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VITAROS 3MG/G CREAM

Active substance(s): ALPROSTADIL / ALPROSTADIL

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Ref: 1698/180517/1/F

Reporting of side effects
If you get any side effects, talk to your doctor. This
includes any possible side effects not listed in this
leaflet. Also you can help to make sure that
medicines remain as safe as possible by reporting
any unwanted side effects via the internet at
www.mhra.gov.uk/yellowcard. Alternatively you can
call Freephone 0808 100 3352 (available from 10
a.m. to 2 p.m. Mondays to Fridays) or fill in a
paper form available from your local pharmacy.
By reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO STORE VITAROS










KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
Do not use Vitaros after the expiry date which is
stated on the carton and sachet label after Exp.
The expiry date refers to the last day of the
month.
Store in a refrigerator (2°C - 8°C). Do not freeze.
Unopened sachets may be kept out of the
refrigerator by the patient, at up to 25°C for up to
3 days prior to use. At the end of this period, the
product should be discarded if not used.
Each dispenser is for single use only. Once
opened, use immediately, discard any unused
portion.
Store in the original sachet in order to protect from
light.
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. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Vitaros contains
The active substance is Alprostadil
Each single dose container contains
300 micrograms of alprostadil in 100mg of cream
(3mg/g).
The other ingredients are purified water, ethanol
anhydrous, ethyl laurate, hydroxypropyl guar gum,
dodecyl-2-N, N-(dimethylamino) propionate
hydrochloride, potassium dihydrogen phosphate,
sodium hydroxide, for pH adjustment and
phosphoric acid, for pH adjustment.
What Vitaros looks like and contents of the
pack
Vitaros is white to off-white cream supplied in
AccuDose™, in a single dose container.
AccuDose™ is a container consisting of a plunger,
barrel, and protective cap. The protective sachets
are composed of aluminium foil/laminate.
Each carton contains 4 containers

Manufacturer and Licence Holder
Manufactured by Manufactured by Bracco s.p.a. Via Caduti di Marcinelle, 13 - 20134 Milano - Italy
and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK)
Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/1698 Vitaros 3mg/g cream

Vitaros is a registered trademark of NexMed
International Limited.

PATIENT INFORMATION LEAFLET

Vitaros ® 3mg/g cream
(alprostadil)
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
phamacist. This includes any possible side
effects not listed in this leaflet. See section 4.

2. WHAT YOU NEED TO KNOW BEFORE YOU
USE VITAROS
Do not use Vitaros
• if you have underlying disorders such as drop in
blood pressure when going from a lying/sitting
to a standing position, history of a heart attack,
and syncope (dizziness)




Leaflet revision date: 18/05/17

Blind or partially sighted?
Is this leaflet hard to see
or read? Phone Lexon
(UK) Limited, Tel: 01527
505414 to obtain the
leaflet in a format
suitable for you

Your medicine is called Vitaros 3mg/g cream and
will be referred to as Vitaros throughout the rest of
this leaflet.
What is in this leaflet:
1. What Vitaros is and what it is used for
2. What you need to know before you use Vitaros
3. How to use Vitaros
4. Possible side effects
5. How to store Vitaros
6. Contents of the pack and other information








1. WHAT VITAROS IS AND WHAT IT IS USED
FOR
Vitaros is available in two dosage strengths of 200
and 300 mcg alprostadil in 100 mg of cream.
Vitaros is used to treat erectile dysfunction (ED) in
men 18 years of age or older. ED is the inability to
attain or maintain an erection sufficient for sexual
intercourse. There are several causes of ED
including medications that you may be taking for
other conditions, poor blood circulation in the
penis, nerve damage, emotional problems, too
much smoking or alcohol use, and hormonal
problems. Often ED is due to more than one
cause. Treatments for ED include switching
medications, if you are taking a medication that
causes ED, prescription medications, medical
devices that produce an erection, surgical
procedures to correct blood flow to the penis,
penile implants and psychological counseling.
After application of Vitaros the onset of erection is
within 5 to 30 minutes. You should not stop taking
any prescription medications, unless told to do so
by your doctor.

if you are allergic to alprostadil or any of the
other ingredients of this medicine (listed in
section 6).
if you have a condition that might result in a
long-lasting erection or a condition such as
sickle cell anaemia or trait, thrombocythemia,
polycythemia, multiple myeloma, or leukaemia
if you have an abnormally formed penis
if you have an inflammation or infection of the
penis
if you are prone to a venous thrombosis
if you have a hyperviscosity syndrome which
could result in a long-lasting erection
if you have been told not to have sex for health
reasons such as heart problems or a recent
stroke
if your partner is pregnant, breast feeding or of
childbearing potential unless you use a condom
barrier.

Warnings and precautions
Talk to your doctor or pharmacist before using
Vitaros if you have a history of the following local
effects that have been observed with the use of
Vitaros:
• prolonged erections lasting >4 hours (priapism)
• symptomatic hypotension (dizziness)
• hepatic and/or renal insufficiency
• a lowered dose due to impaired metabolism may
be required
• fainting
A condom should be used in the following
situations:
• your partner is pregnant or breastfeeding
• your partner is of childbearing potential
• to prevent sexually transmitted diseases
• during oral sex and anal sex
Only latex condoms have been studied. It is not
known if condoms made of other materials may be
damaged.
Other medicines and Vitaros
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.

