Package leaflet: Information for the user

Sinupret, coated tablets
Gentianae radix+ Primulae flos cum calycibus+ Rumicis herba+ Sambuci flos+ Verbenae herba
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described 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 or if your condition worsens after 7–14 days, consult your doctor.

Contents of the leaflet:

What Sinupret is and what it is used for
What you need to know 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 activity. Sinupret
helps to liquefy 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.
If there is no improvement or if you feel worse after 7–14 days, consult your doctor.

2. Important information before using Sinupret

When not to use Sinupret

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

Warnings and precautions
Special caution is required when administering this medicine to patients with a sensitive stomach or gastrointestinal disorders.
Consult a doctor if symptoms last longer than 7–14 days, worsen, recur periodically and/or fever, severe pain, or symptoms of unknown origin persist.
If the patient has previously been diagnosed with rare hereditary conditions such as fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase deficiency, rare hereditary galactose intolerance, or lactase deficiency (Lapp type), the patient should consult a doctor before using this medicine.

Children
Use in children under 6 years of age is not recommended due to insufficient data.

Sinupret and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
To date, no interactions with other medicines are known.

Use of 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 tablets should be administered during pregnancy only after a physician has carefully evaluated the risk-benefit ratio of the therapy.
Sinupret coated tablets should not be used during breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
This medicine has no influence on the ability to drive or operate machinery.

Sinupret coated tablets contain lactose, sorbitol, sucrose, and glucose.
If the patient has previously been diagnosed with disorders involving intolerance to certain sugars, the patient should consult a doctor before using this medicine.
This medicine contains 0.22 mg of sorbitol in each coated tablet.
This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Sinupret

This medicine should always be used exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The usual dosage of Sinupret is as follows:
Adults and adolescents over 12 years of age: 2 coated tablets three times daily, taken orally.
Children from 6 to 11 years of age: 1 coated tablet three times daily, taken orally.
In special cases, the dose may be doubled.
The tablets should be swallowed whole with water.
When taking Sinupret, as with other secretolytic agents, it is recommended to increase fluid intake.
Taking more Sinupret than recommended
In case of overdose, the adverse effects listed below may be intensified.
If a patient has taken more Sinupret than recommended, a doctor should be informed immediately. The doctor will decide on the necessary treatment.
Missing a dose of Sinupret
If a dose of Sinupret is missed, it should be taken as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped. Do not take a double dose to make up for a missed dose.
Stopping treatment with Sinupret
Discontinuing treatment with Sinupret may lead to a worsening of symptoms for which the medicine is being used.
If in doubt about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Sinupret may cause adverse reactions, although not everyone experiences them.
Gastrointestinal disturbances such as abdominal pain, nausea, and local hypersensitivity reactions—such as urticaria, erythema, and pruritus—occur uncommonly (may affect 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 airway constriction (angioedema), dyspnea, and facial swelling.
The frequency of these adverse reactions is unknown (cannot be estimated based on available data).
If any symptoms of hypersensitivity or allergic reactions occur, administration of Sinupret effervescent tablets should be discontinued and medical advice should be sought immediately.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Sinupret medicine

Do not store above 30°C.
Keep the medicine in a place out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the packaging.
The expiry date refers to the last day of the stated month.

6. Contents of the pack and other information
What Sinupret medicine contains
The active substances are powdered extracts of:
6 mg Gentiana lutea L., radix (gentian root),
18 mg Primula veris L. and/or Primula elatior (L.) Hill., flos cum calycibus (primrose flower with calyx),
18 mg of various species of the genus Rumex, including R. acetosa L., R. acetosella L., R. obtusifolius L.,
R. patientia L., R. crispus L., R. thyrsiflorus Fingerh., herba (sorrel herb),
18 mg Sambucus nigra L., flos (elder flower), and 18 mg Verbena officinalis L., herba (vervain herb).

Other ingredients of the medicine:
Ingredients of the core of the coated tablet:
Gelatin, lactose monohydrate, potato starch, colloidal anhydrous silica, sorbitol (E 420 (ii)), stearic acid, purified water.

Ingredients of the coating of the coated tablet:
basic butyl methacrylate copolymer, calcium carbonate (E 170), purified castor oil, chlorophyll powder 25% (containing copper complexes of chlorophyllins (E 141 (ii)) and spray-dried liquid glucose), dextrin, liquid glucose, indigo carmine aluminium lake (E 132), light magnesium oxide, corn starch, Montana wax, riboflavin (E 101 (i)), shellac, sucrose, talc, titanium dioxide (E 171).

What Sinupret looks like and contents of the pack
Sinupret coated tablets are available in packs containing 50, 100 or 200 tablets. One PVC/PVDC/Al blister contains 25 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
BIONORICA SE
Kerschensteinerstrasse 11 - 15
92318 Neumarkt
Germany

For further information about this medicine, please contact the 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