PROSTASAN Capsules, Soft

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

SABALIS SERRULATAE EXTRACTUM SPISSUM

Beszerezhető a:

Bioforce (UK) Ltd

INN (nemzetközi neve):

SABALIS SERRULATAE EXTRACTUM SPISSUM

Gyógyszerészeti forma:

Capsules, Soft

Recept típusa:

Product not subject to medical prescription

Engedélyezési státusz:

Authorised

Engedély dátuma:

2012-05-25

Betegtájékoztató

Read all of this leaflet carefully
before you start taking this
product because it contains
important information for you.
Always take this product exactly as
described in this leaflet or as your
doctor, pharmacist or nurse 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
nurse. 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 after 8 weeks.
What is in this leaflet
1.
What Prostasan is and what it is
used for
2.
What you need to know before
you take Prostasan
3.
How to take Prostasan
4.
Possible side effects
5.
How to store Prostasan
6.
Contents of the pack and other
information
Information
Package Leaflet:
Information for the user
_Please turn over..._
Do's and Don'ts for taking Prostasan
Prostasan
®
soft capsules
Saw Palmetto soft extract
41530IN3
1. What Prostasan is
and what it is used for
Prostasan is a traditional herbal
medicinal product containing the
extract of Saw Palmetto fruit. It is
used to relieve urinary discomfort
in men with an enlarged prostate
(also known as benign prostatic
hyperplasia or BPH). This is
exclusively based on long-standing
use.
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.
This product is used to treat an
enlarged prostate in men over 18.
The prostate gland is found just
below the bladder in men. As men
get older this gland may enlarge
causing urinary discomfort.
2. What you need to
know before you take
Prostasan
Do not take Prostasan
If you are allergic to:
Saw Palmetto fruit. This product
contains Saw Palmetto fruit.
Any of the other ingredients of
this product (listed in Section 6).
Warnings and precautions
This product is for use in men only.
It is not suitable for use in women,
children or adole

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prostasan soft capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 320 mg of extract (as soft extract) from_
Serenoa repens_ (Bartram) Small fructus (_Sabal serrulata_
(Michaux) Nichols fructus) (saw palmetto fruit) (9-12:1).
Extraction solvent: ethanol 96% v/v.
Excipients with known effect:
Each capsule contains 7.7 mg sorbitol (as dry matter).
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Soft capsules (capsules)
It is an oval-shaped, dark brown coloured soft capsule containing a
clear, yellow-brown coloured oil.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A traditional herbal medicinal product used for the relief of lower
urinary tract symptoms in men who have a confirmed
diagnosis of benign prostatic hyperplasia (BPH). 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 older people: One capsule daily to be taken with food.
There is no relevant use of Prostasan in women, or in children or
adolescents under the age of 18 (see Section 4.1).
Patients with hepatic and/or 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 persist, worsen or do not improve after 8 weeks use of
Prostasan a qualified healthcare professional e.g. a
doctor or pharmacist should be consulted.
METHOD OF ADMINISTRATION
For oral use only.
4.3 CONTRAINDICATIONS
Hypersensitivity to saw palmetto or any of the excipients listed in
section 6.1.
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