Leaflet: information for the user

Sildenafilo Aristo 100 mg film-coated tablets EFG

Read this leaflet carefully before you start taking 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, consult your doctor or pharmacist.
  • This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Sildenafilo Aristo is and what it is used for

2. What you need to know before you start taking Sildenafilo Aristo

3. How to take Sildenafilo Aristo

4. Possible side effects

5. Storage of Sildenafilo Aristo

6. Contents of the pack and additional information

Sildenafilo Aristo, contains the active ingredient sildenafilo, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels of the penis, allowing blood to flow when sexually stimulated. Sildenafilo Aristo will only help you get an erection if you are sexually stimulated.

Sildenafilo Aristo is indicated for the treatment of erectile dysfunction in adult men, sometimes referred to as impotence. This occurs when a man cannot obtain or maintain a firm erection of the penis, suitable for a satisfactory sexual activity.

Do not take Sildenafilo Aristo

• If you are using certain medications called nitrates, as the combination may cause a potentially dangerous drop in your blood pressure. Consult your doctor if you are using any of these medications, which are often used to relieve chest pain (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
• If you are using any of the medications called nitric oxide donors such as amyl nitrite ("poppers"), as the combination may cause a potentially dangerous drop in your blood pressure.
• If you are allergic (hypersensitive) to sildenafilo or to any of the other components of Sildenafilo.
• If you are taking riociguat. This medication is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by clots). PDE5 inhibitors, such as Sildenafilo, have shown to increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.
• If you have a severe heart or liver problem.
• If you have recently had a stroke or heart attack, or if you have low blood pressure.
• If you have a rare hereditary eye disorder (such as retinitis pigmentosa).
• If you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sildenafilo Aristo.

Inform your doctor:

• If you have sickle cell anemia (a blood disorder), leukemia (cancer of the blood cells), or multiple myeloma (cancer of the bone marrow)
• If you have a penile deformity or Peyronie's disease.
• If you have heart problems. In this case, your doctor must carefully check if your heart can withstand the additional effort of having sex.
• If you have a current stomach ulcer or bleeding problems (such as hemophilia).
• If you experience a sudden decrease or loss of vision, stop taking Sildenafilo Aristo and contact your doctor immediately.

Do not take Sildenafilo simultaneously with any other oral or local treatment for erectile dysfunction.

Do not take Sildenafilo with treatment for pulmonary arterial hypertension (PAH) that contains sildenafilo or any other PDE5 inhibitor.

Do not take Sildenafilo if you do not have erectile dysfunction.

The use of Sildenafilo is not indicated in women

Children and adolescents

The use of Sildenafilo is not indicated in individuals under 18 years old.

Special considerations in patients with renal or hepatic impairment

You must inform your doctor if you have kidney or liver problems. Your doctor may decide to reduce your dose.

Other medications and Sildenafilo Aristo

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

Sildenafilo tablets may interact with some medications, especially those used to treat chest pain. In case of a medical emergency, you must inform any healthcare professional that you are taking Sildenafilo and when you took it. Do not take Sildenafilo with other medications unless your doctor advises you to.

Do not take Sildenafilo if you are taking medications called nitrates, as the combination of these products may cause a potentially dangerous drop in your blood pressure. Always inform your doctor or pharmacist if you are taking any of these medications, which are often used to relieve chest pain (or "chest pain").

Do not take Sildenafilo if you are taking medications called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these products may also cause a potentially dangerous drop in your blood pressure.

Inform your doctor or pharmacist if you are taking riociguat

If you are taking medications known as protease inhibitors, such as those used to treat HIV, your doctor may recommend that you start treatment with the lowest dose (25 mg) of Sildenafilo.

Some patients taking an alpha-blocker, a medication used to treat high blood pressure or benign prostatic hyperplasia, may experience dizziness or lightheadedness that may be caused by a drop in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking Sildenafilo with alpha-blockers. This is more likely to occur in the 4 hours following Sildenafilo intake. To reduce the likelihood of these symptoms, you should be receiving your daily dose of the alpha-blocker regularly before starting Sildenafilo. Your doctor may recommend that you start treatment with the lower dose (25 mg) of Sildenafilo.

Inform your doctor if you are taking medications that contain sacubitril/valsartan, used to treat heart failure.

Taking Sildenafilo Aristo with food, drinks, and alcohol

Sildenafilo can be taken with or without food. However, you may notice that Sildenafilo Aristo takes a little longer to take effect if taken with a large meal.

Consuming alcohol may temporarily impair your ability to achieve an erection. Therefore, to get the maximum benefit from the medication, it is recommended not to consume large amounts of alcohol before taking Sildenafilo.

Pregnancy and breastfeeding

.

