Muse 1000microgram urethral sticks

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Alprostadil

Available from:

Viatris UK Healthcare Ltd

ATC code:

G04BE01

INN (International Name):

Alprostadil

Dosage:

1mg

Pharmaceutical form:

Stick

Administration route:

Urethral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07040500; GTIN: 7317510000141 7317510000158

Patient Information leaflet

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
1.
WHAT MUSE IS AND WHAT IT IS USED FOR
MUSE contains alprostadil in an applicator. Alprostadil is identical
to a substance
called prostaglandin E
1
(PGE
1
) 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
PGE1

By your doctor to test whether you suffer from impotence.
MUSE is not for use by women and children.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MUSE
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 you

Summary of Product characteristics

OBJECT 1
MUSE 1000 MICROGRAM URETHRAL STICK.
Summary of Product Characteristics Updated 09-Jan-2014 | Meda
Pharmaceuticals
1. Name of the medicinal product
MUSE 1000 microgram urethral stick.
2. Qualitative and quantitative composition
Each urethral stick contains 1000 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 macrogol 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.
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