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ALPROSTADIL 10 MICROGRAM POWDER FOR SOLUTION FOR INJECTION

Active substance(s): ALPROSTADIL / ALPROSTADIL

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Patient Information Leaflet
Caverject® 10 microgram powder for solution for
injection
(alprostadil)
Read all of this leaflet carefully before you start using this
medicine.




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. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
Your medicine is called Caverject 10 micrograms powder for solution
for injection but will be referred to as Caverject throughout this leaflet.
Caverject 10 micrograms powder for solution for injection is also
available in other strengths.
In this leaflet:
1. What Caverject is and what it is used for
2. Before you use Caverject
3. How to use Caverject
4. Possible side effects
5. How to store Caverject
6. Further information
1. What Caverject is and what it is used for
Caverject contains alprostadil which is similar to the natural substance
in your body called prostaglandin E1. It widens blood vessels so that
blood can flow in your penis more easily. This makes it easier for you
to have an erection.
Caverject is used for “erectile dysfunction” including weak erections or
impotence. Your doctor may also use it to help find the exact cause of
your erectile dysfunction along with other tests.
2. Before you use Caverject
Do not use Caverject if you:

How much Caverject should you inject?
Different people need different amounts of Caverject to treat erectile
dysfunction. Your doctor will advise on the right dose for you and
monitor you regularly to check how it is working. The starting dose is
1.25 – 2.5 micrograms.
Most men find that a dose of 5 – 20 micrograms is right for them,
however, some men may require a higher dose. To minimise the risk
of prolonged painful erection, your doctor will select the lowest
effective dose. You should never use more than 60 micrograms. If
Caverject is being used to find the reason for your erectile dysfunction,
the dose will be 5 – 20 micrograms.
If the dose that has been prescribed for you does not work well
enough, tell your doctor. Do not change your dose unless your doctor
tells you to. If you forget how much to use, read the label on the pack
or speak to your doctor.
You and your partner
You may like your partner to be involved in preparing and/or giving the
injection. If so, you should speak to your doctor about training for your
partner. Wash your hands. Dry them on a clean towel. If your partner
wishes to be involved in preparing or giving the injection, they should
wash their hands too.
1. Check your pack
Make sure that the vial is the correct strength and the expiry date is
still valid. The vial, syringe and needles all have protective covers. The
flip-off cap on the vial can rotate; this is normal. Check that all the
covers are on firmly and if they are not on properly, do not use them –
take the whole pack back to your pharmacist. There are two needles in
the pack:
• The larger 22 gauge needle with the grey end is used to mix the
solution and Caverject Powder.
• The smaller and finer 30 gauge needle with the yellow end is used
to inject the mixture into your penis.
If a needle is bent do not use it.
2. To prepare the vial
Flip the plastic cap off the vial. Wipe the rubbery top with one of the
wet antiseptic pads.



are allergic (hypersensitive) to Caverject or any other medicines
containing alprostadil or any of the other ingredients of Caverject.
• have sickle cell anaemia (a blood disease), leukaemia (cancer of
the blood), multiple myeloma (bone cancer) or any other problem
which increases the risk of getting “priapism”. This is a painful
condition when your penis continues to remain erect.
• have an implant in your penis.
• have a condition (such as severe heart disease) in which sexual
activity should be avoided.
• have a penis which is scarred or not straight.
• have a tight foreskin.
Do not use any Caverject until your doctor says that it is right for you.
Take special care with Caverject
Tell your doctor before using Caverject if you:
• have a lung, chest or heart disorder (in these cases you also
should engage in sexual activity with caution)
• have a history of mental illness or addiction
• have had a mini-stroke (transient ischaemic attack)
• have one or more cardiovascular risk factors (these might include
high blood pressure, tobacco use, raised blood glucose, raised
blood cholesterol, overweight and obesity)
• have one or more risk factors for stroke (these might include high
blood pressure, raised blood cholesterol, coronary artery disease,
heart arrhythmia, diabetes)
Sexually transmitted diseases
Caverject will not protect you or your partner from sexually transmitted
diseases like AIDS, herpes and gonorrhoea. Injection of Caverject can
start a small amount of bleeding where the needle enters. This could
increase the risk of transmission of such diseases. Condoms can
protect against sexually transmitted diseases. If you need advice about
contraception or ‘safe sex’ speak to your doctor or contact your local
Family Planning Clinic.
Taking other medicines
Tell your doctor if you are taking any of the following medicines before
you start using Caverject:
• medicines used for treating high blood pressure
(antihypertensives)
• medicines used for respiratory and heart disease
(sympathomimetics)
• medicines that widen blood vessels (vasodilative agents)
• other medicines for erectile dysfunction such as sildenafil or
papaverine
• medicines to thin your blood such as warfarin or heparin, as you
might bleed more when you do the injection.
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
Pregnancy and breast-feeding
Caverject can be used by couples wishing to conceive and with a
partner who is pregnant or breast-feeding. It will not protect your
partner from pregnancy, so you should use a reliable contraceptive if
appropriate.
Driving and using machines
Caverject should not affect your ability to drive or use machines.
Important information about some of the ingredients of Caverject
Caverject contains benzyl alcohol which may cause allergic reactions.
This medicine contains less than 1 mmol sodium (23 mg) per dose and
is essentially ‘sodium-free’.
3. How to use Caverject
A doctor or nurse will show you how to do the injection for at least the
first time. Do not try to do it yourself until you have learnt the correct
way or if you can’t remember what to do, see your trainer again. These
instructions are a reminder only. Keep the antiseptic swab away from
the eyes.

3. Fitting the needle to the syringe
Hold the syringe and twist the white tamper evident cap to break the
seal. Take the foil off the larger needle, (22 gauge) with the grey end,
keeping the cover on. Join the needle to the syringe by turning the
needle clockwise tightly onto the syringe, then remove the needle
cover by pushing it away from the syringe with your thumb and
forefinger.

4. Mixing the solution with the powder
Push the needle through the rubbery middle of the vial top. Press the
plunger down firmly to squirt all the solution onto the powder. Gently
swirl the vial until all the powder has dissolved. If the mixture is cloudy
or does not dissolve completely, do not use it. Never use tap water or
any liquid other than the one supplied in the syringe.

5. Filling the syringe
With the needle still inserted, turn the vial upside down. The needle
should support the vial unaided. Make sure the needle tip is
underneath the level of the liquid. Gently pull the plunger to draw all
the mixture into the syringe. Pull the needle out of the vial.

6. Changing to the injecting needle
Gently twist the larger needle anticlockwise off the syringe. Remove
the smaller injecting needle, (30 gauge) with the yellow end from its
package, keeping the cover on. Twist the needle clockwise tightly onto
the syringe, then remove the needle cover by pushing it away from the
syringe with your thumb and forefinger.

