Virirec 3 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Virirec 3 mg/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 as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Virirec is and what it is used for

2. What you need to know before using Virirec

3. How to use Virirec

4. Possible adverse effects

   1. Storage of Virirec

5. Contents of the pack and other information

1. What Vivirec is and what it is used for

Vivirec 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. Erectile dysfunction may have various causes, 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 due to more than one cause. Treatments for erectile dysfunction include changing medications, if you are taking a drug 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 counseling. After application of Vivirec, the onset of erection occurs within 5 to 30 minutes. Do not stop taking any prescribed medication unless your doctor advises you to do so.

2. What you need to know before using Virirec

Do not use Virirec

• if you have underlying conditions such as a drop in blood pressure when moving from a sitting or lying position to a standing position, history of heart attack, or 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 disorder that could cause prolonged erection or a condition such as anemia or sickle cell trait, thrombocytopenia, 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 a hyperviscosity syndrome that could cause prolonged erection.
• if you have been advised to avoid sexual activity 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 starting Virirec if you have a history of the following local effects observed with the use of Virirec:

• Prolonged erections lasting >4 hours (priapism)
• Symptomatic hypotension (dizziness)
• Hepatic and/or renal impairment; a lower dose may be required due to altered metabolism
• 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 infections
• 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 might need to take any other medicines.

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

Although not studied, Virirec may have reduced effectiveness 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 there may be an increased risk of bleeding or blood in the urine.

When used in combination with medication for high blood pressure, Virirec could 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 unknown whether Virirec has any effect on human male fertility.

Driving and using machines

Virirec may cause dizziness or fainting. Do not drive or operate machinery within 1 to 2 hours after administration.

Virirec contains ethanol

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

3. How to use Virirec

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

Virirec should be used when you need it to achieve an erection. Each Virirec AccuDose container is for single use only and must be properly discarded afterwards.

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 per 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 container (cap), apply the entire contents of Virirec into the opening at the tip of the penis within 5 to 30 minutes before attempting intercourse, following the instructions mentioned below:

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

Plunger Cylinder Tip Cap or cap

Fig.1

1. Rub the applicator between your hands so that the contents of the AccuDose container reach room temperature (see Fig. 2). This step may be avoided if the pouch is removed from the refrigerator in advance (without exceeding the time limit stated in section 5, Storage of Virirec) to allow the contents to reach room temperature.

Fig.2

1. Rotate the plunger several times to ensure it moves smoothly (see Fig. 3). Then remove the cap from the AccuDose container.

Fig.3

1. Hold the tip of the penis with one hand and gently press to widen the opening at the tip of the penis, while keeping it in an upright position (see Fig. 4). Note: if you are uncircumcised, first retract the foreskin and keep it retracted before widening the opening of the penis.

Fig.4

1. Hold the AccuDose container cylinder between your fingers and, without inserting it into the penis (see Fig. 5), bring the tip of the container as close as possible to the opening of the penis so that the cream enters the urethra (the duct connecting to the bladder that transports and expels urine and semen from the body). Remember to slowly but firmly apply all the cream from the container by pushing the plunger with your thumb or finger until all the cream is dispensed onto the opening at the tip of the penis and enters the urethra. Note: It is important that all the cream enters the urethra, but take care not to insert the tip of the AccuDose container into the opening of the penis.

Fig.5

1. Keep the penis in an upright position for approximately 30 seconds to allow the cream to penetrate. There may be a small amount of cream that initially does not fit into the opening at the tip of the penis. Any excess cream remaining around the penis should be gently pushed back into the opening using your finger (see Fig. 6). Do not use a second AccuDose container to compensate for any cream not dispensed into the opening of the penis. Do not urinate immediately after application, as this may cause the medication to be expelled and reduce its effectiveness.

Fig.6

1. Remember that each dose of Virirec is intended for single use only. Replace the closure cap on the AccuDose container and place it back into the opened pouch. Wrap 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

Overdose with Virirec requiring treatment has not been reported. However, overdose with Virirec could cause a drop in blood pressure, fainting, dizziness, persistent penile pain, and possible prolonged erection lasting more than 4 hours. This may lead to permanent damage to erectile function. Contact your doctor immediately if you experience any of these effects.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

If you achieve an erection lasting more than 4 hours, contact your doctor immediately.

Your doctor may reduce your dose of Virirec or discontinue your treatment.

Frequent adverse reactions (may affect more than 1 in 10 patients):

You:

• Mild to moderate local pain, burning or pain and redness of the penis
• Skin rash
• Genital pruritus
• Penile edema
• Inflammation of the glans (balanitis)
• Penile tingling, penile numbness, burning sensation

Your 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 facilitate vaginal penetration.

Uncommon but potentially serious adverse reactions (may affect up to 1 in 100 patients):

You:

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

Your partner: vulvovaginal pruritus

*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 any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Duration of adverse effects:

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish System of Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Virirec

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton, sachet, or label of the AccuDose container after EXP.

The expiry date refers to the last day of the month indicated.

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

Do not freeze.

Unopened sachets may be kept by the patient outside the refrigerator at a temperature below 25 °C for up to 3 days prior to use.

At the end of this period, the product must 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 to protect from light.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you are in doubt, please consult your pharmacist on how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Virirec

• The active substance is alprostadil.

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

Virirec is available in unit packs containing four (4) or twelve (12) single-dose units.

• 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 medicinal product and contents of the pack

Virirec is a cream ranging in color from white to matt white, supplied in AccuDose, a single-dose container. AccuDose is a device consisting of a plunger, a cylinder, and a protective seal cap.

Each container is supplied in a pouch for protection.

The pouches are composed of aluminum laminate/film. The packaging components are polypropylene and polyethylene.

Only certain pack 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

Manufacturers:

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:

Member State	Medicinal Product Name
Germany	Vitaros HEXAL 300 microgram/100 mg cream
United Kingdom	Vitaros 3 mg/g cream
France	Vitaros 300 micrograms cream
Spain	Virirec 3 mg/g cream
Netherlands	Vitaros 300 microgram cream

Date of the most recent review of this leaflet: May 2023

Other sources of information

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - 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 engage in sexual intercourse. After administration, sexual stimulation may be used to assist arousal and the development of an erection. An effective dose of Virirec should produce an erection sufficient for sexual intercourse. The duration of effect is approximately 1 to 2 hours. However, the actual duration may vary between patients and according to the drug dose. Virirec may not produce an erection comparable to those you experienced when younger. Some patients may experience mild pain, a burning sensation, or discomfort in the penis or groin area. Also, your erection may persist for some time after orgasm or ejaculation. After your erection ends, your penis may feel full, warm, and somewhat sensitive to 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 long enough for sexual stimulation or intercourse, you may need an increased dose. Similarly, if an erection lasts longer than desired or if adverse reactions are poorly tolerated, you may need to reduce your dose. Contact your doctor if you suspect you require a dose adjustment.

Factors that may enhance your erection:

• Feeling well rested.
• Sexual stimulation with your partner or self-stimulation when lying down or reclining after applying Virirec.
• Pelvic exercises such as tightening and relaxing the pelvic and gluteal muscles. These are the muscles you use to stop urination.
• Various positions that may favor and not restrict blood flow to the penis.

Factors that may reduce your erection:

• Anxiety, fatigue, stress, and alcohol abuse.
• Urinating immediately after application may result in loss of the medication.