Vitaros

Patient Information Leaflet: Important Information for the User

Vitaros 200 microgram cream, 300 microgram cream

Alprostadil
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Vitaros is and what it is used for
2. What you need to know before using 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 containing 200 and 300 micrograms of alprostadil in 100 mg of cream. Vitaros is used to treat erectile dysfunction (ED) in men aged 18 years and older. ED is the inability to achieve or maintain an erection sufficient for satisfactory sexual intercourse. It may be caused by various factors, for example, medications used to treat other medical conditions, poor blood circulation in the penis, nerve damage, emotional problems, excessive smoking or alcohol consumption, and hormonal imbalances. Often, ED is due to multiple causes. Treatments for ED include: switching to alternative medications if you are taking a drug that causes ED; prescription medicines; medical devices that induce erection; surgical procedures to correct blood flow in the penis; penile prosthesis; and psychological counselling. After application of Vitaros, an erection occurs within 5–30 minutes. Do not stop taking any medication unless your doctor has instructed you to do so.

2. What you need to know before using Vitaros

Do not use Vitaros

• if you suffer from conditions such as low blood pressure when moving from lying down/sitting to standing, history of heart attack and syncope (dizziness)
• if you are allergic to alprostadil or any of the excipients of this medicine (listed in section 6)
• if you have a condition that could lead to prolonged erection, or conditions such as sickle cell anemia or sickle cell trait, thrombocythemia, polycythemia, multiple myeloma, or leukemia
• if you have an abnormally shaped penis
• if you have inflammation or infection of the penis
• if you are prone to venous thrombosis
• if you have hyperviscosity syndrome, which could result in prolonged erection
• if you have been advised not to have sexual intercourse for health reasons, such as heart problems or recent stroke
• if your partner is pregnant, breastfeeding, or of childbearing age unless you use a condom.

Warnings and precautions
Consult your doctor or pharmacist before using Vitaros if you suffer or have previously suffered from any of the following local effects observed with the use of Vitaros:

• prolonged erection lasting more than 4 hours (priapism)
• symptomatic hypotension (dizziness)
• hepatic and/or renal insufficiency; dose reduction may be necessary due to metabolic alterations
• fainting

A condom must be used in the following situations:

• your partner is pregnant or breastfeeding
• your partner is of childbearing age
• to prevent sexually transmitted diseases
• during oral and anal sex

Only latex condoms have been studied; possible risks of damage to condoms made from other materials cannot be ruled out.

Other medicines and Vitaros
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The use of Vitaros in combination with other treatments for erectile dysfunction has not been studied.
Therefore, if you are taking other medications for erectile dysfunction, Vitaros should not be used concomitantly, as adverse effects such as dizziness, fainting, and prolonged erections may occur. Vitaros has not been tested in patients with penile implants or those treated with smooth muscle relaxants such as papaverine, or with drugs used to induce erection such as alpha blockers (e.g. intracavernosal phentolamine, timolol). The risk of priapism (abnormal, prolonged, painful erection) increases when used in combination.
Although not studied, the effect of Vitaros may be reduced when taken concomitantly with antihypertensive drugs, decongestants, and appetite suppressants.
If you are taking anticoagulant medications, do not take Vitaros, as the risk of urethral bleeding and hematuria may increase.
When used in combination with medications for hypertension, Vitaros may increase symptoms of dizziness and fainting, especially in elderly patients.

Pregnancy, breastfeeding and fertility
There are no data on the use of Vitaros in pregnant women. Pregnant women should not be exposed to Vitaros.
Use of Vitaros during breastfeeding is not recommended.
It is not known whether Vitaros has an effect on human male fertility.

Driving and use of machines
Vitaros may cause dizziness or fainting. Do not drive or operate machinery within 1–2 hours after administration.

3. How to use Vitaros

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Vitaros is available in two strengths containing 200 and 300 micrograms of alprostadil in 100 mg of cream. Vitaros should be used in the amount necessary to achieve an erection. Each AccuDose container of Vitaros is for single use only and must be properly disposed of after use.

