Pelaufen

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PELAFEN

Composition:

Active substance: dry root extract of Pelargonium (Pelargonii radicis extractum siccum) (4–7:1); extraction solvent: ethanol 14% (v/v);

One coated tablet contains 20 mg of dry root extract of Pelargonium (Pelargonii radicis extractum siccum) (4–7:1); extraction solvent: ethanol 14% (v/v);

Excipients: extract: powdered cellulose, colloidal anhydrous silicon dioxide; tablet core: microcrystalline cellulose, colloidal anhydrous silicon dioxide, magnesium stearate; tablet coating: hypromellose, talc, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172), macrogol 6000.

Pharmaceutical form. Coated tablets.

Main physicochemical characteristics: round, smooth, biconvex, reddish-brown coated tablets.

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

Pharmacological Properties

Pelafen is a traditional herbal medicinal product of plant origin intended for use according to indications supported by long-standing use.

Pharmacodynamics.

The medicinal product contains an extract from the roots of Pelargonium sidoides DC and/or Pelargonium reniforme Curt., which stimulates non-specific defense mechanisms of the body, has moderate antibacterial and antiviral properties (direct and indirect mechanisms), and cytoprotective effects. In addition, the extract from pelargonium roots stimulates the mucociliary system and helps alleviate the course of the disease.

Pharmacokinetics.

Pharmacokinetic data for the drug are not required.

Clinical characteristics.

Indications.

Symptomatic treatment of colds.

Contraindications.

Hypersensitivity to the active substance of the medicinal product or to excipients. Increased tendency to bleeding, concomitant use of medicinal products that delay blood coagulation; severe liver and kidney diseases (due to lack of sufficient experience with the use of this medicinal product in such cases).

Interaction with other medicinal products and other forms of interaction. Unknown. Due to the possible effect of the medicinal product on blood coagulation parameters, there is a possibility that it may influence the action of indirect anticoagulants such as warfarin when used concomitantly.

The patient should inform the physician about all medicinal products they are taking or have recently taken, as well as about any medicinal products they plan to use.

Special precautions for use

Do not exceed the recommended daily dose.

If symptoms of the disease do not resolve within one week, elevated body temperature persists for more than 3 days, or the general condition worsens, or dyspnea and bloody and/or purulent sputum are observed, consult a physician immediately.

Cases of hepatotoxicity and hepatitis have been reported during the use of the medicinal product. If signs of hepatotoxicity occur, discontinue the drug immediately and consult a physician.

There is no data on use in patients with impaired liver and/or kidney function.

The patient should consult a physician if symptoms of the disease do not resolve during treatment or if adverse reactions not listed in the instructions for medical use occur.

Use during pregnancy or breastfeeding

The safety of using the medicinal product during pregnancy or breastfeeding has not been sufficiently studied. Due to the lack of information, the use of the medicinal product during pregnancy or breastfeeding is not recommended.

Ability to influence reaction speed when driving or operating machinery
Data are lacking.

Method of administration and dosage.

For oral use. Swallow the tablet whole with a small amount of water. Do not chew.

Adults and children aged 12 years and older: 1 tablet 3 times a day.
Children aged 6–12 years: 1 tablet 2 times a day.
Duration of treatment depends on the severity and course of the disease and is determined individually by a physician.

If symptoms persist for more than 1 week, consult a doctor.

Children.

For use in children aged 6 years and older.

Overdose.

No cases of overdose have been reported.

Side effects.

Gastrointestinal disorders: gastrointestinal disturbances (including stomach pain, heartburn, nausea, diarrhea, vomiting, difficulty swallowing), mild bleeding from gums or nose.

Respiratory system: mild nosebleeds.

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

Hepatobiliary system: increased liver function tests. A causal relationship between these increases and the use of the medicinal product has not been demonstrated.

Reporting of suspected side effects after marketing authorization of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of effectiveness of the medicinal product via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 5 years.

Do not use after the expiry date.

Storage conditions.

The medicinal product does not require special storage conditions.

Keep out of reach of children.

Packaging.

15 tablets in a blister; 1, 2, or 3 blisters per cardboard box.

Prescription status.

Over-the-counter.

Manufacturer.

VivelGmbH.

Manufacturer's address.

Dornbrink 19, 49479 Ibbenbüren, Germany

Marketing Authorization Holder.

Fitofarm Klenka S.A.

Address of the Marketing Authorization Holder.

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