tablets 
Extracts of root from baptisia, red sun hat and läkerudbeckia and leaves from thuja

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

Always use this medicine exactly as described in this leaflet or as directed by your doctor or other healthcare professional.

– Save this information, you may need to read it again.

– If you get any side effects, talk to your doctor or nurse. This also applies to any side effects not mentioned in this information. See section 4.

– You should talk to a doctor if you do not feel better or if you feel worse after 10 days.

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

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

Esberitox forte is a traditional herbal medicine used to relieve cold symptoms such as colds and coughs.

The indications for traditional herbal medicine are based solely on the experience of long-term use.

2. What you need to know before using Esberitox forte

Do not use Esberitox forte

  • if you are allergic to baptisia, red sun hat, doctor rudbeckia, thuja, or any of the other ingredients of Esberitox forte (listed in section 6).
  • if you are allergic to basket-flowered plants (eg grebe, chamomile, daisy, dandelion, or wormwood).
  • in progressive systemic diseases such as tuberculosis and rare inflammatory disease ( sarcoidosis ).
  • in diseases that target the immune system against one’s own body (autoimmune diseases) such as inflammatory connective tissue diseases (collagenases), multiple sclerosis (MS).
  • the acquired immune deficiency AIDS diseases, HIV – infection s.
  • in immunosuppressive therapy (eg after transplants) or chemotherapy for the treatment of cancer (chemotherapy).
  • in systemic blood diseases that affect the white blood cells (eg leukemia ) or in the reduction of white blood cell content ( granulocytopenia ).

Warnings and cautions

Take special care with Esberitox forte:

  • if shortness of breath, high fever, or purulent or bloody mucus occurs. Consult your doctor.
  • if you are atopic. There is a possible risk of severe hypersensitivity reactions(anaphylactic reactions) in atopic patients. Stop taking Esberitox forte and contact a doctor immediately if you get swelling of the face, tongue, and/or throat, shortness of breath, difficulty swallowing, or rash.

Children

This medicine should not be given to children under 12 years of age.

For children between 8 and 12 years, there are other tablets with lower strength.

Other medicines and Esberitox forte

The effect of concomitant use of other drugs has not been studied.

In case of contact with a doctor or other healthcare professional, remember to tell them that you are taking or have recently taken Esberitox forte.

Pregnancy, breastfeeding, and fertility

Esberitox forte should not be used during pregnancy and lactation as there is a lack of experience.

The potential effect of the drug on fertility has not been studied.

Driving and using machines

Esberitox has no or negligible effect on the ability to drive and use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or another healthcare professional if you are unsure.

Esberitox forte contains excipients

Sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to use Esberitox forte

Always use this medicine exactly as described in this leaflet or as your doctor advised. If you are not sure, talk to your doctor or other healthcare professional.

The recommended dose is:

Adults, the elderly, and children over 12 years: 1 tablet twice daily.

Esberitox forte should not be given to children under 12 years of age.

Let Esberitox forte melt in your mouth or take the tablet with a sufficient amount of liquid (preferably a glass of water) in the morning and the evening.

Treatment time

In case of cold symptoms, treatment should start as soon as possible. Esberitox forte should not be used for more than 10 days per treatment session. Contact a doctor or other healthcare professional if symptoms persist after 10 days.

If you use more Esberitox forte then you should 

Poisoning with Esberitox forte has not been reported.

If you have accidentally taken one or two tablets more than you should, there are usually no adverse effects.

If you have ingested too much Esberitox forte or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to use Esberitox forte

Do not take a double dose to make up for a forgotten dose. Take your next dose as usual.

If you have any further questions on the use of this product, ask your doctor or other healthcare professional.

4. Possible side effects

Like all medicines, Esberitox forte causes adverse effects, although not everybody gets them.

For products containing Echinacea (eg red sun hat and doctor rudbeckia) hypersensitivity reactions in the form of rash including hives have been reported. In some cases, severe hypersensitivity reactions such as swelling of the face, tongue, or throat, difficulty breathing, and a drop in blood pressure have also been reported. This type of reaction may require urgent hospitalization.

Stop using Esberitox forte at the first sign of a hypersensitivity reaction. See also section 2 Warnings and Precautions.

Gastrointestinal disorders (abdominal pain, vomiting, diarrhea) have also been reported.

The frequency of reported side effects is unknown.

5. How to store Esberitox forte

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 carton and tablet cartons after “EXP”. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substances are 16 mg extract of root from baptisia ( Baptisia tinctoriaL.), red sun hat ( Echinacea purpurea Moench), and medicinal rudbeckia ( Echinacea pallida Nutt.) As well as leaves and twigs from thuja ( Thuja occidentalisL.), corresponding to about 53 mg dried baptisia root, 20 mg dried root from red sun hat, 20 mg dried root from läkerudbeckia and 11 mg dried leaf and twigs from thuja.
  • The other ingredients are mannitol, betadex, lemon aroma, glycerol behenate, magnesium stearate, citric acid monohydrate, and saccharin sodium

What the medicine looks like and the contents of the pack

The tablets are round and slightly cupped, 12 mm in diameter, and have a beige color.

Esberitox forte is available in packs of 20, 40, and 60 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Schaper & Brümmer GmbH & Co. KG

Bahnhofstraße 35

38259 Salt lattice

Germany

Local representative :

Midsona Sverige AB

Box 505 77

202 15 Malmö

Tel: 040-660 20 40

Muhammad Nadeem

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