Sinupret extract

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Sinupret extract,

coated tablets
Dry extract composed of: Gentian root, Primula flower, Rumex herb, Sambucus flower,
Verbena herb

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 7-14 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Sinupret extract and what is it used for
• 2. Important information before taking Sinupret extract
• 3. How to take Sinupret extract
• 4. Possible side effects
• 5. How to store Sinupret extract
• 6. Contents of the packaging and other information

1. What is Sinupret extract and what is it used for

A herbal medicine used to treat acute, uncomplicated sinusitis in adults.

2. Important information before taking Sinupret extract

When not to take Sinupret extract

• if the patient is allergic (hypersensitive) to the active substance or any of the other ingredients of this medicine (listed in section 6) or
• if the patient has or has had stomach ulcers.

Warnings and precautions

You should consult a doctor if the patient experiences nosebleeds, fever, severe pain, purulent discharge from the nose, vision disturbances, facial asymmetry or eye problems, or facial numbness, as these symptoms or results are generally considered serious warnings for all forms of sinusitis that require examination by a specialist doctor and urgent treatment.
You should consult a doctor if the symptoms persist for more than 7-14 days, worsen, or recur periodically.
In the case of diagnosed stomach problems and in patients with sensitive stomachs, you should exercise particular caution when taking this medicine. You should take Sinupret extract after meals, drinking a glass of water.

Children and adolescents

The use of this medicinal product in children and adolescents under 18 years of age is not recommended due to the lack of sufficient data.

Sinupret extract and other medicines

No interaction studies have been conducted. Therefore, it cannot be excluded that the effect of other medicinal products may be enhanced or weakened.
You should tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans 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 the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine.

Driving and using machines

Sinupret extract may have a minor impact on the ability to drive vehicles and operate machines in patients who experience dizziness (see section 4).

Sinupret extract contains glucose and sucrose.

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicinal product.
Diabetics should note:
One coated tablet contains an average of 0.3 g of easily absorbable carbohydrates.

3. How to take Sinupret extract

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, you should consult a doctor or pharmacist.
Recommended dose:
Adults take 1 coated tablet 3 times a day (up to a maximum of 3 coated tablets per day).
There is a lack of sufficient data on special dosing in patients with kidney/liver disorders.

Children and adolescents

The use of this medicinal product in children and adolescents under 18 years of age is not recommended due to the lack of sufficient data.

Method of administration

Sinupret extract should be swallowed, drinking a liquid (e.g., a glass of water), without chewing or crushing, 3 times a day (morning, noon, and evening). If the patient has a sensitive stomach, they should take Sinupret extract after meals.

Duration of treatment

Unless otherwise specified, the duration of treatment is 7-14 days. If there is no improvement within this time or symptoms persist after this time, you should consult a doctor.

Taking a higher dose of Sinupret extract than recommended

If the patient has taken more Sinupret extract than they should, they should inform their doctor.
The doctor will decide on the necessary therapy. The side effects listed below (e.g., nausea, abdominal pain, diarrhea) may be more severe.

Missing a dose of Sinupret extract

If the patient has taken too little Sinupret extract by mistake or if they forgot to take Sinupret extract, they should not take a double dose to make up for the missed dose, but continue taking Sinupret extract as directed by their doctor or as described in the leaflet.

Stopping Sinupret extract treatment

Stopping the use of Sinupret extract is usually harmless.
In case of any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people)
Stomach disorders, e.g., nausea, bloating, diarrhea, dry mouth, abdominal pain.
Uncommon side effects (may affect up to 1 in 100 people)
Local hypersensitivity reactions (e.g., rash, skin redness, itching of the skin or eyes) and severe allergic reactions (swelling of the lips, tongue, and throat, and/or narrowing of the airways, shortness of breath, swelling of the face).
Dizziness.
In case of the first signs of a hypersensitivity reaction, you should not take Sinupret extract anymore.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sinupret extract

Do not store above 30°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the month stated.

6. Contents of the packaging and other information

What Sinupret extract contains

The active substance of the medicine is a dry extract composed of: gentian root, primula flower, rumex herb, sambucus flower, and verbena herb

• One coated tablet contains 160 mg of dry extract (DER 3-6:1) composed of: gentian root (Gentiana lutea L., radix), primula flower (Primula veris L., flos), rumex herb (Rumex crispus L., herba), sambucus flower (Sambucus nigra L.),

verbena herb (Verbena officinalis L., herba) (1:3:3:3:3), extraction solvent: ethanol 51% (m/m).

• The other ingredients are: sucrose, talc, calcium carbonate (E 170); microcrystalline cellulose; maltodextrin; cellulose powder; hypromellose; dextrin; dried spray arabic gum; hydrophobic colloidal silica; anhydrous colloidal silica; titanium dioxide (E 171); liquid glucose; magnesium stearate; stearic acid; chlorophyllin 25%, powder (copper complex of chlorophyllin E 141, liquid glucose); aluminum lake of indigotine (indigotine E 132, aluminum hydroxide); carnauba wax; riboflavin (E
• 101).

What Sinupret extract looks like and what the pack contains

A pack of 20 coated tablets contains 2 blisters, each of 10 coated tablets.
A pack of 40 coated tablets contains 4 blisters, each of 10 coated tablets.
Not all pack sizes may be marketed.
Sinupret extract is green, round, biconvex coated tablets with a smooth surface.

Marketing authorization 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]
To obtain more detailed information, you should contact the representative of the marketing authorization 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 authorized in the Member States of 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
Date of last revision of the leaflet: