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ALPROSTADIL 3 MG/G CREAM

Active substance(s): ALPROSTADIL / ALPROSTADIL

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500078/PL1a

Package leaflet: Information for the user

Vitaros® 3 mg/g Cream
Alprostadil 3 mg/g Cream
(alprostadil)
The name of your medicine is Vitaros 3 mg/g Cream or Alprostadil 3 mg/g Cream. It
will be referred to as Vitaros throughout the remainder of this leaflet. Other strengths
are available.
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.

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.
In combination with high blood pressure medication, Vitaros use may increase
symptoms of dizziness and fainting, especially in the elderly.
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 breast-feeding.
It is not known whether Vitaros has an effect on human male fertility.

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 counselling. 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.
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)
− 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.

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

Figure 1
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 breast-feeding
− 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.

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)

Figure 2
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.

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.

Figure 3

continued overleaf

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.
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.

Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist to throw away medicines you no longer use. These measures will help
protect the environment.
If you notice any signs of discolouration or deterioration of your medicine, please tell
your pharmacist immediately.
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 100 mg of cream
(3mg/g).
Vitaros is available in unit cartons with four (4) single dose containers.
The other ingredients are purified water; ethanol, anhydrous; ethyl laurate;
hydroxypropyl guar gum; dodecyl-2-N,N-dimethylaminopropionate hydrochloride;
potassium dihydrogen phosphate; sodium hydroxide, for pH adjustment; phosphoric
acid, for pH adjustment.
What Vitaros looks like and contents of the pack
Vitaros is a white to off-white cream supplied in a single dose container, consisting of a
plunger, barrel, and protective cap provided in a protective sachet.
The sachets are composed of aluminium foil/laminate. The container components are
composed of polypropylene and polyethylene.

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 (balantitis)
− penile tingling, throbbing numbness, burning
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
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

Manufacturer
Bracco s.p.a.
Via Caduti di Marcinelle, 13
20134 Milan
Italy
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova Ltd and repackager
Ginova UK Ltd both at St James’ House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Vitaros 3 mg/g Cream / Alprostadil 3 mg/g Cream
PL 18067/0499
POM
st
This leaflet was last updated on 31 January 2017.
®
Vitaros is a trademark of NexMed International Limited.
AccuDose™ is a trademark.

Other Sources of Information
Detailed information on this medicine is available on the Medicines and Healthcare
products Regulatory Agency (MHRA) web site: http://www.mhra.gov.uk.
EFFECTS AFTER APPLICATION:
Vitaros requires between 5 to 30 minutes to begin working before you can have
sexual intercourse. After administration you can engage in foreplay, which helps
arousal and the process of developing an erection. An effective dose of Vitaros
should produce an erection sufficient for sexual intercourse. The duration of the
effect is approximately 1 to 2 hours. However, the actual duration will vary from
patient to patient and the dose of the drug. Vitaros may not create an erection
comparable to those you experienced when you were younger. Some patients may
experience some mild pain, a burning sensation, and aching in the penis or groin
area. Also, your erection may continue for a time after orgasm or ejaculation. After
your erection is over your penis may feel full, warm, and somewhat sensitive to
touch. These effects are normal and may last for a few hours.
ADDITIONAL INFORMATION AND PRACTICAL TIPS:
You and your doctor will determine the appropriate dose of Vitaros. If your erection
cannot be maintained for the time needed to have foreplay and sexual intercourse,
you may need to have your dose increased. Similarly, if an erection lasts longer than
desired or if the side effects are not well tolerated you may need your dose reduced.
Call your doctor if you suspect that you may require an adjustment of your dose.
Factors that may enhance your erection:
− being well rested.
− sexual foreplay with your partner or self-stimulation while sitting or lying after
application of Vitaros.
− pelvic exercises such as tightening and releasing your pelvic and buttock muscles.
These are the muscles you use to stop urination.
− various positions that may favour and not restrict blood flow to the penis.
Factors which may reduce your erection:
− anxiety, fatigue, tension, and too much alcohol.
− urination immediately after application may result in loss of medication.

Keep this medicine out of the sight and reach of children.
Do not use Vitaros after the expiry date which is stated on the carton, sachet and
AccuDose™ container 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 a temperature
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.

500078/PL1a

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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