Prospecto: information for theuser

Alprostadil Recordati 3 mg/g cream

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

• Keep this prospect, 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 other people 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 prospect. See section 4.

1.What isAlprostadil Recordatiand for what it is used

2.What you need to know before starting to useAlprostadil Recordati

3.How to useAlprostadil Recordati

4.Possible adverse effects

1. Storage ofAlprostadil Recordati

6.Contents of the package and additional information

Alprostadil Recordati 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 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. 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 are undergoing surgical procedures to correct blood flow to the penis, penile implants, and receive psychological help, your doctor may modify your treatment.After application ofAlprostadil Recordati, the onset of erection occurs within5 to30 minutes.

You should not stop taking any prescribed medication unless your doctor tells you to.

Do not use Alprostadil Recordati

• if you have underlying conditions such as a drop in blood pressure when changing from a seated or lying position to an upright 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 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 prolonged erection
• if you have been advised 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 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 insufficiency, a lower dose may be required due to altered metabolism.
• Weakness.

Use a condom in the following situations:

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

Only latex condoms have been studied. The effect of condoms made with other materials is unknown.

Other medications and Alprostadil Recordati

Inform your doctor or pharmacist if you are taking, have taken recently 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 take other medications for erectile dysfunction, do not combine them with Alprostadil Recordati as they may cause symptoms including dizziness, weakness and prolonged erections.Alprostadil Recordatihas 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 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 appearance of blood in urine.

When used with a medication for high blood pressure, the use of Alprostadil Recordati may increase symptoms of dizziness and weakness, 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.

The effect of Alprostadil Recordati on human male fertility is unknown.

Driving and operating machinery

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

Alprostadil Recordati 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.

Alprostadil Recordatiis available in doses of 200 and 300 micrograms of alprostadil in 100 milligrams of cream.Alprostadil Recordatimust be used when needed to achieve an erection. Each package ofAlprostadil RecordatiAccuDose is for single use and must 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 Alprostadil Recordati more than 2-3 times 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 the entire contents ofAlprostadil Recordatito the tip of the penis within5 to30 minutes before attempting intercourse following the instructions indicated below:

1. Wash your handsbeforeapplyingAlprostadil Recordati. Remove the AccuDose package from the laminated pouch by tearing the closure completely from the center to the top edge. Remove the AccuDose package (see Fig. 1) from the envelope. Save the envelope to dispose of the used AccuDose package later.

Fig. 1

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

Fig. 2

1. Turn the plunger several times ensuring 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 enlarge the tip of the penis opening, 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 enlarging the penis opening.

Fig. 4

1. Hold the AccuDose cylinder 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 tip of the penis opening so that the cream passes into the urethra. Remember to apply all the cream from the package, slowly but firmly, push the plunger with your thumb or finger until all the cream comes out of the tip of the penis and into 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 tip of 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 some cream will not fit into the tip of the penis opening initially. Any excess cream remaining around the penis should be induced back into the opening with the help of your finger (see Fig. 6). Do not use a second AccuDose package to compensate for the cream not dispensed into the tip of the penis opening. Do not urinate immediately after application due to the risk of the medication coming out and not performing its effect.

Fig. 6

1. Remember that each dose ofAlprostadil Recordatiis only suitable for a single administration. Put the cap back on to close the AccuDose package and place it in the open envelope, wrap, and dispose of it according to local regulations.

1. Alprostadil Recordatimay irritate the eyes. Wash your hands after applyingAlprostadil Recordati.

Use in children and adolescents

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

If you use more Alprostadil Recordati than you should

No overdose withAlprostadil Recordatihas been reported that requires treatment. An overdose withAlprostadil Recordatimay cause a drop in blood pressure, dizziness, nausea, 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.

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

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

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

If you get an erection that lasts more than 4 hours, contact your doctor immediately.

Your doctor may reduce your dose ofAlprostadil Recordatiand stop 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
• Skin rash
• Genital itching
• Penile edema
• Inflammation of the glans (balanitis)
• Penile tingling, numbness, or burning

Your partner:

-Mild vaginal burning or itching, vaginitis

This effect may be due to the medication or vaginal penetration. Using a water-based lubricant may facilitate vaginal penetration.

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

You:

• Dizziness or lightheadedness
• Erection lasting more than 4 hours
• Fainting
• Low blood pressure or rapid pulse
• Pain in the application area or in a limb
• Urethral stenosis
• Increased sensitivity
• Penile itching
• Genital rash
• Scrotal pain
• Genital fullness
• Lack of sensation in the penis
• Urinary tract inflammation

Your partner: vulvovaginal itching

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

Duration of side effects:

Most side effects are of short duration and resolve within1 to2 hours.

Reporting side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect not listed in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 device 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.

Medications should not be thrown down the drains or in the trash.Deposit the containers and medications that you no longer need in the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and medications that you no longer need.By doing so, you will help protect the environment.

Composition of Alprostadil Recordati

• The active ingredient is alprostadil.

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

Alprostadil Recordatiis available in unit cartons with four (4) single-dose packages.

• The other components are purified water, anhydrous ethanol, lauryl ethoxylate, 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 contents of the package

Alprostadil Recordatiis a white to off-white paste 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.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Recordati Ireland Ltd.

Raheens East

Ringaskiddy Co.Cork

Irlanda

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).

España

Responsible for manufacturing:

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

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

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

Alprostadil Recordatirequires between 5 and 30 minutes before it starts to work and before you can have sexual intercourse.

After administration, you can use sexual stimulation to help with excitement and the process of developing an erection. A successful dose ofAlprostadil Recordatishould produce a suitable 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.Alprostadil Recordatimay 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. Additionally, 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 ofAlprostadil Recordati. 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 applyingAlprostadil Recordati.

-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 loss of the medication.