PROLUTA

INSTRUCTIONS for medical use of the medicinal product SINUPRET® N (SINUPRET® N)

Composition

active substances: 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 Calyce), verbena herb (Herba Verbenae), sorrel herb (Herba Rumiicis), and elder flowers (Flores Sambuci) (1:3:3:3:3), (extractants: ethanol 59% (v/v); purified water); excipients: cherry flavor, liquid maltitol.

Alcohol content - 8%.

Pharmaceutical form

Syrup.

Main physical and chemical properties

A clear viscous liquid of light brown color with a cherry aroma. During storage, clouding or sedimentation is possible.

Pharmacotherapeutic group

Preparations used for cough and cold diseases. ATC code R05X.

Pharmacological properties

The plant components that are part of the preparation have complex activity, which is manifested in secretolytic action, anti-inflammatory and anti-edematous effects.

Under the influence of the preparation, secretion is regulated and tissue swelling is reduced. The drainage and ventilation of the nasal sinuses are restored, nasal congestion is eliminated, and the protective function of the respiratory tract epithelium is normalized.

Clinical characteristics

Indications

Symptomatic treatment of acute inflammation of the paranasal sinuses.

Contraindications

Increased individual sensitivity to any of the active or excipient components of the preparation, to other types of primrose. Peptic ulcer.

Interaction with other medicinal products and other types of interactions

So far, there is no information about any interactions with other medicinal products.

Special warnings and precautions for use

A doctor's consultation is recommended if the patient has pronounced symptoms of severe rhinosinusitis, such as nosebleeds, fever, severe pain, purulent discharge from the nose, vision disturbances, asymmetry of the middle part of the face or eyes, or facial numbness, as urgent medical therapy may be required in such cases.

If symptoms persist for more than 7-14 days, worsen, or recur periodically during treatment with Sinupret® N syrup, the patient is advised to consult a doctor.

Special attention is required when using the preparation in patients with gastritis or functional dyspepsia (so-called "sensitive stomach"). Such patients should take the preparation mainly after meals, drinking sufficient water (e.g., a glass of water).

This medicinal product contains 440 mg of ethanol (alcohol) in 7 ml, which is equivalent to 63 mg/ml (8%) per 1 dose (7 ml) of syrup, and is also equivalent to 11 ml of beer or 5 ml of wine. This preparation contains 224 mg of alcohol (ethanol) in 3.5 ml, which is equivalent to 63 mg/ml (8%) per 1 dose (3.5 ml), and is equivalent to 6 ml of beer or 3 ml of wine. Sinupret® N, syrup contains 132 mg of alcohol (ethanol) in 2.1 ml, which is equivalent to 63 mg/ml (8%) per 1 dose (2.1 ml), and is also equivalent to 4 ml of beer or 2 ml of wine.

A small amount of alcohol in this preparation does not have a negative effect on patients. However, patients with alcoholism or those who have successfully completed treatment for alcoholism should not use this medicinal product. Also, caution should be exercised when using it in children and patients with liver disease and epilepsy.

Sinupret® N 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 diabetic patients

7 ml of syrup contains 5.5 g of liquid maltitol, which corresponds to approximately 0.35 bread units (BU). This should be taken into account when following 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. The experience of retrospective analysis of the use of other pharmaceutical forms of the Sinupret® preparation involving 762 pregnant women indicates the absence of a risk of fetal malformations or fetal/neonatal toxicity. Experimental studies do not indicate direct or indirect harmful effects on reproductive toxicity. The use of Sinupret® N syrup during pregnancy is possible after consulting a doctor, if it is necessary for clinical indications.

Breastfeeding

It is unknown whether the active substances of Sinupret® N syrup or their metabolites are excreted in breast milk. The risk to the child during breastfeeding cannot be excluded.

Sinupret® N syrup should be used during breastfeeding only on the advice of a doctor.

Fertility

There are no data on the effect of Sinupret® N syrup on fertility. In studies on animals, no effect on fertility was observed when using the Sinupret® preparation in the form of oral drops or tablets.

Ability to influence the speed of reaction when driving vehicles or working with other mechanisms

In recommended doses, the preparation does not affect the ability to drive vehicles and work with other mechanisms, but it should be taken into account that the preparation contains ethanol.

Method of administration and dosage

The doses of the preparation are determined according to the patient's age, as shown in the table below, and are measured using a measuring cap. The preparation is used 3 times a day.

Sinupret® N syrup can be used both in its pure form and with a small amount of liquid (which does not contain alcohol). Before use, the syrup should be shaken. The preparation can be taken during meals, drinks, or between meals. Patients who complain of functional dyspepsia (so-called "sensitive stomach") are recommended to take the syrup after meals. For children under 6 years old, the single dose of syrup should be diluted in 1 tablespoon of liquid.

During storage, clouding or sedimentation is possible, which does not affect the effectiveness of the preparation.

If the doctor has not prescribed otherwise, the recommended course of treatment is 7-14 days.

It is necessary to follow the recommendations set out in the "Special warnings and precautions for use" section.

Children

Due to the lack of research, it is not recommended to use in children under 2 years old.

Overdose

Cases of overdose are currently unknown. It is possible to enhance side reactions (see the "Side reactions" section); in such cases, you should consult a doctor.

Treatment. In case of symptoms of poisoning or overdose, symptomatic therapy is necessary.

Side reactions

Rarely, gastrointestinal disorders (including stomach pain, nausea, diarrhea, vomiting, abdominal discomfort) are observed.

Rarely, skin hypersensitivity reactions (rash, skin redness, itching) are observed. Serious allergic reactions (urticaria, Quincke's edema, dyspnea, facial swelling) are also possible. The frequency of their occurrence is unknown.

In case of any manifestations of side reactions, the use of the preparation should be stopped, and a doctor should be consulted.

Reporting of side reactions after registration of the medicinal product

is of great importance. This allows monitoring the ratio of benefit to risk when using this medicinal product. Medical and pharmaceutical workers, as well as patients or their legal representatives, should report all cases of suspected side reactions and lack of efficacy of the medicinal product through the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.

Shelf life

2 years.

Do not use after the expiration date stated on the packaging.

The shelf life determines the use of the preparation until the last day of the month.

After the first opening of the bottle, the preparation is suitable for use for 6 months.

Storage conditions

Store in the original packaging at a temperature 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.

Release category

Without a prescription.

Manufacturer/applicant

Bionorica SE.

Bionorica SE.

Location of the manufacturer and address of the place of its activity/location of the applicant

Kerschensteinerstrasse, 11-15, 92318, Neumarkt, Germany.

Kerschensteinerstrasse, 11-15, 92318 Neumarkt, Germany.

Contact information of the manufacturer's representative in Ukraine LLC "Bionorica"

phone: 044 521 86 00, [email protected]