UROSTEMOL MEN CAPSULES

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

PUMPKIN SEED, CRUSHED; PUMPKIN SEED OIL; DRY EXTRACT OF SAW PALMETTO FRUIT

Disponível em:

Chefaro Ireland DAC

Código ATC:

G04

DCI (Denominação Comum Internacional):

PUMPKIN SEED, CRUSHED; PUMPKIN SEED OIL; DRY EXTRACT OF SAW PALMETTO FRUIT

Dosagem:

400/340/75 Milligram

Forma farmacêutica:

Capsules Hard

Tipo de prescrição:

Product not subject to medical prescription

Área terapêutica:

UROLOGICALS

Status de autorização:

Authorised

Data de autorização:

2016-03-24

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
PUMPKIN SEED, PUMPKIN SEED OIL AND
DRY EXTRACT FROM SAW PALMETTO FRUIT
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 or pharmacist have
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 or pharmacist.
This includes any possible side
effects not listed in this leaflet.
See section 4.
•
You must talk to a doctor if you
do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1. What UROSTEMOL
®
Men is and
what it is used for
2. What you need to know before you
take UROSTEMOL
®
Men
3. How to take UROSTEMOL
®
Men
4. Possible side effects
5. How to store UROSTEMOL
®
Men
6. Contents of the pack and other
information
1. WHAT UROSTEMOL
®
MEN IS AND
WHAT IT IS USED FOR
UROSTEMOL
®
Men is a traditional
herbal medicinal product used for
the relief of lower urinary tract
symptoms in men related to an
overactive bladder or bladder
weakness. This is exclusively
based on long-standing use.
Used to relieve symptoms such as:
•
frequent urination day and night
• urgency to urinate
•
urinary incontinence/accidental
leakage of urine
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE UROSTEMOL
® MEN
DO NOT TAKE UROSTEMOL
®
MEN:
•
if you are allergic to the active
substances, 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
Visit your doctor before use to rule
out any underlying conditions.
You must see your doctor or
pharmacist 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
•
groin, back or stomach pain
If you are taking warfarin

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Urostemol Men capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 400 mg of pumpkin seed, crushed (_Cucurbita
pepo_ L. convar._ citrullina_ I_._ Greb. var._ styriaca_ I.
Greb); 340 mg of pumpkin seed oil (_Cucurbita pepo_ L. convar._
citrullina_ I_._ Greb. var._ styriaca_ I. Greb); 75 mg of
extract (as dry extract) from saw palmetto fruit (_Serenoa repens_
(Bartram) small) (7
-
13 : 1), extraction solvent ethanol
90% (m/m).
Excipient(s) with known effect: lactose 56.25 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsules.
Brown gelatin hard capsules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A traditional herbal medicinal product for the relief of lower urinary
tract symptoms in men related to an overactive
bladder or bladder weakness, such as urgency to urinate, urinary
incontinence or frequent urination day and night. This
is exclusively based on long-standing use.
Prior to treatment, other serious conditions should have been ruled
out by a doctor.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and elderly patients_
One capsule to be taken three times a day.
_Paediatric population_
The use in children and adolescents under 18 years of age is not
recommended (see section 4.4).
Method of administration
For oral use only.
The capsules should be taken with sufficient fluids, ideally before
meals.
Hepatic and renal impairment: The safety of saw palmetto has not been
studied in patients with hepatic and/or renal
impairment.
Due to a lack of data, the safety of this product for long term use
has not been established.
If symptoms worsen during use or persist after 4 weeks of use a
qualified healthcare professional e.g. a doctor or
pharmacist should be consulted.
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