Sildenafil Aristo

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Leaflet attached to the packaging: patient information

Sildenafil Aristo, 25 mg, film-coated tablets

Sildenafil Aristo, 50 mg, film-coated tablets

Sildenafil

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If you do not improve or feel worse, you should contact your doctor.

Table of contents of the leaflet

• 1. What is Sildenafil Aristo and what is it used for
• 2. Important information 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 is Sildenafil Aristo and what is it used for

Sildenafil Aristo contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5). The medicine works by widening the blood vessels in the penis, allowing blood to flow into the penis during sexual stimulation. Sildenafil Aristo will only help you to get an erection if you are sexually stimulated.

2. Important information before taking Sildenafil Aristo

When not to 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 taking medicines called nitrates, as the combination may lead to a dangerous decrease in blood pressure. You should tell your doctor if you are taking any of these medicines, which are often used to relieve angina (or "chest pain"). If in doubt, you should ask your doctor or pharmacist.
• If you are taking medicines that release nitric oxide, such as amyl nitrite (so-called "poppers"), as their simultaneous use may also lead to a dangerous decrease in blood pressure.
• If you are taking riociguat. This medicine is used to treat pulmonary 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). It has been shown that PDE5 inhibitors, such as Sildenafil Aristo, enhance the blood pressure-lowering effect of this medicine. If you are taking riociguat or are unsure, you should tell your doctor.
• If you have severe heart or liver disease.
• If you have recently had a stroke or heart attack or have low blood pressure.
• If you have a rare, inherited eye disease (such as retinitis pigmentosa, pigmentary retinal degeneration).
• If you have ever lost your vision due to non-arteritic anterior ischemic optic neuropathy (NAION, non-arteritic anterior ischemic optic neuropathy).

Warnings and precautions

Before taking Sildenafil Aristo, you should discuss it with your doctor, pharmacist, or nurse.

• If you have sickle cell anemia (abnormal red blood cells), leukemia (blood cancer), or multiple myeloma (bone marrow cancer).
• If you have a penis deformity or Peyronie's disease.
• If you have heart problems. In this case, your doctor should assess whether your heart condition allows for the additional strain associated with sexual activity.
• If you have stomach ulcers or bleeding disorders (such as hemophilia).
• If you suddenly experience a worsening of vision or loss of vision, you should stop taking Sildenafil Aristo and immediately contact your doctor.

You should not take Sildenafil Aristo with other oral medicines or local treatments for erectile dysfunction. You should not take Sildenafil Aristo with pulmonary arterial hypertension (PAH) therapies that contain sildenafil or other PDE5 inhibitors. You should not take Sildenafil Aristo if you have not been diagnosed with erectile dysfunction. Sildenafil Aristo is not intended for women.

Special recommendations for patients with kidney or liver function disorders

You should tell your doctor if you have kidney or liver disease. Patients with kidney or liver function disorders should not take a dose higher than 25 mg of sildenafil (should not take Sildenafil Aristo in a dose of 50 mg).

Children and adolescents

Sildenafil Aristo should not be taken by patients under 18 years of age.

Sildenafil Aristo and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.

Sildenafil Aristo film-coated tablets may interact with some medicines, especially those used to treat chest pain. In a situation requiring medical intervention, you should tell your doctor, pharmacist, or nurse that you are taking Sildenafil Aristo and when you last took the medicine. You should not take Sildenafil Aristo with other medicines without your doctor's consent.

You should not take Sildenafil Aristo if you are taking nitrate medicines, as their simultaneous use may lead to a dangerous decrease in blood pressure. You should always inform your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often used to relieve angina (or "chest pain").

You should not take Sildenafil Aristo if you are taking medicines that release nitric oxide, such as amyl nitrite (so-called "poppers"), as their simultaneous use may cause a dangerous decrease in blood pressure.

If you are already taking riociguat, you should inform your doctor or pharmacist.

In the case of taking protease inhibitors used to treat HIV infection, you should consult your doctor before taking the medicine; in such a case, it is recommended to start treatment with the lowest dose (25 mg) of Sildenafil Aristo.

