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VITAROS 2 MG/G CREAM

Active substance(s): ALPROSTADIL

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Package leaflet: Information for the user
Vitaros 2mg/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.
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.

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.

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.
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.
In combination with high blood pressure medication, Vitaros use may increase symptoms of dizziness
and fainting, especially in the elderly.
Pregnancy and 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.
It is not known whether Vitaros has an effect on human male fertility.
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 AccuDoseTM 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
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 patients.
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 AccuDoseTM container from the foil
pouch by tearing fully down the seal from the middle of the top edge. Remove the
AccuDoseTM container from the sachet. Save the sachet for discarding the used AccuDoseTM
container later. Remove the cap from the tip of the container. (Figure 1)

Plunger

Barrel
Tip
Cap
Figure 1
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 AccuDoseTM 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 AccuDoseTM container barrel into the opening
and surrounding skin. (Figure 3). Note: do not insert the tip of the AccuDoseTM container
into the opening of the penis.

Figure 3
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 excess 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 AccuDoseTM to compensate for
cream not expelled into the opening of the penis. Any extra 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
AccuDoseTM 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 or 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.
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 and disontinue 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 genital
 lack of sensation to penis
 Urinary tract inflammation
Your partner:
 Vulvovaginal pruritus
*Increased sexual/physical activity in combination with Vitaros my 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

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 AccuDoseTM
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 below 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.

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.

6.

Contents of the pack and other information

What VITAROS contains
The active substance is Alprostadil
Each single container contains 200 micrograms of alprostadil in 100 mg of cream (2mg/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 AccuDoseTM, a single dose container. AccuDoseTM is
a container consisting of a plunger, barrel, and protective cap.
Each container is provided in a protective sachet.
The sachets are composed of aluminium foil/laminate. The container components are composed of
polypropylene and polyethylene.
Marketing Authorisation Holder
Ferring Pharmaceuticals Ltd
Drayton Hall
Church Road
West Drayton
UB7 7PS
UK
PL 03194/0124
Manufacturer
Takeda UK Limited
Building 3
Glory Park
Glory Park Avenue
Wooburn Green
BUCKS
HP10 0DF
United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following
names:
Vitaros 2mg/g cream

Member State

Proposed product name

Germany
UK
France

Alprostadil HEXAL Mikrogramm/100 mg Creme
Vitaros 2mg/g cream
Vitaros 200 microgrammes, crème

Spain
Sweden
Ireland
Belgium
Luxembourg
Netherlands

Virirec CTC 2 mg/g Crema
Vitaros 2 mg/g Kräm
Vitaros 2 mg/g Cream
Vytaros 2 mg/g crème
Vytaros 2 mg/g crème
Vitaros 200 microgram Crème

This leaflet was last revised in 07/2016.
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 the 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 need to have foreplay and sexual intercourse, you may need to have your dose
increased. Similarly, if an erection last 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.

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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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