Instructions Sinupret extract film-coated tablets 160 mg blister No. 20
Composition
active ingredients: 1 tablet contains 160 mg of dry extract (3-6:1) from gentian root (Radix Gentianae), primrose flowers with a calyx (Flores Primulae cum Calysibus), sorrel herb (Herba Rumisis), elderflower flowers (Flores Sambuci), verbena herb (Herba Verbenae) (1:3:3:3:3), (extractant ethanol 51% (m/m));
excipients: maltodextrin, colloidal anhydrous silica, acacia (gum arabic), calcium carbonate (E 170), powdered cellulose, microcrystalline cellulose, magnesium stearate, colloidal aqueous silica, carnauba wax, copper chlorophyllin (E 141), glucose solution, dextrin, hypromellose, aluminum hydroxide, indigo carmine (E 132), riboflavin (E 101), stearic acid, sucrose, talc, titanium dioxide (E 171).
Dosage form
Film-coated tablets.
Main physicochemical properties: round biconvex tablets, coated with a green shell with a smooth surface.
Pharmacotherapeutic group
Drugs used for coughs and colds. ATX code R05X.
Pharmacological properties
The herbal components that make up the drug have complex activity: anti-inflammatory, anti-edematous, and secretolytic.
Under the influence of the drug, secretion is regulated and tissue edema is reduced. Drainage and ventilation of the paranasal sinuses are restored. This leads to a noticeable relief of breathing, nasal congestion is eliminated, and the protective function of the respiratory tract epithelium is normalized.
Indication
Acute uncomplicated inflammatory diseases of the paranasal sinuses (acute uncomplicated rhinosinusitis).
Contraindication
Hypersensitivity to any of the active or other components of the drug. Gastric or duodenal ulcer.
Interaction with other medicinal products and other types of interactions
There is currently no information about any interactions with other drugs. Systematic studies on interactions with other drugs have not been conducted. Therefore, the effect of strengthening or weakening the effect of other drugs when used simultaneously with Sinupret® extract cannot be ruled out.
Application features
Special attention should be paid to the use of the drug in patients with gastritis or functional dyspepsia (the so-called "sensitive stomach"). The drug should be taken after meals with sufficient fluid.
If the symptoms of the disease do not disappear after 7-14 days of treatment, worsen, periodically recur during treatment, or new symptoms appear: nosebleeds, severe pain, purulent nasal discharge, visual impairment, asymmetry of the midface or eyes, or facial numbness, you should consult a doctor, because such observations and symptoms are usually considered serious warnings for all forms of rhinosinusitis that require examination by a specialist and emergency medical care.
Sinupret® extract should not be taken by patients with rare hereditary pathologies such as fructose intolerance, glucose-galactose malabsorption (absorptive disorder) or sucrase-isomaltase insufficiency.
Note for diabetics: one film-coated tablet contains an average of 0.026 bread units (BTU).
Use during pregnancy or breastfeeding
There is no data on the use of Sinupret® extract in pregnant and breastfeeding women, therefore, for safety reasons, the drug is not recommended for use during pregnancy and breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
At recommended doses, the drug does not affect the ability to drive or use other mechanisms.
Method of administration and doses
Adults and children over 12 years of age take 1 tablet 3 times a day. The tablets should be taken without chewing, with sufficient liquid, and preferably after a meal.
There is insufficient data to recommend a specific dosage for renal and/or hepatic dysfunction.
Unless otherwise prescribed by a doctor, the recommended course of treatment is 7-14 days.
Please pay attention to the information in the "Application Features" section.
Children: Not for use in children under 12 years of age due to lack of sufficient data.
Overdose
No cases of intoxication with Sinupret® extract are currently known.
In case of overdose, the following side effects may be aggravated, such as nausea, stomach pain, diarrhea. In such cases, you should stop using the drug and consult a doctor.
Treatment: symptomatic therapy.
Adverse reactions
On the part of the digestive system: nausea, flatulence, diarrhea, dry mouth, stomach pain are often observed.
On the part of the immune system: infrequent local skin hypersensitivity reactions (e.g. rash, redness, itching), as well as possible systemic allergic reactions (e.g. angioedema, shortness of breath, facial swelling).
If any adverse reactions occur, you should stop using the drug and consult a doctor.
Expiration date
3 years. Do not use after the expiry date stated on the packaging.
The expiration date determines the use of the drug until the last day of the month.
Storage conditions
Store in the original packaging at a temperature not exceeding 30 °C, out of the reach of children.
Packaging
10 tablets in a blister; 2 blisters No. 20 (10x2) or 4 blisters No. 40 (10x4) in a cardboard box.
Vacation category
Without a prescription.
Manufacturer/Applicant
Bionorica SE.
Location of the manufacturer and its business address/location of the applicant
Kerchensteinerstrasse, 11-15, 92318, Neumarkt, Germany/Kerschensteinerstrasse, 11-15, 92318 Neumarkt, Germany.
Contact details of the manufacturer's representative in Ukraine, LLC "Bionorika":
phone: 044 521 86 00; fax: 044 521 86 01, info@bionorica.ua
