Pelargonium syrup doctor mom®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Dr. Mom® Pelargonium Syrup (Syrup Pelargonia Doktor Mom®)

Composition:

Active substance: dry extract of pelargonium roots (Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix);

2.5 mL of syrup contain 20 mg of dry extract of pelargonium roots (Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix (4–25:1)), extraction solvent: ethanol 11% (m/m);

Excipients: maltodextrin, liquid maltitol (E 965), non-crystallizing sorbitol solution (E 420), potassium sorbate, anhydrous citric acid, purified water.

Pharmaceutical form. Syrup.

Main physicochemical properties: dark red liquid with a characteristic odour.

The product contains naturally derived ingredients which may cause sedimentation.

Pharmacotherapeutic group.

Agents acting on the respiratory system. Medicinal products used for cough and common cold.

ATC Code: R05X.

Pharmacological properties.

Pharmacodynamics.

Not required.

Pharmacokinetics.

Not required.

Clinical characteristics.

Indications.

Traditional herbal medicinal product for symptomatic treatment of colds.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients.

Interaction with other medicinal products and other forms of interaction.

No reports of interactions available.

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

Special precautions for use

Doctor Mom® Pelargonium Syrup is a traditional herbal medicinal product of plant origin used according to indications supported by long-standing use.

Not recommended for children under 6 years of age due to insufficient data.

Patients with impaired renal or hepatic function should consult a physician before using Pelargonium products.

Cases of hepatotoxicity and hepatitis associated with the use of this medicinal product have been reported. If signs of hepatotoxicity occur, administration of this medicinal product should be discontinued immediately and a physician should be consulted.

If symptoms worsen during treatment with this medicinal product, medical advice should be sought.

If symptoms persist for more than 1 week during treatment with this medicinal product, or if adverse reactions not listed in the product information occur, it is recommended to consult a physician.

This medicinal product contains approximately 893 mg of sorbitol solution and 893 mg of liquid maltitol per 2.5 ml dose. Patients with rare hereditary fructose intolerance should not take this medicinal product.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Use during pregnancy or breastfeeding

Safety during pregnancy and breastfeeding has not been established. Due to insufficient data, use during pregnancy and breastfeeding is not recommended.

Data on effects on fertility are lacking.

Ability to influence reaction speed when driving or operating machinery

Studies on the effect on reaction speed when driving or operating machinery have not been conducted.

Dosage and Administration.

Children aged 6–12 years

2.5 ml twice daily, using the measuring spoon provided.

Adolescents aged 12 years and older, adults, and elderly patients

2.5 ml three times daily, using the measuring spoon provided.

Not recommended for children under 6 years of age (see section "Children").

Duration of use

If symptoms worsen or persist for more than 1 week during treatment with this medicinal product, consult a doctor or qualified healthcare professional.

For oral use only.

Shake the bottle well before use.

Patients should consult a doctor if symptoms do not improve during treatment with the medicinal product or if adverse reactions occur that are not listed in the product's instructions for medical use.

Children.

Not recommended for children under 6 years of age due to insufficient data.

Overdose.

No cases of overdose have been reported.

Side effects.

Very rare cases of mild gastrointestinal symptoms (diarrhea, epigastric discomfort, nausea or vomiting, dysphagia), mild nosebleeds and gum bleeding, as well as allergic reactions have been reported.

Hepatotoxicity has been reported. Frequency is unknown.

If any other side effects not listed above occur, consult a physician or qualified medical professional.

Reporting of suspected adverse reactions

Reporting of adverse reactions after medicinal product registration 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 efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life.

36 months.

Do not use more than 3 months after first opening.

Storage conditions.

No special storage conditions required.

Keep out of reach and sight of children.

Packaging.

100 ml of syrup in a glass bottle; 1 bottle with a measuring spoon, in a cardboard box.

Supply category.

Over-the-counter.

Manufacturer.

Phytopharm Kleka S.A.

Manufacturer's address.

Ul. Kleka 1, Kleka, Nowe Miasto Nad Warta, 63-040, Poland

Marketing Authorization Holder.

McNeil Products Limited

Address of Marketing Authorization Holder.

50-100 Holmers Farm Way, High Wycombe, HP12 4EG, England

Representative of the Marketing Authorization Holder.

LLC "Johnson & Johnson Ukraine"

Address of the Representative.

32/2 Ostrivskykh Knyaziv St., Kyiv, 01010, Ukraine

+38 (044) 498 0888