INVICORP 25 MICROGRAMS / 2 MG SOLUTION FOR INJECTION

Package leaflet: Information for the user
Invicorp 25 micrograms / 2 mg solution for
injection

Warnings and precautions
If your erection is uncomfortable or painful or
lasts for more than 4 hours, you must contact your
doctor or emergency room immediately, since the
treatment of this must be initiated within 6 hours.

aviptadil/phentolamine mesilate
Read all of this leaflet carefully before you start
using this medicine because it contains
important information for you.
− 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
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same
as yours.
− If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Invicorp is and what it is used for
2. What you need to know before you use
Invicorp
3. How to use Invicorp
4. Possible side effects
5. How to store Invicorp
6. Contents of the pack and other information
1. What Invicorp is and what it is used for
The active components in Invicorp (aviptadil and
phentolamine mesilate) affect the flow of blood in
and out of the penis. In broad outline,
phentolamine mesilate increases the flow of blood
into the penis, while aviptadil reduces the flow of
blood from the penis.
If you suffer from an erectile dysfunction, you can
use Invicorp to help you to obtain an erection
more easily.
2. What you need to know before you use
Invicorp
Do not use Invicorp:
− if you are allergic to aviptadil or phentolamine
mesilate or any of the other ingredients of this
medicine (listed in section 6)
− if you have or have had leukaemia (cancer of
the blood), multiple myeloma (bone cancer) or
sickle cell anaemia or trait (a blood disease),
as you may experience a painful, long lasting
erection
− if you are taking blood thinning medicines
such as warfarin or heparin, including oral
blood thinning medicines such as dabigatran,
rivaroxaban, apixaban
− if your doctor has advised you not to have sex
because of your health condition
− if you have a penis which is scarred or not
straight which may sometimes be referred to as
Peyronie’s disease or if you have abnormal
fibrous tissue in the erectile tissue of the penis
(cavernosal fibrosis)
− if you have an implant in your penis.

Talk to your doctor, pharmacist or nurse before
using Invicorp if:
− you suffer from heart or lung problems or have
had a stroke (in these cases you should engage
in sexual activity with caution)
− you have a history of mental illness or
addiction.
Mild transient flushing of the face or trunk occurs
commonly. In rare cases this is associated with
discomfort and abnormal heart beat or rapid pulse.
If you experience an abnormal heart beat or a
rapid pulse, you should stop taking Invicorp.
It is important that you learn how to administer
Invicorp correctly.
Other medicines and Invicorp
Do not take other medicines for erectile
dysfunction at the same time as Invicorp.
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Pregnancy, breast-feeding and fertility
Not relevant. Invicorp is only intended for men.

Dose
The recommended dose is 25 micrograms / 2 mg.
Do not administer more than one injection per day,
and not more than 3 injections per week.
Each ampoule contains the correct amount for a
single injection. You must inject the whole of the
contents of the ampoule.
How you should use Invicorp
Invicorp can be brought to room temperature
before use, or it can be used directly from the
refrigerator. Unless your doctor has instructed
otherwise, you should follow the dose guidelines
that are given in this leaflet, as otherwise Invicorp
cannot work properly.
You should carry out the first Invicorp injection
under a doctor’s or nurse’s supervision.
Preparation of Invicorp injection
1. Wash your hands and dry them with a clean
towel.
2. Take one glass ampoule with two fingers and
turn it gently to ensure that all of the fluid is in
the lowest part of the ampoule.
3. Break off the top of the ampoule and carefully
place the ampoule on an even surface.
4. Open the package containing the long needle.
You need the long needle to fill the syringe
with the solution for injection from the
ampoule. DO NOT USE THIS NEEDLE FOR
INJECTION. Place the needle on a clean
surface such as a clean paper tissue.

Invicorp contains sodium
This medicinal product contains less than 1 mmol 5. Take the syringe out of the package and place
sodium (23 mg) per dose, i.e. essentially “sodium
on the paper tissue.
free”.
6. Hold the syringe at the top
3. How to use Invicorp
end and hold the needle by
the protective cap. Attach the
Always use this medicine exactly as your doctor or
syringe to the open end of the
pharmacist has told you. Check with your doctor
needle. Push and twist a half
or pharmacist if you are not sure.
turn in one direction, until it
fits securely. Remove the
Invicorp is intended for injection into the spongy
protective cap from the
tissue on either side of the shaft of the penis
needle.
(intracavernous injection). A doctor or nurse will
show you how to carry out at least the first 7. Insert the needle into the
injection. Hereafter your doctor will monitor you
ampoule drawing back all the
regularly (e.g. every 3 months) particularly in the
fluid from the ampoule into the
beginning of the self-injection therapy.
syringe by pulling the plunger
of the syringe. Replace the
Do not attempt to inject yourself with Invicorp if:
protective cap on the long
− you have not been shown how to inject
needle and remove the needle
yourself
from the syringe.
− you had any problems with the first injection
− you did not understand the instructions.
8. Open the package containing the short needle
(for injection), and place on a clean surface
If you cannot remember how to administer the
such as a clean paper tissue.
injections, you should contact your doctor. You
must not try to use the injection if you are not sure 9. Hold the syringe at the top
what you should do.
end and hold the short needle
by the protective cap. Attach
Use in children and adolescents:
the needle to the syringe.
Invicorp should not be used in children and
Push and twist a half turn in
adolescents.
one direction until it fits
securely. Then remove
protective cap.