7. Setting the dose
Tap the syringe gently to send any air bubbles to the top, then push
the plunger to squeeze the air bubbles out, ensuring that at least one
drop of solution comes out of the needle. Continue pushing until the
plunger is exactly at the right mark for your dose. Your doctor will have
shown you where this is.

How do you do the injection?
• Get undressed and make yourself comfortable. Take some time to
relax yourself and your partner. If your prescriber has
recommended use of the second antiseptic pad, open it now.
• Make sure that the injection needle is not bent. A bent and restraightened needle is more likely to break. Needle breakage, with
a portion of the needle remaining in the penis, has been reported
and, in some cases, required hospitalisation and surgical removal.
If the needle is bent, do not use it and throw it away. Do not
attempt to straighten it out. Attach a new, unused sterile needle to
the syringe.
• Take hold of the penis from the front, with the first two fingers
underneath close to the testicles and the thumb on top. Gently
squeeze the penis between your thumb and finger so that the
injection site bulges out. If there is a foreskin on the penis, make
sure it is stretched. The injection will go into the part of the penis
shown as the shaded area in diagram A.

A




If recommended by your prescriber wipe the skin over this area
with the second pad and let it dry.
Keeping a firm grip on the penis and taking the syringe in your free
hand, push the needle straight through the skin all the way into the
bulgy part avoiding veins or other obvious blood vessels. The
angle is shown in diagrams B and C. Push the plunger firmly and if
the Caverject does not come out fairly easily, move the needle
slightly and try again. Do not force the Caverject liquid from the
syringe.

B

C



Pull the needle out. On the needle mark, press gently with the pad
or your thumb, as recommended by your prescriber. Massage the
penis to help the Caverject spread through it.
• Do not keep any mixture in the syringe to use for a second
injection.
How to throw away the syringe and needle safely
Ensure that the syringe, vial and needles are disposed of in a closed,
puncture-resistant container such as a sharps bin. Ask your doctor or
pharmacist for instructions on how to properly dispose of the container
after use if you are at all unsure.
How often can you use Caverject?
Do not use Caverject more than once in 24 hours or more than three
times in a week. Change the exact place and side of the penis that you
inject Caverject each time you use it.
Your erection after injecting Caverject
It will take a little while for your erection to come on after the injection.
With the right dose of Caverject, your erection should be strong
enough for you and your partner to enjoy lovemaking. Usually, your
erection should not last longer than an hour. If you would like it to last
longer, talk to your doctor. If your erection lasts longer than four
hours you should seek medical advice (see the section on side
effects below).
What if you use too much Caverject
Tell your doctor straight away as you may need treatment, particularly
if you experience an erection that lasts for longer than four hours.
If you have any further questions on how to use this product, ask your
doctor.
4. Possible side effects
Like all medicines, Caverject can cause side effects, although not
everybody gets them.
Tell your doctor immediately if
your erection goes on for longer than 4 hours. If you cannot
contact your doctor, go to a hospital casualty department
immediately as treatment should be started within 6 hours.
Very common side effects
(occurring in more than 1 in 10 patients)
• Pain in the penis

Common side effects
(occurring in less than 1 in 10 patients)
• Penis can become bruised, scarred, bent or kinked, particularly
after long term use. Tell your doctor if this happens as you may
need to stop Caverject.
• Prolonged erections
• Other problems with your penis
• Swelling and skin discolouration or bruising at site of injection. You
may find this happening the first time you use Caverject but should
occur less often with practice
• Muscle spasms.
Uncommon side effects
(occurring in less than 1 in 100 patients)
• The area injected becomes irritated, inflamed or swollen and may
itch or bleed, or feel numb, warm, tender or painful
• The testes or scrotum could become red, swollen or painful, or
develop lumps called spermatocele, which are cysts containing
sperm. The penis could feel numb
• You may get uncomfortable, painful or prolonged erections or none
at all, your ejaculation may change or your foreskin could feel tight
or swollen, as well as the head of your penis
• The desire to pass urine more urgently or frequently than normal
or you may have pain or difficulty in urinating. Some blood may
appear in the urine or at the end of the penis especially if Caverject
is injected by mistake into the tube which carries urine out through
the penis (urethra)
• Pelvic pain, weakness, sweating, feeling sick or swollen legs or
arms, having a common cold or dry mouth. You may get a yeast
infection (thrush)
• Changes in blood pressure and heart rhythm, faintness, shallow
breathing and collapse could occur because of the injection itself
• Skin itching, redness of the skin at site of injection, rash or skin
growth, increased sweating, eye sensitivity to bright light or
excessive dilation of the pupil (blown pupil), impaired or enhanced
sense of touch, leg cramps, cold hands and feet, venous problems
including bleeding (bleeding from vein(s))
• If you have a blood test you may have raised levels of creatinine (a
substance found in your muscles).
Not known
(frequency cannot be estimated from available data)
• Insufficient blood flow to the heart muscle via the coronary arteries
• Stroke.
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 the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. How to store Caverject
• Do not store above 25°C
• Keep out of the sight and reach of children
• When you have mixed the Caverject Powder with the solution, use
it straight away. Do not keep it to use later on.
• For single use only. Any unused Caverject should be discarded.
• Do not use Caverject if the injection is cloudy or contains particles.
• Do not use Caverject after the ‘expiry’ date on the pack. The expiry
date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Further Information
What Caverject contains
After reconstitution each 1ml contains alprostadil 10 micrograms.
The other ingredients are lactose monohydrate, sodium citrate, αcyclodextrine, hydrochloric acid and sodium hydroxide
The syringe contains benzyl alcohol (8.4 mg/ml) and water for
injections. The antiseptic pads are soaked in isopropyl alcohol.
What Caverject looks like and contents of the pack
In the Caverject box you will find 5 items:
1. One glass vial containing Caverject 10 micrograms as a white to
off-white powder
2. One graduated glass syringe containing 1 ml of a clear solution
3. One larger 22 gauge needle – 11/2 inches long with a grey plastic
end
4. One small 30 gauge needle – 0.5 inch long with a yellow plastic
end
5. Two antiseptic pads
Manufacturer
Pfizer Manufacturing Belgium N.V/S.A, Rijksweg 12, 2870 Puurs,
Belgium.
Product licence holder:
Ecosse Pharmaceutical Limited,
3 Young Place, East Kilbride, G75 0TD
Repackaged by Munro Wholesale Medical Supplies Limited,
3 Young Place, East Kilbride, G75 0TD
PL 19065/0483
POM
This leaflet was revised: 22.03.2017
E0483-4(Y)

If you are blind or partially sighted
and require this leaflet in a different
format, call 01355 574450 and ask
for the Regulatory Department.
Caverject® is a registered trademark of Pharmacia & Upjohn Company LLC

