ECHINAFORCE COLD & FLU Tablets Chewable

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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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:

Bioforce (UK) Ltd

ATC code:

L03A

INN (International Name):

EXTRACT (AS DRY EXTRACT) FROM FRESH ECHINACEA PURPUREA (L.) MOENCH HERB, EXTRACT (AS DRY EXTRACT) FROM FRESH ECHINACEA PURPUREA

Pharmaceutical form:

Tablets Chewable

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Immunostimulating agents

Authorization status:

Authorised

Authorization date:

2012-11-05

Patient Information leaflet

                                669
Package Leaflet:
Information for the user
31453IN3 09549901/20170119
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 under 12 years of age.
If you are allergic to
Echinacea or plants of the
daisy (Asteraceae/Compositae)
family. Echinacea is a member
of the daisy family.
Any of the other ingredients of
this product (listed in section 6).
If you suffer from
TB (the infection tuberculosis)
Sarcoidosis (a connective
tissue disease disorder which
causes the formation of clumps
of cells mainly in the lymph
nodes, lungs and liver)
An autoimmune disease such
as collagenoses (inflammation
of the connective tissue) or
multiple sclerosis
HIV, AIDS or any other
condition which decreases your
resistance to infection
A disorder which affects your
white blood cells such as
agranulocytosis (low white
blood cell count due to bone
marrow disorders) or leukemia
(blood cell cancer)
If you are having treatment
to reduce the response
of your immune system
(immunosuppression) e.g.
chemotherapy, radiotherapy.
If you have had an organ or bone
marrow transplant.
Warnings and precautions
Stop taking this product and see
your doctor if:
You have a high temperature
(fever)
Your symptoms worsen
or if you do not feel an
improvement within 10 days
If you have a tendency to allergies
such as hives, allergic eczema or
asthma consult your doctor before
use. This product may not be
suitable for you.
Children
Do not give this product to children
under 12 years of age.
Other medicines and
Echinaforce
Do not take this product if you are
taking any medicine which affects
your immune system.
If you are speaking to your doctor,
pharmacist or nurse always
remember to
                                
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Summary of Product characteristics

                                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 herb
(equivalent to 100 – 200 mg of fresh_ Echinacea_
_purpurea_ (L.) Moench herb) (Purple coneflower herb)
Extraction solvent: ethanol 65% v/v
and
0.3 mg of dry extract from_ Echinacea purpurea_ (L.) Moench root
(equivalent to 5.6 – 9.8 mg of fresh_ Echinacea_
_purpurea_ (L.) Moench root) (Purple coneflower root)
Extraction solvent: ethanol 65% v/v
Excipients with known effect:
One tablet contains 269.45 mg 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.
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