Infalgan (Powder) Instructions for Use

Marketing Authorization Holder

OV Limited, LLC (Russia)

Manufactured By

Pharmacor Production, LLC (Russia)

ATC Code

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

Dosage Forms

	Infalgan	Powder for oral solution, lemon flavor 325 mg+10 mg+20 mg+50 mg
		Powder for oral solution, honey and lemon flavor 325 mg+10 mg+20 mg+50 mg

Dosage Form, Packaging, and Composition

Powder for oral solution, lemon flavor

5 g – sachets (10 pcs.) – cardboard packs – Over-the-Counter
5 g – sachets (12 pcs.) – cardboard packs – Over-the-Counter
5 g – sachets (4 pcs.) – cardboard packs – Over-the-Counter
5 g – sachets (6 pcs.) – cardboard packs – Over-the-Counter
5 g – sachets (8 pcs.) – cardboard packs – Over-the-Counter

Powder for oral solution, honey and lemon flavor

5 g – sachets (10 pcs.) – cardboard packs – Over-the-Counter
5 g – sachets (12 pcs.) – cardboard packs – Over-the-Counter
5 g – sachets (4 pcs.) – cardboard packs – Over-the-Counter
5 g – sachets (6 pcs.) – cardboard packs – Over-the-Counter
5 g – sachets (8 pcs.) – cardboard packs – Over-the-Counter

Pharmacotherapeutic Group

Analgesics; other analgesics and antipyretics; anilides

Pharmacological Action

Combined medicinal product.

Paracetamol is an analgesic-antipyretic. It has analgesic, antipyretic, and weak anti-inflammatory effects. The mechanism of action is associated with inhibition of prostaglandin synthesis and a predominant effect on the thermoregulation center in the hypothalamus.

Phenylephrine is an alpha₁-adrenergic agonist, causes vasoconstriction, and eliminates swelling and hyperemia of the nasal mucosa.

Pheniramine is an antiallergic agent, a histamine H₁-receptor blocker. It eliminates allergic symptoms, has a moderate sedative effect, and also exhibits m-cholinolytic activity.

Ascorbic acid is involved in the regulation of redox processes, carbohydrate metabolism, blood clotting, tissue regeneration, and the synthesis of steroid hormones; increases the body’s resistance to infections, reduces vascular permeability, and reduces the need for vitamins B₁, B₂, A, E, folic acid, and pantothenic acid. It improves the tolerability of paracetamol and prolongs its action (associated with the prolongation of T_1/2).

Pharmacokinetics

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. C_max in plasma is reached within 10-60 minutes after oral administration. It is distributed in most body tissues. It crosses the placental barrier and is excreted in breast milk. In therapeutic concentrations, binding to plasma proteins is insignificant but increases with increasing concentration. It undergoes primary metabolism in the liver. It is excreted mainly in the urine as glucuronides and sulfates. T_1/2 ranges from 1 to 3 hours.

Phenylephrine is absorbed from the gastrointestinal tract. It is metabolized during the “first pass” through the intestinal wall and in the liver, so when taken orally, phenylephrine hydrochloride is characterized by limited bioavailability. C_max in plasma is reached in the interval from 45 minutes to 2 hours. It is excreted by the kidneys almost completely in the form of sulfate compounds. T_1/2 is 2-3 hours.

C_max of pheniramine in plasma is reached in approximately 1-2.5 hours. T_1/2 of pheniramine is 16-19 hours. 70-83% of the dose is excreted from the body in the urine as metabolites or unchanged.

Ascorbic acid is rapidly and completely absorbed from the gastrointestinal tract. Binding to plasma proteins is 25%. It is excreted in the urine as metabolites. Ascorbic acid taken in excessive amounts is rapidly excreted unchanged in the urine.

Indications

Symptomatic treatment of infectious and inflammatory diseases (ARVI, including influenza), accompanied by high fever, chills, body aches, headache and muscle pain, runny nose, nasal congestion, sneezing.

ICD codes

Dosage Regimen

For oral administration. A single dose is taken every 4-6 hours, no more than 3-4 doses within 24 hours. The duration of use is no more than 5 days.

In patients with impaired liver function or Gilbert’s syndrome, it is necessary to reduce the dose or increase the interval between doses.

In severe renal failure (CrCl<10 ml/min), the interval between doses should be at least 8 hours.

Adverse Reactions

From the hematopoietic system very rarely – thrombocytopenia, agranulocytosis, leukopenia, pancytopenia.

Allergic reactions rarely – hypersensitivity (rash, shortness of breath, anaphylactic shock), urticaria, angioedema; frequency unknown – anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis.

From the nervous system: often – drowsiness; rarely – dizziness, headache.

Mental disorders: rarely – increased excitability, sleep disturbance.

From the organ of vision rarely – mydriasis, accommodation paresis, increased intraocular pressure.

From the cardiovascular system: rarely – tachycardia, palpitations, arterial hypertension.

From the digestive system: often – nausea, vomiting; rarely – constipation, dryness of the oral mucosa, abdominal pain, diarrhea.

From the liver and biliary tract: rarely – increased activity of hepatic transaminases.

From the skin and subcutaneous tissues: rarely – skin rash, itching, erythema.

