VIRIREC 3mg/g CREAM

Introduction

Leaflet: information for theuser

Virirec 3 mg/g cream

Alprostadil

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Virirec and what is it used for
2. What you need to know before taking Virirec
3. How to use Virirec
4. Possible side effects
   1. Storage of Virirec

1. Package contents and additional information

1. What is Virirec and what is it used for

Virirec is used to treat erectile dysfunction in men aged 18 years or older. Erectile dysfunction is the inability to achieve or maintain an erection sufficient for sexual intercourse. There are several causes of erectile dysfunction, including medications you may be taking for other disorders, poor blood circulation in the penis, nerve damage, emotional problems, smoking, or alcohol abuse, and hormonal problems. Often, erectile dysfunction is attributable to more than one cause. Treatments for erectile dysfunction include changing medications if you are taking a medication that causes erectile dysfunction, prescribing medications or medical devices that produce an erection, surgical procedures to correct blood flow to the penis, penile implants, and psychological help. After applying Virirec, the onset of erection occurs within 5 to 30 minutes. Do not stop taking any prescribed medication unless your doctor tells you to.

2. What you need to know before taking Virirec

Do not use Virirec

• if you have underlying conditions such as a drop in blood pressure when changing from a sitting or lying position to a standing position, a history of heart attack, and syncope (dizziness).
• if you are allergic to alprostadil or any of the other components of this medicine (listed in section 6).
• if you have a condition that could cause a prolonged erection or a condition such as anemia or sickle cell trait, thrombocytopenia, polycythemia, or 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 a hyperviscosity syndrome that could cause a prolonged erection
• if you have been told to avoid sex for health reasons, such as heart problems or a 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 starting to take Virirec if you have a history of the following local effects that have been observed with the use of Virirec:

• Prolonged erections for more than 4 hours (priapism)
• Symptomatic hypotension (dizziness)
• Hepatic and/or renal insufficiency; a lower dose may be required due to altered metabolism
• Fainting

A condom should 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. It is unknown whether condoms made from other materials could be damaged.

Other medicines and Virirec

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine.

The use of Virirec with other drugs for the treatment of erectile dysfunction has not been studied. Therefore, if you are taking other drugs for erectile dysfunction, do not combine them with Virirec, as signs may appear, including dizziness, fainting, and prolonged erections. Virirec has not been evaluated for use with penile implants or smooth muscle relaxants, such as papaverine, drugs used to induce erections, such as alpha-blocker drugs (e.g., phentolamine, thymoxamine by intracavernous route). There is a risk of priapism (painful abnormal prolonged erection) when used in combination.

Although it has not been studied, it is possible that Virirec may have less effect when used in combination with treatments for high blood pressure, decongestants, and appetite suppressants.

If you are taking medications to prevent blood clots, do not use Virirec, as it may increase the risk of bleeding or blood in the urine.

In combination with a medication for high blood pressure, the use of Virirec may increase symptoms of dizziness and fainting, especially in elderly patients.

Pregnancy, breastfeeding, and fertility

There are no data on the use of Virirec in pregnant women. Pregnant women should not be exposed to Virirec.

The use of Virirec during breastfeeding is not recommended.

It is not known whether Virirec has any effect on human male fertility.

Driving and using machines

Virirec may make you feel dizzy or faint. Do not drive or use machines for 1 to 2 hours after administration.

Virirec contains ethanol

This medicine contains 5 mg of alcohol (ethanol) per 100 mg dose, which is equivalent to 50 mg/g (5% w/w). It may cause a burning sensation on damaged skin.

3. How to use Virirec

Follow the administration instructions for this medicine exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Virirec should be used when needed to achieve an erection. Each Virirec AccuDose package is for single use only and should be disposed of properly after use.

For an erection:your doctor should recommend the initial dose. Do not adjust the dose on your own.Consult your doctor, who will instruct you on the proper technique for administration and dose adjustment.

Do not use Virirec more than 2-3 times a week and only once within a 24-hour period.

