Pelorsin®
Ukraine
Table of Contents
INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PELORSIN® (PELORSIN)
Composition:
Active substance: dried extract from roots of Pelargonium sidoides;
100 g of syrup (93.809 ml) contain dried extract from roots of Pelargonium sidoides (4–25:1), extraction solvent: ethanol 11% (m/m) – 0.2506 g;
Excipients: xylitol; glycerol 85%; citric acid monohydrate; potassium sorbate; xanthan gum; purified water.
Pharmaceutical form. Syrup.
Main physicochemical properties: viscous liquid ranging from red-brown to light brown in color, with slight opalescence.
Pharmacotherapeutic group. Agents used for cough and colds. ATC code R05.
Pharmacological properties.
Pharmacodynamics.
The medicinal product contains an extract from the roots of Pelargonium sidoides, which stimulates non-specific defense mechanisms of the body, has antimicrobial effects and moderate direct antibacterial and antiviral properties, as well as cytoprotective properties.
Pharmacokinetics.
The medicinal product is a complex mixture of many components, which as a whole is considered the active substance. Data on the pharmacokinetics of the drug are currently unavailable.
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, or concomitant use of medicinal products that impair blood coagulation. Severe liver or 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.
There are currently no data on interactions with other agents.
Due to the potential effect of Pelorsin® on blood coagulation parameters, concomitant use may influence the action of indirect anticoagulants such as warfarin. In a placebo-controlled, double-blind clinical study involving healthy volunteers, no interactions between the medicinal product Pelorsin® and penicillin were observed.
Instructions for Use
If symptoms persist for more than one week, if elevated body temperature continues for several days, or if liver dysfunction of various origins, dyspnea, or hemoptysis occur, it is recommended to consult a physician.
Cases of hepatotoxicity and hepatitis associated with the use of the medicinal product have been reported. If signs of hepatotoxicity occur, the medicinal product should be discontinued immediately and medical advice should be sought. If symptoms worsen during use of the medicinal product, consult a qualified physician.
This medicinal product contains a small amount of ethanol (alcohol), less than 100 mg per dose.
Use during pregnancy or breastfeeding.
Due to insufficient experience with the use of Pelorsin® during pregnancy or breastfeeding, it is not recommended for use during these periods. There is no data available on the effect of Pelorsin® on fertility.
Ability to affect reaction speed when driving or operating machinery.
There are no studies on the influence of the medicinal product on the ability to drive or operate machinery.
Method of Administration and Dosage
For adults and children aged 12 years and older: 7.5 mL of syrup three times daily.
For children aged 6 to 12 years: 5 mL of syrup three times daily.
For children aged 1 to 5 years: 2.5 mL of syrup three times daily.
Method of Administration
The syrup should be taken orally three times daily—in the morning, at noon, and in the evening.
Duration of Treatment
After symptoms disappear, it is recommended to continue treatment for several more days to prevent relapse.
The duration of treatment should not exceed 3 weeks.
If symptoms persist for longer than 1 week during use of the medicinal product, it is recommended to consult a physician.
Children.
Pelorcin® is not recommended for use in children under 1 year of age due to insufficient data on its safety and efficacy in this patient group.
Overdose.
To date, no cases of overdose have been reported.
Overdose may lead to an increase in adverse reactions.
Adverse reactions.
Adverse reactions reported during use of the medicinal product are listed below by system organ classes and frequency of occurrence: 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), not known (frequency cannot be established from available data).
Gastrointestinal disorders:
uncommon: gastrointestinal disturbances (abdominal pain, heartburn, nausea, diarrhoea);
rare: mild bleeding of the gums.
Respiratory system:
rare: mild nosebleeds.
Skin and subcutaneous tissue disorders / immune system disorders:
rare: hypersensitivity reactions (rash, urticaria, itching);
very rare: severe allergic reactions (facial swelling, dyspnoea, hypotension).
Hepatobiliary system:
very rare: liver function abnormalities of various origins, including elevated liver enzymes. A causal relationship between these laboratory findings and the use of the medicinal product has not been demonstrated.
If any adverse reactions occur, the use of the medicinal product must be discontinued and medical advice should be sought.
Shelf life.
2 years.
Shelf life after opening the bottle: 6 months.
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.
100 ml in a bottle. One bottle with a measuring cup in a carton.
Prescription status.
Over-the-counter.
Manufacturer. JSC "Farmak".
Manufacturer's location and address of place of business.
Ukraine, 04080, Kyiv, Kyrylivska St., 74.
