TONSILGON N 50ML

ATC code: R05X 

Active substances: Althaeae Radix, Matricariae Flos, Equiseti Herba, Juglandis Folium, Millefolii Herba, Quercus Cortex, Taraxaci Herba

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

TONSILGON N 50ML

Package leaflet: Information for the user

Tonsilgon N, oral drops, solution
Marshmallow root, camomile flowers, horsetail herb, nut leaves, yarrow herb, oak bark, dandelion
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 days.

What is in this leaflet

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

1. What Tonsilgon N is and what it is used for

Tonsilgon N is used for supplementary treatment of frequently recurring and chronic throat infections, especially tonsillitis (inflammation of the tonsils).

2. What you need to know before you use Tonsilgon N Do not use Tonsilgon N

-   if you are allergic to the active ingredients or any of the other ingredients of this medicine (listed in section 6);
-   if you are allergic to any flowers of the plants in the genus Asteraceae, e.g. Artemisia, yarrow, chrysanthemum, Anthemis, due to possible cross reactions with chamomile flowers
-   in children under the age of 1

Warnings and precautions

If symptoms persist for more than one week, consult your doctor. Seek immediate medical attention if you experience shortness of breath, fever, purulent or bloody sputum.
Other medicines and Tonsilgon N
Interactions with other medicines have not been studied. Clinical interactions between Tonsilgon N oral drops and other medicines have not been reported. .
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

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 for advice before taking this medicine.
Consider that this medicine contains alcohol.
Due to insufficient data, this medicine should be used during pregnancy and breast-feeding only when prescribed by a doctor after a risk/benefit analysis.
Fertility
The effect on fertility has not been studied.

Driving and using machines

Tonsilgon N has no significant effect on the ability to drive or use machines.
Tonsilgon N drops contain 19% alcohol, i.e. 210 mg of alcohol per 25 drops, which corresponds to 5 ml of beer or 2 ml of wine. This medicine is dangerous for patients who suffer from alcoholism.
The alcohol content of this medicine must be taken into account by pregnant and breastfeeding women, children who are using the medicine in larger doses than recommended and high-risk patients, e.g. those with liver disease or epilepsy. In these cases, talk to a doctor before using this medicine.
3. How to use Tonsilgon N
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 doses
Acute symptoms:
Adults and young people from the age of 12: 25 drops 5-6 times a day Children aged 6-11: 15 drops 5-6 times a day Children aged 1-5: 10 drops 5-6 times a day
After improvement of acute symptoms
Adults and young people from the age of 12: 25 drops 3 times a day Children aged 6-11: 15 drops 3 times a day Children aged 1-5: 10 drops 3 times a day
Tonsilgon N drops are taken three times a day (morning, noon and evening)
It is advised to hold the solution in your mouth for a short time before swallowing, or taking the drops with some fluid (e.g. a glass of water) if necessary.
Tonsilgon N should be used for a week after acute symptoms have improved.
This medicine is suitable for long-term use.
Consult with your doctor or pharmacist if you are not sure of anything.

If you take more Tonsilgon N than you should

Acute signs of toxicity in the case of overdose have not been reported. Talk to your doctor if you have taken more medicine than recommended. Your doctor will decide on the appropriate measures.
If you forget to take Tonsilgon N
Take the medicine as soon as possible, but do not exceed the recommended daily dose.
If you stop taking Tonsilgon N
Stopping taking Tonsilgon N drops should cause no problems.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Gastrointestinal problems (e.g. nausea, stomach pain) are common (1 person in 100).
The prevalence of allergic reactions (skin rash, urticaria) is unknown (cannot be estimated from available data).
Stop using Tonsilgon N as soon as you notice the first hypersensitivity symptoms or allergic reactions.
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 Tonsilgon N

Keep this medicine out of the sight and reach of children.
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. The expiry date after the first opening is 6 months.
Store the medicine at a temperature of less than 25 °C, in the original package, protected from light and humidity.
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 Tonsilgon N contains

1 g of the solution contains 0.29 g of liquid extract, which contains the following plants: 4 mg of marshmallow root, 3 mg of chamomile flower, 5 mg of horsetail herb, 4 mg of walnut leaf, 4 mg of yarrow herb, 2 mg of oak bark, 4 mg of dandelion herb.
The extractant is 59% ethanol.
Contains 19% (by volume) alcohol.
1 ml (0.98 g) of the solution corresponds to 18 drops.

What Tonsilgon N looks like and contents of the pack

Tonsilgon N is a clear to slightly cloudy, yellowy brown liquid that tastes and smells like chamomile.
Tonsilgon N oral drops are marketed in a brown glass bottle with a polyethylene dropper and a polyethylene screw cap, which is packaged in a cardboard box.
The following pack sizes are marketed: 50 ml, 100 ml and 500 ml.
Not all package sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Bionorica SE
Kerschensteinerstrasse 11-15 92318 Neumarkt Germany
E-mail: [email protected]
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 August 2017.