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ECHINAFORCE CHEWABLE COLD & FLU TABLETS

Active substance(s): ECHINACEA PURPUREA HERBA TINCTURE 1:12 / ECHINACEA PURPUREA RADIX TINCTURE 1:11

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Important things you need
to know
This product is used to relieve
the symptoms of cold and flu.

Echinaforce
Chewable

®

®

Cold & Flu tablets

Don't take this product if
you are allergic to any of the
ingredients: see section 6.
Before you take this product:
read section 2.
Dosage instructions: see
section 3.
Talk to your doctor if your
symptoms worsen or do not
improve within 10 days.
Side effects can rarely occur
when using this product: see
section 4.
Now read the rest of this leaflet
carefully. Keep this leaflet. You may
need to read it again.

1. What this product
is for

2. Before you take
this product

Echinaforce Chewable is a
traditional herbal medicinal
product used to relieve the
symptoms of:

Do not take this product

Cold
Flu
This is based on traditional use only.

If you are allergic to
Echinacea or plants of
the daisy (Asteraceae/
Compositae) family.
Echinacea is a member of
the daisy family.
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.
If you are pregnant or breastfeeding.
If you are having treatment
to reduce the response
of your immune system
(immunosuppression) e.g.
chemotherapy, radiotherapy.
If you are taking ciclosporin
or methotrexate, or any other
immunosuppressant medicine.
If you have had an organ or bone
marrow transplant.

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Echinaforce Chewable PIL UK Variation Submission Aug 2012.indd 1

S

Do's & Don'ts

Information

If you suffer from
TB (the infection
tuberculosis)
Sarcoidosis (a connective
tissue disease 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)

Using

3. How to take this
product
Adults, the elderly and children
over 12 years: Chew 2 tablets two
to three times daily.
Not for use in children under 12.
Start taking this product at the first
signs of a cold.
For oral use only. Do not take more
than the recommended dose.
Do not take this product for a cold or
flu for more than 10 days.

If you take too much
If you take too much and feel

ill, talk to your doctor. Taking too
much is unlikely to be harmful.

If you forget to take this
product
Don't worry about the missed dose.
Take the next dose as usual.

See your doctor first
If you have been told you have
an intolerance to some sugars.
This product contains sorbitol and
sucrose and may not be suitable for
you.

09540600/060411

Patient Information Leaflet

Please turn over...
22/08/2012 11:56

If you feel this product isn't
working
Stop taking this product and see your
doctor:
If you have a high temperature
(fever)
If your symptoms worsen or if you
don't feel an improvement within
10 days
Adverse events not mentioned
in the patient information leaflet
occur

4. Possible side
effects

There have been isolated reports
suggesting an association between
Echinacea products and autoimmune
diseases such as:

Like all medicines, this product can
cause side effects, although not
everybody gets them.

Inflammation of the brain
and spinal cord (disseminated
encephalitis)

Side effects

Painful lumps on the shins
(erythema nodosum)

Allergic reactions
If you already suffer from allergies
you may be more likely to get them.
Allergic reactions which may occur
are:
Skin rash
Red, itchy skin (hives)
Swelling of the skin due to fluid
(angioedema) or swelling of the
face (Quincke's oedema)
Blistering of the skin and mucous
membranes (Stevens-Johnson
syndrome)
Difficulty in breathing
(bronchospasm with obstruction)
Asthma or anaphylactic shock (a
life-threatening allergic reaction)

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Side effects

Stop taking this product immediately
if any of these occur. Seek medical
advice and take this leaflet with you.

Echinaforce Chewable PIL UK Variation Submission Aug 2012.indd 2

Low blood platelet count
(immunothrombocytopenia)
Destruction of blood cells by
antibodies (Evans Syndrome)
Dryness in the mouth and eyes
with renal tubular dysfunction
(Sjögren Syndrome)
A decrease in the number of white
blood cells (leucopenia) may occur in
long-term use (more than 8 weeks).
The frequency is not known. This
means it is not known how often
these reactions occur as there has not
been enough reports to allow this
information to be calculated.
If you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.

Information

5. How to store this
product
Keep out of the reach and sight of
children.
Do not use this product after the
expiry date which is stated on the
packaging. The expiry date refers
to the last day of that month.
Use within 2 months of opening.
Store in the original container to
protect from moisture.
Do not use this product if you
notice a change in appearance.
The tablets should be speckled
and green in colour.

6. Further Information
What this product contains
1 tablet contains 380 mg of extract
(as dry extract) from fresh Echinacea
purpurea (L.) Moench herb (1:12) and
20 mg of extract (as dry extract) from
fresh Echinacea purpurea (L.) Moench
root (1:11). Extraction solvent:
ethanol 65% v/v.

The other ingredients used for
the tablet are sorbitol, betadex,
anhydrous colloidal silica, magnesium
stearate and orange flavouring
(containing sucrose).

What this product looks like
and the contents of the pack
The tablets are round, speckled
and green in colour. This product is
available in packs containing 40, 80
and 120 tablets. Not all pack sizes
may be marketed.

Traditional Herbal
Registration Holder and
Manufacturer
Traditional Registration Holder and
Batch Release:
Bioforce (UK) Ltd,
2 Brewster Place,
Irvine, Ayrshire, UK
KA11 5DD
Manufacturer:
Bioforce AG, CH-9325, Roggwil
Switzerland
THR No. 13668/0015
Certification Mark

What is Echinacea?
Echinacea is a plant which is native to
America. The herb and root extracts
of the Echinacea species, Echinacea
purpurea, are combined to make
Echinaforce Chewable.

You should also know
Bioforce runs a helpline by phone
and email which can provide you
with further information.
Email: enquiries@avogel.co.uk
Phone: 0845 608 5858
You can help to make medicines
safer by reporting any side effects
to the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
Alternatively you can get a paper
Yellow Card form from your doctor's
surgery or pharmacy, or call
freephone 0808 100 3352 (available
10am-2pm Monday-Friday).

You can get a larger
print or audio version
of this leaflet.
Call this number:
0845 608 5858.

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Using

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This leaflet was revised on 08/2012

22/08/2012 11:56

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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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