The onset of effect occurs within 5 to 30 minutes after administration. The effect usually lasts approximately 1 to 2 hours. However, the actual duration may vary between patients.

It is recommended to urinate before applying the medicine. After removing the cap from the package (cap), apply the entire contents of Virirec to the opening of the tip of the penis within 5 to 30 minutes before attempting intercourse, following the instructions below:

1. Wash your hands before applying Virirec. Remove the AccuDose package (see Fig.1) from the envelope by tearing the seal completely from the center to the top edge. Keep the envelope to dispose of the used AccuDose package later.

Fig.1

1. Rub the applicator between your hands so that the contents of the package reach room temperature (see Fig. 2). This step can be avoided if the envelope is removed from the refrigerator with some time in advance (do not exceed the established limit in section 5 Conservation of Virirec) so that the contents reach room temperature.

Fig.2

1. Turn the plunger several times, making sure it slides easily (see Fig.3). Then, remove the cap from the AccuDose package.

Fig.3

1. Take the tip of the penis with one hand and press it slightly to widen the opening of the tip of the penis, while keeping it in a vertical position (see Fig. 4). Note: If you are not circumcised, first retract the foreskin and keep it retracted before widening the opening of the penis.

Fig.4

1. Hold the cylinder of the AccuDose package between your fingers and, without inserting it into the penis (see Fig.5), bring the tip of the package as close as possible to the opening of the penis so that the cream passes into the urethra (the duct that connects with the bladder and transports and expels urine and semen out of the body). Remember to apply all the cream from the package slowly but firmly, pushing the plunger with your thumb or finger until all the cream comes out of the opening of the tip of the penis and enters the urethra. Note: It is essential that all the cream passes into the urethra, but be careful not to insert the tip of the AccuDose package into the opening of the tip of the penis.

Fig.5

1. Keep the penis in an upright position for approximately 30 seconds to allow the cream to penetrate. It is likely that there will be a little cream that initially does not fit into the opening of the tip of the penis. Any excess cream that remains around the penis should be reintroduced into the opening with the help of a finger (see Fig.6). Do not use a second AccuDose package to compensate for the cream not dispensed into the opening of the tip of the penis. Do not urinate immediately after application due to the risk of the medicine coming out and not taking effect.

Fig.6

1. Remember that each dose of Virirec is suitable only for a single administration. Put the cap back on the AccuDose package and place it in the opened envelope, wrap it, and dispose of it according to local regulations
2. Virirec may irritate the eyes. Wash your hands after applying Virirec.

Children and adolescents

Virirec is not indicated for use in children or individuals under 18 years of age.

If you use more Virirec than you should

No cases of overdose with Virirec that require treatment have been reported. Overdose with Virirec could cause a drop in blood pressure, fainting, dizziness, persistent pain in the penis, and possible prolongation of the erection with a duration of more than 4 hours. This may cause permanent damage to erectile function. Call your doctor immediately if you experience any of these effects.

If you have any doubts, consult your doctor or pharmacist.

4. Possible side effects

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

If you achieve a prolonged erection of more than 4 hours, contact your doctor immediately.

Your doctor may reduce your dose of Virirec and interrupt your treatment.

Common side effects (may affect more than 1 in 10 patients):

You:

• Mild to moderate local pain, burning, or redness of the penis
• Rash
• Genital itching
• Penile edema
• Inflammation of the glans (balanitis)
• Penile tingling, numbness, burning

Your partner:

-Mild burning or itching of the vagina, vaginitis

This effect could be due to the drug or the act of vaginal penetration. The use of a water-based lubricant could facilitate vaginal penetration.

Uncommon but potentially serious side effects (may affect up to 1 in 100 patients):

You:

• Dizziness/fainting
• Prolonged erection for more than 4 hours
• Fainting
• Low blood pressure or rapid pulse
• Pain in the application area or in a limb
• Urethral stricture
• Increased sensitivity
• Penile itching
• Genital rash
• Scrotal pain
• Genital fullness
• Lack of penile sensation
• Inflammation of the urinary tract

Your partner:vulvovaginal itching

*Increased sexual/physical activity in combination with Virirec may increase the risk of heart attack or stroke in patients with underlying disease/risk factors (see section 2).

