VIRIDAL DUO 40 MICROGRAMS/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Active substance: ALPROSTADIL

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Fig 10:

Fig 12:

following please tick the box
(available to UK residents only)
1) Replacement Injector
“Viridal Easy duo”
2) A needle cutter
Please print clearly in block capitals.
Surname
Initials

The injection site must be within the area shown in
figure 10.
Fig 11:

Address

Postcode
Date of birth
Signature
Date
My doctor’s name and address is:
Surname
Initials
Address

Postcode
N.B.This informationwill be sent, even if you prefer
not to fill in your doctor’s name and address.
PLEASE RETURNTHIS SECTION OF LEAFLET
ONLY

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Hold the injector in your fingers as shown. Always
hold it level with the penis and insert the needle
almost completely straight, into the penis.
The place where you inject should be within the
area shown on the picture. Use a different side of
the penis than you used the last time.
Pushing your thumb gently on the plunger, inject
the solution slowly over a period of 5 to
10 seconds.

After injection, remove the injector and needle
from your penis and put it down. If bleeding
occurs, apply pressure to the injection site with
a clean pad for 3 minutes to stop the bleeding. If it
continues to occur, carry on applying pressure
until it stops.
It will take between 5–15 minutes for your erection
to develop. Your erection should last for about one
hour. If it lasts for between 2-4 hours, discuss this
with your doctor. If it lasts for longer than
4 hours, contact your doctor immediately.
Disposing of the used pack:
• Cut the needle with a needle cutter (available
from your doctor, pharmacist or the Marketing
Authorisation holder)
• Unscrew the needle base and put it into a
container for needles (called a sharps bin) (also
available from your doctor or pharmacist)
• Remove the cartridge by unscrewing the plunger
from the injector body and sliding out the
cartridge.
• Wash the Easy-Duo® injector with warm water
and a mild detergent. Once dry, store it in original
carton for your next injection.
• Do not throw the injector away. Not all
packs contain injectors so you will need to use
this again for your next injection. However, do
not use a damaged injector. Replacements are
available from the company.
• Place the cartridge in a plastic bag and tie it
carefully. This can be thrown away with normal
household rubbish.
• It is important to discard any unused
medicine. The mixture of Viridal Duo you have
made is intended for single use only and any
unused contents should be disposed of with the
cartridge

Medical check-ups
After the first time you use this medicine and then
again every 3 months or so, your doctor will ask
you to have check-ups. These are to make sure that
your medicine is working properly and that the
dose you are taking is right for you.
If you use more Viridal than you should
Immediately contact the nearest hospital casualty
department or your doctor. Using too much Viridal
can cause your erection to last too long and may
require treatment by a specialist doctor to reverse
the effects.
4. Possible side effects
Like all medicinesViridal can cause side effects,
although not everybody gets them.
Seek immediate medical help if you have any
of the following symptoms:
• An erection that lasts for more than 4 hours
• Serious allergic reactions which causes
difficulty in breathing or dizziness
• Skin reactions such as rashes and blistering.
Very common side effects (affect more than
1 in 10 people):
• Pain in the penis
Common side effects (affect less than 1 in
10 people):
• Burning sensation during injection which quickly
gets better
• A sensation of tension in the penis
• Pain at the site of injection
• Lumps at the site of injection or in your penis
after long-term use.
• Spot-like bruising at the site of injection
• Uncontrollable muscle movement
• Erections might occur more often and longer in
duration
• Bend or kink in the penis, especially after longterm use

Uncommon side effects (affect less than 1 in
100 people):
• Swollen or tight foreskin
• Reddening, itching, swelling, blistering, numbness,
tenderness or a feeling of warmth at the site of
injection
• Bleeding at the site of injection
• Headache
• Fungal infection
• Common cold
• Reduced sense of touch or sensation
• Heightened sense of touch or sensation
• Dilation of the pupils
• Changes to heart rhythm or increased heart rate
• Low blood pressure
• Decreased or altered blood flow to the arms or legs
• Feeling sick
• Dry mouth
• Skin rash
• Excessive sweating
• Pain when urinating, urinating more frequently or
a sudden need to urinate
• Bleeding in the urethra, which can cause there to
be blood in your urine
• A general increase in iron stores in the body
• Problems attaining or maintaining an erection
• Problems with ejaculation
• Painful or swollen testicles
• Lumps on the testicles
• Pain in the pelvis
• Pain, swelling or reddening of the scrotum
• Pain, swelling or reddening at the tip of the penis
Rare side effects (affect less than 1 in 1000 people)
• Serious allergic reactions which causes difficulty
in breathing or dizziness
• Skin reactions such as rashes and blistering
• Drop in blood pressure, which may cause dizziness
or fainting
• Scarring of the inside of the penis after long-term
use.
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.

5. How to store Viridal
• Keep out of the reach and sight of children
• Do not use Viridal after the expiry date on the
label. The expiry date refers to the last day of
that month
• Store below 25°C and in the original packaging in
order to protect from light
• Do not use Viridal if you notice some moisture in
the powder
• When you have mixed the powder with the
liquid in the injector, use immediately. This cannot
be stored.
• Return any medicine you no longer need to your
pharmacist.
6. Further information
What Viridal contains
There are three strengths of Viridal that contain
the active substance alprostadil 10, 20 or 40
micrograms.
The other ingredients of the powder are lactose
monohydrate and alfadex.
The liquid contains sodium chloride and water for
injection.
What Viridal looks like and contents of the
pack
Viridal is a powder and solvent for solution for
injection. Viridal comes in a glass cartridge with two
chambers. One chamber contains a white powder
with the active ingredient alprostadil. The other
contains a clear, colourless solution of sodium
chloride solution. This is used to dissolve the
powder.
There are various packs containing:
• 1 cartridge, 1 needle with and without injector
• 2 cartridges, 2 needles with and without injector
• 6 cartridges and 6 needles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
In UK
UCB Pharma Limited
208 Bath Road
Slough, Berkshire
SL1 3WE
United Kingdom
In Ireland
UCB (Pharma) Ireland Limited
United Drug House
Magna Drive
Magna Business Park
Citywest Road
Dublin 24, Ireland
Manufacturer
Aesica Pharmaceuticals GmbH
Alfred-Nobel-Strasse 10
D-40789 Monheim
Germany
This leaflet was last updated in October 2012.
If this leaflet is difficult to see or read or you would
like it in a different format, please contact
UCB Pharma Limited
208 Bath Road
Slough, Berkshire
SL1 3WE, UK

viridal duo® 10/20/40
micrograms/ml
powder and solvent
for solution for
injection
ALPROSTADIL

Or
UCB (Pharma) Ireland Limited
United Drug House, Magna Drive
Magna Business Park, Citywest Road
Dublin 24, Ireland  

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21.11.12 09:25

Patient Information 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.
• In this leaflet, Viridal Duo 10, 20 and 40
micrograms/ml powder and solvent for solution
for injection will all be referred to as Viridal.
In this leaflet:
1. What Viridal is for
2. Before you use Viridal
3. How to use Viridal
4. Possible side effects
5. How to store Viridal
6. Further information.
1. What Viridal is for
Viridal belongs to a group of medicines called
prostaglandins.
Viridal contains the active ingredient alprostadil.
Alprostadil is similar to prostaglandin E1 (PGE1)
that occurs naturally in the body. The medicine
works by widening blood vessels and increasing
blood flow to your penis.
Viridal is used:
• To help you get and maintain an erection when
you have insufficient PGE1
• By your doctor to test whether you suffer from
impotence.
Viridal comes in a glass cartridge with two chambers.
One chamber contains alprostadil, the other
contains sodium chloride solution. These are mixed
together to make a solution that is injected into the
penis.
2. Before you use Viridal
Do not use Viridal if:
• You are allergic to alprostadil
• You are allergic to any of the other ingredients of
Viridal (listed in section 6)
• You have a deformity or disease of your penis
• You have sickle-cell disease (abnormal red blood
cells)

CIA76833A_MU1_GI_MON_Viridal_GBR.indd 2

• You have leukaemia (cancer of blood cells)
• You have multiple myeloma (tumour of the bone
marrow)
• You have an implant in your penis
• You have been told not to have sex for health
reasons such as heart problems or a recent
stroke
• You are a woman or a child.
If any of the above applies to you talk to your
doctor or pharmacist.
Check with your doctor before taking Viridal if:
• You have or have ever had any heart problems
• You have or have ever experienced fainting and
blackouts
• You have had short-term changes to your speech,
hearing or vision
• You suffer from lung problems
• You have Peyronie’s disease or any scarring or
deformity of the penis or foreskin.
You may need to have further tests before your
doctor can give you this treatment
Viridal will not protect you or your partner from
sexually transmitted diseases like chlamydia,
gonorrhoea, herpes simplex virus, viral hepatitis,
HIV, genital warts or syphilis. As you may get a
small amount of bleeding at the injection site, it
is especially important that you use a condom to
avoid sexually transmitted diseases.
Tell your doctor if you are taking any of the
following medicines:
• Drugs to treat depression known as MAOIs such
as phenelzine. When taken with Viridal these can
cause very high blood pressure
• Other drugs injected into the penis for the
treatment of erection difficulties such as
papaverine or phentolamine.Taking Viridal as well
could cause a dangerously prolonged erection
• Any other medicines used to treat erection
difficulties including Viagra
• Medicines to thin your blood such as warfarin.
These can cause bleeding at the site of injection
of Viridal
• Drugs to lower your blood pressure and change
the diameter of your blood vessels. Viridal may
increase their effects and cause very low blood
pressure.

