CAVERJECT 10 MICROGRAMS POWDER FOR INJECTION

Active substance: ALPROSTADIL

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PRE-PRESS NO.:

CUSTOMER: Waymade

02-1808
DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

18/01/13

DATE:

PROOF HISTORY:
v.1 - waymade - 18/01/13

DATE:

PRODUCT:

Caverject 10mg 20mg injection

ARTWORKER:

CODE:

6464/2418 2420 E

DATE OF PROOF:

Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TO UK PIL GRANTED NOVEMBER 2012

Pg 1

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5. How to store Caverject
Do not store above 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 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 ‘use-by’ date on the pack. The expiry date refers to the last day of
that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information
What Caverject contains
The active ingredient in Caverject is alprostadil. Each vial contains 10 or 20 micrograms of alprostadil.
Caverject powder for injections also contains the following: lactose monohydrate, 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 each box there are 5 items:
one glass vial containing white lyophilised powder for injections.
one glass syringe containing 1ml of clear solution
one needle-22 gauge (1½ inches long-clear grey needle end)
one needle-27 gauge (half inch long-opaque grey needle end)
two antiseptic pads
POM

PL No: 6464/2418
PL No: 6464/2420

Caverject 20 micrograms powder for injections
Caverject 10 micrograms powder for injections

These products are manufactured by Pfizer Manufacturing Belgium N.V./S.A., Rijksweg 12, B-2870
Puurs, Belgium and procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 17.1.2013
Caverject is a registered trademark of Pfizer

CAVERJECT® 10 micrograms POWDER FOR INJECTIONS
CAVERJECT® 20 micrograms POWDER FOR INJECTIONS
(alprostadil)
Patient Information Leaflet
This product is known by the above names. Throughout this leaflet these products will be collectively
referred to as Caverject. Other strengths (5 micrograms and 40 micrograms) are also 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 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’.

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WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Caverject 10mg 20mg injection

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/2418 2420 E

DATE OF PROOF:

18/01/13

DATE:

PROOF HISTORY:
v.1 - waymade - 18/01/13

DATE:

Leaflet Flat Size = 296 x 317

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TO UK PIL GRANTED NOVEMBER 2012

Pg 2

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 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 clear grey end is used to mix the solution and Caverject
Powder.
• The smaller and finer 27 gauge needle with the opaque grey 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.

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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).

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 clear 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.

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. 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.

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

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.

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.

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

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

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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 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.

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Pg 4

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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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