CAVERJECT DUAL CHAMBER 20 MICROGRAMS

Active substance: ALPROSTADIL

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PATIENT INFORMATION LEAFLET

1793
03.07.14[7]

Caverject Dual Chamber® 20 micrograms
Powder and solvent for solution for injection
(alprostadil)
This medicine is available using any of the above names but will be
referred to as Caverject Dual Chamber throughout this leaflet.
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 a 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
6hours.Ifyoucannot 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. sildenafll 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 breastfeeding. 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.

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

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 (23mg) 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.
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.

 

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), and 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.

The Caverject Dual Chamber device

 
Preparing the injection
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. 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 white 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

 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 needle
mark, 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.
 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.
If the product looks damaged or shows any sign of deterioration consult
your pharmacist who will advise you what to do.
If your doctor tells you to stop using this medicine return any used/unused
devices to your pharmacist for safe disposal.

6. Further Information
What Caverject Dual Chamber contains
The active ingredient in Caverject Dual Chamber is “alprostadil”. The front
compartment of each cartridge delivers a maximum of 20 micrograms of
alprostadil in 0.5ml. This compartment also contains the inactive
ingredients, lactose monohydrate, alfadex, sodium citrate, hydrochloric
acid and sodium hydroxide. The diluent in the rear compartment is
Bacteriostatic Water for Injection and contains benzyl alcohol and water
for injections.
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 lyophilised white
powder in the transparent front compartment and colourless diluent in the
dark blue rear compartment.
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 29G needles
3. Four alcohol cleaning swabs
Manufacturer and Product Licence holder
Caverject Dual Chamber is manufactured by Pfizer Health AB, S-112 87
Stockholm, Sweden. Procured from within the EU by Product Licence
holder: Star Pharmaceuticals Ltd., 5 Sandridge close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
POM

Caverject Dual Chamber® 20 micrograms Powder and
solvent for solution for injection - PL No: 20636/1793

Leaflet revision and issue date (Ref) 03.07.14[7]
Caverject is a registered trademark of Pfizer Enterprises SARL.

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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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