How to give yourself the injection
1. Wash the injection site on your penis, with
soap and water, rinse with water and dry with
a clean towel.
2. Take the syringe positioning the needle
upwards, and carefully tap the barrel of the
syringe until all
trapped air bubbles
move into the top of
the syringe.
Carefully push the
plunger until a few
drops come out of
the needle. Do this
to prevent air in the needle.
3. Hold the
syringe
with the
needle at
right angles
to the side
of the
penis.
4. Make sure you do not
inject into the urinary
tract or into visible
blood vessels. Inject
into the grey shaded
areas shown.
5. Push the needle
into the penis until
about half of the
needle is in.
Carefully push the
plunger of the
syringe and inject
all the fluid.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.

6. Contents of the pack and other information
Serious side effects
Rare: may affect up to 1 in 1,000 people
What Invicorp contains
− Long lasting and painful erection. Contact
− The active substances are aviptadil and
your doctor or emergency room immediately if
phentolamine mesilate.
your erection lasts more than 4 hours.
Each ampoule of Invicorp 25 micrograms / 2 mg
Very rare: may affect up to 1 in 10,000 people
contains 25 micrograms of aviptadil and 2 mg
phentolamine mesilate.
− Angina, chest pain. Contact your doctor or
emergency room.
− Heart attack and difficulty breathing, anxiety, − The other ingredients are: Sodium chloride,
disodium edetate, phosphoric acid,
possibly radiation of strong pains to the left
hydrochloric acid, sodium hydroxide and
arm and chest pain. Stop using the medicine
water for injections.
and seek urgent medical advice immediately if
you experience these side effects.
What Invicorp looks like and contents of the
pack
Other side effects
Invicorp is a sterile solution for injection (0.35ml),
Common: may affect up to 1 in 10 people
contained in a light brown glass ampoule.
− Flushing of the face and upper part of the
The ampoule(s) is(are) packed into cardboard
body.
box(es). The ampoule(s) is(are) co-packed with a
− Bruises around the injection site. To reduce
separate box containing syringe(s) and needles.
the risk of bruising you should avoid visible
blood vessels (veins) during self-injection.
Pack sizes:
Glass ampoule 1 x 0.35 ml with 1 syringe, 1 30G
Uncommon: may affect up to 1 in 100 people
needle and 1 21G needle
− Headache, dizziness.
Glass ampoules 2 x 0.35 ml with 2 syringes, 2 30G
− Increased heart rate (pulse). Abnormal heart
needles and 2 21G needles
beats. Stop using the medicine if you
Glass ampoules 3 x 0.35 ml with 3 syringes, 3 30G
experience these side effects.
− Accumulation of blood under the skin around needles and 3 21G needles
Glass ampoules 4 x 0.35 ml with 4 syringes, 4 30G
the injection site.
needles and 4 21G needles
Glass ampoules 5 x 0.35 ml with 5 syringes, 5 30G
Rare: may affect up to 1 in 1,000 people
needles
and 5 21G needles
− Small nodules on the penis may occur with
Glass ampoules 10 x 0.35 ml with 10 syringes, 10
repeated injections.
30G needles and 10 21G needles
− Pain at the site of injection.

Reporting of side effects
6. Take the needle out and replace the protective If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
cap on the needle.
not listed in this leaflet. You can also report side
effects directly via the the internet at
7. Carefully place the parts of the ampoule, the
www.mhra.gov.uk/yellowcard alternatively you
used syringe and needle in a needle container
can call Freephone 0808 100 3352 (available
for disposal of needles.
between 10am-2pm Monday-Friday) or fill in a
paper form available from your local pharmacy.
After injection of Invicorp
After self-injection of Invicorp it will take a little By reporting side effects you can help provide
time for you to obtain an erection. The injection more information on the safety of this medicine.
should ensure a sufficient erection to enable you to
5. How to store Invicorp
have sexual intercourse.
The erection will normally not last longer than one
Keep this medicine out of the sight and reach of
hour.
children.
Please contact your doctor or emergency room Do not use this medicine after the expiry date
immediately if you have an erection which lasts which is stated on the carton.
longer than 4 hours after injecting Invicorp.

If you use more Invicorp than you should
Contact your doctor, emergency room or
pharmacist if you have taken more Invicorp than
stated in this leaflet or more than your doctor has
prescribed.

throw away medicines you no longer use. These
measures will help protect the environment.

Store in a refrigerator (2 - 8°C).
Do not freeze.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Evolan Pharma AB
Box 120
SE-182 12 Danderyd
Sweden
Manufacturer
HB-Medical ApS
Dr. Neergaardsvej 17
DK- 2970 Hørsholm
Denmark
Rechon Life Science AB
Soldattorpsvägen 5
Limhamn
Sweden

The ampoule can be brought to room temperature This leaflet was last revised in 07/2015
before use. You should use the injection within 24
hours of taking the ampoule out of the refrigerator.
The ampoule and needle should be disposed in a
container suitable for this purpose.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to