Sinupret

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the user

Sinupret, effervescent tablets

Gentianae radix+Primulae flos cum calycibus+Rumicis herba+Sambuci flos+Verbenae herba

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

This medicine should always be used exactly as described in the patient information 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 more information, you should ask your pharmacist.
• If you experience any side effects, including any possible side effects not listed in the 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 using Sinupret
• 3. How to use Sinupret
• 4. Possible side effects
• 5. How to store Sinupret
• 6. Contents of the packaging 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 the thinning of mucus, resulting in a decongestant effect on the mucous membranes of the upper respiratory tract.
Sinupret is used as an adjunct in acute and chronic inflammatory conditions of the sinuses.
If after 7 - 14 days there is no improvement or you feel worse, you should contact your doctor.

2. Important information before using Sinupret

When not to use Sinupret

• if you are allergic (hypersensitive) to gentian root, primrose flower or calyx, sorrel herb, elderflower, or verbena herb or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Patients with sensitive stomachs or stomach disorders require special caution when taking this medicine.
You should consult your doctor if symptoms persist for more than 7 - 14 days, worsen, or recur periodically and/or fever, severe pain, or unclear symptoms persist.
If you have previously been diagnosed with rare hereditary fructose intolerance, glucose-galactose malabsorption syndrome, sucrase-isomaltase deficiency, rare hereditary galactose intolerance, or lactase deficiency (Lapp type), you should consult your doctor before using this medicine.
ChildrenThe use of Sinupret in children under 6 years of age is not recommended due to the lack of sufficient data.

Sinupret and other medicines

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

Using 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 effervescent tablets should only be used during pregnancy after a thorough assessment of the risk-benefit ratio by your doctor.
Sinupret effervescent tablets should not be used during breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.

Driving and using machines

The medicine does not affect the ability to drive or use machines.

Sinupret effervescent tablets contain lactose, sorbitol, sucrose, and glucose.

If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before using this medicine.

3. How to use Sinupret

This medicine should always be used exactly as described in the patient information leaflet or as directed by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.
The usual dose of Sinupret is:
Adults and adolescents over 12 years: orally 2 effervescent tablets 3 times a day.
Children from 6 to 11 years: orally 1 effervescent tablet 3 times a day.
In special cases, the dose can be increased twofold.
The tablets should be swallowed whole, washed down with a small amount of water.
When using Sinupret, as with other secretolytic medicines, it is recommended to drink more fluids.

Using a higher dose of Sinupret than recommended

In the event of an overdose, the side effects listed below may be more pronounced.
If you have taken more Sinupret than you should, you should inform your doctor. Your doctor will decide on the necessary treatment.

Missing a dose of Sinupret

If you miss a dose of Sinupret at the scheduled time, you should take it as soon as possible. However, if it is close to the time for the next dose, you should skip the missed dose. You should not take a double dose to make up for the missed dose.

Stopping the use of Sinupret

Stopping the use of Sinupret may cause the symptoms for which it is used to worsen.
If you have any doubts about using the medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sinupret can cause side effects, although not everybody gets them.
Gastrointestinal disorders, such as stomach pain, nausea, and local hypersensitivity reactions - hives, redness, itching, occur infrequently (may occur in 1 in 100 people).
There is a possibility of serious allergic reactions, such as swelling of the lips, tongue, and throat, and/or larynx with narrowing of the airways (angioedema), shortness of breath, facial swelling. The frequency of these side effects is unknown (cannot be estimated from the available data).
In the event of the first symptoms of hypersensitivity or allergic reactions, you should stop using Sinupret effervescent tablets and consult your doctor.

Reporting side effects

If you experience any side effects, including any possible 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

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 packaging.
The expiry date refers to the last day of the month stated.

6. Contents of the packaging and other information

What Sinupret contains

The active substances of Sinupret are: gentian root, primrose flower with calyx, sorrel herb, elderflower, and verbena herb.
The other ingredients of the medicine are:
Ingredients of the effervescent tablet core:
Gelatin, lactose monohydrate, potato starch, colloidal silica anhydrous, sorbitol, E420 stearic acid, purified water.
Ingredients of the effervescent tablet coating:
Butyl methacrylate copolymer, calcium carbonate, purified castor oil, copper chlorophyllin complex E 141, dextrin, glucose liquid (dry substance), aluminum lake of indigo carmine E 132, light magnesium oxide, corn starch, Montana wax, riboflavin E101, shellac, sucrose, talc, titanium dioxide.

What Sinupret looks like and what the packaging contains

Sinupret effervescent tablets are available in packs of 50, 100, or 200 tablets. One blister pack of PVC/PVDC/Al foil contains 25 tablets.
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, you should contact the representative of the marketing authorization holder:
Bionorica Polska Sp z o.o.
ul. Hrubieszowska 6B01 - 209 Warsaw
Poland
Tel /Fax +(48) 22 886 46 06

Date of the last update of the leaflet: