations are unreliable). Gastric lavage should be performed within 6 hours of a suspected paracetamol overdose. Cytostatic effects can be reduced by administering methionine orally or by administering cysteamine or N-acetylcysteine ​​within 8 hours of the overdose. The effectiveness of the antidote decreases sharply after this time.

Overdose due to the action of phenylephrine and chlorpheniramine maleate can cause increased sweating, psychomotor agitation or depression of the central nervous system, headache, dizziness, drowsiness, impaired consciousness, heart rhythm disturbances, tachycardia, extrasystole, tremor, hyperreflexia, convulsions, nausea, vomiting, irritability, anxiety, increased blood pressure.

In case of an overdose of chlorpheniramine maleate, atropine-like symptoms may be observed: mydriasis, photophobia, dryness of the skin and mucous membranes, increased body temperature, intestinal atony. CNS depression is accompanied by impaired breathing and cardiovascular function (decreased heart rate, decreased blood pressure to vascular insufficiency).

In case of overdose, symptomatic therapy is necessary, in case of severe arterial hypertension – the use of α-adrenergic blockers.

At a temperature not exceeding 25 °C.