In some patients taking alpha-blockers to treat high blood pressure or prostate enlargement, dizziness or lightheadedness may occur, which may be caused by a decrease in blood pressure when standing up or sitting down suddenly. Such symptoms may occur in some patients taking alpha-blockers and Sildenafil Aristo simultaneously. This is most likely to happen within 4 hours of taking Sildenafil Aristo. To reduce the possibility of such symptoms, the patient should regularly take their daily dose of alpha-blocker before starting to take Sildenafil Aristo. The doctor may decide to start treatment with the smallest dose (25 mg) of Sildenafil Aristo. If symptoms of low blood pressure (dizziness, lightheadedness, feeling of impending faint) occur, you should first lie down or sit and wait for the symptoms to pass; drinking water, getting fresh air, or crossing your legs may also help. You should avoid standing up or sitting down quickly.

If you are taking ketoconazole (an antifungal medicine), erythromycin (an antibiotic), or cimetidine (a medicine for heartburn), you should consult your doctor before taking Sildenafil Aristo.

You should inform your doctor or pharmacist if you are taking medicines containing sacubitril with valsartan, used to treat heart failure.

Sildenafil Aristo with food, drink, and alcohol

Sildenafil Aristo can be taken with or without food. If Sildenafil Aristo is taken during a large meal, its effect may be delayed.

The ability to achieve an erection may be temporarily impaired after consuming alcohol.

To fully utilize the therapeutic potential of Sildenafil Aristo, you should not consume significant amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

Sildenafil Aristo is not indicated for use in women.

Driving and using machines

Sildenafil Aristo may cause dizziness and visual disturbances. You should be aware of your reaction to Sildenafil Aristo before driving or operating machinery.

Sildenafil Aristo contains sodium

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

3. How to take Sildenafil Aristo

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.

The recommended starting dose is 25 mg.

If you have previously taken medicines containing sildenafil in a dose of 50 mg or higher, the recommended dose of the medicine is 50 mg. Otherwise, Sildenafil Aristo in a dose of 50 mg should only be taken if you did not experience the desired effect after taking sildenafil in a dose of 25 mg (i.e., you did not achieve an erection sufficient for sexual intercourse).

If taking a lower dose of sildenafil (25 mg) allowed you to achieve an erection that enabled you to have sexual intercourse, you should not take the medicine in a dose of 50 mg.

Sildenafil Aristo should not be taken more than once a day.

You should not take Sildenafil Aristo, film-coated tablets, at the same time as tablets that dissolve in the mouth, containing sildenafil.

Sildenafil Aristo should be taken about an hour before planned sexual activity.

The tablet should be swallowed whole, with a glass of water.

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

Sildenafil Aristo will only help you achieve an erection during sexual stimulation.

The time it takes for Sildenafil Aristo to work varies from person to person, but it usually takes between half an hour and one hour. The effect may occur later if Sildenafil Aristo is taken during a large meal.

If Sildenafil Aristo does not help you achieve an erection or if the duration of the erection is not sufficient for sexual intercourse, you should tell your doctor.

Taking a higher dose of Sildenafil Aristo than recommended

This may increase the frequency and severity of side effects. Doses higher than 100 mg do not increase the efficacy of the medicine.

You should not take more tablets than indicated in the patient leaflet.

If you have taken more tablets than recommended, you should contact your doctor.

If you have any further doubts about the use of this medicine, you should ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Sildenafil Aristo can cause side effects, although not everybody gets them.

The side effects observed in connection with the use of Sildenafil Aristo are usually mild to moderate and short-term.

If you experience any of the following side effects, you should stop taking Sildenafil Aristo and seek medical help immediately:

• An allergic reaction - occurs uncommonly(may occur in up to 1 in 100 patients). Symptoms include: sudden wheezing, difficulty breathing, or

dizziness, swelling of the eyelids, face, lips, or throat.

• Chest pain - occurs uncommonly. If pain occurs during or after sexual intercourse: ˗ You should sit half-up and try to relax. ˗ Do not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occur rarely(may occur in up to 1 in 1,000 patients).
• If an erection lasts for more than 4 hours, you should contact your doctor immediately.
• Sudden worsening or loss of vision - occurs rarely.
• Severe skin reactions - occur rarely.
• Symptoms may include severe skin peeling and swelling, blistering in the mouth, on the genitals, and around the eyes, fever.
• Seizures or convulsions - occur rarely.

