MUSE® 250, 500 or 1000 micrograms urethral stick – patient leaflet, side effects, dosage

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

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-stroke (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.

Children and adolescents

Muse is contraindicated in children aged below 18 years for erectile dysfunction.

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.

Pregnancy and breastfeeding

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 breastfeeding.

Driving and using machines

MUSE may make you feel dizzy or faint. Do not drive or operate machinery if you feel dizzy or faint.

3. How to use MUSE

Always use MUSE exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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.

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 a clean towel
• Urinate and gently shake the 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 MUSE 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 MUSE applicator later

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 the penis gently and slowly to its 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 the urethra up to the collar (Fig. 6c)
• If you feel any discomfort or pulling sensation, withdraw the applicator slightly and then 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

Step h:

• Gently move the applicator from side to side to release the medication (Fig. 8)
• Be careful not to scratch the lining of the 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 that there is no medication left in it
• Do not touch the stem
• If you see any medication left at the end of the applicator, gently re-insert it into the urethra
• Repeat steps g, h and i

Step k:

• Hold your penis upright and stretch to its full length
• Roll the penis firmly between your hands for at least 10 seconds (Fig. 9). This helps to make sure that the medicine is covering the walls of the 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 and 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 (may affect more than 1 in 10people):

• Burning feeling in the urethra
• Painful penis

Common (may affect less than 1 in 10 people):

• 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 (may affect less than 1 in 100people):

• 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 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 (may affect less than 1 in 1000people):

• 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 (may affect less than 1 in 10,000 people):

• 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 via UK: the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

IRELAND: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie e-mail: medsafety@hpra.ie

By reporting side effects you can help provide more information on the safety of this medicine

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. Content of the pack and other information

What MUSE contains

The active substance in MUSE is alprostadil. Each MUSE urethral stick contains 125 micrograms, 250 micrograms, 500 micrograms or 1000 micrograms of alprostadil.

The other ingredient is polyethylene glycol 1450 (PEG 1450).

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: Viatris Products Limited, Station Close, Potters Bar, EN6 1TL, United Kingdom

In Ireland: Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Manufacturer

The manufacturer responsible for batch release is

Meda Pharma GmbH & Co KG, Benzstrasse 1, D-61352 Bad homburg, Germany.

Viatris Santé, 1 rue de Turin, 69007 Lyon, France

1. 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.

1. 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 May 2026.

If this leaflet is difficult to see or read or you would like it in a different format, please contact:

In the UK - Viatris Products Limited, Station Close, Potters Bar, EN6 1TL, United Kingdom.

In Ireland - Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland