ESBERITOX COMPACT

ESBERITOX COMPACT tablets

Important notes (mandatory information)

Esberitox Compact Tablets. Areas of application: for the supportive therapy of viral colds.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Esberitox Compact Tablets for use in adults and adolescents aged 12 and over
Active ingredients: Dry extract from a mixture of dyer's greenwood rootstock, purple coneflower root, pale coneflower root and arborvitae tips and leaves

Read the entire package leaflet carefully as it contains important information for you. This medicine is available without a prescription. However, Esberitox Compact must be taken as directed in order to achieve the best possible treatment results.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after 7 days, you must see a doctor.
• If any of the side effects listed become serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

This package leaflet contains

1. WHAT IS ESBERITOX COMPACT AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE TAKING ESBERITOX COMPACT?
3. HOW TO TAKE ESBERITOX COMPACT?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE ESBERITOX COMPACT?
6. FURTHER INFORMATION

1. WHAT IS ESBERITOX COMPACT AND WHAT IS IT USED FOR?

Esberitox Compact is a herbal medicine for colds. Esberitox Compact is used for the supportive therapy of viral colds.

2. WHAT YOU NEED TO KNOW BEFORE TAKING ESBERITOX COMPACT?

Esberitox Compact must not be taken if you are hypersensitive (allergic) to the active ingredients (dyer's greenwood rootstock, purple coneflower root, coneflower root, arborvitae tips and leaves) or any of the other ingredients of Esberitox Compact (see 6. Further information) or to composite flowers.

For fundamental reasons, Esberitox Compact must not be taken:

• in progressive systemic diseases such as tuberculosis and a rare inflammatory disease (sarcoidosis);
• in diseases in which the immune system is directed against the body's own (autoimmune diseases) such as inflammatory diseases of the connective tissue (collagenoses), multiple sclerosis;
• in acquired immunodeficiencies such as AIDS, HIV infections;
• in immunosuppressive treatment, e.g. after transplants or chemotherapy for cancer (cytostatic therapy);
• in systemic diseases of the white blood cell system such as leukemia and a reduction in certain white blood cells (agranulocytosis).

Special care must be taken when taking Esberitox Compact:

• if the symptoms become more severe or do not improve after one week,
• if shortness of breath, fever or purulent or bloody sputum occurs.

In these cases, a doctor must be consulted.

Children

This medicine is not suitable for children under 12 years of age. For children, appropriate tablets with a lower potency are available.

When taking Esberitox Compact with other medicines

Interactions are not known. However, please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines.

Pregnancy and

Breastfeeding

Pregnancy

Since the safety of using Esberitox Compact during pregnancy has not been proven, you should only take Esberitox Compact after consulting your doctor, who will have carried out a benefit/risk assessment.

Breastfeeding

Since it is not known whether ingredients from Esberitox Compact pass into breast milk and lead to undesirable effects in the breastfed infant, you should not take Esberitox Compact as a precaution during breastfeeding.

Driving and using machines

No special precautions are required.

3. HOW TO TAKE ESBERITOX COMPACT?

Always take Esberitox Compact exactly as described in this leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is: Adults and adolescents aged 12 and over take 1 tablet 3 times a day. Esberitox Compact is not intended for use in children under 12 years of age. There is insufficient data for specific dosage recommendations in the case of impaired liver/kidney function. Please take Esberitox Compact in the morning, at noon and in the evening with sufficient liquid, preferably 1 glass of water. The tablets can also be chewed.

Duration of use

Start treatment as early as possible after the first signs of illness (symptoms) appear and take Esberitox Compact until the symptoms subside. However, please note the information on precautions in section 2 and the information on side effects in section 4. of this package leaflet. Do not take Esberitox Compact for more than 10 days without medical advice.

Please talk to your doctor or pharmacist if you have the impression that the effect of Esberitox Compact is too strong or too weak.

If you have taken more Esberitox Compact than you should

Poisoning with Esberitox Compact has not been reported to date. If you accidentally take 1 or 2 tablets more than you should, this will generally not have any adverse effects. If you have taken a considerably larger amount of Esberitox Compact than you should, please inform a doctor. He/she can decide on any necessary measures.

If you forget to take Esberitox Compact

Do not take a double dose, but continue taking the medicine as described in this package leaflet or as prescribed by your doctor.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Esberitox Compact can have side effects, although not everybody gets them.

Possible side effects

Immune system

Hypersensitivity reactions, e.g. skin rash, itching, facial swelling, shortness of breath, drop in blood pressure

Gastrointestinal tract

Abdominal pain, nausea, diarrhea

General disorders

Dizziness

The frequency of side effects cannot be specified. Esberitox Compact must not be taken again at the first signs of a hypersensitivity reaction.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ESBERITOX COMPACT?

Keep out of reach of children. Do not use the medicine after the expiry date which is stated on the carton. This medicine does not require any special storage conditions.

6. FURTHER INFORMATION

What Esberitox Compact contains

The active ingredient is: 1 tablet contains 16 mg dry extract (4 - 9 : 1) from a mixture of dyer's greenwood rootstock : purple coneflower root : pale coneflower root : arborvitae tips and leaves (4.92 : 1.85 : 1.85 : 1). Extraction agent: Ethanol 30% (V/ V). The other ingredients are: Mannitol (Ph. Eur.), Betadex, lemon flavor, glyceryl dibehenate (Ph. Eur.), magnesium stearate (Ph. Eur.), citric acid monohydrate, saccharin sodium.

What Esberitox Compact looks like and contents of the pack

Round, beige tablets. Esberitox Compact is available in packs of 20 (N1), 40 and 60 tablets.

Pharmaceutical entrepreneur and manufacturer

Schaper & Brümmer GmbH & Co. KG
Bahnhofstraße 35
38259 Salzgitter
Tel. (0 53 41) 3 07-0
Fax (0 53 41) 3 07-124
info@schaper-bruemmer.de
http://www.schaper-bruemmer.de

This leaflet was last revised in June 2015.

Source: Information from the package leaflet
Status: 01/2018
Areas of application: for the supportive therapy of viral colds.