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PHYTOCON SABAL FORTE CAPSULES

Active substance(s): SAW PALMETTO FRUIT

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PACKAGE LEAFLET: INFORMATION FOR THE USER

PhytoCon SABAL FORTE Capsules
Saw palmetto fruit extract 320 mg
Read all of this leaflet carefully because it contains important information for you.
Before using PhytoCon SABAL FORTE Capsules you must have been told by
your doctor that you have an enlarged prostate (also known as benign prostatic
hypertrophy or BPH). This medicine is available without prescription. You need to
take PhytoCon SABAL FORTE Capsules carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your doctor or qualified healthcare practitioner or pharmacist if you need
more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve.
• If any of the side effects gets serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1: What PhytoCon SABAL FORTE Cap sules are and what these are used for
2: Before you take
PhytoCon SABAL FORTE Capsules
3: How to take
PhytoCon SABAL FORTE Capsules
4: Possible side-effects
5: How to store
PhytoCon SABAL FORTE Capsules
6: Further information

1. What PhytoCon SABAL FORTE Cap sules are and what these are used for
A traditional herbal medicinal product
used to relieve the symptoms of urinary
tract discomfort in men who have been
told that they have an enlarged prostate
(benign prostatic hypertrophy or BPH).
This is based on traditional use only.
Used to help relieve symptoms including:
- Feeling like you need to pass urine more
often, especially at night
- When you pass urine, the flow of urine
is weak or interrupted
- Feeling that you cannot empty your
bladder completely
Enlargement of the prostate is also
termed benign prostatic hypertrophy
(BPH). The prostate gland is only present in
men and is located just below the bladder.
This gland may be enlarged as men get
older and cause urinary discomfort.

2. Before you take
PhytoCon SABAL FORTE Capsules
Do not take PhytoCon SABAL FORTE
Capsules if you:
• are allergic (hypersensitive) to Saw
palmetto or any of the other
ingredients of PhytoCon SABAL FORTE
Capsules (see section 6 for a full list of
ingredients)
• are under 18 years of age. This product
is not suitable for this age group.

Take special care with
PhytoCon SABAL FORTE Capsules
Before you take PhytoCon SABAL FORTE
Capsules a doctor must have told you
that you have an enlarged prostate
(benign prostatic hypertrophy or BPH).
Other serious conditions should have
been ruled out by your doctor.
You should see your doctor if your
symptoms of urinary discomfort worsen
or persist.
Your doctor may have done a blood test
for prostatic specific antigen (PSA). It is
unlikely that this product will alter your
levels of PSA.
Contact your doctor immediately:
• if there is blood in your urine
• if you have a fever
Tell your doctor that you are taking
PhytoCon SABAL FORTE Capsules if you
are due to undergo surgery.
Taking other medicines
If you are already taking medicines
for
an
enlarged
prostate
(BPH)
consult your doctor before taking
PhytoCon SABAL FORTE Capsules as this
product may not be suitable for you.
You can use this product with any other
medicines.
Pregnancy and breast-feeding
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.
If affected do not drive.

Please turn over › ›

3. How to take
PhytoCon SABAL FORTE Capsules
For oral use only.
Adults and the elderly
1 capsule daily.
Swallow the capsule with food.
Not suitable for use in children and
adolescents under 18 years of age.
Do not exceed the stated dose.
If you take more PhytoCon SABAL FORTE
Capsules than you should
If you take more than the recommended
dose, speak to a doctor and take this leaflet with you. It is not likely to be harmful if
you take too much of this product.

If you forget to take
PhytoCon SABAL FORTE Capsules
Continue to take your usual dose at the
usual time, it does not matter if you have
missed a dose.
If you stop taking
PhytoCon SABAL FORTE Capsules
The use of this product can be stopped at
any time.
If you have any further questions on the
use of this product, ask your doctor or
qualified healthcare practitioner or pharmacist.
4. Possible side-effects
Like all medicines, PhytoCon SABAL FORTE
Capsules can cause side-effects, although
not everybody gets them. They are listed
below.

• Belching
• Stomach discomfort
• Allergic reactions such as skin rashes
Discontinue use if the side effects are
troubling.
If any of the side effects gets serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.
Remember to see your doctor:
- if your symptoms of urinary discomfort
worsen or persists
- if there is blood in your urine
- if you have a fever

5. How to store
PhytoCon SABAL FORTE Capsules
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Keep the capsules out of the reach and
sight of children.
Do not use this product after the expiry
date which is stated on the box and the
blister pack.
Do not use the product when you notice
a change in the colour of the capsules.
This product does not require any
special storage conditions.

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Medicines should not be disposed of
via wastewater or household waste.
Ask your pharmacist how to dispose
of medicines no longer required. These
measures will help to protect the
environment.

6. Further information
What PhytoCon SABAL FORTE Capsules
contain
The active substance is Saw palmetto
fruit extract.
Each soft capsule contains 320 mg of
extract (as soft extract) from Saw palmetto
fruit (Serenoa repens (Bartram) Small)
(9-11:1). Extraction solvent: ethanol 96 %
(V/V).
The other ingredients are:
Gelatin polysuccinate, Glycerol, Purified
water, Titanium dioxide (E 171), Ferric
oxide (E 172)
What PhytoCon SABAL FORTE Capsules
look like and contents of the pack
PhytoCon SABAL FORTE Capsules are
oval-shaped, ochre coloured soft capsules
containing a yellow-brown, oily mass.
Each pack contains 15, 20, 30, 60, 90, or
100 capsules.
Not all pack sizes maybe marketed.
Traditional Registration holder
PhytoCon GmbH & Co KG
Koblenzer Str. 48-56
56626 Andernach
Germany
Manufacturer of the finished product and
batch release site:
C.P.M. ContractPharma GmbH & Co. KG
Frühlingstrasse 7
83620 Feldkirchen-Westerham
Germany
Traditional herbal registration number:
THR 34863/0003

If you would like further information
about this product, please contact:
PhytoCon GmbH & Co KG
Koblenzer Str. 48-56
56626 Andernach
Germany
Telephone: +49 (0) 2632-924-310
This leaflet was last approved in
Februar 2011.
You can help to make medicines safer by
reporting any side-effects to the Yellow
Card Scheme at www.yellowcard.gov.
uk. Alternatively you can get a paper
Yellow Card form from your GP’s surgery
or pharmacy, or call freephone 0808 100
3352 (available 10am-2pm Monday to
Friday).
The leaflet is available in large print or
audio version.

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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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