Echinaforce Forte Cold and Flu tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Extract (as dry extract) from fresh echinacea purpurea (l.) moench herb; Extract (as dry extract) from fresh echinacea purpurea (l.) moench root

Available from:

A. Vogel Ireland Ltd,

INN (International Name):

Extract (as dry extract) from fresh echinacea purpurea (l.) moench herb; Extract (as dry extract) from fresh echinacea purpurea (l.) moench root

Dosage:

.

Pharmaceutical form:

Tablet

Prescription type:

Product not subject to medical prescription

Authorization status:

Marketed

Authorization date:

2012-11-05

Patient Information leaflet

A.Vogel Ireland
Echinaforce Protect Tablets
IE - Dublin
CTD Module 1
July 2022
___________________________________________________________________________________
PACKAGE LEAFLET
PIL2592.e05
Page 1 of 6
Echinaforce (2) 750mg Tabl.
Art. no. 01324100
PACKAGE LEAFLET: INFORMATION FOR THE USER
ECHINAFORCE FORTE
Cold & Flu 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 Forte is and what it is used for
2.
What you need to know before you take Echinaforce Forte
3.
How to take Echinaforce Forte
4.
Possible side effects
5.
How to store Echinaforce Forte
6.
Contents of the pack and other information
1.
WHAT ECHINAFORCE FORTE IS AND WHAT IT IS USED FOR
Echinaforce Forte 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 Forte is for use in adults and adolescents over 12 years
of age.
A.Vogel Ireland
Echinaforce Protect Tablets
IE - Dublin
CTD Module 1
July 2022
___________________________________________________________________________________
PACKAGE LEAFLET
PIL2592.e05
Page 2 of 6
Echinaforce (2) 750mg Tabl.
Art. no. 01324100
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ECHINAFORCE FORTE
DO NOT TAKE ECHINAFORCE FORTE
•
If you are under 12 years of age.
•
If you are ALLERGIC to
o
Echinacea or

Summary of Product characteristics

Health Products Regulatory Authority
31 August 2022
CRN00D4CM
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Echinaforce Forte Cold and Flu tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
17.7 mg of dry extract from _Echinacea purpurea _(L.) Moench herba
(equivalent to 300 – 600 mg of fresh _Echinacea purpurea _(L.)
Moench herba) (Purple coneflower herb) Extraction solvent: Ethanol 65%
v/v and 0.9 mg of dry extract from _Echinacea purpurea _
(L.) Moench radix (equivalent to 17 – 29 mg of fresh _Echinacea
purpurea _(L.) Moench radix) (Purple coneflower root) Extraction
solvent: Ethanol 65% v/v
Excipients with known effect:
One tablet contains 690.15 mg of lactose monohydrate and 7.5 mg of
soya polysaccharide.
For the full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Tablets
Greenish, round-shaped, bi-convex, bevelled 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:
1 tablet two to three times daily
The use in children below 12 years of age is not recommended (see 4.4
Special warnings and precautions for use).
Start at first signs of common cold.
If symptoms persist, worsen or do not improve after 10 days use of
Echinaforce Forte, 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.
Because of their immuno-modulatory activity, Echinacea extracts must
not be used in cases of progressive systemic disorders
(tuberculosis, sarcoidosis), autoimmune diseases