Alprostadil Recordati 3 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Alprostadil Recordati 3 mg/g cream

Read the entire leaflet carefully before you start using this medicine, as 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 others, 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 they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before using Alprostadil Recordati

3. How to use Alprostadil Recordati

4. Possible side effects

5. How to store Alprostadil Recordati

6. Contents of the pack and other information

1. What Alprostadil Recordati is and what it is 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 conditions, poor blood flow to the penis, nerve damage, emotional problems, smoking or alcohol abuse, and hormonal disorders. Erectile dysfunction is often due to more than one cause. If you are taking a medication that causes erectile dysfunction, or if your doctor has prescribed medications or medical devices to produce an erection, if you undergo surgical procedures to correct blood flow to the penis, penile implants, or receive psychological counseling, your doctor may adjust your treatment. After administration of Alprostadil Recordati, erection onset occurs within 5 to 30 minutes.

Do not stop taking any prescribed medication unless instructed to do so by your doctor.

2. What you need to know before using Alprostadil Recordati

Do not use Alprostadil Recordati

• if you have underlying disorders such as low 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 Alprostadil Recordati if you have a history of the following local effects observed with the use of Alprostadil Recordati:

• Prolonged erections lasting more than 4 hours (priapism).
• Symptomatic hypotension (dizziness).
• Hepatic and/or renal impairment; 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 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 Alprostadil Recordati

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

The use of Alprostadil Recordati with other medications for erectile dysfunction has not been studied. Therefore, if you are taking other drugs for erectile dysfunction, do not combine them with Alprostadil Recordati, as this may result in symptoms including dizziness, fainting, and prolonged erections. Alprostadil Recordati 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., intracavernous phentolamine, timoloxamine). There is a risk of priapism (abnormal prolonged painful erection) when used in combination.

Although not studied, Alprostadil Recordati 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 Alprostadil Recordati, as this may increase the risk of bleeding or blood in the urine.

When used in combination with medication for high blood pressure, Alprostadil Recordati could increase symptoms of dizziness and fainting, especially in elderly patients.

Pregnancy, breastfeeding, and fertility

There are no data regarding 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 unknown whether Alprostadil Recordati has any effect on human male fertility.

Driving and use of machines

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

Alprostadil Recordati 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 Alprostadil Recordati

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

Alprostadil Recordati is available in strengths of 200 and 300 micrograms of alprostadil in 100 milligrams of cream. Alprostadil Recordati should be used when needed to achieve an erection. Each Alprostadil Recordati AccuDose container is for single use only and must be properly discarded 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 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 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 container (cap), apply the entire contents of Alprostadil Recordati to the opening at the tip of the penis within 5 to 30 minutes before attempting intercourse, following the instructions indicated below:

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

Fig. 1

1. Rub the applicator between your hands so that the contents of the single-dose package reach room temperature (see Fig. 2). This step may be avoided if the sachet is removed from the refrigerator in advance (without exceeding the time limit specified in section 5, Storage of Alprostadil Recordati) 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 package.

Fig. 3

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

Fig. 4

1. Hold the barrel 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 enters the urethra. Remember to apply all the cream from the package slowly but firmly by pushing the plunger with your thumb or finger until all the cream exits into the opening 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 package 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 be absorbed. It is possible that some cream may initially remain outside the opening of the penis. Any excess cream remaining around the penis should be gently pressed back into the opening using your finger (see Fig. 6). Do not use a second AccuDose package to compensate for any cream not dispensed into the urethral opening. 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 Alprostadil Recordati is intended for single use only. Replace the cap to close the AccuDose package, place it back into the opened sachet, wrap it, and dispose of it according to local regulations.

2. 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

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

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

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

Your doctor may reduce your dose of Alprostadil Recordati or discontinue your treatment.

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

You:

• Mild to moderate local pain, burning sensation, 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 could be due to the drug or to the act of vaginal penetration. The use of a water-based lubricant may facilitate vaginal penetration.

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

You:

• Dizziness/fainting
• Prolonged erection lasting more than 4 hours
• Collapse
• Low blood pressure or rapid pulse
• Pain at the application site or in a limb
• Urethral stenosis
• 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 Alprostadil Recordati may increase the risk of heart attack or stroke in patients with underlying disease/risk factors (see section 2).

Duration of adverse effects:

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

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

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

5. Storage of Alprostadil Recordati

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

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

The patient may keep unopened sachets 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.

After opening, 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. Dispose of unused medicines and their packaging at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alprostadil Recordati

• The active substance is alprostadil.

Each single-dose unit contains 300 micrograms of alprostadil in 100 milligrams of cream (3 mg/g).

Alprostadil Recordati is available in unit cartons containing four (4) 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

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 closure 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.

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 European Economic Area Member States under the following names:

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 of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/

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EFFECTS AFTER ADMINISTRATION

Alprostadil Recordati takes between 5 and 30 minutes to start working and for you to be able to have sexual intercourse.

After administration, you may use sexual stimulation, which helps arousal and the development of an erection. An effective dose of Alprostadil Recordati 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. Alprostadil Recordati may not produce an erection comparable to those you experienced when you were younger. Some patients may experience mild pain, a burning sensation, or pain in the penis or inguinal 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 Alprostadil Recordati. If your erection cannot be maintained long enough for sexual stimulation or intercourse, you may need a higher 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 need a dose adjustment.

Factors that may enhance your erection:

• Feeling well rested.
• Sexual stimulation with your partner or self-stimulation when sitting or lying down after administration of Alprostadil Recordati.
• Pelvic exercises such as tightening and relaxing 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 administration may result in loss of the medication.