Maxicold^® Rino (Powder) Instructions for Use

Marketing Authorization Holder

Otisipharm, JSC (Russia)

Manufactured By

Pharmstandard-Lexredstva OJSC (Russia)

ATC Code

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

Dosage Forms

	Maxicold® Rino	Powder for preparation of oral solution (raspberry): sachet 15 g 5 or 10 pcs.
		Powder for preparation of oral solution (orange): sachet 15 g 5 or 10 pcs.
		Powder for preparation of oral solution (lemon): sachet 15 g 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of oral solution (lemon) yellow in color, crystalline, with a specific odor; the presence of white crystals and easily crumbling lumps is allowed; the powder dissolves in 250 ml of hot water to form an opalescent solution of light yellow color with a characteristic lemon odor.

Excipients: citric acid monohydrate, malic acid, sucrose (refined sugar), titanium dioxide, sodium citrate dihydrate, lemon flavor, quinoline yellow dye, calcium hydrogen phosphate dihydrate (tricalcium phosphate tribasic), ethylcellulose.

15 g – thermowelded sachets made of combined material (5) – cardboard packs.
15 g – thermowelded sachets made of combined material (10) – cardboard packs.

Powder for preparation of oral solution (orange) yellow in color, crystalline, with a specific odor; the presence of white crystals and easily crumbling lumps is allowed; the powder dissolves in 250 ml of hot water to form an opalescent solution of light yellow color with a characteristic orange odor.

Excipients: citric acid monohydrate, malic acid, sucrose (refined sugar), titanium dioxide, sodium citrate dihydrate, orange flavor, quinoline yellow dye, calcium hydrogen phosphate dihydrate (tricalcium phosphate tribasic), ethylcellulose.

15 g – thermowelded sachets made of combined material (5) – cardboard packs.
15 g – thermowelded sachets made of combined material (10) – cardboard packs.

Powder for preparation of oral solution (raspberry) from light pink to dark pink with a reddish tint, crystalline, with a specific odor; the presence of white crystals and easily crumbling lumps is allowed; the powder dissolves in 250 ml of hot water to form an opalescent solution of pink color with a characteristic raspberry odor.

Excipients: citric acid monohydrate, malic acid, sucrose (refined sugar), titanium dioxide, sodium citrate dihydrate, raspberry flavor, quinoline yellow dye, acid red dye (azorubine), calcium hydrogen phosphate dihydrate (tricalcium phosphate tribasic), ethylcellulose.

15 g – thermowelded sachets made of combined material (5) – cardboard packs.
15 g – thermowelded sachets made of combined material (10) – cardboard packs.

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

A combined drug, it has antipyretic, vasoconstrictive, analgesic, and antiallergic effects.

Paracetamol has antipyretic and analgesic effects: it reduces pain syndrome observed in colds (sore throat, headache, muscle and joint pain), and reduces high fever.

Pheniramine has an antiallergic effect: it eliminates swelling and hyperemia of the mucous membranes of the nasal cavity, nasopharynx and paranasal sinuses, and reduces runny nose and lacrimation.

Phenylephrine has a vasoconstrictive effect: it reduces swelling of the nasopharyngeal mucosa.

The combined action of pheniramine and phenylephrine leads to a reduction in nasal congestion and significant relief of nasal breathing.

Ascorbic acid (vitamin C) replenishes the increased need for vitamin C in colds and influenza, especially in the early stages of the disease; it increases the body’s resistance to infectious diseases.

Pharmacokinetics

Data on the pharmacokinetics of the drug are not provided.

Indications

• Symptomatic treatment of colds, acute respiratory viral infections (ARVI), influenza, accompanied by high fever, chills, headache, runny nose, sinus and throat pain, nasal congestion, sneezing, and muscle and joint pain.

ICD codes

Dosage Regimen

The drug is taken orally. The contents of one sachet should be dissolved in 1 glass of boiled hot water. The prepared solution should be consumed hot; sugar can be added to taste.

A repeated dose can be taken every 4 hours (no more than 3 doses within 24 hours).

Maxicold^® Rino can be used at any time of the day, but the best effect is achieved by taking the drug before bedtime, at night.

If no relief of symptoms is observed within 3 days after starting the drug, the patient should consult a doctor.

Adverse Reactions

From the nervous system drowsiness, sleep onset disturbance, increased excitability, dizziness.

From the organ of vision accommodation paresis.

From the cardiovascular system increased blood pressure.

From the digestive system nausea, pain in the epigastric region, dry mouth.

From the urinary system urinary retention.

Other allergic reactions; rarely – anemia.

Contraindications

• Severe hepatic insufficiency;
• Severe renal insufficiency;
• Pregnancy;
• Lactation period (breastfeeding);
• Children under 12 years of age;
• Hypersensitivity to the components of the drug.

With caution the drug should be prescribed for arterial hypertension, diabetes mellitus, closed-angle glaucoma, liver or kidney diseases, prostatic hyperplasia, glucose-6-phosphate dehydrogenase deficiency.

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy and lactation.

Use in Hepatic Impairment

Use of the drug is contraindicated in severe hepatic insufficiency.

The drug should be prescribed with caution in liver diseases.

Use in Renal Impairment

Use of the drug is contraindicated in severe renal insufficiency.

The drug should be prescribed with caution in kidney diseases.

Pediatric Use

The drug is contraindicated for use in children under 12 years of age.

Special Precautions

To avoid toxic liver damage, Paracetamol should not be combined with the intake of alcoholic beverages, nor should it be taken by persons prone to chronic alcohol consumption.

The risk of liver damage increases in patients with alcoholic hepatosis.

Patients with diabetes mellitus or patients on a low-sugar diet should take into account that each sachet of the drug contains 13 g of sugar, which corresponds to 1.0 Bread Units (XE).

Do not use the drug from damaged sachets.

Effect on ability to drive vehicles and mechanisms

During treatment, it is not recommended to drive a car or other mechanisms requiring concentration and high speed of psychomotor reactions.

Overdose

Symptoms nausea, vomiting, pain in the epigastric region; hepatotoxic and nephrotoxic effects, in severe cases liver failure, encephalopathy and coma develop.

Treatment gastric lavage, intake of activated charcoal.

In case of overdose, the patient should consult a doctor.

Drug Interactions

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

The risk of the hepatotoxic effect of paracetamol increases with the simultaneous administration of barbiturates, diphenylhydantoin, carbamazepine, rifampicin, zidovudine and other inducers of liver microsomal enzymes.

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

The drug reduces the hypotensive effect of guanethidine, which in turn enhances the alpha-adrenergic stimulating activity of phenylephrine.

Storage Conditions

The drug should be stored in a dry, light-protected place, out of the reach of children, at a temperature not exceeding 30°C (86°F).

Shelf Life

Shelf life – 2 years.

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.