Patient Information Leaflet
Caverject® 10 microgram powder for solution for
injection
(alprostadil)
Read all of this leaflet carefully before you start using this
medicine.
• 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. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
Your medicine is called Caverject 10 micrograms powder for solution
for injection but will be referred to as Caverject throughout this leaflet.
Caverject 10 micrograms powder for solution for injection is also
available in other strengths.
In this leaflet:
1. What Caverject is and what it is used for
2. Before you use Caverject
3. How to use Caverject
4. Possible side effects
5. How to store Caverject
6. Further information
1. What Caverject is and what it is used for
Caverject contains alprostadil which is similar to the natural substance
in your body called prostaglandin E1. It widens blood vessels so that
blood can flow in your penis more easily. This makes it easier for you
to have an erection.
Caverject is used for “erectile dysfunction” including weak erections or
impotence. Your doctor may also use it to help find the exact cause of
your erectile dysfunction along with other tests.
2. Before you use Caverject
Do not use Caverject if you:

How much Caverject should you inject?
Different people need different amounts of Caverject to treat erectile
dysfunction. Your doctor will advise on the right dose for you and
monitor you regularly to check how it is working. The starting dose is
1.25 – 2.5 micrograms.
Most men find that a dose of 5 – 20 micrograms is right for them,
however, some men may require a higher dose. To minimise the risk
of prolonged painful erection, your doctor will select the lowest
effective dose. You should never use more than 60 micrograms. If
Caverject is being used to find the reason for your erectile dysfunction,
the dose will be 5 – 20 micrograms.
If the dose that has been prescribed for you does not work well
enough, tell your doctor. Do not change your dose unless your doctor
tells you to. If you forget how much to use, read the label on the pack
or speak to your doctor.
You and your partner
You may like your partner to be involved in preparing and/or giving the
injection. If so, you should speak to your doctor about training for your
partner. Wash your hands. Dry them on a clean towel. If your partner
wishes to be involved in preparing or giving the injection, they should
wash their hands too.
1. Check your pack
Make sure that the vial is the correct strength and the expiry date is
still valid. The vial, syringe and needles all have protective covers. The
flip-off cap on the vial can rotate; this is normal. Check that all the
covers are on firmly and if they are not on properly, do not use them –
take the whole pack back to your pharmacist. There are two needles in
the pack:
• The larger 22 gauge needle with the grey end is used to mix the
solution and Caverject Powder.
• The smaller and finer 27 gauge needle with the grey end is used to
inject the mixture into your penis.
If a needle is bent do not use it.
2. To prepare the vial
Flip the plastic cap off the vial. Wipe the rubbery top with one of the
wet antiseptic pads.



are allergic (hypersensitive) to Caverject or any other medicines
containing alprostadil or any of the other ingredients of Caverject.
• have sickle cell anaemia (a blood disease), leukaemia (cancer of
the blood), multiple myeloma (bone cancer) or any other problem
which increases the risk of getting “priapism”. This is a painful
condition when your penis continues to remain erect.
• have an implant in your penis.
• have a condition (such as severe heart disease) in which sexual
activity should be avoided.
• have a penis which is scarred or not straight.
• have a tight foreskin.
Do not use any Caverject until your doctor says that it is right for you.
Take special care with Caverject
Tell your doctor before using Caverject if you:
• have a lung, chest or heart disorder (in these cases you also
should engage in sexual activity with caution)
• have a history of mental illness or addiction
• have had a mini-stroke (transient ischaemic attack)
• have one or more cardiovascular risk factors (these might include
high blood pressure, tobacco use, raised blood glucose, raised
blood cholesterol, overweight and obesity)
• have one or more risk factors for stroke (these might include high
blood pressure, raised blood cholesterol, coronary artery disease,
heart arrhythmia, diabetes)
Sexually transmitted diseases
Caverject will not protect you or your partner from sexually transmitted
diseases like AIDS, herpes and gonorrhoea. Injection of Caverject can
start a small amount of bleeding where the needle enters. This could
increase the risk of transmission of such diseases. Condoms can
protect against sexually transmitted diseases. If you need advice about
contraception or ‘safe sex’ speak to your doctor or contact your local
Family Planning Clinic.
Taking other medicines
Tell your doctor if you are taking any of the following medicines before
you start using Caverject:
• medicines used for treating high blood pressure
(antihypertensives)
• medicines used for respiratory and heart disease
(sympathomimetics)
• medicines that widen blood vessels (vasodilative agents)
• other medicines for erectile dysfunction such as sildenafil or
papaverine
• medicines to thin your blood such as warfarin or heparin, as you
might bleed more when you do the injection.
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
Pregnancy and breast-feeding
Caverject can be used by couples wishing to conceive and with a
partner who is pregnant or breast-feeding. It will not protect your
partner from pregnancy, so you should use a reliable contraceptive if
appropriate.
Driving and using machines
Caverject should not affect your ability to drive or use machines.
Important information about some of the ingredients of Caverject
Caverject contains benzyl alcohol which may cause allergic reactions.
This medicine contains less than 1 mmol sodium (23 mg) per dose and
is essentially ‘sodium-free’.
3. How to use Caverject
A doctor or nurse will show you how to do the injection for at least the
first time. Do not try to do it yourself until you have learnt the correct
way or if you can’t remember what to do, see your trainer again. These
instructions are a reminder only. Keep the antiseptic swab away from
the eyes.

3. Fitting the needle to the syringe
Hold the syringe and twist the white tamper evident cap to break the
seal. Take the foil off the larger needle, (22 gauge) with the grey end,
keeping the cover on. Join the needle to the syringe by turning the
needle clockwise tightly onto the syringe, then remove the needle
cover by pushing it away from the syringe with your thumb and
forefinger.

4. Mixing the solution with the powder
Push the needle through the rubbery middle of the vial top. Press the
plunger down firmly to squirt all the solution onto the powder. Gently
swirl the vial until all the powder has dissolved. If the mixture is cloudy
or does not dissolve completely, do not use it. Never use tap water or
any liquid other than the one supplied in the syringe.

5. Filling the syringe
With the needle still inserted, turn the vial upside down. The needle
should support the vial unaided. Make sure the needle tip is
underneath the level of the liquid. Gently pull the plunger to draw all
the mixture into the syringe. Pull the needle out of the vial.

6. Changing to the injecting needle
Gently twist the larger needle anticlockwise off the syringe. Remove
the smaller injecting needle, (27 gauge) with the grey end from its
package, keeping the cover on. Twist the needle clockwise tightly onto
the syringe, then remove the needle cover by pushing it away from the
syringe with your thumb and forefinger.