For an erection: The initial dose should be recommended by a doctor. Do not change the dose on your own.
Consult your doctor, who will provide information on the correct administration technique and dose adjustment.

Do not apply Vitaros more than 2–3 times per week and no more than once within 24 hours.

The effect occurs 5–30 minutes after administration. The duration of effect is approximately 1–2 hours. However, the actual duration may vary from patient to patient.

It is recommended to urinate before applying the medicine. After removing the cap, apply the entire contents of Vitaros into the opening at the tip of the penis approximately 5–30 minutes before starting sexual intercourse, following the instructions below:

1. Wash your hands before applying Vitaros. Remove the AccuDose container from the pouch by completely tearing the seal along the middle of the top edge. Remove the AccuDose container (see Fig. 1) from the pouch. Keep the pouch to dispose of the used AccuDose container later.

Fig. 1

2. Bring the contents of the AccuDose container to room temperature by gently rolling it between your hands (see Fig. 2). This step may be omitted if the pouch was previously removed from the refrigerator (within the period specified in section 5, How to store Vitaros) and the contents have already reached room temperature.

Fig. 2

3. Rotate the plunger several times to ensure it slides easily (see Fig. 3). Then remove the cap from the tip of the single-dose container.

Fig. 3

4. With one hand, grasp the tip of the penis and gently squeeze to widen the opening at the tip of the penis, holding it in an upright position (see Fig. 4). Note: If you are uncircumcised, first retract the foreskin and hold it back while widening the opening of the penis.

Fig. 4

5. Hold the AccuDose container cylinder between your fingers without inserting it into the penis (see Fig. 5), and place the tip of the container as close as possible to the opening at the tip of the penis so that the cream flows into the urethra. Remember to push all the cream out of the AccuDose container. Slowly but firmly push down the plunger with your thumb or fingers until all the cream is expelled into the opening at the tip of the penis and along the urethra. Note: Since it is important that all the cream enters the urethra, take care not to insert the tip of the AccuDose container into the opening at the tip of the penis.

Fig. 5

6. Hold the penis in an upright position for about 30 seconds to allow the cream to penetrate. Some cream may initially remain outside the opening at the tip of the penis. Any excess cream covering the opening at the tip of the penis should be gently pushed into the opening using the fingertip (see Fig. 6). Do not use a second AccuDose container to compensate for any cream not inserted into the opening. Do not urinate immediately after application, as the medicine may be expelled before it starts to work.

Fig. 6

7. Remember that each dose of Vitaros is for a single administration only. Replace the cap on the tip of the AccuDose container, return it to the opened pouch, fold it closed, and dispose of it according to local regulations.

8. Vitaros may be irritating to the eyes. Wash your hands after applying Vitaros.

Children and adolescents
Vitaros is not intended for use in children or males under 18 years of age.

If you use more Vitaros than you should
Cases of overdose with Vitaros requiring treatment have not been reported. In case of overdose with Vitaros, hypotension, fainting, dizziness, persistent penile pain, and possible prolonged erection lasting more than 4 hours may occur. This may lead to permanent worsening of erectile function. Contact your doctor immediately if you experience any of these effects.

If you have any doubts about how to use this medicine, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vitaros can cause side effects, although not everyone experiences them.
If you have an erection lasting more than 4 hours, contact your doctor immediately.
Your doctor may reduce the dose of Vitaros or discontinue treatment.

Common side effects (may occur in more than 1 in 10 patients):
In the man:

• mild to moderate local pain, burning sensation, pain or redness of the penis,
• skin rash,
• genital itching,
• penile edema,
• inflammation of the glans (balanitis),
• tingling, throbbing, numbness, burning sensation of the penis.

In his partner:

• mild vaginal burning or itching, vaginitis.

This effect may be due to the medicine or to the act of vaginal penetration. The use of a water-based lubricant may help make vaginal penetration easier.

