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PROSTASAN SAW PALMETTO CAPSULES

Active substance(s): SABALIS SERRULATAE EXTRACTUM SPISSUM 9-12:1

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Read all of this leaflet carefully
because it contains important
information for you.

Prostasan®

Saw Palmetto capsules

Do's and Don'ts

Information

This medicine is available without
prescription. However, before
using Prostasan you must have
been told by your doctor that
you have an enlarged prostate
(also known as benign prostatic
hypertrophy or BPH). You need to
take Prostasan carefully to get the
best results from it.
Keep this leaflet. You may
need to read it again.
If you need more information
or advice ask your doctor,
pharmacist or other qualified
healthcare practitioner.
You must contact a doctor,
pharmacist or qualified
healthcare practitioner if your
symptoms worsen.
If any of the side effects
become serious, or if you
notice any side effect not listed
in this leaflet, please tell your
doctor, pharmacist or qualified
healthcare practitioner.

In this leaflet:
1. What the product is and what it
is used for
2. Before you take this product
3. How to take this product
4. Possible side effects
5. How to store this product
6. Further information

1. What the product
is for
Prostasan is a traditional herbal
medicinal product used to
relieve urinary discomfort in
men with an enlarged prostate
(also known as benign prostatic
hypertrophy or BPH). This is
based on traditional use only.
Used to help relieve symptoms
including:
The need to urinate frequently
(especially at night).
Weak or interrupted urinary
flow.
A feeling that you cannot
empty your bladder completely.
An enlarged prostate is also known
as BPH. The prostate gland is found
just below the bladder in men.
As men get older this gland may
enlarge causing urinary discomfort.

2. Before you take
this product
You must have been told by
your doctor that you have BPH.
This product is not suitable for
anyone under 18 years of age.

Do not take this product if you
are allergic to:
Saw palmetto fruit. This product
contains Saw palmetto fruit.
Any of the other ingredients
of this product. (See Section 6
Further Information)

Take special care with this
product – see your doctor if:
Your symptoms of urinary
discomfort worsen or do not
improve within 8 weeks.
You have blood in your urine
You have a fever
You have difficulty passing urine
You have been told by your
doctor that you have an
intolerance to some sugars. This
product contains sorbitol and
may not be suitable for you.

If you are due to undergo
surgery
Tell your doctor you are taking
this product.

Taking other medicines
If you are taking medication for
an enlarged prostate talk to your
doctor before using this product.
It may not be suitable for you.
You can use this product with
any other medicines.

Taking this product with
food and drink
You can eat and drink as normal
whilst using this product.

Pregnancy and breastfeeding
Do not use this product. It is for
use in men only.

Driving and using machines
This product has no known
effect on your ability to drive or
use machines. Make sure you
know how it affects you before
you drive or use machinery.

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Using

3. How to take this
product
Adults and the elderly: Take one
capsule daily with food.
You can take Prostasan for as long
as is necessary.
If symptoms worsen consult a
doctor as soon as possible.
However you must consult a doctor
immediately if you have:
Blood in your urine
A fever
Difficulty passing urine
If no improvement in symptoms is
seen after 8 weeks of treatment
consult your doctor for further
advice.
Not for use in children or those
under 18.
For oral use only.

If you take more of this
product than you should
If you take too much and feel
ill, talk to your doctor. Taking too
much is unlikely to be harmful.

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Using

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

If you stop taking this
product
You can stop taking this product
at any time.
There is additional information in
Section 6 at the end of this leaflet.

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

If you feel this product isn't
working:
If symptoms worsen consult a
doctor as soon as possible.
See your doctor immediately if
you have:

Minor side effects

Blood in your urine

The following minor side effects can
occur when using this product.

A fever

Digestive symptoms
Belching
Stomach discomfort
Skin reactions
Rash
Itching (pruritis)
Discontinue use if you find these are
troubling you.
The frequency of these side
effects 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 are concerned about any
side effect, if a side effect becomes
serious or if you notice a side effect
not listed in this leaflet, please tell
your doctor, pharmacist or qualified
healthcare practitioner.

Difficulty passing urine
If no improvement is seen after
8 weeks treatment consult your
doctor for further advice.

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 the
month.
This product does not require any
special storage conditions.
Do not use Prostasan if you
notice a change in colour of the
capsules. They should be dark
brown.

What this product looks like
and the contents of the pack
Prostasan capsules are soft, ovalshaped and dark brown in colour.
Prostasan capsules are available in
packs of 30, 60 or 90 capsules. 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 KA11 5DD

6. Further Information

Manufacturer:
Bioforce AG, CH-9325, Roggwil
Switzerland

What this product contains

THR No. 13668/0011

1 capsule contains 320mg of
extract (as soft extract) from Saw
palmetto fruit (Serenoa repens
(Bartram) Small fructus (Sabal
serrulata (Michaux) Nichols
fructus)) (9-12 :1). Extraction
solvent: Ethanol 96% V/V.
The other ingredients used for the
capsule shell are gelatin, glycerol,
sorbitol, iron oxide (red, black and
yellow) and purified water.
1 capsule contains 7.7 mg sorbitol.

Certification Mark
This leaflet was revised on 07/2012

What is Saw Palmetto?
Saw palmetto is a plant which is
native to sub-tropical regions of the
United States. It produces berries
(fruits) and it is the extract of these
berries which is used to make this
product.

You should also know
Your doctor may have done a
blood test for prostate specific
antigen (PSA). It is unlikely that
this product will alter your levels
of PSA.
This product is not suitable for
vegetarians.
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 MondayFriday).

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

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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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