MUSE 500 Microgram Stick/Urethral

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

ALPROSTADIL

Tillgänglig från:

Meda Health Sales Ireland Limited

ATC-kod:

G04BE01

INN (International namn):

ALPROSTADIL

Dos:

500 Microgram

Läkemedelsform:

Stick/Urethral

Receptbelagda typ:

Product subject to prescription which may not be renewed (A)

Terapiområde:

Drugs used in erectile dysfunction

Bemyndigande status:

Transfer Pending

Tillstånd datum:

2006-07-14

Bipacksedel

 
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 
MUSE
®
 125, 250, 500 OR 1000 MICROGRAMS URETHRAL STICK
(Alprostadil)
Read all of this leaflet carefully before you start using this
medicine 
because it contains important information for you. 
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or
nurse
•  This medicine has been prescribed for you only. Do not pass it
on to 
others. It may harm them, even if their signs of illness are the same
as yours. 
•  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.
What is in this leaflet:
1.  What MUSE is and what it is used for
2.  What you need to know before you use MUSE
3.  How to use MUSE
4.  Possible side effects
5.  How to store MUSE
6.  Contents of the pack and other information
7.  Commonly asked questions about MUSE 
8.  Helpful tips for improving your erection
MUSE contains alprostadil in an applicator. Alprostadil is identical
to a 
substance called prostaglandin E1 (PGE1) which occurs naturally in
the 
body. The applicator is used to deliver alprostadil into your penis.
 It 
acts to widen blood vessels and increases blood flow.
MUSE is used:
• To help you get and maintain an erection when you have 
insufficient PGE
1.
• By your doctor to test whether you suffer from impotence.
MUSE is not for use by women and children.
Do not use MUSE:
•  If you are allergic to alprostadil or any of the other
ingredients of MUSE. 
These are listed in section 6. 
•  If your penis is deformed, for example it is bent or severely
curved.
•  If you have a disease of your penis, such as Peyronie's
disease. 
•  If you have any inflammation in your penis or urethra (pathway
for urine 
to pass out of the penis).
•  If you have sickle cell anaemia or traits (abnormal red blood
cells).
•  If you have leukaemia (cancer of blood cells).
•  If

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
MUSE 500 microgram urethral stick.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each urethral stick contains 500 micrograms alprostadil.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Urethral Stick.
MUSE is a sterile,
single-use transurethral
system for the delivery of alprostadil
to the male urethra.
Alprostadil
is
suspended in polyethylene glycol and is formed into a urethral stick
(1.4 mm in diameter by 6 mm in length) which is
contained in the tip of the polypropylene applicator.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of erectile dysfunction of primarily organic etiology.
Adjunct to other tests in the diagnosis and management of erectile
dysfunction.
MUSE is indicated in adults aged 18 years and above.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
USE IN ADULTS
_Treatment of erectile dysfunction_
_Initiation of therapy:_ a medical professional should instruct each
patient on the correct use of MUSE. The
recommended starting dose is 500 micrograms.
Dosage may be increased in a stepwise manner (to 1000 micrograms), or
decreased (to 250 or 125 micrograms) under
medical supervision until the patient achieves a satisfactory
response. After an assessment of the patient's skill and
competence with the procedure, the chosen dose may then be prescribed
for home use.
It is important for the patient to urinate before administration since
a moist urethra makes administration of MUSE
easier and is essential to dissolve the drug. To administer MUSE,
remove the protective cover from the MUSE
applicator, stretch the penis upward to its full length, and insert
the applicator stem into the urethra. Depress the
applicator button to release the medication from the applicator and
remove the applicator from the urethra, (rocking the
applicator gently prior to removal will ensure that the medication is
separated from the applicator stem). Roll the penis
between the hands for at least 10 seconds to ensure that the
medication is