MUSE 1000 MICROGRAMS URETHRAL STICK

Active substance: ALPROSTADIL

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05-11-00000P

Patient Information Leaflet
® 125, 250, 500 or 1000 micrograms urethral stick
MUSE
(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 or pharmacist.
• 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.
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 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 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 have multiple myeloma (tumour of the bone marrow).
• If you have thrombocythaemia (increase in blood platelets).
• If you have polycythaemia (increased blood cells).
• If you are susceptible to venous thrombosis (blood clots in blood
vessels).
• If you have a history of long-lasting erections.
• If you have been told not to have sex for health reasons such as heart
problems or a recent stroke.

If any of the above applies to you, do not use MUSE and talk to
your doctor or pharmacist.
Warnings and precautions
Talk to your doctor before using MUSE:
• If you know that you have a bleeding disorder. Incorrect
use of MUSE can cause bleeding in the urethra.
• If you have a blood born disease. Administration of
MUSE could result in spread of the disease to your
partner
• If you have a heart, lung or chest disorder (in these cases
you also should engage in sexual activity with caution)
• If you have a history of mental illness or addiction
• If you have had a mini-sroke (transient ischaemic attack)
• If you have a penile implant.
• If you have erections lasting 4 hours or longer.
MUSE will not protect you or your partner from sexually
transmitted diseases like chlamydia, gonorrhoea, herpes
simplex virus, viral hepatitis, HIV, genital warts or syphilis.
Always use a condom to avoid these sexually transmitted
diseases.
Other medicines and MUSE
You must tell your doctor if you are taking:
• Antihypertensives (medicines to treat high blood pressure).
MUSE may affect how well your medicine works.
• Anticoagulants (medicines to thin your blood). You are
more likely to get bleeding in the urethra.
• Sympathomimetics (medicines used to treat heart problems
and low blood pressure). MUSE may work less effectively.
• Vasoactive medicines (change the diameter of your blood
vessels). Your blood pressure may decrease or increase.
• Decongestants (medicines for a cold, hay fever or sinus
trouble). MUSE may work less effectively.
• Appetite suppressants (medicines that make you feel less
hungry). MUSE may work less effectively.
• Viagra or other medicines for a weak erection. They may
change the effect of MUSE.
Tell your doctor if you are taking or have recently taken or
might take any other medicines, including any you bought
without a prescription.
Pregnancy and breast feeding
MUSE should not be used if your female partner is or may be
pregnant, unless you use a condom barrier.
Please ask your doctor or pharmacist for advice before using
MUSE if your partner is breast feeding.
Driving and using machines
MUSE may make you feel dizzy or faint. Do not drive or
operate machinery if you feel dizzy or faint.

Do not use more than 2 doses in one day (24-hour
period) or more than 7 doses in 1 week.
To test for erectile dysfunction (impotence): Your doctor
will give you one dose of 500 micrograms.
How to use the applicator
MUSE consists of an applicator (Fig. 1) for delivering
alprostadil into the urethra. Your doctor will show you how to
use MUSE and make sure that you can use it yourself. Follow
the instructions below carefully:

Step a:
• Wash your hands and dry them on clean towel
• Urinate and gently shake your penis several times to
remove excess urine. A moist urethra makes inserting
MUSE easier
Step b:
• Open the foil pouch by tearing fully across the notched
edge (Fig. 2)
• Let MUSE slide out of the pouch onto your hand
• Do not grab the applicator
• Save the pouch for throwing away the used applicator later

Step c:
• Remove the protective cover from the end of the applicator
by holding the body of the applicator with your thumb and
forefinger and twisting (Fig. 3)
• Pull the applicator out of the cover
• Be careful not to touch the applicator stem and tip
• Save the cover for throwing away the used applicator later

3. How to use MUSE

Always use MUSE exactly as your doctor has told you. Check
with your doctor or pharmacist if you are unsure.
How much MUSE to use
For an erection: The usual starting dose is 500 micrograms.
If this does not give you an adequate erection, do not
increase your dose yourself. Talk to your doctor who will try
a higher dose.

Step d:
• Check that you can see the medication at the end of the
stem (Fig. 4.)

