Sinupret®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SİNUPRET® (SINUPRET®)

Composition:

Active ingredients: 100 g of syrup contain: 10 g of extract (1:11) from the root of gentian (Radix Gentianae), primrose flowers with calyx (Flores Primulae cum Calycibus), verbena herb (Herba Verbenae), sorrel herb (Herba Rumicis), elder flowers (Flores Sambuci) (1:3:3:3:3), extraction solvent: ethanol 59% (v/v);

Excipients: purified water, cherry flavor, liquid maltitol (E 953).

Ethanol content – 8%.

Pharmaceutical form. Syrup.

Main physicochemical characteristics: clear, viscous, light brown liquid, sweet in taste, with a cherry aroma.

During storage, slight clouding or sedimentation may occur.

Pharmacotherapeutic group. Other medications used for cough and common cold. ATC code R05X.

Pharmacological properties.

The herbal components contained in the preparation have a complex activity, manifested in secretolytic action, anti-inflammatory and anti-edematous effects.

Under the influence of the preparation, secretion is regulated and tissue edema is reduced. Drainage and ventilation of the nasal sinuses are restored, nasal congestion is relieved, and the protective function of the respiratory epithelium is normalized.

Clinical characteristics.

Indications. Symptomatic treatment of acute inflammation of the nasal sinuses.

Contraindications. Hypersensitivity to any of the active or excipient components of the drug, to other species of primrose, as well as peptic ulcer.

Interaction with other medicinal products and other forms of interaction. Currently, there is no information available regarding interactions with other medicinal products.

If other medicinal products are used concomitantly, consult a physician for advice.

Special precautions for use

Medical advice is recommended if the patient experiences severe symptoms of acute rhinosinusitis such as epistaxis (nosebleed), fever, severe pain, purulent nasal discharge, visual disturbances, facial asymmetry or numbness of the face, since urgent medical treatment may be required.

If symptoms persist for more than 7–14 days, worsen, or recur periodically during treatment with Sinupret® syrup, the patient should consult a physician.

Particular caution is required when administering this medicine to patients with a known history of gastritis or functional dyspepsia (so-called "sensitive stomach"). The medicine should preferably be taken after meals and washed down with sufficient fluid (e.g. a glass of water).

This medicinal product contains 440 mg of alcohol (ethanol), equivalent to 63 mg/mL (8%) per 1 dose (7 mL) of syrup, which is equivalent to 11 mL of beer or 5 mL of wine. The small amount of alcohol in this medicine does not generally cause adverse effects in patients; however, it should not be used in patients suffering from alcoholism or who have successfully completed treatment for alcoholism. Caution is also advised when using this medicine in children and in patients with liver disease or epilepsy.

Sinupret® 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 contains 5.5 g of liquid maltitol, equivalent to approximately 0.35 bread units (BU). This should be taken into account when following a diabetic diet. The energy value is 2.3 kcal/g of liquid maltitol. Liquid maltitol may have a mild laxative effect.

Use during pregnancy or breastfeeding. Sinupret® syrup should be used during pregnancy or breastfeeding only with caution and only after a physician has clearly established the diagnosis and evaluated the benefit-to-risk ratio for mother and fetus (child). It is unknown whether the active ingredients of Sinupret® syrup or their metabolites are excreted in breast milk. A risk to the infant during breastfeeding cannot be excluded.

Due to its ethanol content, the syrup should be used only when tablets of Sinupret® cannot be administered.

Effect on ability to drive or operate machinery. At recommended doses, the medicine does not affect the ability to drive or operate machinery; however, it should be noted that the product contains ethanol.

Method of administration and dosage.

Measure the doses of the medication using the dosing cap as indicated in the table according to age. Administer 3 times a day:

SINUPRET® syrup can be taken either undiluted or diluted with 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 advised 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 duration of treatment is 7–14 days.

Follow the recommendations provided in the section "Special instructions" of the leaflet.

Children. Due to insufficient data, do not use in children under 2 years of age.

Overdose. Cases of overdose have not been reported to date. Possible intensification of adverse reactions (see "Adverse reactions"); in such a case, consult a physician.

Treatment: in case of signs of poisoning or overdose, symptomatic therapy is required.

Side effects.

Gastrointestinal disorders (including stomach pain, nausea, diarrhea, vomiting, abdominal discomfort) are observed infrequently. Hypersensitivity reactions are also possible, including rash, skin redness, itching, urticaria, Quincke's edema (angioedema), dyspnea, facial swelling.

If any side effects 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 allows monitoring of the benefit-risk balance of this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy through the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 4 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 specified month.

After first opening of the bottle, the medicinal product 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 with a measuring cap, placed in a cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer/Marketing Authorisation Holder.

Bionorica SE / Bionorica SE.

Manufacturer’s address and place of business / Marketing Authorisation Holder’s and/or its representative’s address.

Kerschensteinerstrasse, 11-15, 92318 Neumarkt, Germany.

Contact details of the manufacturer's representative in Ukraine, LLC "Bionorica":

Phone: 044 521 86 00; Fax: 044 521 86 01; Email: [email protected]