VITAROS 3 mg /G Крем

Содержание инструкции

1. Vitaros 200 micrograms cream, 300 micrograms cream
   1. What is Vitaros and what is it 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. Package contents and other information

Vitaros 200 micrograms cream, 300 micrograms cream

Alprostadil

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 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 is Vitaros and what is it used for

Vitaros is available in two dosages of 200 and 300 micrograms of alprostadil in 100 mg of cream. Vitaros is
used to treat erectile dysfunction (ED) in men aged 18 years or over. ED is
the inability to achieve or maintain an erection sufficient to allow for satisfactory sexual intercourse.
It can be caused by various factors, such as the medicines you are taking for the treatment
of other conditions, poor blood circulation in the penis, nerve damage, emotional problems, from
excessive smoking or alcohol consumption and hormonal problems. Often ED is due to multiple causes. Treatments for ED
include: switching to other medicines if you are taking a drug that causes ED; prescribing medicines; medical devices that induce an erection; surgical interventions to correct the
blood flow in the penis; penile prostheses and psychological counseling. After application of Vitaros the erection
appears within 5-30 minutes. Do not stop taking any medications unless your doctor has told 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/sitting to an upright position, a 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 suffer from a condition that could lead to a long-lasting erection or a condition such as sickle cell anemia or sickle cell trait, thrombocytosis, 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 suffer from hyperviscosity syndrome which could result in a long-lasting erection
• if you have been told not to have sexual intercourse for health reasons, such as heart problems or a recent stroke
• if your partner is pregnant, breastfeeding or is of childbearing potential unless they use a condom.

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

• prolonged erection lasting more than 4 hours (priapism)
• symptomatic hypotension (dizziness)
• hepatic and/or renal insufficiency, a dose reduction may be necessary following metabolic changes
• fainting

A condom must 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 and anal sex

Only latex condoms have been studied, any risks of damage to condoms made of other materials cannot be excluded.

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, in combination with other treatments for erectile dysfunction, has not been studied.
Therefore, if you are taking other medicines for erectile dysfunction, Vitaros should not be used in
combination because adverse effects may occur including dizziness, fainting and prolonged erections. Vitaros has not been tested in patients with penile implant or treated with smooth muscle relaxants such as papaverine or with medicines used to induce erection such as alpha
blockers (e.g. intracavernous phentolamine, thymoxamine). The risk of priapism (abnormal prolonged painful erection) increases when used in combination.
Although not studied, it is possible that the effect of Vitaros may decrease if taken in
combination with antihypertensive drugs, decongestants and appetite suppressants.
If you are taking anticoagulant drugs, do not take Vitaros, the risk of urethral bleeding and
hematuria may increase.
In combination with medicines for hypertension, the use of Vitaros may increase the symptoms of dizziness and
fainting, especially in the elderly.

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

Driving and operating machinery
Vitaros can cause dizziness or fainting. Do not drive or operate machinery within 1 – 2 hours of
administration.

3. How to use Vitaros

Use this medicine following the instructions of your doctor exactly, always. If you have any doubts, consult your doctor
or pharmacist.
Vitaros is available in two dosages of 200 and 300 micrograms of alprostadil in 100 mg of cream. Vitaros
must be used in the amount necessary to achieve an erection. Each AccuDose container of
Vitaros is for single use and must be disposed of correctly 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 give you information on the correct technique for administration and adjustment
of the dose.

Do not apply Vitaros more than 2-3 times a week and no more than once within 24 hours.
The effect appears 5-30 minutes after administration. The duration of the effect is approximately 1-2 hours. However,
the actual duration varies from patient to patient.
It is recommended to urinate before applying the medicine. After removing the cap, apply all of the
contents of Vitaros into the opening at the tip of the penis about 5-30 minutes before starting sexual intercourse
following the instructions below:

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

Fig. 1

• 2) Bring the contents of the AccuDose container to room temperature by rubbing it between your hands (see Fig. 2). This step can be avoided if the sachet has been removed from the refrigerator previously (within the period indicated 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 can slide easily (see Fig. 3).

Then remove the cap from the tip of the single-dose container.

Fig. 3

• 4) Hold the tip of the penis with one hand and gently squeeze it to widen the opening at the tip of the penis, keeping it in an upright position (see Fig. 4). Note, if uncircumcised, first pull back the foreskin and hold it in that position while subsequently widening the opening of the penis.