The use of Sildenafilo is not indicated in women.

Driving and operating machinery

Sildenafilo may cause dizziness and affect vision. You should know how you react to Sildenafilo before driving vehicles or operating machinery.

Sildenafilo Aristo contains sodium

This medication contains less than 23 mg of sodium (1mmol) per tablet, which is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. The usual starting dose is 50 mg.

Do not take Sildenafilo Aristo 100 mg film-coated tablets more than once a day.

Take Sildenafilo Aristo approximately one hour before planning to have sexual intercourse. Swallow the tablet whole with a glass of water.

If you estimate that the effect of Sildenafilo Aristo is too strong or too weak, inform your doctor or pharmacist.

Sildenafilo Aristo will only help you achieve an erection if you are sexually stimulated. The time it takes for Sildenafilo Aristo to take effect varies from person to person, generally ranging from half an hour to one hour. The effect of Sildenafilo Aristo may be delayed if taken with a large meal.

If Sildenafilo Aristo does not help you achieve an erection or if the erection does not last long enough to complete sexual intercourse, consult your doctor.

If you take more Sildenafilo Aristo than you should

You may experience an increase in side effects and their severity. Doses above 100 mg do not increase efficacy.

Contact your doctor or pharmacist, or call the Toxicological Information Service, phone 91 562 94 29, indicating the medication and the amount taken.

Do not take more tablets than recommended by your doctor.

Contact your doctor if you have taken more tablets than advised.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

The side effects reported associated with the use of Sildenafilo are generally mild to moderate in intensity and of short duration.

If you experience chest pain during or after sexual activity:

• Take a semi-recumbent position and try to relax
• Do not use nitratesto treat your chest pain
• Contact your doctor immediately

All medicines, including Sildenafilo, can cause allergic reactions. You should contact your doctor immediately if you experience any of the following symptoms after taking Sildenafilo: sudden hissing sound while breathing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat. This occurs infrequently

There have been reported cases of prolonged and sometimes painful erections after taking Sildenafilo. If you have an erection that lasts more than 4 hours, you must contact your doctor immediately. This occurs rarely

If you experience a sudden decrease or loss of vision, stop taking Sildenafilo and contact your doctor immediately. This occurs rarely

The most frequent side effect (may affect more than 1 in 10 patients)is headache.

Frequent side effects(may affect up to 1 in 10 patients) include: nausea, facial flushing, warmth (including symptoms such as sudden heat sensation in the upper body) indigestion, effects on vision (including abnormal color perception, light sensitivity, or blurred or decreased visual acuity), nasal congestion, and dizziness.

Infrequent side effects(may affect up to 1 in 100 patients) include: vomiting, skin rash, bleeding in the back of the eye, eye irritation, eye discharge/ red eyes, eye pain, double vision, abnormal sensation in the eye, watery eyes, irregular or rapid heartbeat, muscle pain, feeling drowsy, reduced tactile sensation, vertigo, ringing in the ears, nausea, dry mouth, chest pain, feeling tired, bleeding from the penis, presence of blood in semen and/or urine.

Rare side effects(may affect up to 1 in 1,000 patients) include: high blood pressure, low blood pressure, fainting, stroke, nasal bleeding, sudden hearing loss, and heart attack.

The side effects reported from post-marketing experience include: palpitations, chest pain, sudden death, or transient decrease in blood flow to some parts of the brain. Most, but not all, had pre-existing heart problems before taking this medicine. It is not possible to determine if these events were directly related to Sildenafilo. Also, cases of seizures or crises and severe skin reactions that include blistering, skin peeling, and pain requiring immediate medical attention have been reported.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: htpps://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.

No special storage conditions are required.

Do not use Sildenafilo Aristo after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Sildenafilo Aristo 100 mg film-coated tablets

• The active ingredient is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate). The other components are: calcium dihydrogen phosphate, microcrystalline cellulose, colloidal silica, magnesium stearate, croscarmellose sodium, hypromellose, titanium dioxide (E 171), polyethylene glycol 6000 (macrogol 6000), talc, and carmine lake of indigo (E 132).

Appearance of the product and content of the packaging

Each Sildenafilo Aristo 100 mg film-coated tablet contains 100 mg of sildenafil (as citrate).

Sildenafilo Aristo 100 mg film-coated tablets are blue, elongated, and printed.

Sildenafilo Aristo 100 mg film-coated tablets are presented in a blister pack containing 4, 8, and 12 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer:

Marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26 28850, Torrejón de Ardoz

Madrid. Spain

Responsible manufacturer:

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid, Spain

Or

Laboratorios Liconsa, S.A.

Avenida Miralcampo, 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares – Guadalajara, Spain

Last review date of this leaflet: January 2023

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