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CAVERJECT 20 MICROGRAM POWDER FOR SOLUTION FOR INJECTION

Active substance(s): ALPROSTADIL

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Patient Information Leaflet

Caverject 20 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.
The name of your medicine is Caverject 20 microgram powder for
solution for injection but will be referred to as Caverject throughout the
remainder of this leaflet.
Your medicine is also available in the following strengths 5 microgram,
10 microgram and 40 microgram.
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:
• 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)
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.
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 flipoff 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.
2. To prepare the vial
Flip the plastic cap off the vial.
Wipe the rubbery top with one of the
wet antiseptic pads.

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. 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.
• 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.

• 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, 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. 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 25ºC. Store in the original container.
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.
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 any Caverject after the ‘use-by’ date on the pack. The expiry
date refers to the last day of that month.
If the powder or solution shows any signs of discolouration or
deterioration consult your pharmacist for advice.
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
The active ingredient in Caverject is alprostadil. Each vial contains 20
micrograms of alprostadil.
The other ingredients are lactose monohydrate, alpha-cyclodextrin,
sodium citrate, hydrochloric acid, and sodium hydroxide. The syringe
contains benzyl alcohol 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 syringe containing 1 ml of a clear solution
2. One glass vial with a brown stopper containing 20 micrograms as an
off-white powder with white tamper evident cap.
3. One larger 22 gauge needle - 1½ 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 - cleaning wipes
This medicine is manufactured by Pfizer Manufacturing Belgium
N.V./ S.A. Rijksweg 12, B-2870 Puurs, Belgium. Procured from within
the EU. Product Licence Holder: Quadrant Pharmaceuticals Ltd.
Lynstock House, Lynstock Way, Lostock, Bolton BL6 4SA. Repackaged
by Maxearn Ltd. Bolton BL6 4SA.
PL 20774/1248 Caverject 20 microgram powder for solution for
injection
POM
th
Leaflet prepared 4 August 2015
Caverject is a registered trademark of Pharmacia & Upjohn Company
LLC

PP3/1248/V2

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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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