SINUPRET DRAGEES N100 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 6MG/+18MG/+18MG/+18MG/+18MG N100

Package leaflet: Information for the user Sinupret, coated tablets

Verbena herb, gentian root, sorrel, elder flowers, primula flowers.

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

1. What Sinupret is and what it is used for

Sinupret is an herbal medicine used as adjunctive therapy to loosen secrete in acute and exacerbating chronic inflammations of the paranasal sinuses (sinusitis).
You must talk to a doctor if you do not feel better or if you feel worse after 7-14 days.

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

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

Warnings and precautions

This medicine contains glycose, lactose, sucrose and sorbitol. Sinupret 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

This medicine is not recommended for use in children under 6 years of age due to the lack of sufficient data.

Other medicines and Sinupret

There are no known interactions with other medicines.
Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

Sinupret with food, drink and alcohol

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 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 effect on the ability to drive or use machines.

Sinupret contains glycose, lactose, sucrose and sorbitol.

If your doctor has told you that you have intolerance to certain sugars, please consult talk to your doctor before taking Sinupret tablets.
One tablet contains sugars corresponding to 0.01 BU (bread units).

3. How to use Sinupret

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 adolescents from the age of 12 years - 2 coated tablets 3 times a day.

Use in children

Children aged 6-11 - 1 coated tablet 3 times a day.
Sinupret 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.
You should not take Sinupret tablets for longer than 7-14 days (see Warnings and precautions).

If you use more Sinupret than you should

If you have taken more Sinupret 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

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

You can stop taking Sinupret tablets 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, this medicine 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 rarely occur also allergic reactions (e.g. topical swelling of the skin, difficulty breathing, facial swelling).
Stop taking Sinupret at the first signs of a hypersensitivity/allergic reaction.

Reporting of 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

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 away 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 contains

Active substances
One coated tablet contains dry extract of the following plants
Verbena herb 18 mg
Gentian root 6 mg
Primula flower 18 mg
Sorrel   18 mg
Elder flower   18 mg
Excipients
Chlorophyll, calcium carbonate, colloidal anhydrous silica, dextrin, eudragit E 12.5, gelatine, indigo carmine - aluminium salt (E132), riboflavin (E101), lactose monohydrate, slight magnesium oxide, liquid spray-dried glucose, corn starch, Montan glycol wax, potato starch, purified water, shellac, sorbitol, stearic acid, sucrose, talc, titanium dioxide, refined castor oil.

What Sinupret looks like and contents of the pack

Round, green, biconvex tablets with smooth surface, 25 or 20 tablets in blister pack.
Packages: 50,100, 200 and 500 coated tablets in a cardboard carton.
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 Estonia
Phone: +372 738 0676

This leaflet was last revised in May 2017.