Papalor

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PAPALOR (PAPALOR)

Composition:

Active substance: extract of roots of Pelargonium sidoides (1:10), extraction solvent – ethanol 15% (v/v);

1 g of solution contains 800 mg of extract of roots of Pelargonium sidoides (1:10), extraction solvent – ethanol 15% (v/v);

Excipient: glycerol.

Pharmaceutical form. Oral drops.

Main physicochemical characteristics: clear liquid, reddish-brown to brown in color, with a characteristic slightly bitter taste.

Pharmacotherapeutic group.

Preparations used for cough and colds. Other preparations used for colds.

ATC Code R05X.

Pharmacological Properties

Pharmacodynamics

Papalor is a plant-derived preparation containing an extract from the roots of the South African plant Pelargonium sidoides (Pelargonium sidoides). The drug exerts pronounced antiviral, antibacterial, immunomodulatory, mucolytic, and cytoprotective effects, and is effective at all stages of the pathogenesis of acute respiratory viral infections, while also preventing progression and development of complications. The clinical efficacy of the phytoextract is due to the action of its main components: flavonoids (quercetin, gallocathechin, kaempferol, etc.); coumarins (umckalin, scopolin, scopoletin, etc.), as well as phenolic acids (gallic acid, etc.).

The antibacterial activity of the drug is effective against various gram-positive (Staphylococcus aureus, Streptococcus pneumoniae, beta-hemolytic Streptococcus) and gram-negative (Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae) bacteria.

The effect on nonspecific immune response involves stimulation of macrophage phagocytic activity and release of NO from macrophages, increased expression of CD11b adhesion molecules on the surface of neutrophils, and inhibition of leukocyte chemotaxis. This indicates the immunomodulatory properties of the drug.

The drug promotes activation of airway clearance mechanisms, thereby improving the elimination of viscous mucus and eliminating conditions for the proliferation of pathogenic bacteria.

In addition, phenolic acids stimulate the endogenous antiviral defense system, promote the synthesis of anti-inflammatory interleukins and interferon, and protect cells from damage during infections, thus exerting a beneficial effect on the treatment process.

Pharmacokinetics

Papalor is a complex mixture of numerous components, which collectively are considered the active substance. Data on pharmacokinetics are lacking.

Clinical characteristics.

Indications.

Acute and chronic infectious-inflammatory diseases of the respiratory tract and nasopharynx (bronchitis, catarrhal angina, sinusitis, rhinopharyngitis).

Contraindications.

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

Interaction with other medicinal products and other types of interactions.

No reports of interactions have been reported so far.

Due to the potential effect of Papalor on blood coagulation parameters, the possibility that it may enhance the anticoagulant effect of indirect vitamin K antagonist anticoagulants such as warfarin when used concomitantly cannot be excluded. In a study with healthy volunteers, no interactions were reported between the active substance and penicillin V.

Instructions for use.

If symptoms of the disease do not resolve within 1 week, if elevated body temperature persists for more than 3 days, or if the general condition worsens, or if dyspnea and hemoptysis occur, medical advice should be sought immediately.

This medicinal product contains 15% ethanol (alcohol) v/v, i.e. 180 mg/dose (for a dose of 30 drops), equivalent to 3.5 ml of beer or 1.2 ml of wine per dose. Harmful for patients suffering from alcoholism.

Use during pregnancy or breastfeeding.

Due to insufficient experience with the use of Papalor, it is not recommended during pregnancy or breastfeeding.

Ability to affect reaction speed when driving vehicles or operating machinery.

The effect on reaction speed when driving vehicles or operating machinery has not been studied. It should be noted that the product contains ethyl alcohol.

Method of administration and dosage.

Papalor is taken orally, half an hour before meals. It is recommended to dissolve the preparation in a small amount of liquid prior to administration.

The dosing regimen depending on age is presented in the table.

The duration of treatment is determined individually by a physician.

After the symptoms subside, it is recommended to continue treatment with Papalor for several more days to prevent disease relapse. If symptoms do not resolve within 7 days, it is recommended to consult a physician.

Children.

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

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

Overdose.

There have been no reports of overdose cases to date. An overdose may result in increased adverse reactions.

Adverse Reactions.

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

Respiratory system: Mild nosebleeds.

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

Hepatobiliary system: Increased liver function tests. A causal relationship between these elevated parameters and the use of the drug has not been established.

Shelf life. 2 years.

The shelf life after opening the container is 3 months.

Storage conditions.

Store at a temperature not exceeding 30 °C.

Keep out of reach of children.

Packaging.

20 ml in a container with a dropper and cap; 1 container per cardboard box labeled in Ukrainian and English.

Availability category. Over-the-counter (without prescription).

Manufacturer.

Fitofarm Klenka S.A., Poland.

Manufacturer's address and place of business.

Klenka 1, 63-040 Nowe Miasto nad Wartą, Poland.

Marketing Authorization Holder.

LLC "Ersel Pharma Ukraine".

Address of the Marketing Authorization Holder.

21000, Vinnytsia, Prospekt Yunosti, 20/73, Ukraine.

In case of adverse events, side effects, or lack of therapeutic effect, please report to: LLC "Ersel Pharma Ukraine", 21000, Vinnytsia, Prospekt Yunosti, 20/73, Tel./Fax (0432) 65-78-78, e-mail: [email protected]