Other medicines and Vitaros
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
The use of Vitaros with other drugs used to treat
Erectile Dysfunction have not been studied.
Therefore, if you are taking other drugs for ED, do
not combine with Vitaros as there could be signs
including dizziness, fainting and prolonged
erections. Vitaros has not been tested for use with
penile implants or smooth muscle relaxants such
as papaverine; drugs used to induce erections
such as alpha blocking drugs (e.g. intracavernosal
phentolamine, thymoxamine). There is a risk of
priapism (painful prolonged abnormal erection)
when used in combination.
Although not studied, it is possible that Vitaros
may have less of an effect when taken in
combination with treatments for high blood
pressure, decongestants and appetite
suppressants.
If you are taking drugs to prevent blood clots, do
not take Vitaros as there may be an increased risk
for bleeding or blood found in the urine.

For an erection: the starting dose should be
recommended by a physician. Do not adjust your
dose yourself. Talk to your doctor who will
instruct you on proper technique for administration
and accomodation of your dose.
Do not apply Vitaros more than 2-3 times a
week and only once per 24 hour period.
The onset of effect is within 5 to 30 minutes after
administration. The duration of effect is
approximately 1 to 2 hours. But, the actual
duration can vary from patient to patient.

1. Wash your hands before applying Vitaros.
Remove the AccuDose™ container from the foil
pouch by tearing fully down the seal from the
middle of the top edge. Remove the
AccuDose™ container from the sachet. Save
the sachet for discarding the used AccuDose™
container later. Remove the cap from the tip of
the container. (Figure 1)

Pregnancy, breast-feeding and fertility
There are no data on the use of Vitaros in
pregnant women. Pregnant women should not be
exposed to Vitaros.
It is not recommended to use Vitaros while
breastfeeding.

Driving and using machines
Vitaros may make you feel dizzy or faint. Do not
drive or operate machinery within 1 to 2 hours
after administration.

2. Grasp the tip of the penis with one hand and
gently manipulate to widen the opening of the
penis. Note: if you are not circumcised, first
retract and hold the foreskin back prior to
widening the opening of the penis. (Figure 2)

4. Hold the penis in an upright position for
approximately 30 seconds to allow the cream to
penetrate. There will likely be some cream that
does not fit into the opening of the penis. The
amount of extra cream will vary depending on
the patient and it is not unusual that half of the
dose will remain at the edge of the opening. Do
not use a second AccuDose™ to compensate
for cream not expelled into the opening of the
penis. Any excess cream covering the opening
may be rubbed gently into the opening and skin
surrounding the application site with the tip of a
finger.
5. Remember each Vitaros dose is good for a
single administration only. Replace the cap on
the AccuDose™ container and place in the
opened foil sachet, fold and discard in
accordance with local requirements.
6. Vitaros may be irritating to the eyes. Wash your
hands after applying Vitaros.
Children and adolescents
Vitaros is not indicated for children or men below
18 years of age.

3. HOW TO USE VITAROS
Always use this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure.
Vitaros is available in two dosage strengths of 200
and 300 mcg alprostadil in 100 mg of cream.
Vitaros should be used as needed to achieve an
erection. Each Vitaros AccuDose™ container is for
single use only and should be properly discarded
after use.

4. POSSIBLE SIDE EFFECTS
Like all medicines, VITAROS can cause side
effects, although not everybody gets them.
If you get a long-lasting erection of more than
4 hours, contact your doctor immediately.
Your doctor may reduce your dose of Vitaros or
discontinue your treatment.
Common side effects (may affect more than 1 in
10 patients):
You:
• mild to moderate local aching, burning or pain
and redness of the penis
• rash
• genital pruritus
• penile oedema
• inflammation of the glans penis (balanitis)
• penile tingling, throbbing, numbness, burning

Apply Vitaros to the tip of the penis within 5 to 30
minutes prior to attempting intercourse by
following the instructions below:

In combination with high blood pressure
medication, Vitaros use may increase symptoms
of dizziness and fainting, especially in the elderly.

It is not known whether Vitaros has an effect on
human male fertility.

3. Hold the barrel of the AccuDose™ container
between your fingers and place the tip of the
container over the opening of the penis and
carefully push down the plunger with your
thumb or finger until all the cream is expelled
from the AccuDose™ container barrel into the
opening and surrounding skin (Figure 3).
Note: do not insert the tip of the
AccuDose™ container into the opening of
the penis.

If you use more VITAROS than you should
Overdose with Vitaros requiring treatment has not
been reported. Overdose with Vitaros may result
in a drop in blood pressure, fainting, dizziness,
persistent pain in the penis, and possible
prolonged erection lasting longer than 4 hours.
This can result in permanent worsening of erectile
function. Call your doctor promptly if you suffer
with any of these effects.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

Your partner:
• mild vaginal burning or itching, vaginitis
This effect may be due to the drug or to the act
of vaginal penetration. Using a water-based
lubricant can help to make vaginal penetration
easier.
Uncommon but potentially serious side effects
(may affect up to 1 in 100 patients):
You:
• light-headedness/dizziness
• prolonged erection for more than 4 hours
• fainting
• low blood pressure or rapid pulse
• pain at the application site or in extremity
• urethral stenosis
• increase in sensitivity
• penile itching
• genital rash
• scrotal pain
• fullness in genitals
• lack of sensation to penis
• urinary tract inflammation
Your partner:
• vulvovaginal pruritus
*Increased sexual/physical activity in combination
with Vitaros may increase the risk of heart attack
or stroke in patients with underlying disease/risk
factors (see Section 2).
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.
Duration of side effects:
Most effects are short acting and resolve within
1-2 hours
Ref:1698/180517/1/B

Expand Transcript

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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