Sinupret extract
Poland
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
Sinupret extract,
effervescent tablets
Extractum siccum compositum ex: Gentianae radice, Primulae flore, Rumicis herba, Sambuci flore,
Verbenae herba
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.
This medicine should always be taken according to the instructions provided in this patient leaflet or as directed by a physician or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement after 7–14 days, or if your condition worsens, contact your doctor.
Leaflet contents:
- What Sinupret extract is and what it is used for
- Important information before taking Sinupret extract
- How to take Sinupret extract
- Possible side effects
- How to store Sinupret extract
- Contents of the pack and other information
1. What Sinupret extract is and what it is used for
Sinupret extract is a herbal medicinal product used for the treatment of acute, uncomplicated inflammatory conditions of the paranasal sinuses in adults.
2. Important information before taking Sinupret extract
When not to take Sinupret extract
- if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6), or
- if you have or have had peptic ulcer disease.
Warnings and precautions
Contact your doctor if you experience nosebleeds, fever, severe pain, purulent nasal discharge, visual disturbances, facial or ocular asymmetry, or facial numbness, as these symptoms are generally considered serious warning signs in all forms of sinusitis and require evaluation by a specialist physician and urgent treatment. You should consult a doctor if symptoms persist beyond 7–14 days, worsen, or recur periodically.
Particular caution is advised in patients with diagnosed gastritis or those with a sensitive stomach. Sinupret extract should be taken after meals, with a glass of water.
Children and adolescents
Use of this medicinal product in children and adolescents under 18 years of age is not recommended due to insufficient data.
Sinupret extract and other medicines
No studies on drug interactions have been conducted. Therefore, it cannot be excluded that the effects of other medicinal products may be enhanced or diminished. Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Pregnancy and breastfeeding
For safety reasons, Sinupret extract should be avoided during pregnancy. It is not known whether the active substances of Sinupret extract are excreted in human milk. Sinupret extract should not be used during breastfeeding.
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Driving and operating machinery
Sinupret extract may have a minor influence on the ability to drive and operate machinery in patients who experience dizziness as an adverse reaction (see section 4).
Sinupret extract contains glucose and sucrose.
If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicinal product.
Information for diabetics:
One effervescent tablet contains on average 0.3 g of readily available carbohydrates.
3. How to take Sinupret extract
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
Recommended dose:
Adults should take 1 effervescent tablet three times daily (maximum of 3 effervescent tablets per day).
There is insufficient data on special dosing for patients with impaired renal or hepatic function.
Children and adolescents
Not recommended for children and adolescents under 18 years of age due to insufficient data.
Method of administration
Sinupret extract should be swallowed whole with liquid (e.g., a glass of water), without chewing or crushing, three times daily (in the morning, at noon, and in the evening). If you have a sensitive stomach, take Sinupret extract after meals.
Duration of treatment
Unless otherwise directed, the treatment duration is 7–14 days. If there is no improvement within this period, or if symptoms persist thereafter, consult your doctor.
Taking more Sinupret extract than recommended
If you have taken more Sinupret extract than you should, inform your doctor. The doctor will decide on the necessary treatment. The adverse reactions listed below (e.g., nausea, abdominal pain, diarrhoea) may be more pronounced.
Missing a dose of Sinupret extract
If you have taken too little Sinupret extract by mistake or have forgotten to take a dose, do not take a double dose to make up for the missed dose. Continue taking Sinupret extract as directed by your doctor or as described in this leaflet.
Stopping Sinupret extract
Discontinuation of Sinupret extract is usually harmless.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like any medicine, this medicine may cause adverse reactions, although not everyone experiences them.
Common adverse reactions (may occur in 1 in 10 people):
Stomach disturbances, such as nausea, bloating, diarrhoea, dry mouth, abdominal pain.
Uncommon adverse reactions (may occur in 1 in 100 people):
Local hypersensitivity reactions (e.g. rash, skin redness, skin or eye itching) and severe allergic reactions (swelling of lips, tongue and throat, and/or larynx with narrowing of the airways, shortness of breath, facial swelling).
Dizziness.
If the first signs of hypersensitivity reactions occur, do not take Sinupret extract again.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.
5. How to store Sinupret extract
Do not store above 30°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack.
The expiry date refers to the last day of the stated month.
6. Contents of the pack and other information
What Sinupret extract contains
The active substance in the medicine is a dry extract composed of: gentian root, primrose flower,
sorrel herb, elderflower, and verbena herb.
-
One coated tablet contains 160 mg of dry extract (DER 3-6:1) composed of: gentian root (Gentiana lutea L., radix), primrose flower (Primula veris L., flos), sorrel herb (Rumex crispus L., herba), elderflower (Sambucus nigra L., flos),
and verbena herb (Verbena officinalis L., herba) in a ratio of (1:3:3:3:3), extraction solvent: ethanol 51% (m/m). -
Other ingredients are: sucrose, talc, calcium carbonate (E 170); microcrystalline cellulose; maltodextrin; cellulose powder; hypromellose; dextrin; spray-dried arabic gum; hydrophobic colloidal silica; anhydrous colloidal silica; titanium dioxide (E 171); liquid glucose; magnesium stearate; stearic acid; chlorophyllin 25%, powder (chlorophyllin copper complex E 141, liquid glucose); indigo carmine aluminium lake (indigo carmine E 132, aluminium hydroxide); carnauba wax; riboflavin (E 101).
What Sinupret extract looks like and contents of the pack
Pack size of 20 coated tablets contains 2 blisters, each with 10 coated tablets.
Pack size of 40 coated tablets contains 4 blisters, each with 10 coated tablets.
Not all pack sizes may be marketed.
Sinupret extract is green, round, biconvex coated tablets with a smooth surface.
Marketing Authorisation Holder and Manufacturer
BIONORICA SE
Kerschensteinerstrasse 11-15
92318 Neumarkt, Germany
Tel.: +49 / (0)9181 / 231-90
Fax: +49 / (0)9181 / 231-265
e-mail: [email protected]
For further information, please contact the local representative of the Marketing Authorisation Holder:
Bionorica Polska Sp. z o.o.
ul. Hrubieszowska 6B
01-209 Warsaw, Poland
Tel/Fax: +(48) 22 886 46 06
e-mail: [email protected]
This medicinal product is authorised for sale in the European Economic Area under the following names:
AUSTRIA
Sinupret intens, überzogene Tablette
BULGARIA
Синупрет екстракт обвити таблетки
CROATIA
Sinupret akut obložene tablete
CZECH REPUBLIC
Sinupret akut
GERMANY, LUXEMBOURG
Sinupret extract, überzogene Tablette
DENMARK
Sinux
ESTONIA
Sinupret extract, kaetud tabletid
LATVIA
Sinupret ekstrakts 160 mg apvalkotās tabletes
LITHUANIA
Sinupret intens dengtos tabletės, suaugusiesiems
POLAND
Sinupret extract, tabletki drażowane
ROMANIA
Sinupret acute drajeuri
SLOVENIA
Sinupret exera obložene tablete
SLOVAKIA
Sinupret Akut, obalené tablety
SWEDEN
Sinuxol
