Vitaros

• For erectile dysfunction (ED)
• Cream for single use only
• Effective immediately
• Do not use more than two to three times a week
• Do not drive within two hours after administration

Vitaros cream contains the active substance alprostadil. Alprostadil is a vasodilator, which means it helps to widen the blood vessels, increasing blood flow. When applied into the opening of the penis, alprostadil allows more blood to flow to it, enabling an erection. The duration of effect is approximately one to two hours.

Vitaros cream comes in a pre-filled, syringe-like device called an applicator. Each applicator contains enough cream for one use.

Vitaros should be used as needed to achieve an erection and should be applied about 30 minutes before attempting intercourse. The user instructions in the package leaflet tell you how to do this. Follow these instructions closely. The general guidelines for use are as follows:

• It is recommended to urinate before applying Vitaros cream.
• Wash and dry your hands before application.
• Remove the applicator from the package and bring the contents to room temperature by rolling it between your hands.
• Grasp the tip of the penis with one hand and gently squeeze to widen the opening at the tip of the penis, while holding it in an upright vertical position. Note: if you are not circumcised, first retract and hold the foreskin back prior to widening the opening of the penis.
• Place the tip of the applicator as close as possible to the opening at the tip of the penis. Note: take care that the tip of the applicator does not touch the tip of the penis.
• Slowly, but firmly, push down the plunger with your thumb or finger until all the cream is expelled into the opening at the tip of the penis and down the urethra.
• 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 initially fit into the opening at the tip of the penis. Any excess cream covering the opening at the tip of the penis should be gently moved into the opening with the tip of a finger. Do not use a second dose to compensate for cream not expelled into the opening at the tip of the penis.
• Do not urinate immediately after application, due to the risk that the medicine could come out before the effect takes place.
• After application of Vitaros the onset of erection is within approximately 10 minutes.
• Wash your hands after applying Vitaros and throw away the container.
  

Vitaros should be stored in a refrigerator. Unopened sachets may be kept out of the refrigerator for up to three days prior to use. At the end of this period, the product should be discarded if not used.

Dosage

The general recommended dose in adults is:

• Insert one dose of cream no more than once per 24 hours. Do not apply Vitaros more than two or three times a week.
  

Vitaros is not indicated for children or men below 18 years of age.

Alcohol/driving

Drinking alcohol can temporarily impair your ability to get an erection and thus make Vitaros less effective.

Vitaros may make you feel dizzy or faint. Do not drive or operate machinery within one to two hours after administration.

If you use more Vitaros than you should

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 four hours. This can result in permanent worsening or erectile function. Call your doctor promptly if you suffer with any of these effects.

Do not take Vitaros if:

• You are allergic to any of the ingredients in this medicine (see section 'What Vitaros contains').
• You have underlying disorders such as drop in blood pressure when going from a lying/sitting to a standing position, dizziness, a history of a heart attack or syncope (fainting).
• You have a condition that might result in a longlasting erection or a condition such as sickle cell anaemia or trait, thrombocythemia, polycythemia, multiple myeloma or leukaemia.
• You have an abnormally formed penis.
• You have an inflammation or infection of the penis.
• You are prone to a venous thrombosis.
• You have a hyperviscosity syndrome which could result in a longlasting erection.
• You have been told not to have sex for health reasons such as heart problems or a recent stroke.
  

When should this medicine be used with caution?

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, often painful erections (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.

Pregnancy, breastfeeding and fertility

Vitaros should not be used by women and children.

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

Other medicines and Vitaros

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, herbal medicines or other natural products.

The use of Vitaros with other drugs used to treat erectile dysfunction, in particular phosphodiesterase type 5 (PDE5) inhibitors, has not been studied. Therefore, if you are taking PDE5 inhibitors, do not combine with Vitaros.

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

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

If you get a long-lasting erection of more than four hours, contact your doctor immediately. Your doctor may reduce your dose of Vitaros or discontinue your treatment.

Other side effects associated with Vitaros:

Common (may affect up to 1 in 10 people):

You:

• Rash.
• Mild to moderate local aching, burning or pain and redness of the penis.
• Genital itch or discomfort.
• Increased erectile function.
• Penile oedema.
• Inflammation of the glans (balanitis).
• Penile tingling, throbbing numbness, burning.
  

Your partner:

• Mild vaginal burning or itching, vaginitis. This effect may be due to the medicine or to the act of vaginal penetration. Using a waterbased lubricant can help to make vaginal penetration easier.
  

Uncommon (may affect up to 1 in 100 people):

You:

• Increase in sensitivity.
• Lightheadedness/dizziness.
• Fainting.
• Low blood pressure or rapid pulse.
• Pain at the application site or in arms or legs.
• Urethral stenosis.
• Urinary tract inflammation.
• Penile itching.
• Genital rash.
• Scrotal pain.
• Fullness in genital.
• Prolonged erection.
• Lack of sensation to penis.
  

Your partner:

• Vulval or vaginal itching.
  

If you experience side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.

The active substance is alprostadil.