PELORSIN

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PELORSIN (PELORSIN)

Composition:

Active ingredient: 1 g of solution contains 800 mg of liquid extract from the roots of Pelargonium sidoides (1:8–10), extraction solvent: ethanol 11% (m/m);

Excipients: glycerol (85%).

Pharmaceutical form. Oral solution.

Main physicochemical characteristics: reddish-brown liquid with a characteristic odor. Slight turbidity may occur during storage.

Pharmacotherapeutic group.

Agents acting on the respiratory system. ATC code R05.

Pharmacological properties.

Pharmacodynamics.

The medicinal product contains an extract of the roots of Pelargonium sidoides.

In animal studies, following oral administration of the extract of Pelargonium sidoides roots, a reduction in disease manifestations (non-specific symptoms of disease in the context of infection) and antioxidant activity were observed.

In in vitro tests, the following effects of the drug have been confirmed:

Stimulation of non-specific defense mechanisms:

• stimulation of ciliary beat frequency of ciliated epithelium;
• modulation of interferon and pro-inflammatory cytokine synthesis;
• stimulation of NK cell activity;
• stimulation of phagocytes, expression of adhesion molecules, chemotaxis;

Antimicrobial effects:

• moderate direct antibacterial and antiviral properties;
• increased/inhibited adhesion of A-streptococci to desquamated/viable epithelial cells;
• inhibition of beta-lactamase;

Cytoprotective properties:

• inhibition of human leukocyte elastase;
• antioxidant properties.

Pharmacokinetics.

There are no data available on the pharmacokinetics of the drug.

Clinical characteristics.

Indications.

Acute and chronic respiratory tract and ENT organ infections (bronchitis, sinusitis, tonsillar angina, rhinopharyngitis).

Contraindications.

Hypersensitivity to the components of the medicinal product; increased predisposition to bleeding, concomitant use of medicinal products that impair blood coagulation; severe liver and kidney diseases (due to insufficient experience with the use of this medicinal product in such cases).

Interaction with other medicinal products and other types of interactions.

No reports of interactions have been received to date.

Due to the possible effect of the medicinal product Pelorsin on blood coagulation parameters, the possibility that it may influence the action of indirect anticoagulants such as warfarin when used concomitantly cannot be excluded.

In a placebo-controlled, double-blind clinical study involving healthy volunteers, no interactions between the medicinal product Pelorsin and penicillin V were observed.

Special precautions for use

If symptoms of the disease do not disappear within 1 week, if elevated body temperature persists for more than 3 days, or if the general condition worsens, as well as in case of liver function disorders of any origin, dyspnea, or bloody sputum, medical advice should be sought.

This medicinal product contains 11% ethanol (alcohol) by mass/mass, i.e. 132 mg/dose (30 drops), equivalent to 2.6 ml of beer or 0.9 ml of wine per dose. It may be harmful for patients suffering from alcoholism. Caution should be exercised when administering this product to children, patients with liver disorders, and patients with epilepsy. The use of this medicinal product is not recommended in pregnant women and breastfeeding women.

Use during pregnancy or breastfeeding

The use of this medicinal product is not recommended during pregnancy or breastfeeding due to insufficient clinical experience with its use in these patient groups.

Effect on ability to drive and use machines

The effect on the ability to drive or operate machinery has not been studied; however, it should be noted that the medicinal product contains 11% ethanol (by mass/mass).

Dosage and Administration.

The solution should be taken with a small amount of liquid, 30 minutes before meals, in the morning, afternoon, and evening.

In the acute phase of the disease, the usual dosage is:

for adults and children aged 12 years and older — 30 drops three times daily;

for children aged 6 to 12 years — 20 drops three times daily;

for children aged 1 to 6 years — 10 drops three times daily.

For prevention of relapses and ongoing treatment of chronic conditions, adults and children aged 12 years and older should take 10–20 drops of the medication three times daily.

The average duration of treatment for acute illness and prevention of relapses is 7–10 days. The total treatment duration should not exceed 3 weeks.

Hold the bottle vertically and, if necessary, gently tap its bottom.

Children.

There is no experience with the use of the medicinal product in children under 1 year of age; therefore, Pelorsin is prescribed to children from the age of 1 year.

The use of Pelorsin for the treatment of younger children (aged 1 to 6 years) is recommended under medical supervision.

Overdose.

No cases of overdose have been reported to date. However, an overdose may lead to an increase in adverse reactions.

Adverse reactions.

Gastrointestinal disorders: gastrointestinal disturbances (including stomach pain, heartburn, nausea, diarrhea), mild bleeding from the gums.

Respiratory system disorders: mild nosebleeds.

Skin / Immune system disorders: hypersensitivity reactions (including skin rash, urticaria, itching of the skin and mucous membranes). In very rare cases, severe hypersensitivity reactions with facial swelling, shortness of breath, and decreased blood pressure may occur.

Hepatobiliary disorders: elevated liver function tests. A causal relationship between these elevations and the use of the drug has not been demonstrated.

Shelf life.

2 years.

Shelf life after opening the bottle: 3 months.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze.

Keep out of the reach of children.

Packaging. 20 ml or 25 ml or 50 ml in a bottle. 1 bottle per carton.

Classification. Over-the-counter (OTC).

Manufacturer.

JSC "Farmak".

Address of the manufacturer and location of its business activity.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.