Pelorsin®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PELORSIN® (PELORSIN)

Composition:

Active substance: dry extract of roots of Pelargonium sidoides (Pelargonium sidoides);

One film-coated tablet contains dry extract of roots of Pelargonium sidoides (Pelargonium sidoides) (4 – 25 : 1), extraction solvent: ethanol 11% (m/m) — 20 mg;

Excipients: maltodextrin; microcrystalline cellulose; lactose monohydrate; sodium croscarmellose; colloidal anhydrous silicon dioxide; magnesium stearate;

Excipients for film coating: Opadry Red 03F250013 (hypromellose 2910, polyethylene glycol 4000, iron oxide yellow (E 172), iron oxide red (E 172), iron oxide black (E 172), talc).

Pharmaceutical form. Film-coated tablets.

Main physicochemical characteristics: round, biconvex tablets, coated with reddish-brown film layer.

Pharmacotherapeutic group. Preparations used in cough and colds. ATC code R05.

Pharmacological Properties

Pharmacodynamics

The medicinal product contains an extract from the roots of Pelargonium sidoides, which originates from South Africa.

In animal studies, administration of the extract to mice demonstrated alleviation of disease symptoms (non-specific symptoms associated with infection) and antioxidant properties.

In in vitro tests, the following effects of Pelorcin® 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 phagocyte activity, expression of adhesion molecules, and chemotaxis;

Antimicrobial effects:

• Moderate direct antibacterial and antiviral properties;
• Increased/inhibited adhesion of A-streptococci to desquamated/live epithelial cells;
• Inhibition of beta-lactamase;

Cytoprotective properties:

• Inhibition of human leukocyte elastase;
• Antioxidant properties.

Pharmacokinetics

Currently, there are no data available on the pharmacokinetics of the drug.

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity to any of the components of the medicinal product, increased tendency to bleeding, and concomitant use of medicinal products that delay blood coagulation.

Pelorsin® must not be used in severe liver and kidney diseases.

Interaction with other medicinal products and other forms of interaction.

Currently, there are no data regarding interactions with other agents.

Due to the potential effect of the medicinal product Pelorsin® on blood coagulation parameters, interactions with indirect anticoagulants such as warfarin cannot be excluded when used concomitantly. In a placebo-controlled, double-blind clinical study involving healthy volunteers, no interactions were observed between the dried liquid extract of Pelargonium sidoides roots and penicillin V.

Special precautions for use.

If symptoms do not resolve within one week, if elevated body temperature persists for several days, or if shortness of breath and bloody sputum occur, it is recommended to consult a physician.

Hepatic function disorders of various origins have been reported in connection with the use of medicinal products containing extracts of Pelargonium sidoides.

If symptoms of liver dysfunction occur, administration of the medicinal product must be discontinued immediately and medical advice should be sought.

If you have known intolerance to certain sugars, consult your doctor before taking this medicinal product.

This medicinal product contains a small amount of ethanol (alcohol), less than 100 mg/dose.

Use during pregnancy or breastfeeding.

Due to the lack of sufficient experience with the use of Pelorin® during pregnancy or breastfeeding, its use is not recommended during these periods. There are no data on the effect of Pelorin® on fertility.

Ability to influence reaction speed when driving or operating machinery.

There are no studies on the effect of this medicinal product on the ability to drive or operate machinery.

Dosage and Administration

For adults and children aged 12 years and older: 1 tablet 3 times daily (in the morning, afternoon, and evening).

For children aged 6 to 12 years: 1 tablet 2 times daily (in the morning and evening).

Pelorcin® should be taken whole, without chewing, with a small amount of liquid.

Additionally, to prevent recurrence, treatment is recommended to be continued for several more days after the symptoms have disappeared. The average duration of treatment is 7–10 days.

The total treatment duration should not exceed 3 weeks.

If symptoms persist for more than 1 week without improvement during medication use, it is recommended to consult a physician.

Children.

The drug is indicated for children aged 6 years and older.

Overdose.

There have been no reports of overdose cases to date.

Side effects.

The adverse reactions reported during the use of the medicinal product are listed below by organ systems and by frequency: 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), unknown (frequency cannot be determined from available data).

Gastrointestinal disorders:

uncommon: gastrointestinal disorders (abdominal pain, heartburn, nausea, diarrhea);

rare: mild bleeding of the gums.

Respiratory system disorders:

rare: mild nosebleeds.

Skin and subcutaneous tissue disorders / immune system disorders:

rare: hypersensitivity reactions (rash, urticaria, pruritus);

very rare: severe allergic reactions (facial swelling, dyspnea, decreased blood pressure).

Hepatobiliary disorders:

very rare: liver function abnormalities of various origins, including increased levels of liver enzymes. A causal relationship between these laboratory findings and the use of the drug has not been established.

If any adverse reactions occur, the use of the medicinal product should be discontinued and medical advice should be sought.

Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after authorization of the medicinal product is of great importance. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, as well as patients or their legal representatives, are encouraged to report any suspected adverse reactions and lack of efficacy via the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

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

Storage conditions.

No special storage conditions required.

Keep out of reach of children.

Packaging. 10 tablets per blister. 2 blisters per carton.

Category of supply.

Over-the-counter.

Manufacturer. JSC "Farmak".

Address of the manufacturer and its place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.