• Any other medicine, including medicines obtained
without a prescription.

How to inject Viridal
Fig 1:

For an erection:
• Most men need between 10 and 20 micrograms
for each injection
• Do not use more than 40 micrograms in one
injection.
• Do not use more than 2 or 3 times a week with
at least 24 hours between the injections.

 

(2)

Put the needle on the end of the injector by
screwing it clockwise until it is tight. Always
screw on the injection needle before inserting the
cartridge.

3. How to use Viridal

To test for impotence and to find out the
dose of Viridal you need:
• Your doctor will give you a starting dose of
2.5 or 5 micrograms
• Your doctor will then increase your dose by
2.5 or 5 micrograms at a time
• Your correct dose is the one which produces an
erection which lasts for no longer than 1 hour.

Fig 8:

(1)

Driving and using machines
If you feel dizzy or faint after using Viridal you
should not drive or use machinery or tools.

How much Viridal to use

Fig 6:

C

Pregnancy and breast-feeding
You should wear a condom if your partner is, may
be or could become pregnant. This is to avoid
causing irritation of her vagina or possibly damaging
the unborn baby.
If you have any questions on this or if your
partner is breast-feeding, please ask your doctor or
pharmacist for advice.

Important:
Before you use Viridal at home, you must be taught
how to prepare and inject it by your doctor. You
should never start treatment without talking
to your doctor first.
Remember: If you find it difficult to use your
hands properly or if you cannot see very well your
partner can be taught how to give you the injection.
Discuss this with your doctor if necessary.

Fig 3:

B

Fig 4:

Fig 7:

A
For each injection you will need:
a) Easy-Duo® reusable. If you have used Viridal
before you should already have an injector. You
may also obtain one by calling the free phone
number given at the end of the leaflet
b) One cartridge, which is made up of two
chambers.
There will be 10, 20 or 40 micrograms of
alprostadil (white powder) in the top chamber,
and 1 ml of sterile saline (colourless liquid) in the
bottom chamber
c) One injection needle with outer protective
cap (1) and inner protective cap (2)

Unscrew the plunger from the injector. Take the
cartridge and clean the tip with alcohol swab. Insert
the cartridge into the transparent body of the
injector. Take care to advance the bulge into the
groove of the injector

While you hold the injector with the needle
pointing up, tap against the injector vigorously until
all bubbles have moved upward. Cautiously advance
the plunger until one drop of the solution leaves
the needle. Make sure that all air was removed
from the cartridge.
Set the dose your doctor prescribed you. To do
so, move the plunger of the injector slowly upward
until the upper edge of the front grey stopper has
reached the prescribed dose.
Fig 9:

Fig 5:
Remove the outer and inner protective caps of the
needle. Warning: do not touch anything with
the tip of the needle so that it stays clean and
sterile (free from germs).

Fig 2:

Screw the plunger onto the back thread of the
injector body.
Check that the seal on the injection needle is not
broken. Tear off the seal.

Hold the injector with the needle pointing up. Push
the plunger forward until the two grey stoppers
of the cartridge meet. You will see that the liquid
passes into the front chamber and the powder
dissolves within a few seconds. Shake the injector
gently until no bits can be seen. At first the solution
may appear slightly cloudy because of the bubbles,
but this will clear after a short time.

Telephone Advice Line
Further information is available by telephone from:
• Viridal duo Patient Helpline freephone
0800 7312698 (UK only)
This is a fully automated, free service for ordering
replacement injectors and needle cutters.
Advice and replacement injectors can also be
ordered by writing to:
• FREEPOST RLSG-HARX-BGGA
UCB Pharma Limited
208 Bath Road
Slough
Berkshire
SL1 3WE
UK

Make sure that your penis has been cleaned
thoroughly.
Clean the injection site with an alcohol swab.
Draw the penis slightly away from your body until
the intended injection site has dried.
Take the injector and make sure that the grey
stopper is at the prescribed dose and that no air
bubbles are in the cartridge.
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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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