Echinaforce Cold and Flu chewable tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Available from:

A.Vogel Ireland Limited

Dosage:

.

Pharmaceutical form:

Chewable tablet

Prescription type:

Product not subject to medical prescription

Authorization status:

Marketed

Authorization date:

2012-11-05

Patient Information leaflet

A.Vogel Ireland
Echinaforce Chewable
IE - Dublin
CTD Module 1
June 2023
___________________________________________________________________________________
PACKAGE LEAFLET
PIL2590.e05
Page 1 of 6
Echinaforce Junior (2)
Art. no. 01305900
PACKAGE LEAFLET: INFORMATION FOR THE USER
ECHINAFORCE
COLD & FLU CHEWABLE TABLETS
ECHINACEA PURPUREA HERB & ROOT DRY EXTRACTS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
PRODUCT BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this product exactly as described in this leaflet or as
your doctor,
pharmacist or nurse has told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This
includes any possible side effects not listed in this leaflet. See
section 4.
•
You must talk to a doctor if you do not feel better or if you feel
worse after 10
days.
WHAT IS IN THIS LEAFLET:
1.
What Echinaforce is and what it is used for
2.
What you need to know before you take Echinaforce
3.
How to take Echinaforce
4.
Possible side effects
5.
How to store Echinaforce
6.
Contents of the pack and other information
1.
WHAT ECHINAFORCE IS AND WHAT IT IS USED FOR
Echinaforce is a traditional herbal medicinal product containing the
extracts of fresh
_Echinacea purpurea_ herb and root.
It is used to relieve:
•
Common cold symptoms
•
Flu-like symptoms
This is exclusively based on long-standing use.
Echinaforce is for use in adults and adolescents over 12 years of age.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ECHINAFORCE
DO NOT TAKE ECHINAFORCE
•
If you are ALLERGIC to
o
Echinacea or plants of the daisy (Asteraceae/Compositae) family.
Echinacea is a member of the daisy family.
o
Any of the other ingredients of this product (listed in section 6).
A.Vogel Ireland
Echinaforce Chewable
IE - Dublin
CTD Module 1
June 2023
___________________________________________________________________________________
PACKAGE LEAFLET
PIL2590.e05
P

Summary of Product characteristics

Health Products Regulatory Authority
30 June 2023
CRN00DM14
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Echinaforce Cold and Flu chewable tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
5.9 mg of dry extract from _Echinacea purpurea _(L.) Moench herba
(equivalent to 100 – 200 mg of fresh _Echinacea purpurea _(L.)
Moench herba) (Purple coneflower herb) Extraction solvent: ethanol 65%
v/v and 0.3 mg of dry extract from _Echinacea _
_purpurea _(L.) Moench radix (equivalent to 5.6 – 9.8 mg of fresh
_Echinacea purpurea _(L.) Moench radix) (Purple coneflower root)
Extraction solvent: ethanol 65% v/v
Excipients with known effect:
One tablet contains 269.45 mg of sorbitol and 2.1 mg of orange flavour
(containing sucrose).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Chewable tablet
Greenish, flat, round-shaped, speckled tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A traditional herbal medicinal product used to relieve common cold and
flu-like symptoms, exclusively based on long-standing
use.
This product is indicated for use in adults and adolescents over 12
years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults, older people and adolescents over 12 years: Chew 2 tablets two
to three times daily.
To be chewed.
Start at first signs of common cold.
The use in children below 12 years of age is not recommended (see 4.4
Special warnings and precautions for use).
If symptoms persist, worsen or do not improve after 10 days use of
Echinaforce, a qualified healthcare professional e.g. a
doctor or pharmacist should be consulted.
METHOD OF ADMINISTRATION
For oral short-term use only
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substance,
to plants of the Asteraceae (Compositae) family or to any
of the excipients listed in section 6.1.
Health Products Regulatory Authority
30 June 2023
CRN00DM14
Page 2 of 4
Because of their immuno-modulatory activity, Echinacea extracts must
not