DysheLORz (Drops) Instructions for Use

Marketing Authorization Holder

Vifitech, CJSC (Russia)

Contact Information

AKVION JSC (Russia)

ATC Code

D06BX (Other chemotherapeutic preparations for topical use)

Active Substance

Pelargonium root (Ph.Eur. European Pharmacopoeia)

Dosage Form

DysheLORz

Oral drops: 25 ml or 50 ml dropper bottle, 50 ml bottle.

Dosage Form, Packaging, and Composition

Oral drops in the form of a transparent or slightly opalescent liquid from light brown with a reddish tint to reddish-brown in color, with a weak characteristic odor; sediment formation is allowed during storage.

* liquid extract of Pelargonium sidoides roots (1:8-10) is obtained from dried and crushed roots of Pelargonium sidoides – Pelargonium sidoides DC., family Geraniaceae (Eur. Ph. “Pelargonium Root”) by extraction with ethanol (ethyl alcohol) 11% (w/w) with a total ratio of raw material and extractant (1:10-12).

Excipients: glycerol (glycerin) 85% – 20 g.

25 ml – dark glass dropper bottles (1) – cardboard boxes.
50 ml – dark glass dropper bottles (1) – cardboard boxes.
50 ml – dark glass bottles (1) – cardboard boxes.

Clinical-Pharmacological Group

Herbal preparation, used for infectious diseases of the respiratory tract and ENT organs

Pharmacotherapeutic Group

Antimicrobial agent of plant origin

Pharmacological Action

The drug has an antimicrobial effect, possesses mucolytic properties, and helps to increase the body’s non-specific resistance.

Indications

• acute and chronic infectious and inflammatory diseases of the respiratory tract and ENT organs (sinusitis, rhinopharyngitis, tonsillitis, bronchitis) as part of complex therapy.

ICD codes

Dosage Regimen

Orally, 30 minutes before meals with a small amount of liquid.

Adults and children over 12 years – 20-30 drops 3 times/day.

Children from 6 to 12 years – 10-20 drops 3 times/day.

Children from 1 year to 6 years – 5-10 drops 3 times/day.

When dosing the drug, the bottle should be held vertically, tapping the bottom of the bottle lightly if necessary.

The course of treatment with the drug is 10 days. If there is no positive effect from the therapy carried out for 5-7 days or if the condition worsens, you should consult a doctor.

Adverse Reactions

The assessment of the frequency of adverse reactions is based on the WHO classification: very common (≥1/10); common (from ≥1/100 to <1/10); uncommon (from ≥1/1000 to <1/100); rare (from ≥1/10000 to <1/1000); very rare (<1/10000) and frequency unknown - cannot be estimated from the available data.

From the immune system rare – allergic reactions.

From the respiratory system, thoracic and mediastinal organs rare – nosebleeds.

From the gastrointestinal tract uncommon – nausea, vomiting, epigastric pain, diarrhea; rare – bleeding gums.

From the liver and biliary tract frequency unknown – possible appearance of signs of liver dysfunction (jaundice).

If the adverse reactions mentioned in the instructions occur, or they worsen, or any other adverse reactions not mentioned in the instructions are noted, the patient should inform the doctor.

Contraindications

• hypersensitivity to the components of the drug;
• predisposition to bleeding;
• severe hepatic insufficiency;
• severe renal insufficiency;
• concomitant use of anticoagulants;
• pregnancy;
• breastfeeding period;
• children under 1 year of age (due to the presence of ethyl alcohol in the drug).

With caution alcoholism, craniocerebral trauma, brain diseases, epilepsy, impaired liver and kidney function (no experience of use), children over 1 year of age.

Use in Pregnancy and Lactation

The use of the drug is contraindicated during pregnancy and breastfeeding.

Special Precautions

Turbidity of the drug is possible during storage, but this does not affect its pharmacological efficacy. Since the drug is a natural product, slight changes in the color and taste of the drug are possible.

The drug contains from 7.0 to 10.6% ethanol.

In a single dose of the drug, the maximum ethanol content is

• In adults and children over 12 years – about 0.125 g;
• In children under 12 years – less than 0.1 g;

In a daily dose of the drug, the maximum ethanol content is

• In adults and children over 12 years – about 0.375 g;
• In children under 12 years – less than 0.3 g.

If there is no therapeutic effect while taking the drug for 7 days, if elevated temperature persists for several days, if shortness of breath or bloody sputum appears, if signs of liver dysfunction (jaundice) appear, it is necessary to consult a doctor.

Influence on the ability to drive vehicles and mechanisms

During treatment with the drug, one should refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

No cases of overdose have been reported to date.

Drug Interactions

With simultaneous use with anticoagulants, including coumarin derivatives, it is possible to enhance their anticoagulant effect and cause bleeding (nosebleed, bleeding gums).

Storage Conditions

The drug should be stored in the original packaging (bottle in a box), in a place inaccessible to children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

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.