Zvezdochka FLU (Powder) Instructions for Use

Marketing Authorization Holder

Dominanta-Service, JSC (Russia)

Manufactured By

Danapha Pharmaceutical, Joint Stock Company (Vietnam)

ATC Code

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

Dosage Form

Zvezdochka FLU

Powder for preparation of oral solution [with lemon, orange, raspberry flavor]: pkg. 5, 6, 8, 10 or 12 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of oral solution [with lemon, orange, raspberry flavor].
For lemon flavor: granules from white to light yellow with a slight lemon odor; reconstituted solution is transparent or almost transparent, light yellow in color.
For orange flavor: granules from white to light orange with a slight orange odor; reconstituted solution is transparent or almost transparent, light orange in color.
For raspberry flavor: granules from white to light pink with a slight raspberry odor; reconstituted solution is transparent or almost transparent, light red in color.

Excipients : maltodextrin, mannitol, sucralose, sodium chloride, citric acid, sucrose, colloidal silicon dioxide, polyethylene glycol 6000 (for orange flavor), Allura Red AC (E129) (for raspberry flavor), Quinoline Yellow (E104) (for lemon flavor), Sunset Yellow FCF (E110) (for orange flavor), raspberry flavor (for raspberry flavor), lemon flavor (for lemon flavor), orange flavor (for orange flavor).

15 g – sachets made of combined material (5) – cardboard packs.
15 g – sachets made of combined material (6) – cardboard packs.
15 g – sachets made of combined material (8) – cardboard packs.
15 g – sachets made of combined material (10) – cardboard packs.
15 g – sachets made of combined material (12) – cardboard packs.

Clinical-Pharmacological Group

Drug for symptomatic therapy of acute respiratory diseases

Pharmacotherapeutic Group

Analgesics; other analgesics and antipyretics; anilides

Pharmacological Action

A combined drug.

Paracetamol is a non-narcotic analgesic; by acting on the centers of pain and thermoregulation, it has analgesic and antipyretic effects.

Pheniramine is an H₁-histamine receptor blocker; it reduces rhinorrhea and lacrimation, and eliminates spasmodic phenomena.

Phenylephrine is an adrenomimetic with a moderate vasoconstrictive effect (stimulation of alpha₁-adrenergic receptors).

Ascorbic acid is involved in the regulation of redox processes, carbohydrate metabolism, blood clotting, tissue regeneration, and the synthesis of steroid hormones; it increases the body’s resistance to infections and reduces vascular permeability; it 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).

Indications

• Symptomatic treatment of “common cold” diseases, acute respiratory viral infections (ARVI), including influenza (febrile syndrome, pain syndrome, rhinorrhea).

ICD codes

Dosage Regimen

Administer orally.

Dissolve the contents of one sachet in one glass of boiled hot water.

Consume the solution hot.

Add sugar to taste if desired.

Take a repeated dose every 4 hours.

Do not exceed 4 doses within 24 hours.

You may take this medication at any time of day.

Consult a doctor if no symptom relief occurs within 3 days of starting treatment.

Avoid driving vehicles or operating machinery due to potential dizziness and drowsiness.

Refrain from consuming alcoholic beverages during treatment.

Do not use with other products containing paracetamol.

Adverse Reactions

Allergic reactions (skin rash, itching, urticaria, angioedema), nausea, epigastric pain; anemia, thrombocytopenia, agranulocytosis. Increased excitability, dizziness, increased blood pressure, sleep onset disturbance. Mydriasis, accommodation paresis, increased intraocular pressure, dry mouth; urinary retention.

With long-term use in large doses – hepatotoxic effect, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia; nephrotoxicity (renal colic, glucosuria, interstitial nephritis, papillary necrosis).

Contraindications

• Hypersensitivity;
• Children under 12 years of age;
• Phenylketonuria;
• Diabetes mellitus;
• Portal hypertension;
• Alcoholism;
• Renal failure;
• Pregnancy;
• Lactation period;
• Glucose-6-phosphate dehydrogenase deficiency;
• Concomitant use of tricyclic antidepressants, MAO inhibitors (MAOIs), beta-blockers.

With caution

Congenital hyperbilirubinemias (Gilbert’s, Dubin-Johnson and Rotor syndromes), children under 15 years of age, angle-closure glaucoma, prostatic hyperplasia, severe coronary artery atherosclerosis, arterial hypertension, hepatic and/or renal failure, pheochromocytoma.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

Use with caution in hepatic insufficiency.

Use in Renal Impairment

Contraindicated in renal failure.

Pediatric Use

Contraindicated in children under 12 years of age.

Special Precautions

During treatment, it is necessary to refrain from consuming ethanol (development of a hepatotoxic effect is possible).

Effect on the ability to drive vehicles and machinery

It is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Symptoms (caused by paracetamol) pallor of the skin, decreased appetite, nausea, vomiting; hepatonecrosis (the severity of necrosis due to intoxication is directly dependent on the degree of overdose). Toxic effects in adults are possible after ingestion of more than 10-15 g of paracetamol: increased activity of “liver” transaminases, increased prothrombin time (12-48 hours after ingestion); the full clinical picture of liver damage appears after 1-6 days. Rarely, liver failure develops rapidly and may be complicated by renal failure (tubular necrosis).

Treatment administration of SH-group donors and precursors of glutathione synthesis – methionine 8-9 hours after overdose and N-acetylcysteine after 12 hours.

The need for additional therapeutic measures (further administration of methionine, intravenous administration of N-acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as the time elapsed after its ingestion.

Drug Interactions

It enhances the effects of MAO inhibitors, sedative drugs, ethanol.

Ethanol enhances the sedative effect of pheniramine, which is part of the drug.

Pheniramine simultaneously with MAO inhibitors, furazolidone can lead to hypertensive crisis, excitation, hyperpyrexia.

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

Glucocorticosteroids (GCS) increase the risk of increased intraocular pressure.

Paracetamol reduces the effectiveness of uricosuric drugs and increases the effectiveness of indirect anticoagulants.

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

It reduces the hypotensive effect of guanethidine, which in turn enhances the alpha-adrenostimulating activity of phenylephrine.

Storage Conditions

In a dry place, protected from light, at a temperature from 15 to 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 3 years.

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.