SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF MEDICINAL PRODUCT
ECHINERBA, 100 mg, tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Purple coneflower herb dry extract (3.5-4.5:1) 100 mg
(Echinaceae purpureae herbae extractum siccum)
1 tablet contains at least 1 mg of polyphenolic acids expressed as chlorogenic acid.
See below for full list of excipients.
3. PHARMACEUTICAL FORM
Tablet
4. CLINICAL PARTICULARS
Traditional herbal medicinal product intended for traditional use for stated indications. Its efficacy is based solely on long-term use and experience.
4.1. Indications for use
Used traditionally as an adjunctive agent in cold-related diseases.
4.2. Posology and method of administration
Posology
Adults and adolescents over 12 years: 1 tablet, 3 times a day.
Duration of use should not exceed 10 days.
Children:
Due to lack of data, not recommended for children under 12 years.
Method of administration
Oral.
Duration of use
Do not use for longer than 10 days.
4.3. Contraindications:
Hypersensitivity to plants from the aster family (Asteraceae, formerly composite Compositae), diseases with immune disorders: tuberculosis, HIV and AIDS infection, leukemia, autoimmune diseases, such as multiple sclerosis, systemic connective tissue diseases (collagenosis), immunosuppression.
4.4. Special warnings and precautions for use
Use by patients with diagnosed allergies (inhalation, skin, food) should be consulted with a doctor.
If cold symptoms worsen or are accompanied by fever, consult a doctor.
Due to lack of data, not recommended for children under 12 years.
4.5. Drug interactions and other interactions
None observed. Concomitant use of cyclosporin and corticosteroids may cancel the immunosuppressing effect. Concomitant use with amiodarone, ketoconazole and methotrexate may cause liver damage.
4.6. Impact on fertility, pregnancy and lactation
Due to lack of safety data, use of Echinacea purpurea products is not recommended during pregnancy and lactation.
4.7. Impact on ability to drive vehicles and operate machinery
None.
4.8. Adverse effects
Purple coneflower herb products may cause hypersensitivity reactions (rash, hives, Stevens-Johnson syndrome, Quincke's edema, bronchospasm, asthma and anaphylactic shock). In patients with atopy, coneflower may cause allergic reactions related to autoimmune disease. In case of use exceeding 8 weeks, leukopenia may occur. Frequency of adverse effect occurrence is unknown.
Reporting suspected adverse effects
After a medicinal product receives marketing authorisation, it is important to report suspected adverse effects. It allows for continuous monitoring of the medicinal product's risk-benefit ratio. Medical professionals should report all suspected adverse effects to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warszawa,
tel.: + 48 22 49-21-301, fax: +48 22 49-21-309, e-mail: ndl@urpl.gov.pl.
Adverse effects can also be reported to the marketing authorisation holder.
4.9. Overdose
Mild gastrointestinal symptoms may occur. In case of overdose, use medicinal charcoal.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamics
Has not been studied in humans.
Based on available studies of bioactivity of dry purple coneflower heb aqueous extract, it is assumed it stimulates the immune system.
5.2. Pharmacokinetics
No pharmacokinetic data on compounds contained in purple coneflower or its extracts.
5.3. Preclinical safety data
Single dose toxicity
At the highest dose, single oral or intravenous administration of juice pressed from purple coneflower herb did not cause poisoning symptoms in rats and mice. Therefore, LD50 for rats should be considered to be exceeding 15,000 mg/kg BW with oral administration and 5,000 mg/kg BW with IV, and for mice to be exceeding 30,000 mg/kg BW with oral administration and 10,000 mg/kg BW with IV.
Multiple dose toxicity
After 4 weeks of use of pressed purple coneflower juice in doses of 0, 800, 2400 or 8000 mg/kg BW per day in female and male rats, no significant changes were observed, not in laboratory observation, nor in sectional observation.
No reproductive toxicity and carcinogenicity studies have been conducted.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Microcrystalline cellulose
Potato starch
Colloidal anhydrous silica
Magnesium stearate
6.2. Incompatibilities
No data.
6.3. Expiry date
Glass containers with polytethylene cap or polyethylene containers and caps:
1 year
Polypropylene containes with polyethylene caps:
2 years
6.4. Special precautions for storage
Store closed in max. 25° C, keep away from children.
6.5. Box type and contents
Glass containers with polytethylene caps, polyethylene or polypropylene containers with polyethylene caps, with 30, 60 or 90 tablets.
Not all types of packaging need to be marketed.
6.6. Special precautions for disposal and preparation for use
No special requirements.
7. MARKETING AUTHORISATION HOLDER
- Labofarm Sp. z o.o.
83-200 Starogard Gdański
ul. Lubichowska 176 b
tel. 058 561-20-08
fax 058 561-20-16
e-mail: poczta@labofarm.com.pl
- MARKETING AUTHORISATION NUMBER
10450
- FIRST MARKETING AUTHORISATION ISSUE DATE / RENEWAL DATE AND RENEWAL DATE
First marketing authorisation issue date: 20.04.2004
Last marketing authorisation renewal date: 15.10.2012
- DATE OF APPROVAL OR PARTIAL CHANGE OF
SUMMARY OF PRODUCT CHARACTERISTICS
05.10.2017
PL