SINUPRET DRAGEES N50 N20

ATC code: R05X 

Active substances: Gentianae Radicis, Primulae Floris, Rumicis Herbae, Sambuci Floris, Verbenae Herbae Extractum Siccum

Vendor, principal: Bionorica Gmbh. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

SINUPRET FORTE 12MG/+36MG/+36MG/+36MG/+36MG N20

Package leaflet: Information for the user Sinupret forte, coated tablets

Gentian root, primula flower, sorrel, elder flower, verbena herb.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after 7-14 days.

What is in this leaflet

1.   What Sinupret forte is and what it is used for
2.   What you need to know before you use Sinupret forte
3.   How to use Sinupret forte
4.   Possible side effects
5.   How to store Sinupret forte
6.   Contents of the pack and other information

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

Sinupret forte is an herbal medicine used as adjunctive therapy to loosen secrete in acute and exacerbating chronic inflammations of the paranasal sinuses (sinusitis).

2. What you need to know before you use Sinupret forte Do not use Sinupret forte:

-   if you are allergic to active substance(s) or any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Sinupret forte.
This medicine contains glycose, lactose, sucrose and sorbitol. Sinupret forte tablets must not be used in patients with rare hereditary problems of fructose or galactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome, sucrase-isomaltase deficiency.
If symptoms persist for more than 7-14 days or periodically return, or if you experience dyspnoea, fever or purulent sputum, a doctor should be consulted.

Children

Sinupret forte is not recommended for use in children under 12 years of age due to the lack of sufficient data.

Other medicines and Sinupret forte

To date, there are no data on interactions with other medicines.
Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

Sinupret forte with food and drink

Patients with gastric disorders are recommended to take tablets after meal.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Like all medicines, Sinupret forte should not be used during pregnancy and breast-feeding, unless prescribed by a doctor and clearly necessary.
In animal studies, Sinupret did not indicate harmful effects with respect to fertility.

Driving and using machines

This medicine has no significant effect on the ability to drive or use machines.

Important information on some ingredients of Sinupret forte

This medicine contains glycose, lactose, sucrose and sorbitol. If your doctor has told you that you have an intolerance to certain sugars, please talk to your doctor before taking Sinupret forte tablets.
One tablet contains sugars corresponding to 0.03 BU (bread units).

3. How to use Sinupret forte

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
Recommended dose: adults and children from the age of 12 years take 1 tablet 3 times a day, unless otherwise prescribed by the doctor.
Sinupret forte tablets are swallowed whole with some liquid (e.g. a glass of water).
If you have stomach disorders, you should preferably take the medicine after meals.
Unless otherwise prescribed by the doctor, the recommended duration of treatment is 7-14 days (see Section “Warnings and precautions”).
If you feel that the effect of Sinupret forte is too strong or too weak, talk to your doctor or pharmacist.

If you use more Sinupret forte than you should

If you have taken more Sinupret forte than prescribed dose, contact your doctor who can decide on any measures that may be required.
Overdose may intensify the side effects.

If you forget to take Sinupret forte

Do not take a double dose to make up for a forgotten dose. Keep taking the medicine according to instructions.

If you stop taking Sinupret forte

You can stop taking Sinupret forte without any problems.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, Sinupret forte can cause side effects, although not everybody gets them.
Side effects are classified as follows: very common (>1/10) common (>1/100 to <1/10) uncommon (>1/1,000 to <100) rare (>1/10,000 to<1/1,000) very rare (<1/10,000)
not known (cannot be estimated from the available data).
Common side effects are gastrointestinal complaints (e.g. nausea, stomach ache).
Uncommon side effects include hypersensitivity reactions of the skin (e.g. skin rash, redness, itching). There may occur also allergic reactions (e.g. topical swelling of the skin, difficulty breathing, facial swelling).
Stop taking Sinupret forte at the first signs of a hypersensitivity/allergic reaction.
Possible side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sinupret forte

Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Store in the original package, protected from light and humidity.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment

6. Contents of the pack and other information What Sinupret forte contains

Active substances
One coated tablet contains dry extract of the following plants:
Gentian root 12 mg Primula flower    36 mg
Sorrel   36    mg
Elder flower   36 mg
Verbena herb   36 mg
Excipients
Tablet core: potato starch, colloidal anhydrous silica, purified water, lactose monohydrate, gelatine (E441), sorbitol (E420), stearic acid.
Tablet coating:
Chlorophyll powder 25% (E141), calcium carbonate (E170), refined castor oil, eudragit E 12.5, liquid spray-dried glucose, indigo carmine - aluminium salt (E132), light magnesium oxide, corn starch, dextrin (E1400), Montan glycol wax, riboflavin (E101), shellac (E904), sucrose, talc (E553b), titanium oxide (E171).

What Sinupret forte looks like and contents of the pack

Round, green, biconvex tablets with smooth surface.
Pack contains 20, 50 or 100 coated tablets.
Hospital pack contains 500 (10x50) tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Bionorica SE
Kerschensteinerstrasse 11-15 D-92318 Neumarkt Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Miecys-Pharm OÜ Vitamiini 4 Tartu 51014 Phone: +372 7380676
This leaflet was last revised in June 2015.