Fig. 4

• 5) Hold the cylinder of the AccuDose container between your fingers and without inserting it into the penis(see Fig. 5), position the tip of the container as close as possible to the opening at the tip of the penis so that the cream runs into the urethra. Remember to push all the cream from the AccuDose container. Slowly, but firmly, push down on 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 goes into the urethra, be careful not to insert the tip of theAccuDose 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. There will probably be some cream that initially does not enter the opening at the tip of the penis. All excess cream covering the opening at the tip of the penis must be pushed into the opening with the tip of a finger (see Fig. 6). Do not use a second AccuDose container to compensate for cream not introduced into the opening at the tip of the penis. Do not urinate immediately after application, the medicine may come out before the effect begins.

Fig. 6

• 7) Remember that each dose of Vitaros is for a single application only. Replace the cap on the tip of the AccuDose container and put it back in the open sachet, fold and dispose of in accordance with local regulations.
• 8) Vitaros may be irritating to the eyes. Wash your hands after applying Vitaros.

Children and adolescents
Vitaros is not indicated for children or men under the age of 18.

If you use more Vitaros than you should
No cases of overdose with Vitaros requiring treatment have been reported. In case of
overdose with Vitaros, hypotension, fainting, dizziness, persistent pain in the
penis and possible prolonged erection lasting more than 4 hours may occur. This may cause permanent
worsening of erectile function. Contact your doctor immediately if you experience any of these
effects.
If you have any doubts about using this medicine, contact your doctor or pharmacist.

4. Possible side effects

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

If you have an erection lasting longer than 4 hours, contact your doctor immediately.
The doctor may reduce the dose of Vitaros and stop the treatment.
Common side effects (may affect more than 1 in 10 people):

In men:

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

In your partner:

• mild vaginal burning or itching, vaginitis.

This effect may be due to the medicine or the act of vaginal penetration. Using a
water-based lubricant may help make vaginal penetration easier.
Uncommon side effects, but potentially serious (may affect up to 1 in 100 people):

In men:

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

In your 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 effects become severe, including those not listed in this leaflet, tell your doctor

or pharmacist.

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 that is stated on the carton, sachet and on the
AccuDose container label after Expiry.
The expiry date refers to the last day of that month.
Store in a refrigerator (2° C - 8° C).
Do not freeze.
Sealed sachets can be stored outside the refrigerator by the patient, at a temperature
below 25° C for a maximum of 3 days before use.
After this period, the product must be discarded.
Each container is for single use.
Once opened, use it immediately and discard any unused portion.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Vitaros contains
The active ingredient 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 boxes 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; dipotassium hydrogen phosphate; sodium hydroxide, for
pH adjustment; phosphoric acid, for pH adjustment.

Description of Vitaros and package contents
Vitaros is a cream ranging in colour from white to ivory white supplied in a single-dose container, AccuDose. The
container consists of a plunger, a cylinder and a protective cap supplied in a protective
sachet.
The protective sachets are made of an aluminium/laminate foil. The container parts are
made of polypropylene and polyethylene.

Marketing Authorisation 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, Italy
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 authorised in the Member States of the European Economic Area under the following
denominations:
Vitaros 200 micrograms cream

Vitaros 300 micrograms cream

_________________________________________________________________________________

EFFECTS AFTER APPLICATION:
Apply Vitaros 5-30 minutes before having sexual intercourse. After application, you can begin
foreplay, which helps with excitement and the onset of an erection. An effective dose of Vitaros should
produce an erection sufficient for sexual intercourse. The duration of the effect is approximately 1-2 hours. However,
the actual duration varies from patient to patient and depending on the dose of the drug. Vitaros may not produce an erection
as you had when you were younger. Some patients may experience some mild pain, a
burning sensation and pain in the penis or groin. Also, the erection may continue for a
certain time after orgasm or ejaculation. After the erection, you may feel a sense of
fullness, warmth and some sensitivity to the touch above the penis. These effects are normal and may last for a few hours.

FURTHER INFORMATION AND PRACTICAL TIPS:
Together with your doctor, you will determine the appropriate dose of Vitaros. If the erection cannot be maintained
for the time necessary for foreplay and sexual intercourse, it may be necessary to increase the dose.
Similarly, if the erection lasts longer than desired or if the side effects are not well
tolerated, a dose reduction may be necessary. Call your doctor if you think a dose adjustment may be needed.

Factors that can improve the erection:

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