Esberitox Family 3,2mg 60 Tablets
Esberitox Family 3,2mg 60 Tablets
-For use in adults and children aged 4 years and over
-Dry extract from a mixture of wild indigo rootstock, purple coneflower root, pale coneflower root and arbour vitae tips and leaves
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without a prescription. However, you still need to take Esberitox Family tablets as directed in order to get the best results from them.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must talk to a doctor if your symptoms worsen or do not improve after several days.
• If you are considerably affected by any of the side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Esberitox Family tablets are and what they are used for
2. What you need to know before you take Esberitox Family tablets
3. How to take Esberitox Family tablets
4. Possible side effects
5. How to store Esberitox Family tablets
6. Further information
1. What Esberitox Family tablets are and what they are used for
Esberitox Family tablets are an herbal medicine for common colds.
Esberitox Family tablets are used as supportive therapy of viral colds.
2. What you need to know before you take Esberitox Family tablets
2.1 Do not take Esberitox Family tablets:
§ if you are hypersensitive (allergic) to the pharmacologically active substances (wild indigo rootstock, purple coneflower root, coneflower root, arbour vitae tips and leaves) or any of the other ingredients of Esberitox® tablets or to composite plants.
For general reasons, Esberitox® tablets should not be used in case of:
§ progressive systemic diseases such as tuberculosis and a rare inflammatory disease (sarcoidosis)
§ diseases causing the body’s immune system to turn against itself (autoimmune diseases) like inflammatory connective tissue diseases (collagenoses), multiple sclerosis
§ acquired immunodeficiency disorders like AIDS, HIV-infections
§ an immunosuppressive therapy e.g. after transplantations or chemotherapy for the treatment of cancer (cytostatic therapy).
§ systemic diseases of the white blood cells like leukaemia and a reduction of certain white blood cells (agranulocytosis).
2.2 Take special care with Esberitox® tablets:
§ if the symptoms intensify or last longer than 10 days
§ if breathlessness, fever, or purulent or bloody secretion occurs. In these cases, consult a doctor.
2.3 Children
There are no reliable studies on the use of this medicine in children under 4 years of age. In particular, studies regarding the long-term effects of Esberitox® tablets on the maturing immune system of children in this age group are lacking. Esberitox® tablets should, therefore, not be given to children under 4 years of age.
2.4 Other medicines and Esberitox® tablets:
Interactions with other medicines are not known. Studies on possible interactions of Esberitox® tablets with other medicines are not available.
Tell your doctor or pharmacist, if you are taking/using or have recently taken/used other medicines, including medicines obtained without a prescription.
2.5 Pregnancy and breastfeeding
a. Pregnancy
The safety of the use of Esberitox® tablets during pregnancy has not been proven. You should only take Esberitox® tablets after talking to your doctor, and they have assessed the benefits and risks.
b. Breastfeeding
It is not known whether certain ingredients of Esberitox® tablets are excreted in human milk and result in adverse effects for the breastfed baby. As a precaution, you should not take Esberitox® tablets during breastfeeding.
2.6 Driving and operating machines
No special precautions are required.
2.7 Important information about some of the other ingredients of Esberitox® tablets
This medicine contains lactose and sucrose (sugar). Therefore, please take Esberitox® tablets only after consultation with your doctor, if you know, that you suffer from an intolerance to certain sugars.
3. How to take Esberitox® tablets
Always take Esberitox® tablets exactly as described in this leaflet. Consult with your doctor or pharmacist if you are not sure.
3.1 Unless otherwise prescribed by your doctor, the recommended dose is:
Adults and adolescents aged 12 years and over: take 4 – 6 tablets x 3 times a day.
Children from 7 to 11 years of age: take 2 – 3 tablets x 3 times a day.
Children from 4 to 6 years of age: take 1 – 2 tablets x 3 times a day.
There is not enough data for specific dosage recommendations in impaired kidney /liver function.
Please take Esberitox® tablets in the morning, in the middle of the day, and in the evening with sufficient liquid, preferably water. The tablets may also be chewed.
3.2 Duration of use
Start the treatment as early as possible after the first symptoms appear and continue taking Esberitox® tablets until the symptoms disappear. However, take note of the details of the precautionary measures in section 2.2 and the details of the side effects in section 4 in this leaflet.
Do not take Esberitox® tablets for longer than 10 days without medical advice.
Please talk to your doctor or pharmacist if you feel like the effects of Esberitox® tablets are too strong or too weak.
3.3 If you take more Esberitox® tablets than you should
To date, no cases of poisoning with Esberitox® tablets have been reported. If you have accidentally taken one or two tablets more than you should, there are normally no adverse effects. If you have taken a considerably larger quantity of Esberitox® tablets than you should, please consult a doctor. They can decide on the appropriate measures to take, if necessary.
3.4 If you forget to take Esberitox® tablets
Do not take a double dose. Continue to take as described in this leaflet or as prescribed by your doctor.
4. Possible side effects
Like all medicines, Esberitox® tablets can cause side effects, although not everybody gets them.
Possible side effects:
Immune system disorders:
Hypersensitivity reactions, e. g. skin rashes, itching, facial swelling, shortness of breath, drop in blood pressure
Gastrointestinal disorders: Abdominal pain, nausea, diarrhoea
General disorders: Dizziness
No data are available regarding frequency.
In these cases you should discontinue taking the medicine and talk to your doctor. As soon as the first symptoms of a hypersensitivity reaction appear, do not take any more Esberitox® tablets.
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 to Bun- desinstitut für Arzneimittel und Medizinprodukte, Abt. Pharmakovigilanz, 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® tablets
Keep out of the reach and sight of children.
Do not use the medicine after the expiry date which is stated on the carton.
Do not store above 30°C.
6. Further information
What Esberitox® tablets contain
The active substance is:
1 tablet contains 3.2 mg dry extract (4 – 9 : 1) from a mixture of wild indigo rootstock : purple coneflower root : pale coneflower root : arbour vitae tips and leaves (4.92 : 1.85 : 1.85 : 1). Extracting agent: ethanol 30% (V/V)
The other ingredients are:
Lactose, magnesium stearate, macrogol (M:6000), sucrose (saccharose).
Note for diabetics: 1 tablet contains 0.02 calculable carbohydrate units (CU).
What Esberitox® tablets look like and contents of the pack
Round, beige-brown tablets
Esberitox® tablets are available in packs containing 60, 100 (N3) or 200 tablets. (Hos- pital pack size 1000 tablets [10 x 100 tablets].)
Marketing authorisation holder and manufacturer Schaper & Brümmer GmbH & Co. KG Bahnhofstr. 35 38259 Salzgitter Tel. (0 53 41) 3 07-0 Fax (0 53 41) 3 07-124 info@schaper-bruemmer.de www.schaper-bruemmer.de
This product information leaflet was last revised in October 2018.