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ECHINAFORCE (ECHINACEA DROPS)

Active substance(s): ECHINACEA PURPUREA HERB TINCTURE (1:2 IN ALCOHOL 68%) / ECHINACEA PURPUREA RADIX TINCTURE (1:10 IN ALCOHOL 60%)

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

Echinaforce

®

Echinacea Drops

Do's & Don'ts

Information

This product is suitable for
children over 12 years of age.
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 is a traditional
herbal remedy used to relieve
the symptoms of:

Do not use this product

Cold
Flu
Upper respiratory tract
infections
Echinaforce helps maintain the
body's resistance by supporting the
immune system.

For children 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 in this product
(see section 6)
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
breast-feeding.
If you are taking another medicine
which is affected by alcohol.
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.

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 in a high risk group
(patients with liver disease or
epilepsy) you should consider
the alcohol content before taking
this product.

You should also know
This medicinal product contains
65 vol % ethanol (alcohol), i.e.
up to 348 mg per 15 drop dose,
equivalent to 7.8 ml beer (less
than a tablespoon) or 3.25 ml
wine (less than a teaspoon).

30316IN2

Patient Information Leaflet

If you suffer from alcoholism the
alcohol content of this product
may be harmful.
Please turn over...

Echinaforce Drops PIL UK variation RFI Aug 2012.indd 1

17/08/2012 11:30

3. How to take this
product
Adults, elderly and children
over 12 years: Take 15 drops
(0.6 ml) in a little water 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

i

Side effects
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

Driving and using machines
This product contains alcohol
(see section 2 'You should also
know' for alcohol content).

If you take too much and feel
ill, talk to your doctor. Taking
too much is unlikely to be
harmful.
Overdose of this product may
result in alcohol intoxication and
should be treated accordingly
(see section 2 'You should also
know').

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

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

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.

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

Echinaforce Drops PIL UK variation RFI Aug 2012.indd 2

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.
Store below 25°C.
Do not use this product if you
notice a change in appearance.
It should be a clear liquid that is
olive in colour.

6. Further Information

Marketing Authorisation
Holder and Manufacturer
Marketing Authorisation Holder
and Batch Release:
Bioforce (UK) Ltd,
2 Brewster Place,
Irvine, Ayrshire, UK
KA11 5DD
Manufacturer:
Bioforce AG, CH-9325, Roggwil
Switzerland
PL No. 13668/0002
This leaflet was revised on 08/2012

What is Echinacea?

1 ml of oral liquid contains the
tinctures of:
Fresh Echinacea herb
860 mg

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 Echinacea
Drops.

(Echinacea purpurea (L.) Moench) (1:7.514.6). Extraction solvent: ethanol 65% v/v

You should also know

What this product contains

Fresh Echinacea root

45 mg

(Echinacea purpurea (L.) Moench) (1:7.112.5). Extraction solvent: ethanol 65% v/v

1 ml of Echinaforce is equivalent to
25 oral drops.
The other ingredients used for the
liquid are ethanol.

What this product looks like
and the contents of the pack
Echinaforce Echinacea Drops is a
clear liquid that is olive in colour.
This product is available in 15 ml, 50
ml and 100 ml bottles. Not all pack
sizes may be marketed.

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).



Using

30316IN2

S

17/08/2012 11:30

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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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