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AVENACALM AVENA SATIVA ORAL DROPS

Active substance(s): AVENA SATIVA TINCTURE 1:1.2

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Patient Information Leaflet

i

Important things you need to
know

AvenaCalm
Avena sativa
oral drops

This product is used for the temporary
relief of the symptoms of mild stress
such as mild anxiety and to help sleep.
This product is suitable for adults over
18 years.
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 you do not feel any benefit
from this product within 4 weeks.
Now read the rest of this leaflet
carefully. Keep this leaflet. You may need
to read it again.

CI N A L

IS

Do's & Don'ts

Information
1. What this product is for
AvenaCalm is a traditional herbal
medicinal product for the temporary
relief of symptoms associated with mild
stress such as:
Mild anxiety
To help sleep
This is based on traditional use only.

2. Before you use this
product
Do not use this product:
If you are under 18 years of age.
If you are allergic to any of the
ingredients in this product (see section 6
Further Information).
If you are taking another medicine which is
affected by alcohol.
If you are pregnant or breast-feeding.
If you suffer from coeliac disease consult
your doctor before using this product.
The protein content of this product is not
known.

You should also know
This medicinal product contains 51 vol %
ethanol (alcohol), i.e. up to 327 mg per
30 drop dose, equivalent to 8.26 ml beer
(less than a tablespoon) or 3.44 ml wine
(less than a teaspoon) per dose.
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 product.

S

Using

3. How to use this product
Adults and the elderly:
For mild stress and mild anxiety:
Take 25-30 drops in a little water twice daily.
This product may also be used to help
sleep: Take 30 drops in a little water half an
hour before bedtime.
Do not take more than 90 drops a day.
Not for use in children or those under 18.

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 product
Don't worry about the missed dose. Take
the next dose as usual.

If you feel this product isn't
working
See your doctor if your symptoms worsen
or do not improve within 4 weeks.

Driving and using machines
This product is intended to help you
relax. If you feel drowsy do not drive or
operate machinery.
This product contains alcohol (see
section 2 'You should also know' for
alcohol content).
Please turn over...

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Side effects
4. Possible side effects
No side effects have been reported with
the use of products containing Avena sativa
extract.
If you notice any side effects please tell
your doctor or pharmacist.

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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 on the packaging. The expiry date
refers to the last day of that month.
Use within 4 months of opening.
This product does not require any special
storage conditions.
Do not use this product if you notice a
change in colour. It should be a clear
liquid that is yellow-brown to greenbrown in colour.

6. Further Information
What this product contains
1 ml of oral liquid contains 940 mg of
tincture from the pressed juice of fresh oat
herb (Avena sativa L.) (1:1.2). Extraction
solvent: ethanol 51% v/v.
1 ml of AvenaCalm oral drops is equivalent
to 37 drops.

AvenaCalm is a clear liquid that is yellowbrown to green-brown in colour. AvenaCalm
is available in 50 ml and 100 ml bottles. Not
all pack sizes may be marketed.

Traditional Herbal Registration
Holder and Manufacturer
Traditional Herbal 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. 13668/0023

Certification Mark
This leaflet was revised on 06/2012

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.

What is Avena sativa?
Avena sativa is more commonly known as
oats. It is the extract of the above-ground
parts of the plant which is used to make
AvenaCalm.

30408IN1



The other ingredients used for the liquid are
ethanol and water.

What this product looks like and
the contents of the pack

Avena sativa PIL UK RFI Response June 2012.indd 2

11/06/2012 14:50

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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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