Label: information for the useruser

Virirec 3 mg/g cream

Alprostadil

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1.What isVirirecand how it is used

2.What you need to know before starting to useVirirec

3.How to useVirirec

4.Possible adverse effects

1. Storage ofVirirec

6.Contents of the package and additional information

Vivirec is used to treat erectile dysfunction in men 18 years of age or older. Erectile dysfunction is the inability to achieve or maintain an adequate erection for sexual intercourse. There are several causes of erectile dysfunction including medications you may be taking for other conditions, poor blood flow to 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 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 application ofVivirec, the onset of erection occurs within5 to30 minutes. Do not stop any prescribed medication unless your doctor advises you to do so.

Do not use Virirec

• if you have underlying conditions such as a drop in blood pressure when standing up from a seated or lying position, a history of heart attack and syncope (dizziness).
• if you are allergic to alprostadil or any of the other components of this medication (listed in section 6).
• if you have a condition that could cause prolonged erection or a condition such as anemia, 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 condition of hyperviscosity that could cause 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 using 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 lasting >4 hours (priapism)
• Symptomatic hypotension (dizziness)
• Liver and/or kidney insufficiency, may require a lower dose due to altered metabolism
• Weakness

A condom should be used in the following situations:

• Pregnant or breastfeeding partner
• Partner of childbearing age
• To prevent sexually transmitted diseases.
• During oral and anal sex

Only latex condoms have been studied. The use of condoms made with other materials may be damaged.

Other medications and Virirec

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

The use of Virirec with other medications for erectile dysfunction has not been studied. Therefore, if you take other medications for erectile dysfunction, do not combine them with Virirec as they may cause symptoms including dizziness, weakness and prolonged erections.Virirechas not been evaluated for use with penile implants or smooth muscle relaxants, such as papaverine, medications used to induce erections, such as alpha blockers (e.g. fentolamine, timoxamine intracavernously). There is a risk of priapism (painful prolonged erection) when used in combination.

Although not 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 appearance of blood in urine.

When used with a medication for high blood pressure, the use of Virirec may increase symptoms of dizziness and weakness, 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 is not recommended during breastfeeding.

The effect of Virirec on human male fertility is unknown.

Driving and operating machinery

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

Virirec contains ethanol

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

For an erection:your doctor must 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 adjustment of your dose.

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

The onset of effect occurs within5 to30 minutes after administration. The effect usually lasts approximately between 1 and 2 hours. However, the actual duration may vary among patients.

It is recommended to urinate before applying the medication. After removing the cap from the package (cap), apply all the contents ofVirirecto the opening of the tip of the penis within5 to30 minutes before attempting intercourse, following the instructions mentioned below:

1.Wash your handsbeforeapplyingVirirec. Remove the AccuDose package (see Fig.1) from the envelope by tearing it completely from the center to the top edge. Save the envelope to dispose of the used AccuDose package later.

Fig.1

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

Fig.2

1. Turn the plunger several times, ensuring it slides smoothly (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 gently to expand the opening of the tip of the penis, while keeping it in an upright position (see Fig. 4). Note: if you are not circumcised, remove the foreskin first and keep it retracted before expanding 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 tube that connects with the bladder and transports and expels urine and semen out of the body). Remember to apply all the cream slowly but firmly, push 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

6.Keep the penis in an upright position for approximately 30 seconds to allow the cream to penetrate. It is likely that there will be some cream that initially does not fit into the opening of the tip of the penis. You should reintroduce into the opening any excess cream that remains around the penis with the help of your finger (see Fig.6). Do not use a second AccuDose package to compensate for the undispensed cream within the opening of the tip of the penis. Do not urinate immediately after application due to the risk of the medication coming out and not performing its effect.

Fig.6

7. Remember that each dose of Virirec is only suitable for a single administration. Place the closure cap back on the AccuDose package and deposit it inside the open envelope, wrap, and dispose of it according to local regulations

8.Virirecmay irritate the eyes. Wash your hands after applyingVirirec.

Children and adolescents

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

If you use more Virirec than you should

No overdose withVirirechas been reported that requires treatment. An overdose withVirirecmay cause a drop in blood pressure, fainting, dizziness, persistent pain in the penis, and possible prolonged erection with a duration exceeding 4 hours. This may cause permanent deterioration of erectile function.Call your doctor immediately if you experience any of these effects.

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

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

Do not use this medication after the expiration date that appears on the box, the pouch, the AccuDose container label after CAD.

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

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

Do not freeze.

The patient may keep the unopened pouches 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 dosifier is for single use.

Once opened, use immediately, discard any unused portion.

Store in the original pouch to protect it from light.

Medicines should not be thrown down the drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE collection point of the pharmacy.Ask your pharmacist how to dispose of the containers and medicines you no longer need if you are unsure. By doing so, you will help protect the environment.

Composition of Virirec

• The active principle is alprostadil.

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

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

• The other components are purified water, anhydrous ethanol, etillaureate, guar hydroxypropyl 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 contents of the package

Virirec is a white to off-white matte cream supplied in AccuDose, a single-dose package. AccuDose is a package consisting of a plunger, a cylinder, and a protective closure capsule.

Each package is supplied in a protective overwrap.

The overwraps are composed of laminated/aluminum foil. The components of the package are polypropylene and polyethylene.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Recordati Ireland Ltd.

Raheens East

Ringaskiddy Co.Cork

Irlanda

Local representative:

Casen Recordati, S.L.

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

España

Responsible for manufacturing:

Laphal Industries

Avenue de provence

13190 Allauch

Francia

Recordati Industria Chimica e Farmaceutica S.p.A.

Via M. Civitali, 1

20148 Milán

Italia

Casen Recordati, S.L.

Autovía de Logroño, km. 13,300

50180 Utebo (Zaragoza)

España

Delpharm Huningue SAS

26 rue de la Chapelle

68330 Hunningue

Francia

Centre Specialités Pharmaceutiques- Saint Amant Tallende

ZAC des Suzots; 35 rue de la Chapelle,

63450 Saint Amant Tallende, Francia

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

Last review date of this leaflet: May 2023

Other sources of information

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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EFFECTS AFTER APPLICATION

Virirec requires between 5 and 30 minutes before it starts to work and before you can have sexual intercourse. After administration, you can use sexual stimulation that helps to excite and develop an erection. A single effective dose ofVirirecshould produce an adequate erection for sexual intercourse. The duration of the effect is approximately between 1 and 2 hours. However, the actual duration will be variable between patients and the dose of the drug.Virirecmay not produce an erection comparable to those you experienced when you were younger. Some patients may experience a little mild pain, a burning sensation, and pain in the penis or inguinal area. Also, your erection may continue for some time after orgasm or ejaculation. After your erection has ended, your penis may feel full, warm, and somewhat 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 ofVirirec. If your erection cannot be maintained for the necessary time for sexual stimulation or sexual intercourse, you will need to increase the dose. 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 you need a dose adjustment.

Factors that may increase your erection:

-Feeling well rested.

-Sexual stimulation with your partner or self-stimulation when you feel or lie down after applyingVirirec.

-Kegel exercises such as tensing and relaxing the pelvic muscles and gluteal muscles. These are the muscles you use to interrupt urination.

-Several positions that may favor and not limit blood flow to the penis.

Factors that may reduce your erection:

• Anxiety, fatigue, tension, and excessive alcohol consumption.
• Urinating immediately after application may cause the loss of the medication.