ALPROSTADIL RECORDATI 3 mg/g CREAM

Introduction

Leaflet: information for theuser

Alprostadil Recordati 3 mg/g cream

Read the entire leaflet carefully before starting to use this medication, 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 medication 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 Alprostadil Recordati and what is it used for
2. What you need to know before starting to use Alprostadil Recordati
3. How to use Alprostadil Recordati
4. Possible side effects
   1. Storage of Alprostadil Recordati

1. Package contents and additional information

1. What is Alprostadil Recordati and what is it used for

Alprostadil Recordati 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. If you are taking a medication that causes erectile dysfunction, if your doctor has prescribed medications or medical devices that produce an erection, if you undergo surgical procedures to correct blood flow to the penis, penile implants, and receive psychological help, your doctor may modify your treatment. After applying Alprostadil Recordati, 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 starting to use Alprostadil Recordati

Do not use Alprostadil Recordati

• 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 medication (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 Alprostadil Recordati if you have a history of the following local effects that have been observed with the use of Alprostadil Recordati:

• Prolonged erections lasting more than 4 hours (priapism).
• Symptomatic hypotension (dizziness).
• Liver and/or kidney failure, 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 not known if condoms made from other materials could be damaged.

Other medications and Alprostadil Recordati

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

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

Although it has not been studied, it is possible that Alprostadil Recordati 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 Alprostadil Recordati, 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 Alprostadil Recordati may increase symptoms of dizziness and fainting, especially in elderly patients.

Pregnancy, breastfeeding, and fertility

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

The use of Alprostadil Recordati is not recommended during breastfeeding.

It is not known if Alprostadil Recordati has any effect on human male fertility.

Driving and using machines

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

Alprostadil Recordati contains ethanol

This medication 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 Alprostadil Recordati

Follow your doctor's instructions for administering this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Alprostadil Recordati is available in doses of 200 and 300 micrograms of alprostadil in 100 milligrams of cream. Alprostadil Recordati should be used as needed to achieve an erection. Each AccuDose container 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 Alprostadil Recordati 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 medication. After removing the cap from the container, apply the entire contents of Alprostadil Recordati to the opening of the penis tip within 5 to 30 minutes before attempting intercourse, following the instructions below:

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

Fig. 1

1. Rub the applicator between your hands so that the contents of the single dose container 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 Storage of Alprostadil Recordati) 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 container.

Fig. 3

1. Take the tip of the penis with one hand and press it slightly to enlarge the opening of the penis tip, 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 enlarging the penis opening.

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 tip so that the cream passes into the urethra. Remember to apply all the cream from the container, slowly but firmly, push the plunger with your thumb or finger until all the cream comes out of the penis opening and enters the urethra. Note: It is essential that all the cream enters the urethra, but be careful not to insert the tip of the AccuDose container into the penis opening.

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 penis opening. Any excess that remains around the penis should be pushed back into the opening with the help of a finger (see Fig. 6). Do not use a second AccuDose container to compensate for the cream not dispensed into the penis opening. Do not urinate immediately after application due to the risk of the medication coming out and not taking effect.

Fig. 6

1. Remember that each dose of Alprostadil Recordati is suitable only for a single administration. Put the cap back on the AccuDose container and place it in the opened envelope, wrap it, and dispose of it according to local regulations.

1. Alprostadil Recordati may irritate the eyes. Wash your hands after applying Alprostadil Recordati.

Use in children and adolescents

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

If you use more Alprostadil Recordati than you should

There have been no reports of overdose with Alprostadil Recordati that require treatment. Overdose with Alprostadil Recordati could cause a drop in blood pressure, fainting, dizziness, persistent pain in the penis, and possible prolonged erection lasting more than 4 hours. This may cause permanent damage to erectile function. Call your doctor immediately if you experience any of these effects.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

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

Your doctor may reduce your dose of Alprostadil Recordati or 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 medication or the act of vaginal penetration. The use of a water-based lubricant may facilitate vaginal penetration.

Uncommon but potentially serious side effects (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 in the application area or in a limb
• Urethral stricture
• Increased sensitivity
• Penile itching
• Genital rash
• Scrotal pain
• Genital fullness
• Lack of penile sensation
• Urinary tract inflammation

Your partner: vulvovaginal itching

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

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 Medication Surveillance System for Human Use: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Alprostadil Recordati

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

Do not use this medication after the expiration date shown on the box, envelope, or 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 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 dispenser is for single use only.

Once opened, use immediately and discard any unused portion.

Store in the original envelope to protect it from light.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Alprostadil Recordati

• The active ingredient is alprostadil.

Each individual container contains 300 micrograms of alprostadil in 100 milligrams of cream (3mg/g).

Alprostadil Recordati is available in single-unit boxes with four (4) 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 Contents

Alprostadil Recordati 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.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Recordati Ireland Ltd.

Raheens East

Ringaskiddy Co. Cork

Ireland

Tel. +353 (0) 21 4379 400

Fax +353 (0) 21 4379 2800

Local Representative:

Casen Recordati, S.L.

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

Spain

Manufacturer:

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

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

Alprostadil Recordati requires between 5 and 30 minutes to start working and before you can have sexual intercourse.

After administration, you can use sexual stimulation that helps with arousal and the development of an erection. An effective dose of Alprostadil Recordati 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 drug. Alprostadil Recordati may not produce an erection comparable to those experienced when you were younger. Some patients may experience a little 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, hot, 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 Alprostadil Recordati. 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 Alprostadil Recordati.
• 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.