Sinupret® h
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SINOUPRET® N (SINUPRET® N)
Composition:
Active substances: 100 ml (120.8 g) of syrup contains: 41.7 g of liquid extract (1:38.5) from 1.1 g of a mixture of gentian root (Radix Gentianae), primrose flowers with calyx (Flores Primulae cum Calycibus), verbena herb (Herba Verbenaе), sorrel herb (Herba Rumicis), and elder flowers (Flores Sambuci) (1:3:3:3:3), (extraction agents: ethanol 59% v/v; purified water);
Excipients: cherry flavor, liquid maltitol.
Ethanol content – 8%.
Pharmaceutical form. Syrup.
Main physicochemical properties: clear, viscous, light brown liquid with a cherry aroma. During storage, slight opalescence or precipitation may occur.
Pharmacotherapeutic group. Preparations used for cough and colds. ATC code R05X.
Pharmacological properties.
Plant components included in the drug have a complex activity manifested as secretolytic action, anti-inflammatory and anti-edematous effects.
Under the influence of the drug, secretion is regulated and tissue edema is reduced. Drainage and ventilation of the nasal sinuses are restored, nasal congestion is relieved, and protective function of the respiratory epithelium is normalized.
Clinical characteristics.
Indications. Symptomatic treatment of acute inflammation of the nasal sinuses.
Contraindications. Increased individual sensitivity to any of the active or excipient components of the medicine, to other species of primrose. Peptic ulcer.
Interaction with other medicinal products and other forms of interaction. To date, there is no information about any interactions with other medicinal products.
Special precautions for use
Medical advice is recommended if a patient presents with pronounced symptoms of severe rhinosinusitis such as nasal bleeding, fever, severe pain, purulent nasal discharge, visual disturbances, facial asymmetry (midface or eyes), or facial numbness, as emergency medical treatment may be required.
If symptoms persist for more than 7–14 days, worsen, or recur periodically during treatment with Sinupret® H syrup, the patient should consult a physician.
Particular caution is required when administering the product to patients with known gastritis or functional dyspepsia (so-called "sensitive stomach"). Such patients should take the medication preferably after meals, accompanied by sufficient fluid intake (e.g., 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 corresponds to approximately 11 ml of beer or 5 ml of wine. This preparation contains 224 mg of alcohol (ethanol) in 3.5 ml, equivalent to 63 mg/ml (8%) per 1 dose (3.5 ml), and corresponds to approximately 6 ml of beer or 3 ml of wine. Sinupret® H syrup contains 132 mg of alcohol (ethanol) in 2.1 ml, equivalent to 63 mg/ml (8%) per 1 dose (2.1 ml), and corresponds to approximately 4 ml of beer or 2 ml of wine.
The small amount of alcohol in this product is unlikely to cause adverse effects in most patients. However, this medicinal product should not be used by patients suffering from alcoholism or those who have successfully completed treatment for alcohol dependence. Caution is also advised when administering this product to children and patients with liver disease or epilepsy.
Sinupret® H syrup should not be taken without medical advice by patients with known sugar intolerances, as this medicinal product contains liquid maltitol.
Note for diabetic patients. 7 ml of syrup contain 5.5 g of liquid maltitol, equivalent to approximately 0.35 carbohydrate exchange units (CEU). This should be taken into account when following a diabetic diet. 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 clinical data on the use of Sinupret® H syrup during pregnancy. Retrospective analysis of data on other dosage forms of the medicinal product Sinupret® involving 762 pregnant women indicates no risk of fetal malformations or fetal/neonatal toxicity. Experimental studies have not shown direct or indirect harmful effects related to reproductive toxicity. Sinupret® H syrup may be used during pregnancy only after consultation with a physician and if clinically indicated.
Breastfeeding
It is unknown whether the active ingredients of Sinupret® H syrup or their metabolites are excreted in human breast milk. A risk to the breastfed infant cannot be excluded.
Sinupret® H syrup should be used during breastfeeding only under medical supervision and if clearly indicated.
Fertility
There are no data available on the effects of Sinupret® H syrup on fertility. Animal studies with other dosage forms of Sinupret® (oral drops or tablets) showed no effects on fertility.
Ability to affect reaction speed when driving or operating machinery.
At recommended doses, the product does not impair the ability to drive or operate machinery. However, it should be noted that the product contains ethanol.
Method of administration and dosage.
The dosage of the medication is determined according to the patient's age, as shown in the table below, and should be measured using the dosing cap. The medication is administered 3 times a day.
| Age |
Single dose |
Daily dose |
| Children from 2 to 6 years |
2.1 ml (2.5 g) |
6.3 ml (7.5 g), i.e. 3 times 2.1 ml |
| Children from 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 from 12 years |
7 ml (8.4 g) |
21 ml (25.2 g), i.e. 3 times 7 ml |
Syrup Sinupret® N can be taken either undiluted or diluted in a small amount of liquid (alcohol-free). The syrup should be shaken before use. The medication may be taken during meals, drinks, or between meals. Patients complaining of functional dyspepsia (so-called "sensitive stomach") are recommended to take the syrup after meals. For children under 6 years of age, the single dose of syrup should be diluted in 1 tablespoon of liquid.
During storage, slight cloudiness or sediment formation may occur, which does not affect the drug's efficacy.
Unless otherwise prescribed by a physician, the recommended treatment duration is 7–14 days.
Follow the recommendations provided in the section "Special instructions" of the leaflet.
Children.
Due to insufficient data from studies, do not use in children under 2 years of age.
Overdose.
Cases of overdose have not been reported to date. An overdose may increase the incidence of adverse reactions (see section "Adverse reactions"); in such a case, consult a physician.
Treatment. In case of poisoning or overdose, symptomatic therapy is required.
Adverse reactions.
Gastrointestinal disorders (including stomach pain, nausea, diarrhea, vomiting, abdominal discomfort) are observed uncommonly.
Skin hypersensitivity reactions (rash, skin redness, itching) are also observed uncommonly. Serious allergic reactions (urticaria, Quincke's edema, dyspnea, facial swelling) are possible. The frequency of these reactions is unknown.
If any adverse reactions occur, discontinue use of the medicinal product immediately and consult a physician without delay.
Reporting of adverse reactions after medicinal product registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to 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. 2 years.
Do not use after the expiry date stated on the packaging.
The shelf life is defined as valid until the last day of the month indicated.
After first opening of the bottle, the product remains suitable for use for 6 months.
Storage conditions. Store in the original packaging at temperatures not exceeding 30 °C, in a place inaccessible to children.
Packaging. 100 ml in a bottle, 1 bottle with a measuring cap in a cardboard box.
Availability category. Over-the-counter (without prescription).
Manufacturer/Marketing authorization holder.
Bionorica SE.
Bionorica SE.
Address of manufacturer's location and place of business / Address of marketing authorization holder.
Kerchensteinerstrasse, 11-15, 92318 Neumarkt, Germany.
Kerschensteinerstrasse, 11-15, 92318 Neumarkt, Germany.
Contact details of the manufacturer's representative in Ukraine, LLC "Bionorica":
Phone: 044 521 86 00, [email protected]