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UROSTEMOL PROSTA CAPSULES

Active substance(s): PUMPKIN SEED SOFT EXTRACT 15-25:1 / PUMPKIN SEED SOFT EXTRACT 15-25:1 / PUMPKIN SEED SOFT EXTRACT 15-25:1

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Pumpkin seed soft extract
Read all of this leaflet carefully
before you start taking this
medicine because it contains
important information for you.
Always take this medicine exactly
as described in this leaflet or
as your doctor, pharmacist, or
qualified healthcare practitioner
has told you.
• Keep this leaflet. You may need
to read it again.
• Ask your pharmacist if you need
more information or advice.
• If you get any side effects, talk
to your doctor, pharmacist or
qualified healthcare practitioner.
This includes any possible side
effects not listed in this leaflet.
See section 4.
• You must talk to a doctor or
qualified healthcare practitioner
if you do not feel better or if you
feel worse.

overactive bladder, or who have a
confirmed diagnosis of enlarged
prostate (benign prostatic
hyperplasia; BPH). This is based on
traditional use only.

under 18 years of age is not
recommended, because lower
urinary tract symptoms in
these patients require medical
supervision.

Used to relieve symptoms such as:
• urgency to urinate
• frequent urination day and night
• incomplete emptying of the bladder
• weak or interrupted urinary flow.

Other medicines and
UROSTEMOL™ Prosta

Prior to treatment other serious
conditions should have been ruled
out by a doctor.
2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE
UROSTEMOL™ PROSTA
Do not take UROSTEMOL™ Prosta:
• if you are allergic to pumpkin
seeds or other pumpkin-like
plants (such as watermelon,
courgettes, etc.), or any of the
other ingredients of this medicine
(listed in section 6).
Warnings and precautions

What is in this leaflet
1. What UROSTEMOL Prosta is and
what it is used for
2. hat you need to know before you
W
take UROSTEMOL™ Prosta
3. ow to take UROSTEMOL™ Prosta
H
4. Possible side effects
5. How to store UROSTEMOL™ Prosta
6. Contents of the pack and other
information


1. WHAT UROSTEMOL™ PROSTA IS
AND WHAT IT IS USED FOR
UROSTEMOL™ Prosta is a traditional
herbal medicinal product used for
the relief of lower urinary tract
symptoms in men related to an

You must see your doctor,
pharmacist or qualified healthcare
practitioner if you have any of the
following symptoms or if they occur
during the use of this product:
• a fever
• bladder spasms
• blood in your urine
• pain when urinating
• difficulty urinating
• loin, back or stomach pain
You must talk to a doctor if you feel
worse.
Children and adolescents
The use of UROSTEMOL™ Prosta
in children and adolescents

Tell your doctor, pharmacist or
qualified healthcare practitioner
if you are taking or have recently
taken any other medicines.
Pregnancy and breast-feeding
UROSTEMOL™ Prosta is intended for
men only, and is not indicated for
use by women.
Driving and using machines
No studies on the effects on
the ability to drive and use
machines have been performed.
UROSTEMOL™ Prosta does not
contain any ingredients that are
known to cause drowsiness.
3. HOW TO TAKE UROSTEMOL™ PROSTA
Always take this medicine exactly
as described in this leaflet or as
your doctor, pharmacist or qualified
healthcare practitioner has told you.
Check with them if you are not sure.
For oral use only.
Adults and the elderly: The
recommended dose is one capsule
2 times a day.
The capsules should be taken with
sufficient water, ideally before meals.
Do not exceed the stated dose.
Long-term use should be discussed
with your doctor or qualified
healthcare practitioner.

Use in children and adolescents
under 18 years of age
UROSTEMOL™ Prosta is not
recommended for patients under 18
years of age.
If you take more UROSTEMOL™ Prosta
than you should
Contact your doctor, qualified
healthcare practitioner or
pharmacist if you have accidently
taken more than the recommended
dosage of UROSTEMOL™ Prosta.
If you forget to take
UROSTEMOL™ Prosta
Do not take a double dose to make
up for a forgotten dose. Take the
next dose at the usual time as you
would normally.
If you have any further questions
on the use of this medicine, ask
your doctor, pharmacist or qualified
healthcare practitioner.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine
can cause side effects, although not
everybody gets them.
Common
• Mild stomach complaints such
as stomach pain or discomfort,
indigestion, feeling or being
sick, swallowing problems and
diarrhoea have been reported.
There have been post marketing
reports of
• Allergic reactions such as skin
rashes, hives, itching, fluid
retention and anaphylactic shock.
The frequency is not known.
If allergic reactions should
occur, discontinue the use of this
medicinal product and consult a
doctor immediately.
Reporting of side effects
If you experience any side effects,
talk to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet. You
can also report side effects directly

via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By
reporting side effects you can help
provide more information on the
safety of this medicine.

Traditional Herbal Registration Holder
Omega Pharma Ltd.,
32 Vauxhall Bridge Road,
London, SW1V 2SA, UK.
Manufacturer

5. HOW TO STORE
UROSTEMOL™ PROSTA
Keep this medicine out of the sight
and reach of children.

Omega Pharma Manufacturing
GmbH & Co. KG
Benzstr. 25
71083 Herrenberg
Germany

This medicinal product does
not require any special storage
conditions and should be stored in
the original package.
Do not use this medicine after the
expiry date which is stated on the
blister and the carton after “EXP”.
The expiry date refers to the last
day of that month.
Do not throw away any medicines
via wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help protect
the environment.
6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What UROSTEMOL™ Prosta
contains
• Each hard capsule contains
500 mg Pumpkin seed soft extract
(Cucurbita pepo L. convar.
citrullina I. Greb. var. styriaca
I. Greb) (15–25 : 1), extraction
solvent ethanol 92 % (m/m).
• The other ingredients are:
hydrophobic colloidal silica,
gelatin, iron oxide black (E 172),
iron oxide red (E 172) and iron
oxide yellow (E 172).
What UROSTEMOL™ Prosta looks
like and contents of the pack
UROSTEMOL™ Prosta are brown,
gelatin capsules in a PVC/­
PVdC-­aluminium blister.
Pack sizes: 20, 40, 80 or 140 hard
capsules.
Not all pack sizes may be marketed.

THR 02855/0241
This leaflet was last revised in
04/2015.
LF-2552A/1000005415

Expand Transcript

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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