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ESBERELIEF TABLETS

Active substance(s): SOFT EXTRACT OF BAPTISIA TINCTORIA ECHINACEA PALLIDA THUJA OCCIDENTALIS ECHINACEA PURPUREA / SOFT EXTRACT OF BAPTISIA TINCTORIA ECHINACEA PALLIDA THUJA OCCIDENTALIS ECHINACEA PURPUREA / SOFT EXTRACT OF BAPTISIA TINCTORIA ECHINACEA PALLIDA THUJA OCCI

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Esberelief Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
3.2 mg of extract (as dry extract) (4-9:1) from:
Wild indigo root (Baptisia tinctoria (L.) R.Br.),
Echinacea purpurea root (Echinacea purpurea (L.) Moench),
Echinacea pallida root (Echinacea pallida (Nutt.) Nutt.),
White cedar tips and leaves (Thuja occidentalis L.)
(4.92:1.85:1.85:1).
Extraction solvent: ethanol 30 % v/v.
Each tablet contains 170.6 mg lactose monohydrate and 91.5 mg of sucrose.
(See Section 4.4. ‘Special warnings and precautions for use.’
For a full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Tablets.
Beige-brown, round tablets.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
A traditional herbal medicinal product used to relieve the symptoms of the
common cold, such as cough, catarrh, sore throat, runny or blocked nose,
based on traditional use only.

4.2

Posology and method of administration
For oral use only.
Adults, elderly and children over 12 years: 5 tablets three times a day.

The tablets should be taken at regular intervals, in the morning, in the middle
of the day and in the evening, with sufficient liquid, preferably water.
The use in children under 12 years of age is not recommended (see section 4.4
“Special warnings and precautions for use”).
Start at first signs of common cold.
If symptoms worsen, during the use of the product or persist for more than 10
days, a doctor or qualified healthcare practitioner should be consulted.
4.3

Contraindications
Hypersensitivity to any of the active ingredients or plants of the Asteraceae
(Compositae) family or to any of the excipients.
Because of its immunostimulating activity, Echinacea must not be used in
cases of progressive systemic disorders (tuberculosis, sarcoidosis),
autoimmune
diseases
(e.g.
collagenoses,
multiple
sclerosis),
immunodeficiencies (e.g. HIV infection, AIDS), immunosuppression (e.g.
onocological cytostatic therapy, history of organ or bone marrow transplant)
and diseases of the white blood cell system (e.g. agranulocytosis, leukaemias)
and allergic diathesis (e.g. urticaria, atopic dermatitis, asthma).

4.4

Special warnings and precautions for use
Do not exceed the stated dose.
There is a possible risk of anaphylactic reactions in atopic patients. Atopic
patients should consult their doctor before using products containing
Echinacea.
There is a possible risk of allergic reactions in sensitive individuals. Those
patients should consult their doctor before using Echinacea.
If dyspnoea, fever or purulent sputum occurs, a doctor or a qualified
healthcare practitioner should be consulted.
If symptoms worsen, or persist for more than 10 days, a doctor or a qualified
healthcare practitioner should be consulted.
The use in children under 12 years of age is not recommended because no data
on safety are available.
Contains lactose and sucrose: Patients with rare hereditary problems of
galactose or fructose intolerance, glucose galactose malabsorption, sucrase
isomaltase insufficiency or the Lapp lactase deficiency should not take this
medicine.

4.5

Interaction with other medicinal products and other forms of interaction
None reported.

The product should not be used concomitantly with immunosuppressant
medications such as ciclosporin and methotrexate.

4.6

Fertility, Pregnancy and lactation
Safety during pregnancy and lactation has not been established.
In the absence of sufficient data, the use during pregnancy and lactation is not
recommended.
Studies on the effects on fertility have not been performed.

4.7

Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been
performed.
This product may cause dizziness. If affected the patient should not drive and
use machines.

4.8

Undesirable effects
Hypersensitivity reactions (rash, urticaria, swelling of the face) may occur.
Cases of severe hypersensitivity reactions such as Stevens-Johnson Syndrome,
angioedema of the skin, Quincke edema, bronchospasm with airway
obstruction, asthma and anaphylactic shock) may occur.
Gastrointestinal disorders (abdominal pain, vomiting, diarrhoea, nausea) may
occur.
Dizziness may occur.
Echinacea can trigger allergic reactions in atopic patients. Association with
autoimmune diseases (encephalitis disseminata, erythema nodosum,
immunothrombocytopenia, Evans Syndrome, Sjögren syndrome with renal
tubular dysfunction) has been reported.
Leucopenia may occur in long-term use (more than 8 weeks).
The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified
health care practitioner should be consulted.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via Yellow Card Scheme, Website:
www.mhra.gov.uk/yellowcard.

4.9

Overdose
No case of overdose has been reported.

Symptomatic and supportive measures should be taken as appropriate.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.2

Pharmacokinetic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.3

Preclinical safety data
Reproduction toxicology
In a fertility study in rats Esberelief had no effect on the fertility of male and
female animals. Embryofetal development and peri-/postnatal studies have not
been performed with Esberelief.

Mutagenic potential
The bacterial reversion mutation test (Ames test) revealed no evidence of any
mutagenic activity of Esberelief. The chromosome aberration test in vivo with
dosages between 250 and 5,000 mg/kg bw. also showed no evidence of any
genotoxic properties of the ingredients.
Tests on carcinogenicity have not been performed.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Lactose monohydrate
Magnesium stearate
Macrogol 6000
Sucrose

6.2

Incompatibilities
None known.

6.3

Shelf life
2 years

6.4

Special precautions for storage
Do not store above 30°C.

6.5

Nature and contents of container
PVC/PVDC-Al blister strips in cardboard carton.
Packs of 60, 100 and 200 tablets.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
Any unused product or waste material should be disposed of in accordance
with local requirements.

7

MARKETING AUTHORISATION HOLDER
Schaper & Brümmer GmbH & Co. KG
Bahnhofstraße 35
38259 Salzgitter
Germany

8

MARKETING AUTHORISATION NUMBER(S)
THR 26548/0002

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
13/06/2017

10

DATE OF REVISION OF THE TEXT
13/06/2017

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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