• Hold the applicator in the way which is most comfortable
for you (Fig. 5)

Step e:
• Look carefully at the drawing of a penis (Fig. 6a)
• While sitting or standing, whichever is the more comfortable
for you, take several seconds to stretch your penis
gently and slowly to it's full length
• Do this with gentle compression from the top to the bottom
of the glans (Fig. 6b). This straightens and opens the urethra

Step f:
• Slowly insert the MUSE stem into your urethra up to the
collar (Fig 6c)
• If you feel any discomfort or pulling sensation,
withdraw the applicator slightly and gently re-insert.
Step g:
• Gently and completely push down the button at the
top of the applicator (Fig. 7) until it stops
• This ensures the stick is completely released
• Hold the applicator in this position for 5 seconds
6c

Step h:
• Gently move the applicator from side to side to
release the medication (Fig. 8)
• Be careful not to scratch the lining of your urethra
which could cause it to bleed

Step i:
• Remove the applicator whilst keeping your penis upright
Step j:
• Look at the applicator to check there is no medication left in it
• Do not touch the stem
• If you see any medication left in the applicator,
gently reinsert it into your urethra
• Repeat steps g, h and i
Step k:
• Hold your penis upright and stretch it to its full length
• Roll your penis firmly between your hands for at
least 10 seconds (Fig. 9). This helps to make sure that
the medicine covers the walls of your urethra
• If you feel a burning sensation, it may help to
continue to roll your penis until the burning stops

Step l:
• Remember, use each MUSE applicator once only
• After use, replace the cover on the applicator
• Put the applicator in the opened foil pouch and fold it
• Ask your pharmacist how to dispose of it
Step m:
• After you have used MUSE it is important to sit, or
preferably stand or walk about for 10 minutes whilst
your erection develops. This will make your erection
better
• Your erection should last for 30 to 60 minutes
• You may get a red warm penis that is sensitive to the
touch (this is normal).
If you use more MUSE than you should
Contact your doctor for advice. You may get low blood
pressure, pain in your penis that does not go away and, very
rarely, an erection which lasts for more than 4 hours.

4. Possible side effects

Like all medicines, MUSE can cause side effects, although not
everybody gets them. They are usually mild and disappear
after a short time.
If you experience any of the following symptoms, contact
your doctor immediately:
• You have a long lasting erection of more than 4 hours

• Your penis becomes scarred, bent or kinked
• Your testes or scrotum become red, swollen or painful,
or develop lumps called spermatocele, which are cysts
containing sperm
Very common side effects (affects more than 1 in 10 patients):
• Burning feeling in the urethra
• Painful penis
Common possible side effects (affects less than 1 in 10 patients):
• Headache
• Dizziness
• Muscle spasms
• Low blood pressure
• Minor bleeding in the urethra
• Pain in the testes
• Burning or itching in partner’s vagina
• Bruised penis
• Increased erection
• Peyronie’s disease (condition resulting in pain and abnormal
curvature, shortening or narrowing of the penis).
Uncommon possible side effects (affects less than 1 in 100
patients):
• Fainting or feeling faint
• Impaired or enhanced sense of touch
• Swelling of the leg veins
• Leg pain
• Common cold
• Pain in the perineum (between the penis and rectum)
• Increased heart rate
• Widening of your blood vessels and decreased blood pressure
which may make you feel lightheaded
• Problems with your blood vessels, such as bleeding from your
vein(s)
• Feeling sick
• Skin rash, which may be itchy or red
• Increased sweating
• Need to pass urine more urgently or frequently than normal
• Pain or difficulty in urinating
• Blood in your urine
• Increased levels of creatinine in your blood.
• Priapism (prolonged erection)
• Your testes or scrotum could become red, swollen or painful, or
develop lumps called spermatocele, which are cysts containing
sperm. The penis could feel numb
• Uncomfortable or painful erections, or no erection at all
• Change in ejaculation
• Swollen or tight foreskin and/or the head of your penis.
Rare possible side effects (affects less than 1 in 1000 patients):
• Urinary tract infection
• Disorders of the penis which may result in your penis becoming
scarred, bent or kinked, particularly after long term use of MUSE
Very rare possible side effects (affects less than 1 in 10,000
patients):
• Red or white itchy patches (urticaria)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or

nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly (see details
below). By reporting side effects you can help provide more
information on the safety of this medicine.
UK: Via the Yellow Card Scheme at: www.mhra.gov.uk/
yellowcard
IRELAND: Via IMB Pharmacovigilance, Earlsfort Terrace, IRL
- Dublin 2;
Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.
imb.ie, email: imbpharmacovigilance@imb.ie