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

Duration of side effects:

Most effects are short-lived and resolve within 1 to 2 hours.

Reporting side effects

If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Virirec

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the carton, envelope, or label of the AccuDose package after CAD.

The expiration date is the last day of the month indicated.

Store in a refrigerator (between 2°C and 8°C).

Do not freeze.

The patient may keep unopened envelopes outside the refrigerator, at a temperature below 25°C, for up to 3 days before use.

At the end of this period, the product must be discarded if not used.

Each dose is for single use only.

Once opened, use immediately; discard any unused portion.

Store in the original envelope to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Place the packages and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Virirec

• The active ingredient is alprostadil.

Each individual container contains 300 micrograms of alprostadil in 100 mg of cream.

Virirec is available in single-unit boxes with four (4) or twelve (12) single-dose containers.

• The other components are purified water, anhydrous ethanol, ethyl laurate, hydroxypropyl guar gum, dodecyl-2-N,N-dimethylaminopropionate hydrochloride, potassium dihydrogen phosphate, sodium hydroxide for pH adjustment, phosphoric acid for pH adjustment.

Appearance of the Product and Container Content

Virirec is a white to off-white cream supplied in AccuDose, a single-dose container. AccuDose is a container consisting of a plunger, a cylinder, and a protective cap.

Each container is supplied in a pouch for protection.

The pouches are composed of laminated/aluminum film. The container components are polypropylene and polyethylene.

Only some container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing authorization holder:

Recordati Ireland Ltd.

Raheens East

Ringaskiddy Co. Cork

Ireland

Local representative:

Casen Recordati, S.L.

Autovía de Logroño, km. 13,300. 50180 Utebo (Zaragoza).

Spain

Manufacturer:

Laphal Industries

Avenue de provence

13190 Allauch

France

Recordati Industria Chimica e Farmaceutica S.p.A.

Via M. Civitali, 1

20148 Milan

Italy

Casen Recordati, S.L.

Autovía de Logroño, km. 13,300

50180 Utebo (Zaragoza)

Spain

Delpharm Huningue SAS

26 rue de la Chapelle

68330 Hunningue

France

Centre Specialités Pharmaceutiques - Saint Amant Tallende

ZAC des Suzots ; 35 rue de la Chapelle,

63450 Saint Amant Tallende, France

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

Date of the last revision of this leaflet: May 2023

Other sources of information

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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EFFECTS AFTER APPLICATION

Virirec requires between 5 and 30 minutes to start working and before you can have sexual intercourse. After administration, you can use sexual stimulation to help with arousal and the development of an erection. An effective dose of Virirec should produce an adequate erection for sexual intercourse. The duration of the effect is approximately between 1 and 2 hours. However, the actual duration will vary between patients and the dose of the medication. Virirec may not produce an erection comparable to those experienced when you were younger. Some patients may experience mild pain, a stinging sensation, and pain in the penis or groin area. Similarly, your erection may continue for some time after orgasm or ejaculation. After your erection has ended, your penis may feel full, warm, and slightly sensitive to the touch. These effects are normal and may last for a few hours.

ADDITIONAL INFORMATION AND PRACTICAL ADVICE

You and your doctor will determine the appropriate dose of Virirec. If your erection cannot be maintained for the necessary time for sexual stimulation or intercourse, you will need a dose increase. Similarly, if an erection lasts longer than desired or if adverse reactions are not well tolerated, you will need to reduce your dose. Call your doctor if you suspect that you need a dose adjustment.

Factors that may increase your erection:

• Feeling well-rested.
• Sexual stimulation with your partner or self-stimulation when you are sitting or lying down after applying Virirec.
• Pelvic exercises such as tensing and relaxing the pelvic and gluteal muscles. These are the muscles you use to interrupt urination.
• Various positions that can favor and do not limit blood flow to the penis.

Factors that may reduce your erection:

• Anxiety, fatigue, tension, and alcohol abuse.
• Urination immediately after application may cause loss of the medication.