SINUPRET® EXTRACT

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

Composition:

Active substances: 1 tablet contains 160 mg of dry extract (3–6:1) from the root of gentian (Radix Gentianae), primrose flowers with calyx (Flores Primulae cum Calycibus), sorrel herb (Herba Rumicis), elder flowers (Flores Sambuci), and verbena herb (Herba Verbenae) (1:3:3:3:3), (extraction solvent: ethanol 51% m/m);

Excipients: maltodextrin, anhydrous colloidal silicon dioxide, acacia (gum arabic), calcium carbonate (E 170), powdered cellulose, microcrystalline cellulose, magnesium stearate, aqueous colloidal silicon dioxide, carnauba wax, copper chlorophyllin (E 141), glucose solution, dextrin, hypromellose, aluminium hydroxide, indigo carmine (E 132), riboflavin (E 101), stearic acid, sucrose, talc, titanium dioxide (E 171).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: green, round, biconvex, film-coated tablets with a smooth surface.

Pharmacotherapeutic group. Preparations used for cough and colds. ATC code R05X.

Pharmacological properties.

The herbal components contained in the medicinal product have a complex effect: anti-inflammatory, anti-edematous, and secretolytic.

Under the influence of the drug, secretion is regulated and tissue swelling is reduced. Drainage and ventilation of the nasal sinuses are restored. This leads to a noticeable improvement in breathing, relieves nasal congestion, and normalizes the protective function of the respiratory epithelium.

Clinical characteristics.

Indications. Acute uncomplicated inflammatory diseases of the nasal sinuses (acute uncomplicated rhinosinusitis).

Contraindications. Hypersensitivity to any of the active or other components of the medicinal product. Peptic ulcer of the stomach or duodenum.

Interaction with other medicinal products and other forms of interaction. Currently, there is no information available regarding interactions with other medicinal products. Systemic studies on interactions with other medicinal products have not been conducted. Therefore, the possibility of enhanced or diminished effects of other medicinal products when used concomitantly with Sinupret® extract cannot be excluded.

Special precautions for use.

Particular caution is required when administering the drug to patients with gastritis or functional dyspepsia (so-called "sensitive stomach"). The drug should be taken after meals with an adequate amount of liquid.

If symptoms of the disease do not resolve within 7–14 days of treatment, worsen, recur intermittently during treatment, or if new symptoms appear—such as nosebleeds, severe pain, purulent nasal discharge, visual disturbances, facial or ocular asymmetry, or facial numbness—medical advice should be sought immediately. These symptoms are generally considered serious in all forms of rhinosinusitis and require evaluation by a specialist physician and urgent medical attention.

Sinupret® extract should not be administered to patients with rare hereditary conditions such as fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency.

Note for diabetic patients: One coated tablet contains on average 0.026 bread units (BU).

Use during pregnancy or breastfeeding. There are no data on the use of Sinupret® extract in pregnant or breastfeeding women. Therefore, as a precaution, the drug is not recommended during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery. At recommended doses, Sinupret® extract does not impair the ability to drive or operate machinery. However, the possibility of dizziness occurring in some patients should be taken into account, as it may affect the ability to drive or operate machinery (see section "Side effects").

Dosage and Administration

For adults and children aged 12 years and older: take 1 tablet three times daily. The tablets should be swallowed whole, without chewing, with sufficient liquid, for example a glass of water, preferably after meals.

There is insufficient data to recommend specific dosing in patients with renal and/or hepatic dysfunction.

Unless otherwise prescribed by a physician, the recommended duration of treatment is 7–14 days.

See also section "Special precautions for use".

Children. Not recommended for children under 12 years of age due to lack of sufficient data.

Overdose. No cases of intoxication with Sinupret® extract have been reported to date.

In case of overdose, the adverse reactions listed below may be intensified, such as nausea, stomach pain, and diarrhea. In such cases, discontinue use of the medication and consult a physician.

Treatment: symptomatic therapy.

Side effects.

Gastrointestinal system: nausea, flatulence, diarrhea, dry mouth, stomach pain are commonly observed.

Immune system: infrequent local skin hypersensitivity reactions (e.g., rash, redness, itching), as well as possible systemic allergic reactions (e.g., Quincke's edema, dyspnea, facial swelling).

Nervous system: infrequent dizziness.

If any adverse reactions occur, discontinue use of the product and consult a physician.

Shelf life. 2 years. Do not use after the expiry date stated on the packaging.

The shelf life indicates that the product may be used until the last day of the specified month.

Storage conditions. Store in the original packaging at a temperature not exceeding 30 °C, in a place inaccessible to children.

Packaging. 10 tablets per blister; 2 blisters № 20 (10×2) or 4 blisters № 40 (10×4) per cardboard box.

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

Manufacturer/Applicant.

Bionorica SE / Bionorica SE.

Manufacturer's address and location of business operations / Applicant's location.

Kerschensteinerstrasse, 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; Fax: 044 521 86 01; Email: [email protected]