Name:
Sinupret Extract tabl. po 160mg in bl. in pack. No. 10×2
Description:
Tablets, coated green, round, biconvex, with a smooth surface. Release form: 10 tablets in a blister. 2 or 4 blisters, together with instructions for use, are placed in a cardboard box. Special instructions for patients with gastritis or other diseases of the gastrointestinal tract in the acute stage, Sinupret® extract is recommended to be taken with caution, preferably after meals with a glass of water. The package insert explains to the patient that if the symptoms of the disease last longer than 7-14 days, recur periodically or worsen (for example, fever, nosebleeds, severe headache or facial pain, purulent discharge from the nose, blurred vision, asymmetry of the middle parts of the face or eyes, numbness of the face) you should seek medical advice as these symptoms are considered serious for all forms of rhinosinusitis. Patients with rare hereditary diseases such as fructose intolerance, glucose-galactose malabsorption syndrome, sucrase-isomaptase deficiency should not take Sinupret® extract. Information for patients with diabetes: 1 tab. the drug contains about 0.026 bread units (XE). Use in pediatrics Not recommended for use in children under 12 years of age due to insufficient data. Preclinical safety data In toxicological studies, the dry extract of Sinupret® extract was administered orally to dogs (for 39 weeks) and rats (for 26 weeks). In a dog study, the NOAEL was 320 mg/kg body weight, corresponding to 22 times the human dose. In a rat study, the NOAEL was 320 mg/kg body weight, corresponding to 7 times the human dose. In various test systems (in vitro, in vivo) for the native dry extract, which is part of the drug Sinupret extract, no indications of mutagenic potential were found. Carcinogenicity studies have not been conducted. In reproductive toxicity studies with Sinupret® drops in several animal species (rats and rabbits), no effects on fertility, embryonic/fetal, perinatal or postnatal development, nor teratogenic effects were observed. Reproductive toxicity studies of the dry extract contained in Sinupret® extract in rabbits showed that no embryotoxic or teratogenic effects were observed at doses corresponding to 32 times the human dose. Influence on the ability to drive vehicles and control mechanisms. When used in recommended doses, the drug does not affect the ability to drive or use machines. Pharmacological action A medicinal product containing components of plant origin as active substances is used in the treatment of inflammation of the paranasal sinuses. Indications for use In the complex therapy of acute uncomplicated inflammation of the paranasal sinuses (acute uncomplicated rhinosinusitis). Dosage and administration Apply inside. Tablets should be swallowed whole with a sufficient amount of water (for example, a glass of water). Adults and adolescents from 12 years of age are prescribed 1 tab. 3 times / day. Unless otherwise prescribed by a doctor, the recommended duration of taking the drug is 7-14 days. Use in patients with impaired liver and/or kidney function: No information available. Use during pregnancy and lactation Do not use the drug during pregnancy and lactation (due to insufficient clinical data). Precautions For patients with gastritis or other diseases of the gastrointestinal tract in the acute stage, it is recommended to take Sinupret extract tablets with caution, preferably after meals with a glass of water. If symptoms persist for more than 7-14 days, recur intermittently, or worsen (eg, fever, nosebleeds, severe headache or facial pain, purulent nasal discharge, blurred vision, asymmetry of the midface or eyes, facial numbness), consultation should be sought. see a doctor, as these symptoms are considered serious for all forms of rhinosinusitis. It is not recommended for use in children under 12 years of age due to the lack of necessary data. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome, sucrase-isomaltase deficiency should not take Sinupret® extract tablets. Information for patients with diabetes: 1 tablet contains about 0.026 bread units (XE). Does not contain gluten and lactose. Interaction with other drugs Interaction with other drugs is currently unknown. Special interaction studies with other drugs have not been conducted, so an increase or decrease in the effect of other drugs cannot be ruled out. Contraindications Peptic ulcer of the stomach and duodenum. Individual hypersensitivity to the components of the drug. Composition One tablet contains 160 g dry extract (3-6:1) of gentian root (Gentianae radix), primrose flowers (Primulae flos), sorrel herb (Rumicis herba), elder flowers (Sambuci flos), verbena herb (Verbenae herba) ( 1:3:3:3:3) Extractant: ethanol 51% (m/m). Excipients: maltodextrin, anhydrous colloidal silicon dioxide, gum arabic, calcium carbonate (E170), cellulose (powder), microcrystalline cellulose, magnesium stearate, colloidal aqueous silicon dioxide, carnauba wax, chlorophyllin (E141), dextrin, dextrose (glucose) liquid , hypromellose, indigo carmine aluminum lacquer (E132), riboflavin (E101), stearic acid, sucrose, talc, titanium dioxide (E171). 1 tablet contains about 0.026 bread units (XE). Does not contain gluten and lactose. 10 pieces. – blisters (2) – cardboard boxes. 10 pieces. – blisters (4) – cardboard boxes. Overdose So far, no cases of intoxication have been reported with an overdose of the drug. Symptoms: in case of an overdose, the side effects described in the “Side Effects” section may be more pronounced. In this case, the patient should stop taking the drug and consult a doctor. Treatment: symptomatic therapy. Side effects Like all medicines, Sinupret® extract can have side effects. When assessing side effects, the frequency of occurrence is estimated as follows: very often (?1/10), often (?1/100, but <1/10), infrequently (?1/1000, but <1/100), rarely (? 1/10,000 but <1/1000), very rare (<1/10,000), not known (frequency cannot be determined from the available data). From the digestive system: often - gastrointestinal disorders, such as nausea, flatulence, diarrhea, dry mouth, abdominal pain. From the immune system: infrequently - local allergic reactions, for example, exanthema, erythema, itching of the skin or eyes; unknown - systemic allergic reactions, for example, angioedema, shortness of breath, swelling of the face. From the nervous system: infrequently - dizziness. If the above or other adverse reactions occur, the patient should stop taking the drug and consult a doctor. Storage conditions The drug should be stored out of the reach of children at a temperature not exceeding 30°C. Buy Sinupret Extract tablets p/o 160mg â„–10x2 The price of Sinupret Extract tablets p/o 160mg â„–10x2
The code | 92760 |
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Barcode | 4 029 799 168 001 |
Active substance | Powder from gentian root, sorrel herb, verbena, flower |
Manufacturer | Rottendorf Pharma GmbH, Germany |
Trademark | Bionorica |
trade line | Sinupret |
Importer | IOOO Interfarmaks 223028 Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Star, 19a-5, room. 5-2 |
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