Instructions for Sinupret H syrup bottle 100 ml
Composition
active ingredients: 100 ml (120.8 g) of syrup contain: 41.7 g of liquid extract (1:38.5) from 1.1 g of a mixture of gentian root (Radix Gentianae), primrose flowers with a calyx (Flores Primulae cum Calysibus), verbena herb (Herba Verbenae), sorrel herb (Herba Rumisis), elderberry flowers (Flores Sambuci) (1:3:3:3:3), (extractants: ethanol 59% (v/v); purified water);
excipients: cherry flavoring, liquid maltitol.
Ethanol content – 8%.
Dosage form
Syrup.
Main physicochemical properties: transparent viscous liquid of light brown color
with cherry aroma. During storage, cloudiness or sedimentation may occur.
Pharmacotherapeutic group
Drugs used for coughs and colds. ATX code R05X.
Pharmacological properties
The herbal components that make up the preparation have complex activity, which is manifested in secretolytic action, anti-inflammatory and anti-edema effects.
Under the influence of the drug, secretion is regulated and tissue edema is reduced. Drainage and ventilation of the sinuses are restored, nasal congestion is eliminated, and the protective function of the respiratory tract epithelium is normalized.
Indication
Symptomatic treatment of acute inflammation of the paranasal sinuses.
Contraindication
Increased individual sensitivity to any of the active or auxiliary components of the drug, to other types of primrose. Peptic ulcer.
Interaction with other medicinal products and other types of interactions
To date, there is no information about any interactions with other drugs.
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 with Sinupret® H syrup symptoms persist for more than
7–14 days, worsen or recur periodically, the patient is advised to consult a doctor.
Special care should be taken when using the drug if the patient is known to have gastritis or functional dyspepsia (the so-called "sensitive stomach"). Such patients should take the drug preferably after meals, with sufficient water (for example, a glass of water).
This medicinal product contains 440 mg of alcohol (ethanol) in 7 ml, equivalent to 63 mg/ml (8%).
per 1 dose (7 ml) of syrup, and is equivalent to 11 ml of beer or 5 ml of wine. This medicine contains
224 mg alcohol (ethanol) in 3.5 ml, which is equivalent to 63 mg/ml (8%) per 1 dose (3.5 ml), and equivalent to 6 ml beer or 3 ml wine. Sinupret® H, syrup contains 132 mg alcohol (ethanol) in 2.1 ml, which is equivalent to 63 mg/ml (8%) per 1 dose (2.1 ml), and also equivalent to 4 ml beer or
2 ml of wine.
The small amount of alcohol in this medicine does not cause any adverse effects on patients. However, patients with alcoholism or patients who have successfully completed treatment for alcoholism should not use this medicine. Caution should also be exercised when using it in children and patients with liver disease and epilepsy.
Sinupret® H, syrup, should not be taken without consulting a doctor by patients with intolerance to certain sugars, as this medicinal product contains liquid maltitol.
Note for diabetics. 7 ml of syrup contains 5.5 g of liquid maltitol, which corresponds to approximately 0.35 bread units (CU). This should be taken into account if you need to follow a diet for diabetes. The caloric value of liquid maltitol is 2.3 kcal/g. Liquid maltitol may have a mild laxative effect.
Use during pregnancy or breastfeeding
Pregnancy
There are no data on the use of Sinupret® N syrup during pregnancy. Experience of retrospective analysis of the use of other dosage forms of the drug Sinupret® with the participation of
762 pregnant women indicate no risk of malformations or fetal/neonatal toxicity. Experimental studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. The use of Sinupret® H syrup during pregnancy is possible after consultation with a doctor, if clinically necessary.
Breast-feeding
It is not known whether the active substances of Sinupret® H syrup or their metabolites are excreted in breast milk. A risk to the child during breastfeeding cannot be excluded.
Sinupret® H, syrup should be used during breastfeeding only as prescribed by a doctor.
Fertility
There are no data on the effect of Sinupret® H syrup on fertility. In animal studies, no effect on fertility was observed when using Sinupret® in the dosage form of oral drops or tablets.
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
The dosage of the drug is determined according to the patient's age, as shown in the table below, and is measured using a measuring cap. The drug is used 3 times a day.
Age - Single dose; daily dose:
- children aged 2 to 6 years: 2.1 ml (2.5 g); 6.3 ml (7.5 g), i.e. 3 times 2.1 ml;
- children aged 6 to 12 years: 3.5 ml (4.2 g); 10.5 ml (12.6 g), i.e. 3 times 3.5 ml;
- adults and children over 12 years of age: 7 ml (8.4 g); 21 ml (25.2 g), i.e. 3 times 7 ml.
Sinupret® H, syrup, can be used both undiluted and with a small amount of liquid (which does not contain alcohol). The syrup should be shaken before use. The drug can be taken with food, drinks or between meals. Patients who complain of functional dyspepsia (the so-called "sensitive stomach") are recommended to take the syrup after a meal. For children under 6 years of age, a single dose of syrup should be diluted in 1 tablespoon of liquid.
During storage, cloudiness or precipitation may occur, which does not affect the effectiveness of the drug.
Unless otherwise prescribed by a doctor, the recommended course of treatment is 7–14 days.
You should follow the recommendations set out in the “Special Instructions for Use” section of the instructions.
Children.
Due to insufficient research, do not use in children under 2 years of age.
Overdose
Cases of overdose are not yet known. Adverse reactions may be aggravated (see section "Adverse reactions"); in this case, you should consult a doctor.
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 (rash, redness of the skin, itching) are uncommon. Serious allergic reactions (urticaria, angioedema, shortness of breath, facial swelling) are also possible. The frequency of their occurrence is unknown.
If any adverse reactions occur, you should stop using the drug and consult a doctor.
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
2 years.
Do not use after the expiry date stated on the packaging.
The expiration date determines the use of the drug until the last day of the month.
After first opening the bottle, the drug is suitable for use for 6 months.
Storage conditions
Store in the original packaging at a temperature not exceeding 30 °C, out of the reach of children.
Packaging: 100 ml in a bottle, 1 bottle with a measuring cap in a cardboard box.
Vacation category
Without a prescription.
Manufacturer/Applicant
Bionorica CE.
Bionorica SE.
Location of the manufacturer and address of its place of business/location of the applicant.
Kerchensteinerstrasse, 11-15, 92318, Neumarkt, Germany.
Kerschensteinerstrasse, 11-15, 92318 Neumarkt, Germany.
Contact details of the manufacturer's representative in Ukraine, LLC "Bionorika":
phone: 044 521 86 00, info@bionorica.ua
