Vicks AntiGripp Max (Powder) Instructions for Use

Marketing Authorization Holder

Procter & Gamble Distributor Company LLC (Russia)

Manufactured By

Wrafton Laboratories, Limited (United Kingdom)

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)

Dosage Forms

	Vicks AntiGripp Max	Powder for oral solution (black currant) 1000 mg+12.2 mg/5 g: sachet 5 or 10 pcs.
		Powder for oral solution (lemon) 1000 mg+12.2 mg/5 g: sachet 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Powder for oral solution (black currant) ; finely crystalline, light purple in color, with a characteristic black currant odor; prepared solution is red-violet in color, with a characteristic black currant odor.

Excipients: ascorbic acid – 100 mg, sucrose – 2351 mg, citric acid – 812 mg, sodium citrate – 501 mg, aspartame – 53 mg, acesulfame potassium – 51 mg, black currant flavor S-133747 – 56 mg, black currant flavor 1007348 – 60 mg, black currant colorant – 6 mg.

5 g – laminated sachets (5) – cardboard packs.
5 g – laminated sachets (10) – cardboard packs.

Powder for oral solution (lemon), finely crystalline, light yellow in color, with a characteristic lemon odor; prepared solution is yellow in color, with a characteristic lemon odor, with opalescence.

Excipients: ascorbic acid – 100 mg, sucrose – 1936 mg, citric acid – 812 mg, sodium citrate – 501 mg, aspartame – 25 mg, acesulfame potassium – 65 mg, quinoline yellow dye – 1 mg, lemon flavor F/29088 – 30 mg, lemon flavor F/29089 – 240 mg, lemon flavor F/28151 – 240 mg, lemon flavor F/501.476/AP0504 – 40 mg.

5 g – laminated sachets (5) – cardboard packs.
5 g – laminated sachets (10) – 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 agent + alpha-adrenergic agonist)

Pharmacological Action

Combined drug.

Paracetamol – 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.

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

The effect occurs 15-20 minutes after taking the drug and lasts 4-6 hours.

Pharmacokinetics

Paracetamol is rapidly and completely absorbed from the small intestine. C_max in the blood is observed 15-20 minutes after oral administration. Systemic bioavailability is determined by presystemic metabolism and, depending on the dose, ranges from 70% to 90%. Paracetamol is rapidly distributed throughout all body tissues and has

T_1/2 of paracetamol is approximately 2 hours. Paracetamol is metabolized in the liver and excreted in the urine as glucuronides and sulfate conjugates (>80%).

Phenylephrine is rapidly absorbed from the gastrointestinal tract. C_max is reached in 1-2 hours. The level of phenylephrine metabolism during the “first pass” through the liver is quite high (about 60%), so oral administration of phenylephrine reduces its bioavailability (about 40%). T_1/2 varies from 2 to 3 hours. It is excreted in the urine as sulfate conjugates.

Indications

Symptomatic treatment of colds and influenza: pain of various localization, incl. headache; sore throat and paranasal sinuses; nasal congestion; elevated body temperature.

ICD codes

Dosage Regimen

Dissolve the contents of one sachet in one glass of hot water. Stir thoroughly until the powder is completely dissolved. Consume the solution while it is still warm.

Administer orally. Maintain a minimum interval of 4-6 hours between doses. Do not exceed three sachets (3 grams of paracetamol) within a 24-hour period.

Limit the total duration of treatment to five days for pain relief and three days for fever reduction. If symptoms persist, discontinue use and consult a physician.

Do not use this medication for more than the recommended duration or dosage. Avoid concomitant use of other products containing paracetamol or phenylephrine.

This medication is contraindicated in children and adolescents under 18 years of age. It is also contraindicated during pregnancy and lactation.

Patients with hepatic impairment, renal impairment, or phenylketonuria should not use this product. Do not combine with alcohol, sedatives, or monoamine oxidase inhibitors.

Adverse Reactions

Allergic reactions skin rash, urticaria, angioedema.

From the hematopoietic system anemia, thrombocytopenia, agranulocytosis, hemolytic and aplastic anemia, methemoglobinemia, pancytopenia.

From the CNS dizziness, sleep onset disturbance, increased excitability.

From the cardiovascular system increased blood pressure, tachycardia.

From the sensory organs accommodation paresis, mydriasis, increased intraocular pressure.

Other hepatotoxic effect, nephrotoxicity (papillary necrosis), bronchospasm, nausea, vomiting, dry mouth, urinary retention.

Contraindications

Arterial hypertension; coronary artery atherosclerosis; aortic stenosis; acute myocardial infarction; tachyarrhythmia; thyrotoxicosis; pheochromocytoma; closed-angle glaucoma; prostatic hyperplasia; renal/hepatic insufficiency; simultaneous use of beta-blockers, tricyclic antidepressants, MAO inhibitors (including within 14 days after their discontinuation); pregnancy; lactation period (breastfeeding); children under 18 years of age; hypersensitivity to paracetamol and/or phenylephrine.

With caution

Diabetes mellitus, bronchial asthma, COPD, blood diseases, congenital hyperbilirubinemias (Gilbert’s, Dubin-Johnson, Rotor syndromes), hyperoxaluria.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Contraindication — hepatic insufficiency.

Use in Renal Impairment

Contraindication — renal insufficiency.

Pediatric Use

The drug is contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

The drug should not be combined with ethanol intake.

During treatment, it is necessary to refrain from taking hypnotics, anxiolytic drugs, other drugs containing Paracetamol, as well as from alcohol consumption.

The use of this combination distorts the results of laboratory tests assessing the concentration of glucose and uric acid in plasma.

If symptoms persist for more than 5 days, the patient should consult a doctor.

Drug Interactions

Stimulators of microsomal oxidation in the liver (including phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites of paracetamol, which may lead to the possibility of severe intoxications.

Paracetamol reduces the effectiveness of uricosuric drugs.

The absorption rate of paracetamol is increased by metoclopramide or domperidone and decreased by cholestyramine.

The anticoagulant effect of warfarin and other coumarin derivatives is enhanced with prolonged use of paracetamol.

This combination enhances the effects of MAO inhibitors, sedative drugs, ethanol.

With simultaneous use of phenylephrine with antidepressants, antiparkinsonian, antipsychotic agents, phenothiazine derivatives, urinary retention, dry mouth, and constipation are possible.

When used with corticosteroids, the risk of developing glaucoma increases.

Tricyclic antidepressants enhance the adrenomimetic effect of phenylephrine; simultaneous administration of halothane increases the risk of ventricular arrhythmia.

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.