Instructions for Sinupret Oral Drops 100 ml bottle
Composition
active ingredients: 100 g of drops contain 29 g of extract (1:11) from gentian root (Radix Gentianae); primrose flowers with a calyx (Flores Primulae cum Calysibus); sorrel herb (Herba Rumisis); elderflower flowers (Flores Sambuci); verbena herb (Herba Verbenae) (1:3:3:3:3), (extractant ethanol 59% (v/v);
excipient: purified water.
Ethanol content - 19% (v/v).
Dosage form
Oral drops.
Main physicochemical properties: transparent or slightly cloudy liquid of yellow-brown color, with an aromatic odor. During storage, turbidity or precipitation is possible.
Pharmacotherapeutic group
Drugs used for coughs and colds. ATX code R05X.
Pharmacological properties
The components that make up the herbal medicine have complex activity, manifested in secretolytic action, anti-edematous, anti-inflammatory, immunostimulating and antiviral effects.
The active ingredients of the drug Sinupret® inhibit the reproduction of various respiratory viruses, such as influenza A virus, parainfluenza and RSV (respiratory syncytial virus).
Under the influence of the drug, secretion is regulated and tissue edema is reduced. Drainage and ventilation of the paranasal sinuses are restored, nasal congestion is eliminated, the protective function of the respiratory tract epithelium is normalized. The effectiveness of antibiotic therapy is increased.
Indication
Acute and chronic inflammation of the paranasal sinuses.
Contraindication
Increased individual sensitivity to any of the active or auxiliary substances of the drug, to other types of primrose, as well as peptic ulcer.
Interaction with other medicinal products and other types of interactions
No interactions with other drugs have been observed. Combination with antibiotics is possible and advisable.
Application features
It is recommended to consult a doctor if the patient experiences severe symptoms of rhinosinusitis, such as nosebleeds, fever, severe pain, purulent nasal discharge, visual disturbances, asymmetry of the midface or eyes, or facial numbness, as urgent medical treatment may be required.
If during treatment the patient's symptoms persist for more than 7–14 days, worsen, or recur periodically, the patient is advised to consult a doctor.
Special attention should be paid to the use of the drug in patients with gastritis or functional dyspepsia (the so-called "sensitive stomach"). The drug should be used after meals.
The medicine contains 19% ethanol (v/v), therefore it should not be used in patients who suffer from alcoholism or have successfully completed treatment for alcoholism.
Also, when taking doses exceeding the recommended ones, there is a risk to the health of children and patients with liver diseases, epilepsy, and organic brain diseases.
During storage, the drug may become cloudy or precipitate, but this does not affect the effect of the drug. Shake before use.
Use during pregnancy or breastfeeding
During pregnancy or breastfeeding, the drug can be used with caution and only after a doctor has clearly established the diagnosis and assessed the benefit-risk ratio for the mother and the fetus (child).
Ability to influence reaction speed when driving vehicles or other mechanisms
At recommended doses, the drug does not affect the ability to drive vehicles and work with other mechanisms, but it should be borne in mind that the drug contains ethanol.
Method of administration and doses
Unless otherwise prescribed by a doctor, the drug should be used in the following doses:
| Age | Single dose | Daily dose |
|---|
| Children aged 2 to 5 years | 15 drops each, which is equivalent to 0.9 ml | 45 drops (3 times 15 drops), which is equivalent to 2.7 ml |
| Children aged 6 to 11 years | 25 drops each, which is equivalent to 1.5 ml | 75 drops (3 times 25 drops), which is equivalent to 4.5 ml |
Children aged from 12 years old and adults | 50 drops each, which is equivalent to 3 ml | 150 drops (3 times 50 drops), which is equivalent to 9 ml |
Adults take the drops, as a rule, undiluted or, if desired, with the required amount of liquid. Children should use the drops in diluted form, and to hide the bitter taste, they can be added to juice or tea.
The recommended course of treatment is usually 7-14 days, unless otherwise prescribed. You should follow the recommendations set out in the "Special Instructions for Use" section of the instructions.
Children
Due to lack of experience, the drug should not be used in children under 2 years of age.
Overdose
Cases of overdose are currently unknown. If the dose is exceeded, adverse reactions may be exacerbated (see "Adverse reactions").
Treatment: if signs of poisoning or overdose occur, symptomatic therapy is necessary.
Adverse reactions
Gastrointestinal disorders, including stomach pain, nausea, diarrhea, vomiting, abdominal discomfort, are uncommon. Hypersensitivity reactions, including rash, skin redness, itching, urticaria, angioedema, shortness of breath, facial swelling, are possible.
If any adverse reactions occur, you should stop using the drug and consult a doctor.
Expiration date
2 years.
Do not use the drug after the expiration date indicated on the package.
The expiration date determines the use of the drug until the last day of the specified month.
After first opening the bottle, the drug is suitable for use for 3 months.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 oC, out of the reach of children.
Packaging
50 ml or 100 ml of solution in a bottle, with a dosing dropper on top, with a screw cap and a tamper-evident ring, placed in a cardboard box.
Vacation category
Without a prescription.
Manufacturer/Applicant
Bionorica SE.
Location of the manufacturer and its business address/location of the applicant and/or the applicant's representative
Kerchensteinerstrasse, 11-15, 92318 Neumarkt, Germany.
Contact details of the manufacturer's representative in Ukraine, LLC "Bionorika":
phone: 044 521 86 00; fax: 044 521 86 01, info@bionorica.ua
