Rankof^® Flu (Powder) Instructions for Use

Marketing Authorization Holder

Profit-Pharm LLC (Russia)

Manufactured By

PharmVILAR NPO, LLC (Russia)

ATC Code

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

Dosage Forms

	Rankof® Flu	Powder for preparation of oral solution (raspberry flavor): sachet 17 g 5 pcs.
		Powder for preparation of oral solution (apple and cinnamon flavor): sachet 17 g 5 pcs.
		Powder for preparation of oral solution (honey and lemon flavor): sachet 17 g 5 pcs.
		Powder for preparation of oral solution (lemon flavor): sachet 17 g 5 pcs.
		Powder for preparation of oral solution (ginger flavor): sachet 17 g 5 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of oral solution [raspberry flavor] in the form of a mixture of microgranulated powder from white to light yellow with a brownish tint, with inclusions of a darker color and the presence of white granules, with a characteristic raspberry odor.

Excipients : sucrose – 15438.2 mg, lemon flavor – 90 mg, raspberry flavor – 278.8 mg, citric acid monohydrate – 340 mg, colloidal silicon dioxide – 70 mg, sodium citrate dihydrate – 34 mg.

17 g – thermowelded sachets made of combined material (5) – cardboard packs.

Powder for preparation of oral solution [apple and cinnamon flavor] in the form of a mixture of microgranulated powder from white to light yellow with a brownish tint, with inclusions of a darker color and the presence of white granules, with a characteristic apple and cinnamon odor.

Excipients : sucrose – 15438.2 mg, apple flavor – 102 mg, cinnamon flavor – 102 mg, citric acid monohydrate – 340 mg, colloidal silicon dioxide – 70 mg, sodium citrate dihydrate – 34 mg.

17 g – thermowelded sachets made of combined material (5) – cardboard packs.

Powder for preparation of oral solution [honey and lemon flavor] in the form of a mixture of microgranulated powder from white to light yellow with a brownish tint, with inclusions of a darker color and the presence of white granules, with a characteristic honey and lemon odor.

Excipients : sucrose – 15603 mg, lemon flavor – 129 mg, honey flavor – 75 mg, citric acid monohydrate – 340 mg, colloidal silicon dioxide – 70 mg, sodium citrate dihydrate – 34 mg.

17 g – thermowelded sachets made of combined material (5) – cardboard packs.

Powder for preparation of oral solution [lemon flavor] in the form of a mixture of microgranulated powder from white to light yellow with a brownish tint, with inclusions of a darker color and the presence of white granules, with a characteristic lemon odor.

Excipients : sucrose – 15603 mg, lemon flavor – 204 mg, citric acid monohydrate – 340 mg, colloidal silicon dioxide – 70 mg, sodium citrate dihydrate – 34 mg.

17 g – thermowelded sachets made of combined material (5) – cardboard packs.

Powder for preparation of oral solution [ginger flavor] in the form of a mixture of microgranulated powder from white to light yellow with a brownish tint, with inclusions of a darker color and the presence of white granules, with a characteristic ginger odor.

Excipients : sucrose – 15526.5 mg, ginger flavor – 280.5 mg, citric acid monohydrate – 340 mg, colloidal silicon dioxide – 70 mg, sodium citrate dihydrate – 34 mg.

17 g – sachets made of combined material (5) – cardboard packs.

Clinical-Pharmacological Group

Drug for symptomatic therapy of acute respiratory diseases

Pharmacotherapeutic Group

Acute respiratory diseases and "common cold" symptoms elimination agent (non-narcotic analgesic + alpha-adrenomimetic + H1-histamine receptor blocker + vitamin)

Pharmacological Action

Combined drug.

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, with a predominant effect on the thermoregulation center in the hypothalamus.

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, reduces the need for vitamins B₁, B₂, A, E, folic acid, pantothenic acid. Improves the tolerability of paracetamol and prolongs its action (associated with prolongation of T_1/2).

Chlorphenamine is a histamine H₁-receptor blocker, has antihistamine, weak anticholinergic, sedative effects. Reduces the severity of allergic reactions mediated by the action of histamine, reduces capillary permeability, constricts blood vessels, eliminates swelling and hyperemia of the nasal mucosa, nasopharynx and paranasal sinuses; reduces local exudative manifestations, suppresses symptoms of allergic rhinitis: sneezing, rhinorrhea, itchy eyes, nose.

Phenylephrine is a sympathomimetic, has pronounced alpha-adrenergic activity, constricts blood vessels of the nasal mucosa, eliminates swelling and hyperemia of the nasal mucosa.

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 to most body tissues. Penetrates the placental barrier, 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.

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

Chlorphenamine after oral administration is relatively slowly absorbed from the gastrointestinal tract. C_max is reached after 2.5-6 hours. Bioavailability is low – 25-50%. It undergoes the “first pass” effect through the liver. Binding to plasma proteins is about 70%. It is widely distributed in the organs and tissues of the body, penetrates the central nervous system. It is intensively metabolized in the liver with the formation of desmethyl- and didesmethylchlorphenamine. It is excreted mainly in the urine unchanged and in the form of metabolites. Excretion depends on urine pH and urine flow rate. Only trace amounts of chlorphenamine are found in feces. T_1/2 varies from 2 hours to 43 hours.

Phenylephrine. Absorption after oral administration varies significantly, it undergoes intensive presystemic metabolism. As a result, its systemic bioavailability is only 40%, and C_max in plasma is reached 1-2 hours after oral administration. V_d is 200-500 l, and the average T_1/2 from plasma is 2-3 hours. After absorption, it undergoes intensive biotransformation in the intestinal wall. After oral administration, 24% of phenylephrine is deaminated, since most of the orally administered drug is metabolized by sulfation even before it reaches the liver.