Other side effects:

Very common(may occur in more than 1 in 10 patients): headache.

Common(may occur in up to 1 in 10 patients): nausea, sudden flushing, hot flushes (symptoms include a feeling of heat in the upper body), indigestion, seeing with a blue tint, blurred vision, visual disturbances, stuffy nose, and dizziness.

Uncommon(may occur in up to 1 in 100 patients): vomiting, skin rash, eye irritation, conjunctival hyperemia, and (or) eye redness, eye pain, seeing flashes of light, increased sensitivity to light, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, decreased sensation, vertigo, ringing in the ears, dry mouth, stuffy or runny nose, sinusitis (symptoms include a runny nose, sneezing, and a stuffy nose), stomach pain, gastroesophageal reflux disease (symptoms include heartburn), blood in the urine, pain in the arms or legs, nosebleeds, feeling hot, and feeling tired.

Rare(may occur in up to 1 in 1,000 patients): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to part of the brain, feeling of constriction in the throat, numbness of the lips, bleeding in the back of the eye, double vision, decreased visual acuity, abnormal sensations in the eye, swelling of the eyes or eyelids, small particles or spots in the field of vision, seeing halos around light sources, dilated pupils, abnormal discoloration of the white of the eye, bleeding from the penis, blood in the semen, dry nose, swelling inside the nose, feeling irritable, and sudden loss of hearing.

After the introduction of sildenafil to the market, rare cases of unstable angina (heart disease) and sudden death have been reported. It is important to note that in most, but not all, men who experienced these side effects, heart function disorders existed before taking sildenafil. It is not possible to determine whether these side effects were directly related to the use of sildenafil.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C

02-222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

5. How to store Sildenafil Aristo

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the month stated.

There are no special precautions for storing the medicine.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Sildenafil Aristo contains

The active substance of the medicine is sildenafil. Each film-coated tablet contains 25 mg or 50 mg of sildenafil (as citrate).

The other ingredients are:

Tablet core:microcrystalline cellulose (PH 102), calcium hydrogen phosphate anhydrous, croscarmellose sodium, magnesium stearate, colloidal anhydrous silica

Coating:polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc, indigo carmine, lake (E 132), yellow iron oxide (E 172)

What Sildenafil Aristo looks like and contents of the pack

Sildenafil Aristo, 25 mg:

Blue film-coated tablets of a rounded square shape.

Sildenafil Aristo, 50 mg:

Blue film-coated tablets of a rounded square shape, scored on both sides. The tablet can be divided into equal doses.

Sildenafil Aristo, 25 mg:

The tablets are packaged in PVC/PE/PVDC/Aluminum blisters in a cardboard box.

Package sizes: 4 or 8 film-coated tablets.

Sildenafil Aristo, 50 mg:

The tablets are packaged in PVC/PE/PVDC/Aluminum blisters in a cardboard box.

Package sizes: 2 or 4 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder:

Aristo Pharma Sp. z o.o.

ul. Baletowa 30

02-867 Warsaw

tel: +48 22 855 40 93

Manufacturer/Importer:

Advance Pharma GmbH

Wallenroder Strasse 8-14

13435 Berlin

Germany

Aristo Pharma GmbH

Wallenroder Strasse 8-10

13435 Berlin

Germany

Delorbis Pharmaceuticals Limited

Athinon 17 V, Industrial Area

2643 Ergates

Cyprus

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic

Sildenafil Aristo

France

SILDENAFIL ARISTO 25 mg / 50 mg / 100 mg film-coated tablet

Netherlands

Sildenafil Aristo 25 mg / 50 mg / 100 mg film-coated tablets

Germany

Sildenafil Aristo

Poland

Sildenafil Aristo

Portugal

Sildenafil Aristo Pharma

Slovakia

Sildenafil Aristo

Italy

Sildenafil Aristo Pharma

Date of last revision of the leaflet:August 2024