INSTRUCTION
on medical use of medicinal product
PELORSIN
(PELORSIN)
Composition:
active substance: dry extract of roots of Pelargonium sidoides;
100 g of syrup (93.809 ml) contains dry extract of roots of Pelargonium sidoides (4–25:1), extraction solvent: ethanol 11% (m/m) – 0.2506 g;
excipients: xylitol; glycerol 85%; citric acid monohydrate; potassium sorbate; xanthan gum; purified water.
Medicinal form. Syrup.
Main physicochemical properties: viscous liquid ranging from red-brown to light brown in color, with slight opalescence.
Pharmacotherapeutic group. Medicinal products used for cough and colds. ATC code: R05.
Pharmacological properties.
Pharmacodynamics.
The medicinal product contains an extract of Pelargonium sidoides roots, which stimulates non-specific defense mechanisms of the body, exhibits antimicrobial effects, mild direct antibacterial and antiviral properties, as well as cytoprotective properties.
Pharmacokinetics.
The medicinal product is a complex mixture of many components, considered as a whole to be the active substance. Data on the pharmacokinetics of the product are currently unavailable.
Clinical characteristics.
Indications.
Acute and chronic infections of the respiratory tract and ENT organs (bronchitis, sinusitis, tonsillar angina, rhinopharyngitis).
Contraindications.
Hypersensitivity to the components of the medicinal product, increased tendency to bleeding, or concomitant use of medicinal products that impair 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 types of interactions.
Currently, there are no data on interactions with other medicinal products.
Due to the potential effect of PELORSIN on blood coagulation parameters, concomitant use may possibly influence the effect of indirect anticoagulants such as warfarin. In a placebo-controlled, double-blind clinical study involving healthy volunteers, no interactions between PELORSIN and penicillin were observed.
Special precautions for use.
If symptoms do not resolve within one week, fever persists for several days, or if liver function abnormalities of any origin, dyspnoea, or bloody sputum occur, medical consultation is recommended.
Cases of hepatotoxicity and hepatitis associated with the use of the medicinal product have been reported. In the event of signs of hepatotoxicity, the use of the medicinal product must be discontinued immediately and medical advice sought. If symptoms worsen during treatment, consult a qualified physician.
This medicinal product contains a small amount of ethanol (alcohol), less than 100 mg per dose.
Use during pregnancy or breastfeeding.
Due to insufficient experience with the use of PELORSIN, it is not recommended during pregnancy or breastfeeding. There are no data on the effect of PELORSIN on fertility.
Ability to affect reaction speed when driving or operating machinery.
There are no studies on the effect of the medicinal product on the ability to drive or operate machinery.
Method of administration and dosage.
Adults and children over 12 years: 7.5 ml of syrup three times daily.
Children aged 6 to 12 years: 5 ml of syrup three times daily.
Children aged 1 to 5 years: 2.5 ml of syrup three times daily.
Method of administration
The syrup should be taken orally three times daily, in the morning, at noon, and in the evening.
Duration of treatment
After symptoms disappear, treatment should be continued for several more days to prevent relapse.
The duration of treatment should not exceed 3 weeks.
If symptoms persist for more than 1 week during use of the medicinal product, medical consultation is recommended.
Children.
PELORSIN is not recommended for use in children under 1 year of age due to insufficient data on safety and efficacy in this patient group.
Overdose.
No cases of overdose have been reported to date.
Possible intensification of adverse reactions may occur.
Adverse reactions.
Adverse reactions reported during use of the medicinal product are listed below by system organ classes and frequency of occurrence: 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), not known (frequency cannot be established from available data).
Gastrointestinal disorders:
uncommon: gastrointestinal disturbances (abdominal pain, heartburn, nausea, diarrhoea);
rare: mild bleeding of the gums.
Respiratory system:
rare: mild nosebleeds.
Skin and subcutaneous tissue disorders / immune system disorders:
rare: hypersensitivity reactions (rash, urticaria, pruritus);
very rare: severe allergic reactions (facial swelling, dyspnoea, hypotension).
Hepatobiliary system:
very rare: liver function abnormalities of various origins, including elevated liver enzymes. A causal relationship between these laboratory findings and the use of the medicinal product has not been demonstrated.
If any adverse reactions occur, the use of the medicinal product must be discontinued and medical advice should be sought.
Shelf life.
2 years.
Shelf life after opening the bottle: 6 months.
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.
100 ml in a bottle. One bottle with a measuring cup in a carton.
Prescription status.
Over-the-counter.
Manufacturer. JSC "Farmak".
Manufacturer's location and address of place of business.
Ukraine, 04080, Kyiv, Kyrylivska St., 74.