SILDENAFIL ARISTO 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sildenafilo Aristo 100 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. You may need to read it again.
• • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

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

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

2. What you need to know before you take Sildenafilo Aristo

Do not take Sildenafilo Aristo

• If you are using medicines called nitrates, as the combination can cause a potentially dangerous drop in your blood pressure. Consult your doctor if you are using any of these medicines, which are often given to relieve angina pectoris (or "chest pain"). If you are not sure, consult your doctor or pharmacist.
• If you are using any of the medicines called nitric oxide donors, such as amyl nitrate ("poppers"), as the combination can cause a potentially dangerous drop in your blood pressure.
• If you are allergic (hypersensitive) to sildenafil or any of the other ingredients of Sildenafilo Aristo.
• 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 Sildenafilo, have shown that they increase the hypotensive effect of this medicine. If you are taking riociguat or are not sure, 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 a loss of vision due to a non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

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

Tell 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 penis deformity or Peyronie's disease.
• If you have heart problems. In this case, your doctor should carefully check if your heart can withstand the extra effort of having sex.
• If you currently have stomach ulcers 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.

It is not recommended to take Sildenafilo Aristo at the same time as any other oral or local treatment for erectile dysfunction.

You should not take Sildenafilo Aristo with treatment for pulmonary arterial hypertension (PAH) that contains sildenafil or any other PDE5 inhibitor.

You should not take Sildenafilo Aristo if you do not have erectile dysfunction.

The use of Sildenafilo Aristo is not indicated in women.

Children and adolescents

The use of Sildenafilo Aristo is not indicated in persons under 18 years of age.

Special considerations in patients with kidney or liver problems

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

Other medicines and Sildenafilo Aristo

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

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

You should not take Sildenafilo Aristo if you are taking medicines called nitrates, as the combination of these products can 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 pectoris (or "chest pain").

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

Tell your doctor or pharmacist if you are taking riociguat.

If you are taking medicines 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 Aristo.

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

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

Taking Sildenafilo Aristo with food, drinks, and alcohol

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

Drinking alcohol can temporarily make it more difficult to get an erection. Therefore, to get the maximum benefit from the medicine, it is recommended not to drink large amounts of alcohol before taking Sildenafilo Aristo.

Pregnancy and breastfeeding

.

The use of Sildenafilo Aristo is not indicated in women.

Driving and using machines

Sildenafilo Aristo can cause dizziness and affect vision. You should know how you react to Sildenafilo Aristo before driving vehicles or using machines.

Sildenafilo 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 Sildenafilo Aristo

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again. The normal starting dose is 50 mg.

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

You should take Sildenafilo Aristo approximately one hour before you plan to have sex. Swallow the tablet whole with a glass of water.

If you think the effect of Sildenafilo Aristo is too strong or too weak, tell your doctor or pharmacist.

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

In case Sildenafilo Aristo does not help you to get an erection or if the erection is not maintained 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, telephone 91 562 94 29, indicating the medicine and the amount taken.

Do not take more tablets than your doctor recommends.

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects associated with the use of Sildenafilo Aristo are generally mild to moderate and short-lived.

If you experience chest pain during or after having sex:

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

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

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

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

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

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

Uncommon 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 of tiredness, reduced sense of touch, vertigo, ringing in the ears, dry mouth, chest pain, feeling of fatigue, bleeding from the penis, presence of blood in the 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, nosebleeds, sudden decrease or loss of hearing, and heart attack.

Post-marketing experience includes: palpitations, chest pain, sudden death, or transient reduction of blood flow to some 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 if these events were directly related to Sildenafilo Aristo. There have also been reports of seizures or convulsions and severe skin reactions that include blistering, peeling of the skin, and pain that require immediate medical attention.

If you consider that any of the side effects you are experiencing is serious, or if you notice any side effect not mentioned in this leaflet, tell your doctor.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sildenafilo Aristo

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

No special storage conditions are required.

Do not use Sildenafilo Aristo after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you are in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sildenafilo Aristo 100 mg film-coated tablets EFG

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

Appearance of the product and packaging contents

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 engraved.

Sildenafilo Aristo 100 mg film-coated tablets are available in blisters containing 4, 8, and 12 tablets.

Not all 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

Miralcampo Industrial Estate

19200 Azuqueca de Henares – Guadalajara, Spain

Date of the last revision of this leaflet:January 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/