7. Setting the dose
Tap the syringe gently to send any air bubbles to the top, then push
the plunger to squeeze the air bubbles out, ensuring that at least one
drop of solution comes out of the needle. Continue pushing until the
plunger is exactly at the right mark for your dose. Your doctor will have
shown you where this is.

How do you do the injection?
• Get undressed and make yourself comfortable. Take some time to
relax yourself and your partner. If your prescriber has
recommended use of the second antiseptic pad, open it now.
• Make sure that the injection needle is not bent. A bent and restraightened needle is more likely to break. Needle breakage, with
a portion of the needle remaining in the penis, has been reported
and, in some cases, required hospitalisation and surgical removal.
If the needle is bent, do not use it and throw it away. Do not
attempt to straighten it out. Attach a new, unused sterile needle to
the syringe.
• Take hold of the penis from the front, with the first two fingers
underneath close to the testicles and the thumb on top. Gently
squeeze the penis between your thumb and finger so that the
injection site bulges out. If there is a foreskin on the penis, make
sure it is stretched. The injection will go into the part of the penis
shown as the shaded area in diagram A.

A




If recommended by your prescriber wipe the skin over this area
with the second pad and let it dry.
Keeping a firm grip on the penis and taking the syringe in your free
hand, push the needle straight through the skin all the way into the
bulgy part avoiding veins or other obvious blood vessels. The
angle is shown in diagrams B and C. Push the plunger firmly and if
the Caverject does not come out fairly easily, move the needle
slightly and try again. Do not force the Caverject liquid from the
syringe.

B

C



Pull the needle out. On the needle mark, press gently with the pad
or your thumb, as recommended by your prescriber. Massage the
penis to help the Caverject spread through it.
• Do not keep any mixture in the syringe to use for a second
injection.
How to throw away the syringe and needle safely
Ensure that the syringe, vial and needles are disposed of in a closed,
puncture-resistant container such as a sharps bin. Ask your doctor or
pharmacist for instructions on how to properly dispose of the container
after use if you are at all unsure.
How often can you use Caverject?
Do not use Caverject more than once in 24 hours or more than three
times in a week. Change the exact place and side of the penis that you
inject Caverject each time you use it.
Your erection after injecting Caverject
It will take a little while for your erection to come on after the injection.
With the right dose of Caverject, your erection should be strong
enough for you and your partner to enjoy lovemaking. Usually, your
erection should not last longer than an hour. If you would like it to last
longer, talk to your doctor. If your erection lasts longer than four
hours you should seek medical advice (see the section on side
effects below).
What if you use too much Caverject
Tell your doctor straight away as you may need treatment, particularly
if you experience an erection that lasts for longer than four hours.
If you have any further questions on how to use this product, ask your
doctor.
4. Possible side effects
Like all medicines, Caverject can cause side effects, although not
everybody gets them.
Tell your doctor immediately if
your erection goes on for longer than 4 hours. If you cannot
contact your doctor, go to a hospital casualty department
immediately as treatment should be started within 6 hours.
Very common side effects
(occurring in more than 1 in 10 patients)
• Pain in the penis

Common side effects
(occurring in less than 1 in 10 patients)
• Penis can become bruised, scarred, bent or kinked, particularly
after long term use. Tell your doctor if this happens as you may
need to stop Caverject.
• Prolonged erections
• Other problems with your penis
• Swelling and skin discolouration or bruising at site of injection. You
may find this happening the first time you use Caverject but should
occur less often with practice
• Muscle spasms.
Uncommon side effects
(occurring in less than 1 in 100 patients)
• The area injected becomes irritated, inflamed or swollen and may
itch or bleed, or feel numb, warm, tender or painful
• The testes or scrotum could become red, swollen or painful, or
develop lumps called spermatocele, which are cysts containing
sperm. The penis could feel numb
• You may get uncomfortable, painful or prolonged erections or none
at all, your ejaculation may change or your foreskin could feel tight
or swollen, as well as the head of your penis
• The desire to pass urine more urgently or frequently than normal
or you may have pain or difficulty in urinating. Some blood may
appear in the urine or at the end of the penis especially if Caverject
is injected by mistake into the tube which carries urine out through
the penis (urethra)
• Pelvic pain, weakness, sweating, feeling sick or swollen legs or
arms, having a common cold or dry mouth. You may get a yeast
infection (thrush)
• Changes in blood pressure and heart rhythm, faintness, shallow
breathing and collapse could occur because of the injection itself
• Skin itching, redness of the skin at site of injection, rash or skin
growth, increased sweating, eye sensitivity to bright light or
excessive dilation of the pupil (blown pupil), impaired or enhanced
sense of touch, leg cramps, cold hands and feet, venous problems
including bleeding (bleeding from vein(s))
• If you have a blood test you may have raised levels of creatinine (a
substance found in your muscles).
Not known
(frequency cannot be estimated from available data)
• Insufficient blood flow to the heart muscle via the coronary arteries
• Stroke.
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 the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. How to store Caverject
• Do not store above 25°C
• Keep out of the sight and reach of children
• When you have mixed the Caverject Powder with the solution, use
it straight away. Do not keep it to use later on.
• For single use only. Any unused Caverject should be discarded.
• Do not use Caverject if the injection is cloudy or contains particles.
• Do not use Caverject after the ‘expiry’ date on the pack. The expiry
date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Further Information
What Caverject contains
After reconstitution each 1ml contains alprostadil 10 micrograms.
The other ingredients are lactose monohydrate, sodium citrate, αcyclodextrine, hydrochloric acid and sodium hydroxide
The syringe contains benzyl alcohol (8.4 mg/ml) and water for
injections. The antiseptic pads are soaked in isopropyl alcohol.
What Caverject looks like and contents of the pack
In the Caverject box you will find 5 items:
1. One glass vial containing Caverject 10 micrograms as a white to
off-white powder
2. One graduated glass syringe containing 1 ml of a clear solution
3. One larger 22 gauge needle – 11/2 inches long with a grey plastic
end
4. One small 27 gauge needle – 0.5 inch long with a grey plastic end
5. Two antiseptic pads
Manufacturer
Pfizer Manufacturing Belgium N.V/S.A, Rijksweg 12, 2870 Puurs,
Belgium.
Product licence holder:
Ecosse Pharmaceutical Limited,
3 Young Place, East Kilbride, G75 0TD
Repackaged by Munro Wholesale Medical Supplies Limited,
3 Young Place, East Kilbride, G75 0TD
PL 19065/0483
POM
This leaflet was revised: 22.03.2017
E0483-4(G)

If you are blind or partially sighted
and require this leaflet in a different
format, call 01355 574450 and ask
for the Regulatory Department.
Caverject® is a registered trademark of Pharmacia & Upjohn Company LLC

Patient Information Leaflet
Alprostadil 10 microgram powder for solution for
injection
Read all of this leaflet carefully before you start using this
medicine.




