ECHINAFORCE SORE THROAT SPRAY
Active substance(s): ECHINACEA PURPUREA HERBA TINCTURE 1:12 / ECHINACEA PURPUREA RADIX TINCTURE 1:11 / SAGE LEAF EXTRACT / ECHINACEA PURPUREA HERBA TINCTURE 1:12 / ECHINACEA PURPUREA RADIX TINCTURE 1:11 / SAGE LEAF EXTRACT / ECHINACEA PURPUREA HERBA TINCTURE 1:12 / ECHINACEA PURPURE
Important things you need
This product is used to relieve
Sore Throat Spray
Echinacea & Sage extracts
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
Talk to your doctor if your
symptoms worsen or do not
improve within 7 days.
Side effects can 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.
Echinaforce Sore Throat Spray is
a traditional herbal medicinal
product used to relieve sore throats
associated with coughs, colds and
flu. This is based on traditional use
N A L IS
1. What this product
Echinaforce Throat Spray PIL UK RFI Submission Nov 2011.indd 1
Do's & Don'ts
2. Before you use
Do not take this product
If you are under 18 years of age.
If you are allergic to
Echinacea or plants of
the daisy (Asteraceae/
Echinacea is a member of
the daisy family.
Peanut or soya. This
product contains soy
Any of the other ingredients
in this product (see section
6 Further Information)
If you have a tendency to allergies
such as hives, allergic eczema or
If you are pregnant or breastfeeding.
If you are taking ciclosporin
or methotrexate, or any other
If you are taking another medicine
which is affected by alcohol
If you suffer from
TB (the infection
Sarcoidosis (a connective
tissue disease disorder
which causes the formation
of clumps of cells mainly in
the lymph nodes, lungs and
An autoimmune disease
such as collagenoses
(inflammation of the
connective tissue) or
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
If you are having treatment
to reduce the response
of your immune system
If you have had an organ or bone
See your doctor first
If you have problems swallowing
If your sore throat is severe and
you have a high temperature
(fever), headache or if you feel
sick or are being sick.
If you have been told by
your doctor that you have an
intolerance to some sugars. This
product may not be suitable for
3. How to use this
Remove the cap from the bottle and
fit the nozzle onto the cap. Replace
the cap gently but firmly onto the
bottle, taking care to point the nozzle
away from you. Before using this
product for the first time press the
pump 2-3 times to activate the spray.
You should also know
This medicinal product contains
38 - 42 vol % ethanol (alcohol),
i.e. up to 163 mg per 2 sprays,
equivalent to 3.7 ml beer (less
than a teaspoon) or 1.5 ml wine
(less than half a teaspoon) per
If you suffer from alcoholism the
alcohol content of this product
may be harmful.
If you are in a high-risk group
(patients with liver disease or
epilepsy) you should consider the
alcohol content before taking this
To use the spray shake the bottle
well, place the nozzle just inside
your mouth and point it towards the
back of your throat. Press the pump
After use, turn the nozzle back down.
If you are unsure if this product is
suitable for you please speak to your
pharmacist or our helpline on 0845
Patient Information Leaflet
Please turn over...
Shake well before use.
Adults and the elderly: 2 sprays
six to ten times daily.
Not for use in children or those under
Do not take more than the
Avoid getting this product in your
eyes. If you accidentally spray into the
eyes, rinse thoroughly with water.
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.
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
Don't worry about the missed
dose. Take the next dose as usual.
If you feel this product isn't
Stop taking this product and see your
If your symptoms worsen or if
you don't feel an improvement
within 7 days
Driving and using machines
This product contains alcohol (see
section 2 'You should also know'
for alcohol content').
4. Possible side
Like all medicines, this product can
cause side effects, although not
everybody gets them.
If you already suffer from allergies
you may be more likely to get them.
Allergic reactions which may occur
Rash inside the mouth
Burning sensation in the throat
Stop taking this product if these occur.
Frequency not known
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
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.
There have been isolated reports
suggesting an association between
Echinacea products and autoimmune
diseases such as:
Inflammation of the brain
and spinal cord (disseminated
Painful lumps on the shins
Low blood platelet count
Destruction of blood cells by
antibodies (Evans Syndrome)
Dryness in the mouth and eyes
with renal tubular dysfunction
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 have
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
5. How to store this
What this product looks like
and the contents of the pack
Keep out of the reach and sight of
Echinaforce Sore Throat Spray is a clear
liquid that is brown to yellow-green in
colour. It is available in 30 ml bottles.
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.
Registration Holder and
Use within 2 months of opening.
Traditional Registration Holder and
Bioforce (UK) Ltd,
2 Brewster Place,
Irvine, Ayrshire, UK
This product does not require any
special storage conditions.
Do not use this product if you
notice a change in appearance.
It should be a clear liquid that is
brown to yellow-green in colour.
6. Further Information
What this product contains
1 ml of spray contains the tinctures of:
Fresh Echinacea herb
(Echinacea purpurea (L.)) (1:12–13)
Extraction solvent: ethanol 65% V/V
Fresh Echinacea root
(Echinacea purpurea (L.)) (1:11–12)
Extraction solvent: ethanol 65% V/V
Fresh Sage leaves
(Salvia officinalis L.) (1:17–18)
Extraction solvent: ethanol 68% V/V
The other ingredients in the spray are
sucrose laurate, soy lecithin, ethanol,
peppermint oil and sorbitol liquid.
Bioforce AG, CH-9325, Roggwil
THR No. 13668/0026
This leaflet was approved on 11/2011
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 for use in
Echinaforce Sore Throat Spray.
What is Sage?
Sage is a flowering plant which is
native to the Mediterranean. It is the
extract of Sage leaves which is used
in Echinaforce Sore Throat Spray.
You should also know
Bioforce runs a helpline by phone
and email which can provide you
with further information.
Phone: 0845 608 5858
You can help to make medicines
safer by reporting any side effects to
the Yellow Card Scheme at
Alternatively you can get a paper
Yellow Card form from your doctor's
surgery or pharmacy, or call
freephone 0808 100 3352 (available
You can get a larger
print or audio version
of this leaflet.
Call this number:
0845 608 5858.
Echinaforce Throat Spray PIL UK RFI Submission Nov 2011.indd 2
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.