Pelargovir (Drops) Instructions for Use

Marketing Authorization Holder

Vifitech, CJSC (Russia)

ATC Code

D06BX (Other chemotherapeutic preparations for topical use)

Active Substance

Pelargonium root (Ph.Eur. European Pharmacopoeia)

Dosage Form

Pelargovir

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.

Excipients: glycerol 85% – 20 g.

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

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

A herbal remedy. Contains an extract from the roots of Pelargonium sidoides.

It is assumed that the plant root extract may exert the following effects in vitro: stimulation of non-specific defense mechanisms; stimulation of the ciliary beat frequency of the ciliated epithelium of epithelial cells; modulation of interferon synthesis and pro-inflammatory cytokines; stimulation of NK-cell activity; stimulation of phagocytes, expression of adhesion molecules, chemotaxis.

Antimicrobial effects are possible: moderate direct antibacterial and antiviral properties; increase/inhibition of adhesion of group A streptococci to desquamative/live epithelial cells; inhibition of β-lactamase; cytoprotective properties: inhibition of human leukocyte elastase; antioxidant properties.

Indications

• Symptomatic treatment of acute bronchitis.

ICD codes

Dosage Regimen

Administer orally. Do not exceed a treatment duration of 3 weeks.

Adhere strictly to the prescribed dosing schedule. Use the provided dropper for accurate measurement.

Shake the bottle well before each use. Do not use if the solution appears contaminated or has changed color significantly.

Adverse Reactions

Gastrointestinal disorders occur infrequently. Mild bleeding from the gums or nosebleeds occur rarely.

Hypersensitivity reactions are rare but possible. Discontinue use immediately and seek medical attention if signs of an allergic reaction appear.

Monitor for any unusual bleeding or bruising. Report any persistent or severe adverse effects to a healthcare professional.

Drug Interactions

Concomitant use with indirect anticoagulants like warfarin is not recommended due to a potential increase in anticoagulant effect.

Monitor coagulation parameters closely if co-administration is unavoidable. The extract may influence blood coagulation parameters.

Inform your physician about all concomitant medications, including over-the-counter drugs and herbal supplements, before starting treatment.

Contraindications

• Hypersensitivity to Pelargonium sidoides or any excipient.
• Patients with an increased tendency to bleeding.
• Concurrent use of anticoagulant therapy.
• Severe hepatic or renal impairment due to insufficient clinical experience.

Overdose

Symptoms of overdose may include severe gastrointestinal upset and an increased risk of bleeding. In case of suspected overdose, discontinue use immediately.

Initiate symptomatic and supportive care. There is no specific antidote. Gastric lavage may be considered if ingestion is recent.

Contact a poison control center or physician for management advice. Provide supportive measures based on the clinical presentation.

Use in Pregnancy and Lactation

Not recommended for use during pregnancy and lactation, due to insufficient safety data during pregnancy and breastfeeding.

Special Precautions

The patient should consult a doctor if the condition does not improve within 1 week, in case of fever lasting for several days, shortness of breath, or bloody sputum.

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.