5. How to store MUSE
• Keep out of the sight and reach of children.
• Store unopened pouches in a refrigerator (2-8ºC). Prior to use
you may remove them from the refrigerator and store them at
room temperature (not above 30ºC) for a maximum of 14 days.
• Do not use MUSE after the expiry date which is stated on the
pouch. The expiry date refers to the last day of that month.
• Do not throw away 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 MUSE contains
The active ingredient in MUSE is alprostadil. Each MUSE
urethral stick contains 125 microgram, 250 micrograms, 500
micrograms or 1000 micrograms of alprostadil. The other
ingredient is macrogol.
What MUSE looks like and contents of the pack
MUSE is a single use applicator for giving alprostadil directly
into your urethra (the pathway for urine through the penis).
The applicator consists of a urethral stick, stem, collar, body,
button and cover as one unit. Each applicator comes in a
protective foil pouch.
MUSE comes in packs of 1, 2, 3, 6 or 10 pouches. (Not all
packs may be marketed.)
Marketing Authorisation Holder
In the UK: Meda Pharmaceuticals Ltd, Skyway House,
Parsonage Road, Takeley, Bishop’s Stortford, CM22 6PU, UK.
In Ireland: Meda Health Sales Ireland Limited, Unit 34/35,
Block A, Dunboyne Business Park, Dunboyne, Co Meath,
Ireland.
Manufacturer
The manufacturer responsible for batch release is Recipharm
Limited, Vale of Bardsley, Ashton-under-Lyne, Lancashire, OL7
9RR, UK.
Sexual Dysfunction Helpline
For more information on impotence or any aspects of its
treatment, you can call:
The Sexual Dysfunction Association, on 0870 774 3571(UK
only) or email info@sda.uk.net. The Association’s address is
Suite 301, Emblem House, London Bridge Hospital, 27 Tooley
Street, London SE1 2PR. The Helpline is open on Mondays,
Wednesdays and Fridays from 10 a.m. to 4 p.m. All calls are
answered in the strictest confidence.

7. Commonly asked questions about MUSE
•Will the use of MUSE hurt? Inserting MUSE may cause
you some discomfort. Urinating before using MUSE, stretching
your penis to its full length and using MUSE repeatedly will
reduce the chance of discomfort. Using MUSE may cause
some burning and aching, which should not last long.
•How long will the effect of MUSE last? An erection
should begin 5 to 10 minutes after using MUSE. It should
last for about 30 to 60 minutes. However, this will vary from
patient to patient.
•What will the erection be like? How will it compare
with the erections in the past? MUSE should produce
an erection for sexual intercourse. The erection may not be
the same as those you had in the past. There may be some
mild pain and aching in the penis or groin and your erection
may continue after orgasm. Your penis may feel warm and
become red because MUSE increases blood flow in it.
•How do I know if I have the correct dose of MUSE?
You and your doctor will decide the correct dose for you. If
your erection does not last enough for you to have foreplay
and sexual intercourse, you may need to have the dose
increased. Or, if your erection lasts too long, a lower dose
may be better for you. Tell your doctor if you think your dose
needs to be changed.
•After my erection is over, will my penis feel sensitive?
Your penis may be red and feel warm and sensitive to the
touch for a few hours. This is normal.

8. Helpful tips for improving your erection

Factors which may enhance your erection:
• Being well rested and relaxed.
• Sexual foreplay with your partner or self-stimulation while
sitting or standing.
• Pelvic exercises, e.g. tightening and releasing your pelvic
and buttock muscles (which you use to stop urination).
Factors which may reduce your erection:
• Anxiety, fatigue, tension or too much alcohol.
• Lying on your back too soon after administration of MUSE
may decrease blood flow to the penis and result in loss of
erection. You should sit, stand or walk about for 10 minutes
before sexual intercourse.
• Urination or dribbling immediately following administration
may result in loss of medication from the urethra.
• Using medications that contain decongestants, such as
cold remedies, allergy, sinus medications and appetite
suppressants, may lessen the effect of MUSE.
If you have any further questions on the use of MUSE, ask
your doctor or pharmacist.
This leaflet was last revised in 04/2014.
If this leaflet is difficult to see or read or you would like it in a
different format, please contact:
In the UK - Meda Pharmaceuticals Ltd, Skyway House, Parsonage
Road, Takeley, Bishop's Stortford, CM22 6PU, UK
In Ireland - Meda Health Sales Ireland Limited, Unit 34/35, Block A,
Dunboyne Business Park, Dunboyne, Co Meath, Ireland

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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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