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. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
Your medicine is called Alprostadil 10 micrograms powder for solution
for injection but will be referred to as Alprostadil throughout this leaflet.
Alprostadil 10 micrograms powder for solution for injection is also
available in other strengths.
In this leaflet:
1. What Alprostadil is and what it is used for
2. Before you use Alprostadil
3. How to use Alprostadil
4. Possible side effects
5. How to store Alprostadil
6. Further information
1. What Alprostadil is and what it is used for
Alprostadil contains alprostadil which is similar to the natural
substance in your body called prostaglandin E1. It widens blood
vessels so that blood can flow in your penis more easily. This makes it
easier for you to have an erection.
Alprostadil is used for “erectile dysfunction” including weak erections or
impotence. Your doctor may also use it to help find the exact cause of
your erectile dysfunction along with other tests.
2. Before you use Alprostadil
Do not use Alprostadil if you:

How much Alprostadil should you inject?
Different people need different amounts of Alprostadil to treat erectile
dysfunction. Your doctor will advise on the right dose for you and
monitor you regularly to check how it is working. The starting dose is
1.25 – 2.5 micrograms.
Most men find that a dose of 5 – 20 micrograms is right for them,
however, some men may require a higher dose. To minimise the risk
of prolonged painful erection, your doctor will select the lowest
effective dose. You should never use more than 60 micrograms. If
Alprostadil is being used to find the reason for your erectile
dysfunction, the dose will be 5 – 20 micrograms.
If the dose that has been prescribed for you does not work well
enough, tell your doctor. Do not change your dose unless your doctor
tells you to. If you forget how much to use, read the label on the pack
or speak to your doctor.
You and your partner
You may like your partner to be involved in preparing and/or giving the
injection. If so, you should speak to your doctor about training for your
partner. Wash your hands. Dry them on a clean towel. If your partner
wishes to be involved in preparing or giving the injection, they should
wash their hands too.
1. Check your pack
Make sure that the vial is the correct strength and the expiry date is
still valid. The vial, syringe and needles all have protective covers. The
flip-off cap on the vial can rotate; this is normal. Check that all the
covers are on firmly and if they are not on properly, do not use them –
take the whole pack back to your pharmacist. There are two needles in
the pack:
• The larger 22 gauge needle with the grey end is used to mix the
solution and Alprostadil Powder.
• The smaller and finer 30 gauge needle with the yellow end is used
to inject the mixture into your penis.
If a needle is bent do not use it.
2. To prepare the vial
Flip the plastic cap off the vial. Wipe the rubbery top with one of the
wet antiseptic pads.



are allergic (hypersensitive) to Alprostadil or any other medicines
containing alprostadil or any of the other ingredients of Alprostadil.
• have sickle cell anaemia (a blood disease), leukaemia (cancer of
the blood), multiple myeloma (bone cancer) or any other problem
which increases the risk of getting “priapism”. This is a painful
condition when your penis continues to remain erect.
• have an implant in your penis.
• have a condition (such as severe heart disease) in which sexual
activity should be avoided.
• have a penis which is scarred or not straight.
• have a tight foreskin.
Do not use any Alprostadil until your doctor says that it is right for you.
Take special care with Alprostadil
Tell your doctor before using Alprostadil if you:
• have a lung, chest or heart disorder (in these cases you also
should engage in sexual activity with caution)
• have a history of mental illness or addiction
• have had a mini-stroke (transient ischaemic attack)
• have one or more cardiovascular risk factors (these might include
high blood pressure, tobacco use, raised blood glucose, raised
blood cholesterol, overweight and obesity)
• have one or more risk factors for stroke (these might include high
blood pressure, raised blood cholesterol, coronary artery disease,
heart arrhythmia, diabetes)
Sexually transmitted diseases
Alprostadil will not protect you or your partner from sexually
transmitted diseases like AIDS, herpes and gonorrhoea. Injection of
Alprostadil can start a small amount of bleeding where the needle
enters. This could increase the risk of transmission of such diseases.
Condoms can protect against sexually transmitted diseases. If you
need advice about contraception or ‘safe sex’ speak to your doctor or
contact your local Family Planning Clinic.
Taking other medicines
Tell your doctor if you are taking any of the following medicines before
you start using Alprostadil:
• medicines used for treating high blood pressure
(antihypertensives)
• medicines used for respiratory and heart disease
(sympathomimetics)
• medicines that widen blood vessels (vasodilative agents)
• other medicines for erectile dysfunction such as sildenafil or
papaverine
• medicines to thin your blood such as warfarin or heparin, as you
might bleed more when you do the injection.
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
Pregnancy and breast-feeding
Alprostadil can be used by couples wishing to conceive and with a
partner who is pregnant or breast-feeding. It will not protect your
partner from pregnancy, so you should use a reliable contraceptive if
appropriate.
Driving and using machines
Alprostadil should not affect your ability to drive or use machines.
Important information about some of the ingredients of
Alprostadil
Alprostadil contains benzyl alcohol which may cause allergic reactions.
This medicine contains less than 1 mmol sodium (23 mg) per dose and
is essentially ‘sodium-free’.
3. How to use Alprostadil
A doctor or nurse will show you how to do the injection for at least the
first time. Do not try to do it yourself until you have learnt the correct
way or if you can’t remember what to do, see your trainer again. These
instructions are a reminder only. Keep the antiseptic swab away from
the eyes.

3. Fitting the needle to the syringe
Hold the syringe and twist the white tamper evident cap to break the
seal. Take the foil off the larger needle, (22 gauge) with the grey end,
keeping the cover on. Join the needle to the syringe by turning the
needle clockwise tightly onto the syringe, then remove the needle
cover by pushing it away from the syringe with your thumb and
forefinger.

4. Mixing the solution with the powder
Push the needle through the rubbery middle of the vial top. Press the
plunger down firmly to squirt all the solution onto the powder. Gently
swirl the vial until all the powder has dissolved. If the mixture is cloudy
or does not dissolve completely, do not use it. Never use tap water or
any liquid other than the one supplied in the syringe.

5. Filling the syringe
With the needle still inserted, turn the vial upside down. The needle
should support the vial unaided. Make sure the needle tip is
underneath the level of the liquid. Gently pull the plunger to draw all
the mixture into the syringe. Pull the needle out of the vial.

6. Changing to the injecting needle
Gently twist the larger needle anticlockwise off the syringe. Remove
the smaller injecting needle, (30 gauge) with the yellow end from its
package, keeping the cover on. Twist the needle clockwise tightly onto
the syringe, then remove the needle cover by pushing it away from the
syringe with your thumb and forefinger.

7. Setting the dose
Tap the syringe gently to send any air bubbles to the top, then push
the plunger to squeeze the air bubbles out, ensuring that at least one
drop of solution comes out of the needle. Continue pushing until the
plunger is exactly at the right mark for your dose. Your doctor will have
shown you where this is.

How do you do the injection?
• Get undressed and make yourself comfortable. Take some time to
relax yourself and your partner. If your prescriber has
recommended use of the second antiseptic pad, open it now.
• Make sure that the injection needle is not bent. A bent and restraightened needle is more likely to break. Needle breakage, with
a portion of the needle remaining in the penis, has been reported
and, in some cases, required hospitalisation and surgical removal.
If the needle is bent, do not use it and throw it away. Do not
attempt to straighten it out. Attach a new, unused sterile needle to
the syringe.
• Take hold of the penis from the front, with the first two fingers
underneath close to the testicles and the thumb on top. Gently
squeeze the penis between your thumb and finger so that the
injection site bulges out. If there is a foreskin on the penis, make
sure it is stretched. The injection will go into the part of the penis
shown as the shaded area in diagram A.

A




If recommended by your prescriber wipe the skin over this area
with the second pad and let it dry.
Keeping a firm grip on the penis and taking the syringe in your free
hand, push the needle straight through the skin all the way into the
bulgy part avoiding veins or other obvious blood vessels. The
angle is shown in diagrams B and C. Push the plunger firmly and if
the Alprostadil does not come out fairly easily, move the needle
slightly and try again. Do not force the Alprostadil liquid from the
syringe.

B

C



Pull the needle out. On the needle mark, press gently with the pad
or your thumb, as recommended by your prescriber. Massage the
penis to help the Alprostadil spread through it.
• Do not keep any mixture in the syringe to use for a second
injection.
How to throw away the syringe and needle safely
Ensure that the syringe, vial and needles are disposed of in a closed,
puncture-resistant container such as a sharps bin. Ask your doctor or
pharmacist for instructions on how to properly dispose of the container
after use if you are at all unsure.
How often can you use Alprostadil?
Do not use Alprostadil more than once in 24 hours or more than three
times in a week. Change the exact place and side of the penis that you
inject Alprostadil each time you use it.
Your erection after injecting Alprostadil
It will take a little while for your erection to come on after the injection.
With the right dose of Alprostadil, your erection should be strong
enough for you and your partner to enjoy lovemaking. Usually, your
erection should not last longer than an hour. If you would like it to last
longer, talk to your doctor. If your erection lasts longer than four
hours you should seek medical advice (see the section on side
effects below).
What if you use too much Alprostadil
Tell your doctor straight away as you may need treatment, particularly
if you experience an erection that lasts for longer than four hours.
If you have any further questions on how to use this product, ask your
doctor.

Common side effects
(occurring in less than 1 in 10 patients)
• Penis can become bruised, scarred, bent or kinked, particularly
after long term use. Tell your doctor if this happens as you may
need to stop Alprostadil.
• Prolonged erections
• Other problems with your penis
• Swelling and skin discolouration or bruising at site of injection. You
may find this happening the first time you use Alprostadil but
should occur less often with practice
• Muscle spasms.
Uncommon side effects
(occurring in less than 1 in 100 patients)
• The area injected becomes irritated, inflamed or swollen and may
itch or bleed, or feel numb, warm, tender or painful
• The testes or scrotum could become red, swollen or painful, or
develop lumps called spermatocele, which are cysts containing
sperm. The penis could feel numb
• You may get uncomfortable, painful or prolonged erections or none
at all, your ejaculation may change or your foreskin could feel tight
or swollen, as well as the head of your penis
• The desire to pass urine more urgently or frequently than normal
or you may have pain or difficulty in urinating. Some blood may
appear in the urine or at the end of the penis especially if
Alprostadil is injected by mistake into the tube which carries urine
out through the penis (urethra)
• Pelvic pain, weakness, sweating, feeling sick or swollen legs or
arms, having a common cold or dry mouth. You may get a yeast
infection (thrush)
• Changes in blood pressure and heart rhythm, faintness, shallow
breathing and collapse could occur because of the injection itself
• Skin itching, redness of the skin at site of injection, rash or skin
growth, increased sweating, eye sensitivity to bright light or
excessive dilation of the pupil (blown pupil), impaired or enhanced
sense of touch, leg cramps, cold hands and feet, venous problems
including bleeding (bleeding from vein(s))
• If you have a blood test you may have raised levels of creatinine (a
substance found in your muscles).
Not known
(frequency cannot be estimated from available data)
• Insufficient blood flow to the heart muscle via the coronary arteries
• Stroke.
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 the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. How to store Alprostadil
• Do not store above 25°C
• Keep out of the sight and reach of children
• When you have mixed the Alprostadil Powder with the solution,
use it straight away. Do not keep it to use later on.
• For single use only. Any unused Alprostadil should be discarded.
• Do not use Alprostadil if the injection is cloudy or contains
particles.
• Do not use Alprostadil after the ‘expiry’ date on the pack. The
expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Further Information
What Alprostadil contains
After reconstitution each 1ml contains alprostadil 10 micrograms.
The other ingredients are lactose monohydrate, sodium citrate, αlphacyclodextrine, hydrochloric acid and sodium hydroxide
The syringe contains benzyl alcohol (8.4 mg/ml) and water for
injections. The antiseptic pads are soaked in isopropyl alcohol.
What Alprostadil looks like and contents of the pack
In the Alprostadil box you will find 5 items:
1. One glass vial containing Alprostadil 10 micrograms as a white to
off-white powder
2. One graduated glass syringe containing 1 ml of a clear solution
3. One larger 22 gauge needle – 11/2 inches long with a grey plastic
end
4. One small 30 gauge needle – 0.5 inch long with a yellow plastic
end
5. Two antiseptic pads
Manufacturer
Pfizer Manufacturing Belgium N.V/S.A, Rijksweg 12, 2870 Puurs,
Belgium.
Product licence holder: Ecosse Pharmaceutical Limited, 3 Young
Place, East Kilbride, G75 0TD Repackaged by Munro Wholesale
Medical Supplies Limited, 3 Young Place, East Kilbride, G75 0TD
PL 19065/0483
E0483A-4 (Y)
POM
This leaflet was revised: 22/03/2017

4. Possible side effects
Like all medicines, Alprostadil can cause side effects, although not
everybody gets them.
Tell your doctor immediately if
your erection goes on for longer than 4 hours. If you cannot
contact your doctor, go to a hospital casualty department
immediately as treatment should be started within 6 hours.
Very common side effects
(occurring in more than 1 in 10 patients)
• Pain in the penis

If you are blind or partially sighted
and require this leaflet in a different
format, call 01355 574450 and ask
for the Regulatory Department.

Patient Information Leaflet
Alprostadil 10 microgram powder for solution for
injection
Read all of this leaflet carefully before you start using this
medicine.




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. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
Your medicine is called Alprostadil 10 micrograms powder for solution
for injection but will be referred to as Alprostadil throughout this leaflet.
Alprostadil 10 micrograms powder for solution for injection is also
available in other strengths.
In this leaflet:
1. What Alprostadil is and what it is used for
2. Before you use Alprostadil
3. How to use Alprostadil
4. Possible side effects
5. How to store Alprostadil
6. Further information
1. What Alprostadil is and what it is used for
Alprostadil contains alprostadil which is similar to the natural
substance in your body called prostaglandin E1. It widens blood
vessels so that blood can flow in your penis more easily. This makes it
easier for you to have an erection.
Alprostadil is used for “erectile dysfunction” including weak erections or
impotence. Your doctor may also use it to help find the exact cause of
your erectile dysfunction along with other tests.
2. Before you use Alprostadil
Do not use Alprostadil if you:

How much Alprostadil should you inject?
Different people need different amounts of Alprostadil to treat erectile
dysfunction. Your doctor will advise on the right dose for you and
monitor you regularly to check how it is working. The starting dose is
1.25 – 2.5 micrograms.
Most men find that a dose of 5 – 20 micrograms is right for them,
however, some men may require a higher dose. To minimise the risk
of prolonged painful erection, your doctor will select the lowest
effective dose. You should never use more than 60 micrograms. If
Alprostadil is being used to find the reason for your erectile
dysfunction, the dose will be 5 – 20 micrograms.
If the dose that has been prescribed for you does not work well
enough, tell your doctor. Do not change your dose unless your doctor
tells you to. If you forget how much to use, read the label on the pack
or speak to your doctor.
You and your partner
You may like your partner to be involved in preparing and/or giving the
injection. If so, you should speak to your doctor about training for your
partner. Wash your hands. Dry them on a clean towel. If your partner
wishes to be involved in preparing or giving the injection, they should
wash their hands too.
1. Check your pack
Make sure that the vial is the correct strength and the expiry date is
still valid. The vial, syringe and needles all have protective covers. The
flip-off cap on the vial can rotate; this is normal. Check that all the
covers are on firmly and if they are not on properly, do not use them –
take the whole pack back to your pharmacist. There are two needles in
the pack:
• The larger 22 gauge needle with the grey end is used to mix the
solution and Alprostadil Powder.
• The smaller and finer 27 gauge needle with the grey end is used to
inject the mixture into your penis.
If a needle is bent do not use it.
2. To prepare the vial
Flip the plastic cap off the vial. Wipe the rubbery top with one of the
wet antiseptic pads.



are allergic (hypersensitive) to Alprostadil or any other medicines
containing alprostadil or any of the other ingredients of Alprostadil.
• have sickle cell anaemia (a blood disease), leukaemia (cancer of
the blood), multiple myeloma (bone cancer) or any other problem
which increases the risk of getting “priapism”. This is a painful
condition when your penis continues to remain erect.
• have an implant in your penis.
• have a condition (such as severe heart disease) in which sexual
activity should be avoided.
• have a penis which is scarred or not straight.
• have a tight foreskin.
Do not use any Alprostadil until your doctor says that it is right for you.
Take special care with Alprostadil
Tell your doctor before using Alprostadil if you:
• have a lung, chest or heart disorder (in these cases you also
should engage in sexual activity with caution)
• have a history of mental illness or addiction
• have had a mini-stroke (transient ischaemic attack)
• have one or more cardiovascular risk factors (these might include
high blood pressure, tobacco use, raised blood glucose, raised
blood cholesterol, overweight and obesity)
• have one or more risk factors for stroke (these might include high
blood pressure, raised blood cholesterol, coronary artery disease,
heart arrhythmia, diabetes)
Sexually transmitted diseases
Alprostadil will not protect you or your partner from sexually
transmitted diseases like AIDS, herpes and gonorrhoea. Injection of
Alprostadil can start a small amount of bleeding where the needle
enters. This could increase the risk of transmission of such diseases.
Condoms can protect against sexually transmitted diseases. If you
need advice about contraception or ‘safe sex’ speak to your doctor or
contact your local Family Planning Clinic.
Taking other medicines
Tell your doctor if you are taking any of the following medicines before
you start using Alprostadil:
• medicines used for treating high blood pressure
(antihypertensives)
• medicines used for respiratory and heart disease
(sympathomimetics)
• medicines that widen blood vessels (vasodilative agents)
• other medicines for erectile dysfunction such as sildenafil or
papaverine
• medicines to thin your blood such as warfarin or heparin, as you
might bleed more when you do the injection.
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
Pregnancy and breast-feeding
Alprostadil can be used by couples wishing to conceive and with a
partner who is pregnant or breast-feeding. It will not protect your
partner from pregnancy, so you should use a reliable contraceptive if
appropriate.
Driving and using machines
Alprostadil should not affect your ability to drive or use machines.
Important information about some of the ingredients of
Alprostadil
Alprostadil contains benzyl alcohol which may cause allergic reactions.
This medicine contains less than 1 mmol sodium (23 mg) per dose and
is essentially ‘sodium-free’.
3. How to use Alprostadil
A doctor or nurse will show you how to do the injection for at least the
first time. Do not try to do it yourself until you have learnt the correct
way or if you can’t remember what to do, see your trainer again. These
instructions are a reminder only. Keep the antiseptic swab away from
the eyes.

3. Fitting the needle to the syringe
Hold the syringe and twist the white tamper evident cap to break the
seal. Take the foil off the larger needle, (22 gauge) with the grey end,
keeping the cover on. Join the needle to the syringe by turning the
needle clockwise tightly onto the syringe, then remove the needle
cover by pushing it away from the syringe with your thumb and
forefinger.

4. Mixing the solution with the powder
Push the needle through the rubbery middle of the vial top. Press the
plunger down firmly to squirt all the solution onto the powder. Gently
swirl the vial until all the powder has dissolved. If the mixture is cloudy
or does not dissolve completely, do not use it. Never use tap water or
any liquid other than the one supplied in the syringe.

5. Filling the syringe
With the needle still inserted, turn the vial upside down. The needle
should support the vial unaided. Make sure the needle tip is
underneath the level of the liquid. Gently pull the plunger to draw all
the mixture into the syringe. Pull the needle out of the vial.

6. Changing to the injecting needle
Gently twist the larger needle anticlockwise off the syringe. Remove
the smaller injecting needle, (27 gauge) with the grey end from its
package, keeping the cover on. Twist the needle clockwise tightly onto
the syringe, then remove the needle cover by pushing it away from the
syringe with your thumb and forefinger.

