Sinupret® forte

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

Composition:

Active substances: 1 tablet contains dried medicinal plants in the form of powder:

Excipients: acrylic copolymer, aluminum hydroxide, glycol montan wax, purified water, glucose solution, dextrin, gelatin, indigocarmine (E 132), stearic acid, colloidal anhydrous silicon dioxide, calcium carbonate (E 170), potato starch, corn starch, lactose monohydrate, light magnesium oxide, copper chlorophyllin (E 141), refined castor oil, riboflavin (E 101), sucrose, sorbitol (E 420), talc, titanium dioxide (E 171), shellac.

Dosage form. Film-coated tablets.

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

Pharmacotherapeutic group. Other drugs used in cough and colds. ATC code R05X.

Pharmacological properties.

The herbal components contained in the medicinal product have a complex action, manifested in secretolytic activity, 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 paranasal sinuses are restored, nasal congestion is relieved, and the protective function of the respiratory epithelium is normalized.

Clinical characteristics.

Indications. Acute and chronic inflammation of the nasal sinuses.

Contraindications. Hypersensitivity to any of the active substances or other components of the medicinal product, to other species of primrose, as well as peptic ulcer.

Interaction with other medicinal products and other types of interactions. Currently, there is no information available regarding any interactions between Sinupret® forte and other medicinal products.

If other medicinal products are used concomitantly, medical advice should be sought.

Special precautions for use.

If the patient experiences nosebleeds, persistent fever, severe pain, purulent nasal discharge, or if symptoms of the illness last longer than 7–14 days, worsen, or recur, medical advice should be sought.

Particular caution is required when using this medicinal product in patients with known gastritis or functional gastrointestinal disorders (so-called "sensitive stomach"). Sinupret® forte should preferably be taken after meals with sufficient fluid (e.g. a glass of water).

Due to the content of glucose, lactose, sucrose, and sorbitol, this medicinal product should not be used in patients with hereditary fructose intolerance, galactose intolerance, lactase deficiency, glucose-galactose malabsorption, or sucrase-isomaltase deficiency. If you have been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicinal product.

Note for diabetic patients. 1 coated tablet contains on average 0.03 bread units (BU).

Use during pregnancy or breastfeeding. During pregnancy or breastfeeding, the medicinal product Sinupret® forte should only be used after a clear diagnosis has been established by a physician and after careful assessment of the benefit-risk ratio for the mother and fetus (child).

Effect on ability to drive and use machines. No influence.

Dosage and Administration.

For adults and children aged 12 years and older, the recommended dose is 1 tablet three times daily. Tablets should be swallowed whole with an adequate amount of liquid. Patients with gastritis or functional stomach disorders (so-called "sensitive stomach") should take the medication after meals.

Unless otherwise prescribed by a physician, the recommended duration of treatment is 7–14 days. Follow the instructions in the section "Special Instructions".

Children. Do not use in children under 12 years of age due to insufficient data.

Overdose. Cases of overdose have not been reported to date. Overdose may result in an increased occurrence of the adverse reactions listed; in such a case, seek medical advice.

Treatment: symptomatic therapy.

Side effects

Gastrointestinal disorders (e.g., stomach pain, nausea, diarrhea, vomiting, abdominal discomfort) are observed rarely. In isolated cases, hypersensitivity reactions may occur, including rash, skin redness, itching, urticaria, Quincke's edema (angioedema), dyspnea, and facial swelling.

If any adverse reactions occur, discontinue use of the medicinal product immediately and consult a physician without delay.

In case of hypersensitivity/allergic reaction, coated tablets of Sinupret® forte must not be taken again.

Shelf life. 4 years. Do not use after the expiry date stated on the packaging. The expiry date refers to 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. 20 or 25 tablets in a blister pack;

1 blister pack of 20 (20×1) or 2 blister packs of 50 (25×2), or 4 blister packs of 100 (25×4) in a cardboard box.

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

Manufacturer/Applicant.

Bionorica SE / Bionorica SE.

Manufacturer's address and place of business / Applicant's and/or applicant's 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 protected]