Sildenafil Aristo 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sildenafil Aristo 50 mg film-coated tablets EFG

Read all of 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, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
  • If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Sildenafil Aristo is and what it is used for
2. What you need to know before taking Sildenafil Aristo
3. How to take Sildenafil Aristo
4. Possible side effects
5. How to store Sildenafil Aristo
6. Contents of the pack and other information

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

Sildenafilo Aristo contains the active substance sildenafilo and belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels in the penis, allowing blood flow into the penis when sexually stimulated. Sildenafilo Aristo will only help you achieve 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 is unable to achieve or maintain a firm penile erection suitable for satisfactory sexual activity.

2. What you need to know before taking Sildenafil Aristo

Do not take Sildenafil Aristo

• If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If you are using medicines called nitrates, as the combination may cause a potentially dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medicines, which are often administered to relieve angina pain (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
• If you are using any medicines known as nitric oxide donors, such as amyl nitrate ("poppers"), as the combination may cause a potentially dangerous drop in your blood pressure.
• If you are taking riociguat. This medicine 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 blood clots). PDE5 inhibitors, such as Sildenafil, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.
• If you have a serious 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 inherited eye disease (such as retinitis pigmentosa).
• If you have previously experienced sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Talk to your doctor or pharmacist before taking Sildenafil Aristo.

Inform your doctor:

• If you have sickle cell anemia (an abnormality of red blood cells), leukemia (cancer of 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 should carefully assess whether your heart can tolerate the additional strain of sexual activity.
• If you currently have a stomach ulcer or bleeding disorders (such as hemophilia).
• If you experience sudden decrease or loss of vision, stop taking Sildenafil Aristo and contact your doctor immediately.

It is not recommended to take Sildenafil together with any other oral or local treatments for erectile dysfunction.

Sildenafil must not be taken with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitor.

You should not take Sildenafil if you do not have erectile dysfunction.

The use of Sildenafil is not indicated in women.

Children and adolescents

The use of Sildenafil is not indicated in individuals under 18 years of age.

Special considerations in patients with renal impairment or hepatic problems

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

Other medicines and Sildenafil Aristo

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

Sildenafil tablets may interact with certain medicines, especially those used to treat chest pain. In a medical emergency, you must inform any healthcare professional that you are taking Sildenafil and when you took it. Do not take Sildenafil with other medicines unless your doctor advises you to do so.

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

Do not take Sildenafil if you are taking medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), as the combination may also lead to a potentially dangerous drop in your blood pressure.

Inform your doctor or pharmacist if you are taking riociguat.

If you are taking protease inhibitors, such as those used in the treatment of HIV, your doctor may recommend starting treatment with the lowest dose (25 mg) of Sildenafil.

Some patients receiving an alpha-blocker, a medicine used to treat high blood pressure or benign prostatic hyperplasia, may experience dizziness or lightheadedness caused by a drop in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking Sildenafil with alpha-blockers. This is more likely to occur within 4 hours after taking Sildenafil. To reduce the likelihood of these symptoms, you should already be on a regular daily dose of the alpha-blocker before starting Sildenafil Aristo. Your doctor may advise you to begin treatment with the lowest dose (25 mg) of Sildenafil.

Inform your doctor if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.

Taking Sildenafil Aristo with food, drinks, and alcohol

Sildenafil Aristo can be taken with or without food. However, you may notice that Sildenafil Aristo takes slightly longer to work if taken with a heavy meal.

Alcohol intake may temporarily impair your ability to achieve an erection. Therefore, to achieve the maximum benefit from the medicine, it is advisable not to consume large amounts of alcohol before taking Sildenafil.

Pregnancy and breastfeeding

The use of Sildenafil is not indicated in women.

Driving and using machines

Sildenafil may cause dizziness and affect vision. You should be aware of how you react to Sildenafil before driving or operating machinery.

Sildenafil Aristo contains sodium

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

3. How to take Sildenafil Aristo

Follow exactly the instructions for use provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. The normal starting dose is 50 mg.

Sildenafil Aristo 50 mg film-coated tablets must not be taken more than once a day.

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

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

Sildenafil Aristo will only help you achieve an erection if you are sexually stimulated. The time required for Sildenafil Aristo to take effect varies from person to person, but generally ranges between half an hour and one hour. The effect of Sildenafil Aristo may be delayed if taken with a heavy meal.

If Sildenafil 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 Sildenafil Aristo than you should

You may experience an increase in the frequency and severity of side effects. Doses higher than 100 mg do not increase effectiveness.

Contact your doctor or pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, stating 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone gets them.

Adverse effects reported with Sildenafilo Aristo are generally of mild to moderate intensity and short duration.

If you experience chest pain during or after sexual activity:

• Sit in a semi-upright position and try to relax
• Do not use nitrates to treat your chest pain
• Contact your doctor immediately

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

Cases of prolonged and sometimes painful erections have been reported after taking Sildenafil. If you have an erection lasting more than 4 hours, you must contact your doctor immediately. This occurs rarely.

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

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

Frequent adverse effects (may affect up to 1 in 10 patients) include: nausea, facial flushing, hot flushes (symptoms include sudden feeling of warmth in the upper body), indigestion, visual disturbances (including abnormal colour vision, light sensitivity or blurred vision or reduced visual acuity), nasal congestion and dizziness.

Uncommon adverse effects (may affect up to 1 in 100 patients) include: vomiting, skin rash, bleeding behind the eye, eye irritation, eye haemorrhage/red eyes, eye pain, double vision, abnormal sensation in the eye, watery eyes, irregular or rapid heartbeat, muscle pain, drowsiness, reduced sense of touch, vertigo, ringing in the ears, nausea, dry mouth, chest pain, feeling of fatigue, penile bleeding, presence of blood in semen and/or urine.

Rare adverse effects (may affect up to 1 in 1,000 patients) include: high blood pressure, low blood pressure, fainting, stroke, nosebleeds, sudden decrease or loss of hearing, and heart attack.

Adverse effects reported from post-marketing experience include: palpitations, chest pain, sudden death, and transient reduction in blood flow to parts of the brain. Most, but not all, of these patients had pre-existing heart problems before taking this medicine. It is not possible to determine whether these events were directly related to Sildenafilo Aristo. Additionally, cases of seizures or convulsions and serious skin reactions characterized by blistering rash, skin peeling and pain requiring immediate medical attention have been reported.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sildenafil Aristo

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

No special storage conditions are required.

Do not use Sildenafil Aristo after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sildenafil Aristo 50 mg film-coated tablets EFG

• The active substance is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate). The other components are: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, sodium croscarmellose, hypromellose, titanium dioxide (E 171), polyethylene glycol 6000 (macrogol 6000), talc, and indigo carmine lake (E 132).

Appearance of the product and contents of the pack

Sildenafil Aristo 50 mg film-coated tablets EFG are blue, elongated, and printed.

They are presented in aluminum/PVC blisters containing 1, 4, 8, and 12 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Aristo Pharma Iberia, S.L.
C/ Solana, 26
28850 Torrejón de Ardoz
Madrid, Spain

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

Date of the most recent revision of this leaflet: January 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/