Indications

Infectious and inflammatory diseases (ARVI, influenza), accompanied by fever, chills, headache, joint and muscle pain, nasal congestion, and sore throat and sinuses.

ICD codes

Dosage Regimen

Prepare the oral solution immediately before use by dissolving the entire contents of one sachet in a glass of hot boiled water.

Stir thoroughly until the powder is completely dissolved. Consume the prepared solution while warm.

Administer orally. The maximum single dose is one sachet. The maximum daily dose is three sachets.

For adults and children over 15 years of age, administer one sachet 2 to 3 times daily.

For children aged 12 to 15 years, administer one sachet 2 times daily.

For children aged 6 to 12 years, administer one sachet 1 to 2 times daily.

For children aged 3 to 6 years, administer one sachet 1 time daily.

Maintain an interval of at least 4 hours between doses. Do not exceed the recommended dosage.

In patients with impaired liver function or impaired kidney function, and in elderly patients, extend the interval between doses to at least 8 hours.

The duration of use without medical consultation should not exceed 3 days as an antipyretic and 5 days as an analgesic.

If symptoms persist, discontinue use and consult a physician.

Adverse Reactions

From the nervous system in isolated cases – headache, feeling of fatigue, drowsiness.

From the digestive system : in isolated cases – nausea, pain in the epigastric region, dry mouth.

From the endocrine system in isolated cases – hypoglycemia (up to the development of coma).

From the hematopoietic system in isolated cases – anemia, hemolytic anemia (especially for patients with glucose-6-phosphate dehydrogenase deficiency); extremely rarely – thrombocytopenia.

Allergic reactions skin rash, itching, urticaria, angioedema, anaphylactoid reactions (including anaphylactic shock), multiform exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome).

Other in isolated cases – hypervitaminosis C, metabolic disorders, feeling of heat, accommodation paresis, urinary retention.

Contraindications

Erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase), severe renal and/or hepatic failure; alcoholism; closed-angle glaucoma; phenylketonuria; prostatic hyperplasia; children under 3 years of age; children under 15 years of age (for dosage forms intended for adults); pregnancy, lactation period (breastfeeding); hypersensitivity to the components of the combination.

With caution

Renal and/or hepatic insufficiency, glucose-6-phosphate dehydrogenase deficiency, congenital hyperbilirubinemias (Gilbert, Dubin-Johnson and Rotor syndromes), viral hepatitis, alcoholic hepatitis, old age.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and during the lactation period (breastfeeding).

Use in Hepatic Impairment

The drug is contraindicated for use in case of impaired liver function

Pediatric Use

Contraindicated for use in children under 3 years of age. In children under 15 years of age, the use in the form of dosage forms intended for adults is contraindicated.

Special Precautions

When taking metoclopramide, domperidone or cholestyramine, it is also necessary to consult a doctor.

With long-term use in doses significantly exceeding the recommended ones, the likelihood of impaired liver and kidney function increases, and peripheral blood counts should be monitored.

Paracetamol and Ascorbic acid may distort laboratory test indicators (quantitative determination of glucose and uric acid in blood plasma, bilirubin, activity of “liver” transaminases, LDH).

To avoid toxic liver damage, Paracetamol should not be combined with the intake of alcoholic beverages, and should not be taken by persons prone to chronic alcohol consumption. The risk of liver damage increases in patients with alcoholic hepatosis.

Prescribing ascorbic acid to patients with rapidly proliferating and intensively metastasizing tumors may worsen the course of the process.

In patients with increased iron content in the body, ascorbic acid should be used in minimal doses.

Drug Interactions

Ethanol enhances the sedative effect of antihistamine drugs.

Antidepressants, antiparkinsonian, antipsychotic drugs (phenothiazine derivatives) increase the risk of side effects (urinary retention, dry mouth, constipation).

Corticosteroids increase the risk of glaucoma.

Microsomal oxidation inducers (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of severe intoxication with small overdoses.

Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxic effects.

Paracetamol reduces the effectiveness of uricosuric drugs .

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 into 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.

Phenylephrine

Reduces the hypotensive effect of diuretics and antihypertensive drugs (including methyldopa, mecamylamine, guanadrel. guanethidine ).

Phenothiazines, alpha-blockers (phentolamine), furosemide and other diuretics reduce the hypertensive effect.

MAO inhibitors (including furazolidone, procarbazine, selegiline), oxytocin, ergot alkaloids, tricyclic antidepressants, methylphenidate, adrenergic stimulants enhance the pressor effect and arrhythmogenicity of phenylephrine.

Beta-blockers reduce the cardiotonic activity; against the background of reserpine, arterial hypertension is possible (due to depletion of catecholamine reserves in adrenergic endings, sensitivity to adrenergic agonists increases).

Inhalational anesthetics (including chloroform, enflurane, halothane, isoflurane, methoxyflurane) increase the risk of severe atrial and ventricular arrhythmias, as they sharply increase the sensitivity of the myocardium to sympathomimetics.

Ergometrine, ergotamine, methylergometrine, oxytocin, doxapram increase the severity of the vasoconstrictor effect.

Reduces the antianginal effect of nitrates, which in turn can reduce the pressor effect of sympathomimetics and the risk of arterial hypotension (simultaneous use is allowed depending on the achievement of the necessary therapeutic effect).

Thyroid hormones increase (mutually) the effect and the associated risk of coronary insufficiency (especially with coronary atherosclerosis).

Simultaneous use of phenylephrine and other sympathomimetic amines may lead to increased blood pressure and other side effects from the cardiovascular system.

Simultaneous use of cardiac glycosides (for example, digoxin) and phenylephrine may increase the risk of arrhythmia and myocardial infarction.

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.