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

Active substance(s): ALPROSTADIL

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500000/PL1a

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)

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.

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
protective needle
cap

Clear plastic
tip (glass
cartridge
inside)

Dose
window

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.

5.

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.

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’.

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.

Continued overleaf

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. If it is, do not use it and throw it away. Do
not attempt to straighten it out.
• 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.

• 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.


Pull the needle out. On the needlemark, press gently with the alcohol swab.
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.

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 specially 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, 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).
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 Dual Chamber







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
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
POM
PL No: 18067/0431
Caverject® is a registered trademark.
This leaflet was last approved on 30th September 2014.
To request a copy of this leaflet in Braille, large print or audio please call 01622 690172.

500000/PL1a

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)

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.

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
protective needle
cap

Clear plastic
tip (glass
cartridge
inside)

Dose
window

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.

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.

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.

If Alprostadil Dual Chamber is being used to find the reason for your erectile
dysfunction, the dose will be 5-20 micrograms.

5.

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.

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’.

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.

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.

Continued overleaf

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. If it is, do not use it and throw it away. Do
not attempt to straighten it out.
• 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.

• 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.


Pull the needle out. On the needlemark, press gently with the alcohol swab.
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.

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 specially 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, 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).
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 Dual Chamber







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
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 30th September 2014.
To request a copy of this leaflet in Braille, large print or audio please call 01622 690172.

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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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