From the urinary system rarely – difficulty urinating.

General reactions rarely – malaise.

Contraindications

Severe cardiovascular diseases; arterial hypertension; portal hypertension; diabetes mellitus; hyperthyroidism; angle-closure glaucoma; pheochromocytoma; alcoholism; simultaneous or within the preceding 2 weeks use of MAO inhibitors; simultaneous use of tricyclic antidepressants, beta-blockers, other sympathomimetics; pregnancy; lactation (breastfeeding); children under 12 years of age; hypersensitivity to the components of the combined medicinal product.

With caution

Severe atherosclerosis of the coronary arteries, cardiovascular diseases, acute hepatitis, hemolytic anemia, bronchial asthma, severe liver or kidney diseases, prostatic hyperplasia, difficulty urinating due to prostatic hypertrophy, blood diseases, congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes), in exhaustion, dehydration, pyloroduodenal obstruction, stenosing gastric and/or duodenal ulcer, epilepsy, with simultaneous use of drugs that can adversely affect the liver (e.g., inducers of liver microsomal enzymes); in patients with recurrent formation of urate stones in the kidneys.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Pediatric Use

Contraindicated for use in children under 12 years of age.

Geriatric Use

The drug is approved for use in elderly patients

Special Precautions

Consultation with a doctor is necessary if patients have bronchial asthma, emphysema or chronic bronchitis; symptoms do not go away within 5 days or are accompanied by severe fever lasting for 3 days, rash or persistent headache.

To avoid toxic liver damage, the combined product should not be combined with the consumption of alcoholic beverages.

Effect on ability to drive vehicles and machinery

The combined medicinal product may cause drowsiness, therefore, during treatment, it is not recommended to drive vehicles or engage in other activities that require concentration and high speed of psychomotor reactions.

Drug Interactions

Paracetamol

It enhances the effects of MAO inhibitors, sedatives, ethanol.

The risk of hepatotoxic action of paracetamol increases with simultaneous use of barbiturates, phenytoin, phenobarbital, carbamazepine, rifampicin, isoniazid, zidovudine and other inducers of liver microsomal enzymes.

With long-term regular use of paracetamol, the anticoagulant effect of warfarin and other coumarins may be enhanced, thereby increasing the risk of bleeding. A single use of paracetamol does not have a significant effect.

Metoclopramide increases the rate of absorption of paracetamol and reduces the time to reach its C_max in blood plasma. Similarly, domperidone may lead to an increase in the absorption rate of paracetamol.

Paracetamol may lead to an increase in T_1/2 of chloramphenicol.

Paracetamol can reduce the bioavailability of lamotrigine, and a decrease in the effectiveness of lamotrigine is possible due to the induction of its metabolism in the liver.

The absorption of paracetamol may be reduced with simultaneous use with cholestyramine, but the reduction in absorption is insignificant if cholestyramine is taken one hour later.

Regular use of paracetamol simultaneously with zidovudine may cause neutropenia and increase the risk of liver damage.

Probenecid affects the metabolism of paracetamol. In patients simultaneously using probenecid, the dose of paracetamol should be reduced.

The hepatotoxicity of paracetamol is enhanced by long-term excessive consumption of ethanol (alcohol).

Paracetamol may affect the results of the uric acid test using the phosphotungstate precipitating reagent.

Pheniramine

Enhancement of the influence of other substances on the central nervous system (e.g., MAO inhibitors, tricyclic antidepressants, alcohol, antiparkinsonian drugs, barbiturates, tranquilizers, and narcotics) is possible. Pheniramine may inhibit the action of anticoagulants.

Phenylephrine

Phenylephrine may potentiate the action of MAO inhibitors and cause a hypertensive crisis.

Simultaneous use of phenylephrine with other sympathomimetic drugs or tricyclic antidepressants (e.g., amitriptyline) may lead to an increased risk of adverse reactions from the cardiovascular system.

Phenylephrine may reduce the effectiveness of beta-blockers and other antihypertensive drugs (e.g., debrisoquine, guanethidine, reserpine, methyldopa). An increase in the risk of arterial hypertension and other side effects from the cardiovascular system is possible.

Simultaneous use of phenylephrine with digoxin and cardiac glycosides may increase the risk of cardiac arrhythmia or myocardial infarction.

Simultaneous use of phenylephrine with ergot alkaloids (ergotamine and methysergide) may increase the risk of ergotism.

With simultaneous use with barbiturates, primidone, the excretion of ascorbic acid in the urine increases.

Ascorbic acid

With simultaneous use of oral contraceptives, the concentration of ascorbic acid in the blood plasma decreases. An increase in the concentration of ethinyl estradiol in the blood plasma is possible with its simultaneous use as part of oral contraceptives.

With simultaneous use with iron preparations, Ascorbic acid, due to its reducing properties, converts ferric iron to ferrous iron, which contributes to improved absorption.

With simultaneous use with warfarin, a decrease in the effects of warfarin is possible.

With simultaneous use, Ascorbic acid increases the excretion of iron in patients receiving deferoxamine.

With simultaneous use with tetracycline, the excretion of ascorbic acid in the urine increases.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.