Sinupret

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the user

Sinupret,

oral drops, solution
Gentianae radix +Primulae flos cum calycibus +Rumicis herba +Sambuci flos +Verbenae herba

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 this patient leaflet or as directed by your 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 ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 7-14 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet:

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

1. What is Sinupret and what is it used for

Sinupret is a traditionally used herbal medicine with secretolytic action.
Sinupret causes thinning of mucus, giving an effect that reduces swelling of the mucous membranes of the upper respiratory tract.
Sinupret is used as an adjunct in acute and chronic inflammatory conditions of the sinuses.
The herbal product is intended for traditional use in the indications listed and its effectiveness is based on a long period of use and experience.

2. Important information before taking Sinupret

When not to take Sinupret

• if you are allergic (hypersensitive) to the active substance and to gentian root, primrose flower or calyx, sorrel herb, elderberry flower, or verbena herb.

Warnings and precautions

You should contact your doctor if you experience nosebleeds, fever, severe pain, purulent nasal discharge, vision disturbances, facial asymmetry or eye problems, or facial numbness, as these symptoms or findings are generally considered serious warnings for all forms of sinusitis that require examination by a specialist doctor and urgent treatment.
You should see a doctor if symptoms persist for more than 7-14 days, worsen, or recur periodically.
In cases of diagnosed gastritis and in patients with sensitive stomachs, you should exercise particular caution when taking this medicine. You should then take Sinupret in the form of oral drops after meals, drinking a glass of water.

Children

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

Sinupret and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
So far, no interactions with other medicines are known.

Taking Sinupret with food and drink

Food and drink do not affect the action of the medicine.

Pregnancy and breastfeeding

As with all other medicines, Sinupret in the form of oral drops should be used during pregnancy only after your doctor has carefully assessed the risk-benefit ratio of therapy.
Sinupret in the form of oral drops should not be used during breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Sinupret in the form of oral drops has no effect on driving or using machines.

Sinupret oral drops contain ethanol

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

3. How to take Sinupret

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.
Usually, the recommended dose of Sinupret is:
Adults: orally, usually 3 times a day 50 drops, which corresponds to 3.1 ml in a single dose.
Children and adolescents from 6 to 17 years old: orally, usually 3 times a day 25 drops, which corresponds to 1.55 ml in a single dose.
In special cases, the dose can be increased twice.
Sinupret oral drops can be administered diluted with a small amount of liquid or undiluted.
When taking Sinupret, as with other secretolytic medicines, it is recommended to drink plenty of fluids. To facilitate dosing, the bottle should be held in a vertical position.

Use in children

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

Taking a higher dose of Sinupret than recommended

If you have taken more Sinupret oral drops than you should, you should inform your doctor. Your doctor will decide on the necessary therapy. The side effects listed below may be more severe.

Missing a dose of Sinupret

If you miss a dose, you should not take a double dose to make up for the missed dose, but continue taking Sinupret in the form of oral drops as recommended by your doctor or as described in the leaflet.

Stopping Sinupret treatment

Stopping Sinupret treatment may cause worsening of symptoms. If you have any further doubts about taking the medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sinupret can cause side effects, although not everybody gets them.
Uncommon side effects (may affect up to 1 in 100 people)
Gastrointestinal disorders: stomach pain, nausea.
Rare side effects (may affect up to 1 in 1,000 people)
Local hypersensitivity reactions, such as hives, redness, itching.
Frequency not known (cannot be estimated from the available data):
Severe allergic reactions (swelling of the lips, tongue, and throat, and/or larynx with narrowing of the airways, shortness of breath, facial swelling).
If you experience the first symptoms of hypersensitivity or allergic reactions, you should stop taking Sinupret oral drops and consult your doctor.

Reporting side effects

If you experience any side effects, including those not listed in this 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

Store in a temperature below 25°C.
Protect from moisture and sunlight.
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 month stated.

Additional information:

As with all herbal medicines, Sinupret oral drops may become cloudy or form a sediment during storage. However, this does not affect the quality of the medicine.

6. Package contents and other information

What Sinupret contains

The active substance of Sinupret is a liquid extract of a mixture: Gentiana luteaL., radix (gentian root),
Primula verisL. and/or Primula elatior(L.) Hill, flos cum calycibus (primrose flower with calyx),
various species of the genus Rumex, including R. acetosaL., R. acetosellaL., R. obtusifoliusL., R. patientiaL., R. crispusL., R. thyrsiflorusFingerh., herba (sorrel herb), Sambucus nigraL., flos (elderberry flower), and Verbena officinalisL., herba (verbena herb). The other ingredients are purified water.

• The herbal product is intended for traditional use in the indications listed and its effectiveness is based on a long period of use and experience.

What Sinupret looks like and contents of the pack

Sinupret oral drops are available in brown glass bottles with a dropper, containing 100 ml and 200 ml, placed in a cardboard box.
The cardboard box with printing contains 1 bottle with an informational leaflet.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

BIONORICA SE
Kerschensteinerstrasse 11 - 15
92318 Neumarkt
Germany
To obtain more detailed information about this medicine, you should contact the local 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

Date of last revision of the leaflet: