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CAVERJECT DUAL CHAMBER 20 MICROGRAMS POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Active substance(s): ALPROSTADIL / ALPROSTADIL / ALPROSTADIL

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504427/PL1c

Patient Information Leaflet

Caverject® Dual Chamber
20 micrograms,
Powder and solvent for solution for injection
(alprostadil)
The name of your medicine is Caverject Dual Chamber 20 micrograms,
Powder and solvent for solution for injection. Throughout this leaflet it
will be referred to as Caverject Dual Chamber. Other strengths are
available.
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.
In this leaflet:
1. What Caverject Dual Chamber is and what it is used for
2. Before you use Caverject Dual Chamber
3. How to use Caverject Dual Chamber
4. Possible side effects
5. How to store Caverject Dual Chamber
6. Further information

1. What Caverject Dual Chamber is and what it is
used for
Caverject Dual Chamber contains alprostadil which is similar to the
natural substance in your body called prostaglandin E1. It widens blood
vessels, increasing blood flow to your penis making it easier for you to
have an erection. Caverject Dual Chamber 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 Dual Chamber
Do not use Caverject Dual Chamber if you:
• are allergic (hypersensitive) to Caverject Dual Chamber, any other
medicines containing alprostadil or any of the other ingredients of
Caverject Dual Chamber.
• have sickle cell anaemia (an abnormality of red blood cells),
leukaemia (cancer of the blood), multiple myeloma (bone cancer) or
any other problem which increases risk of getting “priapism”. This is
when your erection lasts for longer than 6 hours.
• 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, bent or kinked, or Peyronie’s disease.
• have a tight foreskin.
Take special care with Caverject Dual Chamber
If you experience an erection that lasts for longer than 4 hours seek
medical advice immediately as treatment should be started within 6
hours. If you cannot contact your doctor go to the hospital emergency
department.
Tell your doctor before using Caverject Dual Chamber 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 Dual Chamber will not protect you or your partner from
sexually transmitted diseases like AIDS, herpes or gonorrhoea. The
injection of Caverject Dual Chamber 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 Dual Chamber:






Antihypertensives (used for treating high blood pressure)
Sympathomimetics (used for respiratory and heart disease)
Vasodilative agents (drugs that widen blood vessels)
Anticoagulants (blood-thinning agents)
Other treatments for erectile dysfunction (e.g. sildenafil or
papaverine)

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 Dual Chamber 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 Dual Chamber should not affect your ability to drive or use
machines.
Important information about some of the ingredients of Caverject
Dual Chamber
Caverject Dual Chamber 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’.

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.
The Caverject Dual Chamber device

Outer
protective
cap

Inner
Superfine Clear plastic Dose
protective needle
tip (glass window
cartridge
cap
inside)

Plunger
rod

Preparing the injection
Wash your hands. Dry them with a clean towel. If your partner wishes to
be involved in preparing or giving the injection, they should wash their
hands too.
1.

Remove one of the injection devices and
needles from the box. Peel the foil cover
from the needle.

2.

Attach the needle to the device by pushing
the needle on to the tip of the device. Turn
clockwise until it is firmly in place. The
injection needle is enclosed in 2 protective
caps. Pull off the outer protective cap of
the needle.

3.

Hold the device with the needle pointing
upwards. The plunger rod should be in the
extended position.

4.

Turn the plunger rod clockwise until it
stops. This mixes the powder and diluent.
Gently shake to make sure that the
solution is evenly mixed and the powder
has dissolved. Do not use if it remains
cloudy or contains particles.

3. How to use Caverject Dual Chamber
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 doctor again. These
instructions are a reminder only.
How much Caverject Dual Chamber should you inject?
Different people need different amounts of Caverject Dual Chamber 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 in the clinic is 1.25-2.5 micrograms, although doses
lower than 2.5 micrograms cannot be delivered with Caverject Dual
Chamber. In this case, Caverject Powder for Injection will be used. Most
men find that a dose of 5-20 micrograms works 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 40 micrograms.
If Caverject Dual Chamber 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.
How do you use Caverject Dual Chamber?
These instructions are intended as a reminder only; you should follow
your doctor’s advice where it differs from this leaflet. If you are using
Caverject Dual Chamber for the first time and you have previously used
Caverject Powder for Injection, your doctor should have given you
advice about using Caverject Dual Chamber.

5.

6. To remove any large bubbles from the
solution, flick the cartridge with your finger
until the bubbles disappear. Then, keeping
the device upright, make sure that the
plunger rod is fully turned to the stop by
screwing it to the right (clockwise) then
immediately press the plunger rod as far as
it will go. A few drops will appear at the
needle point. It is normal for there to be
small bubbles at the side of the glass
cartridge.
7. Turn the end of the plunger rod slowly
clockwise to select your dose. There are
four dosage options. Each option is one of
four quarterly parts of a full dose delivered
by the device. Your doctor will have told
you what this should be. The number
appearing in the window indicates the dose
of the injection. If you make a mistake,
continue to turn the plunger rod clockwise
until you reach the correct dose.
You can prepare your injection up to 24 hours before using it, providing
it is kept at room temperature.
How do you do the injection?
• Get undressed and make yourself comfortable. Take some time to
relax yourself and your partner. If your doctor has recommended you
use an alcohol cleansing pad, open one now.
• Make sure that the needle is not bent. A bent and re-straightened
needle is predisposed to breakage. 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.
• Using the alcohol swab, wipe over the
area and let it dry. Check or if necessary
adjust so that the right dose is in the
dose window.

Hold the device with the needle upwards.
Carefully remove the inner protective cap
from the needle. Make sure that the
needle is not bent. If it is, do not use it
and throw it away. Do not attempt to
straighten it out.
• 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
solution does not come out fairly easily,
move the needle slightly and try again.
Do not force the Caverject Dual
Chamber liquid from the syringe.

Continued overleaf

• Pull the needle out. Massage the penis to help the alprostadil spread
through it.
• Do not keep any mixture in the cartridge to use for a second
injection. When you have finished with the needle, throw it away
carefully as recommended by your doctor, so no-one will see it, use
it, or prick themselves on it.
How often can you use Caverject Dual Chamber?
Do not use Caverject Dual Chamber 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 Dual Chamber each time you use it.
Your erection after injecting Caverject Dual Chamber
It will take a little while for your erection to come on after the injection.
With the right dose of Caverject Dual Chamber, 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 immediately (see section on
Take special care with Caverject Dual Chamber).
If you use too much Caverject Dual Chamber
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.







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.

Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova Ltd,
repackager Ginova UK Ltd, both of St James' House, 8 Overcliffe,
Gravesend, Kent, DA11 0HJ.
Manufacturer
Pfizer Manufacturing Belgium NV, Rijksweg 12, Puurs 2870, Belgium.
Caverject® Dual Chamber 20 micrograms, Powder and
solvent for solution for injection
PL No: 18067/0431
POM
Caverject® is a registered trademark.
This leaflet was last approved on 14th July 2017.

To request a copy of this leaflet in
Braille, large print or audio please
call 01622 690172.

5. How to store Caverject Dual Chamber

4. Possible side effects



Like all medicines, Caverject Dual Chamber 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 Dual Chamber
• 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 Dual
Chamber 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 Dual
Chamber 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).





Keep the cartridge and needles out of the sight and reach of
children.
You can prepare your injection up to 24 hours before using it.
The reconstituted solution should not be stored above 25ºC and
should be used within 24 hours.
Do not use any Caverject Dual Chamber after the expiry date on
the pack. The expiry date refers to the last day of that month.
For single use only. Any unused contents of the syringe should be
discarded.
Do not use Caverject Dual Chamber if the injection is cloudy or
contains particles.

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 Dual Chamber contains
The active ingredient in Caverject Dual Chamber is alprostadil. After
reconstitution each 0.5 ml contains alprostadil 20 micrograms.
The other ingredients are lactose monohydrate, alfadex, sodium citrate
dihydrate, hydrochloric acid and sodium hydroxide.
The diluent in the rear compartment is Bacteriostatic Water for Injection
and contains 0.9% w/v benzyl alcohol and water for injections. The
antiseptic pads are soaked in isopropyl alcohol.
What Caverject Dual Chamber looks like and contents of the pack
The product is a dual chamber glass cartridge assembled as a single
unit in a disposable delivery device. The cartridge contains a white
lyophilised powder in the front compartment and diluent for
reconstitution in the rear compartment. Two injection needles and four
pouches containing antiseptic pads are included in the pack.
There are sufficient components in each box to enable two separate
injections of Caverject Dual Chamber.
In the Caverject Dual Chamber box you will find:
1. Two single use injection devices each containing a dual chamber
cartridge
2. Two needles
3. Antiseptic pads

504427/PL1c

504429/PL1c

Patient Information Leaflet

Alprostadil Dual Chamber
20 micrograms,
Powder and solvent for solution for injection
The name of your medicine is Alprostadil Dual Chamber 20
micrograms, Powder and solvent for solution for injection. Throughout
this leaflet it will be referred to as Alprostadil Dual Chamber. Other
strengths are available.
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.
In this leaflet:
1. What Alprostadil Dual Chamber is and what it is used for
2. Before you use Alprostadil Dual Chamber
3. How to use Alprostadil Dual Chamber
4. Possible side effects
5. How to store Alprostadil Dual Chamber
6. Further information

1. What Alprostadil Dual Chamber is and what it is
used for
Alprostadil Dual Chamber contains alprostadil which is similar to the
natural substance in your body called prostaglandin E1. It widens blood
vessels, increasing blood flow to your penis making it easier for you to
have an erection. Alprostadil Dual Chamber 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 Dual Chamber
Do not use Alprostadil Dual Chamber if you:
• are allergic (hypersensitive) to Alprostadil Dual Chamber, any other
medicines containing alprostadil or any of the other ingredients of
Alprostadil Dual Chamber.
• have sickle cell anaemia (an abnormality of red blood cells),
leukaemia (cancer of the blood), multiple myeloma (bone cancer) or
any other problem which increases risk of getting “priapism”. This is
when your erection lasts for longer than 6 hours.
• 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, bent or kinked, or Peyronie’s disease.
• have a tight foreskin.
Take special care with Alprostadil Dual Chamber
If you experience an erection that lasts for longer than 4 hours seek
medical advice immediately as treatment should be started within 6
hours. If you cannot contact your doctor go to the hospital emergency
department.
Tell your doctor before using Alprostadil Dual Chamber 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 Dual Chamber will not protect you or your partner from
sexually transmitted diseases like AIDS, herpes or gonorrhoea. The
injection of Alprostadil Dual Chamber 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 Dual Chamber:






Antihypertensives (used for treating high blood pressure)
Sympathomimetics (used for respiratory and heart disease)
Vasodilative agents (drugs that widen blood vessels)
Anticoagulants (blood-thinning agents)
Other treatments for erectile dysfunction (e.g. sildenafil or
papaverine)

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 Dual Chamber 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 Dual Chamber should not affect your ability to drive or use
machines.
Important information about some of the ingredients of Alprostadil
Dual Chamber
Alprostadil Dual Chamber 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’.

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.
The Alprostadil Dual Chamber device

Outer
protective
cap

Inner
Superfine Clear plastic Dose
protective needle
tip (glass window
cartridge
cap
inside)

Plunger
rod

Preparing the injection
Wash your hands. Dry them with a clean towel. If your partner wishes to
be involved in preparing or giving the injection, they should wash their
hands too.
1.

Remove one of the injection devices and
needles from the box. Peel the foil cover
from the needle.

2.

Attach the needle to the device by pushing
the needle on to the tip of the device. Turn
clockwise until it is firmly in place. The
injection needle is enclosed in 2 protective
caps. Pull off the outer protective cap of
the needle.

3.

Hold the device with the needle pointing
upwards. The plunger rod should be in the
extended position.

4.

Turn the plunger rod clockwise until it
stops. This mixes the powder and diluent.
Gently shake to make sure that the
solution is evenly mixed and the powder
has dissolved. Do not use if it remains
cloudy or contains particles.

3. How to use Alprostadil Dual Chamber
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 doctor again. These
instructions are a reminder only.
How much Alprostadil Dual Chamber should you inject?
Different people need different amounts of Alprostadil Dual Chamber 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 in the clinic is 1.25-2.5 micrograms, although doses
lower than 2.5 micrograms cannot be delivered with Alprostadil Dual
Chamber. In this case, Alprostadil Powder for Injection will be used.
Most men find that a dose of 5-20 micrograms works 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 40 micrograms.
If Alprostadil Dual Chamber 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.
How do you use Alprostadil Dual Chamber?
These instructions are intended as a reminder only; you should follow
your doctor’s advice where it differs from this leaflet. If you are using
Alprostadil Dual Chamber for the first time and you have previously
used Alprostadil Powder for Injection, your doctor should have given
you advice about using Alprostadil Dual Chamber.

5.

6. To remove any large bubbles from the
solution, flick the cartridge with your finger
until the bubbles disappear. Then, keeping
the device upright, make sure that the
plunger rod is fully turned to the stop by
screwing it to the right (clockwise) then
immediately press the plunger rod as far as
it will go. A few drops will appear at the
needle point. It is normal for there to be
small bubbles at the side of the glass
cartridge.
7. Turn the end of the plunger rod slowly
clockwise to select your dose. There are
four dosage options. Each option is one of
four quarterly parts of a full dose delivered
by the device. Your doctor will have told
you what this should be. The number
appearing in the window indicates the dose
of the injection. If you make a mistake,
continue to turn the plunger rod clockwise
until you reach the correct dose.
You can prepare your injection up to 24 hours before using it, providing
it is kept at room temperature.
How do you do the injection?
• Get undressed and make yourself comfortable. Take some time to
relax yourself and your partner. If your doctor has recommended you
use an alcohol cleansing pad, open one now.
• Make sure that the needle is not bent. A bent and re-straightened
needle is predisposed to breakage. 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.
• Using the alcohol swab, wipe over the
area and let it dry. Check or if necessary
adjust so that the right dose is in the
dose window.

Hold the device with the needle upwards.
Carefully remove the inner protective cap
from the needle. Make sure that the
needle is not bent. If it is, do not use it
and throw it away. Do not attempt to
straighten it out.
• 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
solution does not come out fairly easily,
move the needle slightly and try again.
Do not force the Alprostadil Dual
Chamber liquid from the syringe.

Continued overleaf

• Pull the needle out. Massage the penis to help the alprostadil spread
through it.
• Do not keep any mixture in the cartridge to use for a second
injection. When you have finished with the needle, throw it away
carefully as recommended by your doctor, so no-one will see it, use
it, or prick themselves on it.
How often can you use Alprostadil Dual Chamber?
Do not use Alprostadil Dual Chamber 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 Dual Chamber each time you use it.
Your erection after injecting Alprostadil Dual Chamber
It will take a little while for your erection to come on after the injection.
With the right dose of Alprostadil Dual Chamber, 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 immediately (see
section on Take special care with Alprostadil Dual Chamber).
If you use too much Alprostadil Dual Chamber
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.







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.

Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova Ltd,
repackager Ginova UK Ltd, both of St James' House, 8 Overcliffe,
Gravesend, Kent, DA11 0HJ.
Manufacturer
Pfizer Manufacturing Belgium NV, Rijksweg 12, Puurs 2870, Belgium.
Alprostadil Dual Chamber 20 micrograms, Powder and
solvent for solution for injection
POM
PL No: 18067/0431
This leaflet was last approved on 14th July 2017.

To request a copy of this leaflet in
Braille, large print or audio please
call 01622 690172.

5. How to store Alprostadil Dual Chamber

4. Possible side effects



Like all medicines, Alprostadil Dual Chamber 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 Dual Chamber
• 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 Dual
Chamber 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 Dual
Chamber 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).





Keep the cartridge and needles out of the sight and reach of
children.
You can prepare your injection up to 24 hours before using it.
The reconstituted solution should not be stored above 25ºC and
should be used within 24 hours.
Do not use any Alprostadil Dual Chamber after the expiry date on
the pack. The expiry date refers to the last day of that month.
For single use only. Any unused contents of the syringe should be
discarded.
Do not use Alprostadil Dual Chamber if the injection is cloudy or
contains particles.

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 Dual Chamber contains
The active ingredient in Alprostadil Dual Chamber is alprostadil. After
reconstitution each 0.5 ml contains alprostadil 20 micrograms.
The other ingredients are lactose monohydrate, alfadex, sodium citrate
dihydrate, hydrochloric acid and sodium hydroxide.
The diluent in the rear compartment is Bacteriostatic Water for Injection
and contains 0.9% w/v benzyl alcohol and water for injections. The
antiseptic pads are soaked in isopropyl alcohol.
What Alprostadil Dual Chamber looks like and contents of the
pack
The product is a dual chamber glass cartridge assembled as a single
unit in a disposable delivery device. The cartridge contains a white
lyophilised powder in the front compartment and diluent for
reconstitution in the rear compartment. Two injection needles and four
pouches containing antiseptic pads are included in the pack.
There are sufficient components in each box to enable two separate
injections of Alprostadil Dual Chamber.
In the Alprostadil Dual Chamber box you will find:
1. Two single use injection devices each containing a dual chamber
cartridge
2. Two needles
3. Antiseptic pads

504429/PL1c

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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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