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CAVERJECT 10 MICROGRAMS POWDER FOR SOLUTION FOR INJECTION

Active substance: ALPROSTADIL

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Patient Information Leaflet

Caverject

®

5, 10, 20, 40 micrograms

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.

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

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.

2. To prepare the vial

Flip the plastic cap off the vial. Wipe the rubbery top with one of the wet antiseptic pads.

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)

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.

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.

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.

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

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.

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

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.

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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

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.

(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).
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.

• If recommended by your prescriber wipe the skin over this area with the second pad and

5. How to store Caverject

• Keeping a firm grip on the penis and taking the syringe in your free hand, push the needle

• Store below 25°C.
• Keep the syringe and needles out of the sight and reach of children.
• When you have mixed the Caverject Powder with the solution, use it straight away. Do

How do you do the injection?

• Get undressed and make yourself comfortable. Take some time to relax yourself and your

let it dry.

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.

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 any Caverject after the ”expiry” date on the pack. The expiry date refers to the

last day of that month.

• For Caverject 40 micrograms vials: these vials should only be used within 3 months from

when they were given to you. Your doctor or pharmacist will make a note of this date on
the packs. You should not use the vials after this date has passed. Please note that this
date may be earlier than the “expiry” date printed on the packs.
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

• 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

The active ingredient in Caverject is alprostadil. Each vial contains 5, 10, 20 or
40 micrograms of alprostadil.
Caverject 5 micrograms and Caverject 40 micrograms:
The other ingredients are lactose, sodium citrate, hydrochloric acid and sodium hydroxide.
Caverject 10 micrograms and Caverject 20 micrograms:
The other ingredients are lactose monohydrate, sodium citrate, α-cyclodextrine, 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 5, 10, 20 or 40 micrograms as a white to off-white
powder
2 One glass syringe containing 1mL of a clear solution
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

Marketing Authorisation Holder
Pfizer Limited,
Ramsgate Road,
Sandwich, Kent
CT13 9NJ, UK.

Manufacturer
Caverject 5, 10 or 20 micrograms:
Pfizer Manufacturing NV
Rijksweg 12,
2870 Puurs,
Belgium

Caverject 40 micrograms:
Valdepharm
Parc Industriel d’Incarville,
27100 Val de Reuil,
France

This leaflet was last revised in: 6/2015
Ref: CJ 9_0

(occurring in more than 1 in 10 patients)
• Pain in the penis

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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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