7. Setting the dose
Tap the syringe gently to send any air bubbles to the top, then push
the plunger to squeeze the air bubbles out, ensuring that at least one
drop of solution comes out of the needle. Continue pushing until the
plunger is exactly at the right mark for your dose. Your doctor will have
shown you where this is.

How do you do the injection?
• Get undressed and make yourself comfortable. Take some time to
relax yourself and your partner. If your prescriber has
recommended use of the second antiseptic pad, open it now.
• Make sure that the injection needle is not bent. A bent and restraightened needle is more likely to break. Needle breakage, with
a portion of the needle remaining in the penis, has been reported
and, in some cases, required hospitalisation and surgical removal.
If the needle is bent, do not use it and throw it away. Do not
attempt to straighten it out. Attach a new, unused sterile needle to
the syringe.
• Take hold of the penis from the front, with the first two fingers
underneath close to the testicles and the thumb on top. Gently
squeeze the penis between your thumb and finger so that the
injection site bulges out. If there is a foreskin on the penis, make
sure it is stretched. The injection will go into the part of the penis
shown as the shaded area in diagram A.

A




If recommended by your prescriber wipe the skin over this area
with the second pad and let it dry.
Keeping a firm grip on the penis and taking the syringe in your free
hand, push the needle straight through the skin all the way into the
bulgy part avoiding veins or other obvious blood vessels. The
angle is shown in diagrams B and C. Push the plunger firmly and if
the Alprostadil does not come out fairly easily, move the needle
slightly and try again. Do not force the Alprostadil liquid from the
syringe.

B

C



Pull the needle out. On the needle mark, press gently with the pad
or your thumb, as recommended by your prescriber. Massage the
penis to help the Alprostadil spread through it.
• Do not keep any mixture in the syringe to use for a second
injection.
How to throw away the syringe and needle safely
Ensure that the syringe, vial and needles are disposed of in a closed,
puncture-resistant container such as a sharps bin. Ask your doctor or
pharmacist for instructions on how to properly dispose of the container
after use if you are at all unsure.
How often can you use Alprostadil?
Do not use Alprostadil more than once in 24 hours or more than three
times in a week. Change the exact place and side of the penis that you
inject Alprostadil each time you use it.
Your erection after injecting Alprostadil
It will take a little while for your erection to come on after the injection.
With the right dose of Alprostadil, your erection should be strong
enough for you and your partner to enjoy lovemaking. Usually, your
erection should not last longer than an hour. If you would like it to last
longer, talk to your doctor. If your erection lasts longer than four
hours you should seek medical advice (see the section on side
effects below).
What if you use too much Alprostadil
Tell your doctor straight away as you may need treatment, particularly
if you experience an erection that lasts for longer than four hours.
If you have any further questions on how to use this product, ask your
doctor.
4. Possible side effects
Like all medicines, Alprostadil can cause side effects, although not
everybody gets them.
Tell your doctor immediately if
your erection goes on for longer than 4 hours. If you cannot
contact your doctor, go to a hospital casualty department
immediately as treatment should be started within 6 hours.
Very common side effects
(occurring in more than 1 in 10 patients)
• Pain in the penis

Common side effects
(occurring in less than 1 in 10 patients)
• Penis can become bruised, scarred, bent or kinked, particularly
after long term use. Tell your doctor if this happens as you may
need to stop Alprostadil.
• Prolonged erections
• Other problems with your penis
• Swelling and skin discolouration or bruising at site of injection. You
may find this happening the first time you use Alprostadil but
should occur less often with practice
• Muscle spasms.
Uncommon side effects
(occurring in less than 1 in 100 patients)
• The area injected becomes irritated, inflamed or swollen and may
itch or bleed, or feel numb, warm, tender or painful
• The testes or scrotum could become red, swollen or painful, or
develop lumps called spermatocele, which are cysts containing
sperm. The penis could feel numb
• You may get uncomfortable, painful or prolonged erections or none
at all, your ejaculation may change or your foreskin could feel tight
or swollen, as well as the head of your penis
• The desire to pass urine more urgently or frequently than normal
or you may have pain or difficulty in urinating. Some blood may
appear in the urine or at the end of the penis especially if
Alprostadil is injected by mistake into the tube which carries urine
out through the penis (urethra)
• Pelvic pain, weakness, sweating, feeling sick or swollen legs or
arms, having a common cold or dry mouth. You may get a yeast
infection (thrush)
• Changes in blood pressure and heart rhythm, faintness, shallow
breathing and collapse could occur because of the injection itself
• Skin itching, redness of the skin at site of injection, rash or skin
growth, increased sweating, eye sensitivity to bright light or
excessive dilation of the pupil (blown pupil), impaired or enhanced
sense of touch, leg cramps, cold hands and feet, venous problems
including bleeding (bleeding from vein(s))
• If you have a blood test you may have raised levels of creatinine (a
substance found in your muscles).
Not known
(frequency cannot be estimated from available data)
• Insufficient blood flow to the heart muscle via the coronary arteries
• Stroke.
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 the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. How to store Alprostadil
• Do not store above 25°C
• Keep out of the sight and reach of children
• When you have mixed the Alprostadil Powder with the solution,
use it straight away. Do not keep it to use later on.
• For single use only. Any unused Alprostadil should be discarded.
• Do not use Alprostadil if the injection is cloudy or contains
particles.
• Do not use Alprostadil after the ‘expiry’ date on the pack. The
expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Further Information
What Alprostadil contains
After reconstitution each 1ml contains alprostadil 10 micrograms.
The other ingredients are lactose monohydrate, sodium citrate, αlphacyclodextrine, hydrochloric acid and sodium hydroxide
The syringe contains benzyl alcohol (8.4 mg/ml) and water for
injections. The antiseptic pads are soaked in isopropyl alcohol.
What Alprostadil looks like and contents of the pack
In the Alprostadil box you will find 5 items:
1. One glass vial containing Alprostadil 10 micrograms as a white to
off-white powder
2. One graduated glass syringe containing 1 ml of a clear solution
3. One larger 22 gauge needle – 11/2 inches long with a grey plastic
end
4. One small 27 gauge needle – 0.5 inch long with a grey plastic end
5. Two antiseptic pads
Manufacturer
Pfizer Manufacturing Belgium N.V/S.A, Rijksweg 12, 2870 Puurs,
Belgium.
Product licence holder: Ecosse Pharmaceutical Limited, 3 Young
Place, East Kilbride, G75 0TD Repackaged by Munro Wholesale
Medical Supplies Limited, 3 Young Place, East Kilbride, G75 0TD
PL 19065/0483
E0483A-4 (G)
POM
This leaflet was revised: 22/03/2017

If you are blind or partially sighted
and require this leaflet in a different
format, call 01355 574450 and ask
for the Regulatory Department.

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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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