Uncommon but potentially serious side effects (may occur in up to 1 in 100 patients):
In the man:

• confusion/dizziness
• prolonged erection lasting more than 4 hours
• fainting
• low blood pressure or rapid heartbeat
• pain at the application site or extremity
• urethral stenosis
• increased sensitivity
• penile itching
• genital rash
• scrotal pain
• genital fullness
• loss of penile sensitivity
• urinary tract inflammation

In his partner: vulvovaginal itching
* Increased sexual/physical activity in combination with Vitaros may increase the risk of heart attack or
stroke in patients with risk factors and pre-existing diseases (see section 2).
If any of these side effects become severe, including those not listed in this leaflet, consult your doctor
or pharmacist.

Duration of side effects
Most side effects are short-lived and resolve within 1–2 hours.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. 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 reach and sight of children.
Do not use Vitaros after the expiry date stated on the carton, sachet, and on the AccuDose container label after "Exp.".
The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Sealed sachets may be stored outside the refrigerator by the patient, at a temperature below 25°C, for up to a maximum of 3 days before use.
After this period, the product must be discarded.
Each container is for single use only.
Once opened, use immediately and discard any unused portion.
Keep in the original packaging to protect the medicine from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Vitaros contains
The active substance is Alprostadil.
Each single-dose container contains 200 micrograms of alprostadil in 100 mg of cream (2 mg/g).
Each single-dose container contains 300 micrograms of alprostadil in 100 mg of cream (3 mg/g).
Vitaros is available in cardboard packs containing four (4) single-dose containers.
The excipients are: purified water; anhydrous ethanol; ethyl laurate; hydroxypropyl guar gum; dodecyl-
2-(N,N-dimethylamino)-propionate hydrochloride; potassium dihydrogen phosphate; sodium hydroxide, for
pH adjustment; phosphoric acid, for pH adjustment.

Description of the appearance of Vitaros and contents of the pack
Vitaros is a white to off-white cream supplied in a single-dose container, AccuDose. The container consists of a plunger, a cylinder, and a protective cap provided in a protective pouch.
The protective pouches are made of aluminium/laminated foil. The container components are made of polypropylene and polyethylene.

Marketing Authorization Holder
The Simple Pharma Company Limited
Ground Floor, 71 Lower Baggot St, Dublin D02 P593, Ireland

Batch release
Bracco spa
Via Caduti di Marcinelle, 13 – 20134 Milano, Italia
Alternatively, only for Vitaros 3 mg/g cream:
Dompé farmaceutici s.p.a.
Via Campo di Pile snc
67100 L'Aquila
Italy
Ferring GmbH
Wittland 11,
24109 Kiel,
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Vitaros 200 micrograms cream

Vitaros 300 micrograms cream

EFFECTS AFTER APPLICATION:
Apply Vitaros 5–30 minutes before engaging in sexual intercourse. After application, you may begin
foreplay, which helps arousal and the onset of erection. An effective dose of Vitaros should
produce an erection sufficient for sexual intercourse. The duration of effect is approximately 1–2 hours. However,
the actual duration varies from patient to patient and depends on the drug dose. Vitaros may not produce an erection
as strong as those you had when younger. Some patients may experience mild pain, a burning sensation, or pain in the penis or groin area.
Additionally, the erection may persist for some time after orgasm or ejaculation. After the erection, you may feel
a sensation of fullness, warmth, and increased sensitivity to touch above the penis. These effects are normal and may last for several hours.
ADDITIONAL INFORMATION AND PRACTICAL ADVICE:
Together with your doctor, the appropriate dose of Vitaros will be determined. If the erection cannot be maintained
for the time needed for foreplay and sexual intercourse, it may be necessary to increase the dose.
Likewise, if the erection lasts longer than desired or if side effects are poorly tolerated, a dose reduction may be required.
Contact your doctor if you think a dose adjustment may be needed.
Factors that may improve erection:

• being well rested
• sexual foreplay with your partner or self-stimulation, sitting or lying down after Vitaros application
• pelvic floor exercises, such as tightening and releasing the pelvic and gluteal muscles. These are the muscles used to stop urination
• various positions that may enhance and not restrict blood flow to the penis. Factors that may reduce erection:
• anxiety, fatigue, stress, and excessive alcohol consumption
• urinating immediately after application may cause loss of the drug.