Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
Sinupret, oral drops, solution
Gentianae radix + Primulae flos cum calycibus + Rumicis herba + Sambuci flos + Verbenae herba
Please read carefully all the information contained in this leaflet before taking the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if symptoms worsen after 7–14 days, consult your doctor.

Table of contents:

What Sinupret is and what it is used for
Important information before taking Sinupret
How to take Sinupret
Possible side effects
How to store Sinupret
Contents of the pack and other information

1. What Sinupret is and what it is used for

Sinupret is a traditionally used herbal medicinal product with secretolytic action.
Sinupret liquefies mucus, thereby reducing swelling of the mucous membranes of the upper respiratory tract.
Sinupret is used as an adjunctive treatment in acute and chronic inflammatory conditions of the sinuses. This herbal product has been traditionally used for the indications mentioned above, and its efficacy is based on long-term use and experience.

2. Information before using Sinupret

When not to use Sinupret

if the patient is allergic (hypersensitive) to the active substance and to the root of gentian, flower or calyx of primrose, herb of sorrel, flower of black elder, herb of verbena.

Warnings and precautions
Contact a doctor if the patient experiences nosebleeds, fever, severe pain,
purulent nasal discharge, vision disturbances, facial or ocular asymmetry, or facial numbness,
as these symptoms or findings are generally considered serious warning signs of all forms of
sinusitis requiring examination by a specialist physician and urgent treatment.
Consult a doctor if symptoms persist longer than 7–14 days, worsen, or
recur periodically.
In cases of diagnosed gastric inflammation and in patients with sensitive stomach,
particular caution should be exercised when taking this medicine. In such cases,
Sinupret oral drops should be taken after meals, followed by a glass of water.

Children
Due to the alcohol content and lack of sufficient data, the product should not be used
in children under 6 years of age.

Sinupret with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking,
have recently taken, or plan to take.
No interactions with other medicines are currently known.

Taking Sinupret with food and drink
Food and drink do not affect the medicine’s action.

Pregnancy and breastfeeding
As with all other medicines, Sinupret oral drops should be used during pregnancy
only after careful assessment by the physician of the benefit-risk ratio of the therapy.
Sinupret oral drops should not be used during breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant,
or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Sinupret oral drops have no influence on the ability to drive or operate machinery.

Sinupret oral drops contain ethanol
This medicine contains 465 mg of alcohol (ethanol) in 3.1 ml, equivalent to 150 mg/ml (19% V/V).
The amount of alcohol contained in 3.1 ml of this product corresponds to less than 12 ml of beer or 5 ml of wine.
The small alcohol content in this product will not have noticeable effects.

3. How to use Sinupret

This medicine should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The usual dosage of Sinupret drops is as follows:
Adults: orally, usually 3 times daily 50 drops, corresponding to 3.1 ml per single dose.
Children and adolescents aged 6 to 17 years: orally, usually 3 times daily 25 drops, corresponding to 1.55 ml per single dose.
In special cases, the dose may be doubled.
Sinupret oral drops may be taken diluted in a small amount of liquid or undiluted.
When using Sinupret, as with other secretolytic agents, it is recommended to increase fluid intake. To facilitate dosing, the bottle should be held in an upright position.
Use in children
Due to the alcohol content and lack of sufficient data, the product should not be used in children under 6 years of age.
Taking more than the recommended dose of Sinupret
If a patient has taken more Sinupret oral drops than recommended, inform a doctor. The doctor will decide on the necessary therapy. The adverse effects listed below may be more pronounced.
Missing a dose of Sinupret
If a dose is missed, do not take a double dose to make up for it. Continue taking Sinupret oral drops as prescribed by the doctor or described in the leaflet.
Stopping the use of Sinupret
Discontinuing the use of Sinupret may lead to worsening of symptoms. If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Sinupret may cause adverse reactions, although not everyone experiences them.

Uncommon adverse reactions (may occur in 1 out of 100 people):
Gastrointestinal disorders: stomach pain, nausea.

Rare adverse reactions (may occur in 1 out of 1,000 people):
Local hypersensitivity reactions such as urticaria, erythema, itching.

Frequency not known (cannot be estimated from available data):
Severe allergic reactions (swelling of lips, tongue and throat, and/or larynx with airway constriction, dyspnea, facial swelling).

If the first symptoms of hypersensitivity or allergic reactions occur, treatment with Sinupret oral drops should be discontinued and medical advice should be sought immediately.

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 at 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.

Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Sinupret medication

Store below 25°C. Keep in the original packaging to protect from light.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Shelf-life after first opening: 3 months.
Additional information:
As with all herbal medicines, a slight cloudiness or sediment may appear in Sinupret oral drops during storage. However, this does not affect the quality of the medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Sinupret contains
The active substance in Sinupret is a liquid extract from a mixture of: Gentianae radix (gentian root),
Primulae flos cum calycibus (primrose flower with calyx), Rumicis herba (dock herb),
Sambuci flos (elder flower), and Verbenae herba (vervain herb) (1/3/3/3/3).
Extraction solvent: ethanol 59% (V/V).
Other components of the medicine: purified water.

What Sinupret looks like and contents of the pack
Sinupret oral drops are available in a brown glass bottle (type III), equipped with an opaque HDPE dropper pipette, a white PP screw cap, and a white tamper-evident ring made of HDPE, placed in a cardboard box.
The cardboard box contains one bottle with the patient information leaflet.

For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, country of export:
BIONORICA SE
Kerschensteinerstraße 11-15
92318 Neumarkt
Germany

Manufacturer:
BIONORICA SE
Kerschensteinerstraße 11-15
92318 Neumarkt
Germany

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing authorization number in Romania, country of export: 9942/2017/01
Parallel import authorization number: 58/26