Sildenafil Aristo

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Leaflet included in 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 feel better or if you 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 taking them together can lead to a dangerous drop 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 consult your doctor or pharmacist.
• If you are taking medicines that release nitric oxide, such as amyl nitrite (so-called "poppers"), as their simultaneous use can also lead to a dangerous drop 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 inform 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 extra effort associated with sexual activity.
• If you have stomach ulcers or bleeding disorders (such as hemophilia).
• If you suddenly experience a deterioration or loss of vision, you should stop taking Sildenafil Aristo and immediately consult 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 therapies (PAH) using 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, and about the 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 taking them together can lead to a dangerous drop 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 can cause a dangerous drop in blood pressure. If you are already taking riociguat, you should inform your doctor or pharmacist. When taking protease inhibitors used to treat HIV infection, you should consult your doctor before taking Sildenafil Aristo; in this 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 drop in blood pressure when standing up or sitting down suddenly. Such symptoms may occur in some patients taking alpha-blockers and Sildenafil Aristo. This is most likely to happen within 4 hours of taking Sildenafil Aristo. To reduce the likelihood 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 down and wait for the symptoms to pass; drinking water, getting fresh air, or crossing your legs may also help. You should avoid getting 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 with 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 large 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 get to know 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 it 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 in doubt, you should consult 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 Sildenafil Aristo 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 intercourse). If taking a lower dose of sildenafil (25 mg) allowed you to achieve an erection that enabled you to have intercourse, you should not take the 50 mg dose. 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 with a large meal. If Sildenafil Aristo does not help you achieve an erection or if the duration of the erection is not sufficient for 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 consult 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.

In case of the following side effects, you should stop taking Sildenafil Aristo and seek medical help immediately:

• An allergic reaction - occurs uncommonly(may affect up to 1 in 100 people). 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 intercourse: ˗ You should sit half-up and try to relax. ˗ Do not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occurs rarely(may affect up to 1 in 1,000 people).
• If an erection lasts for more than 4 hours, you should seek medical help immediately.
• Sudden visual impairment or loss of vision - occurs rarely.
• Severe skin reactions - occurs rarely.
• Symptoms may include severe skin peeling and swelling, blistering in the mouth, on the genitals, and around the eyes, fever.
• Seizures or convulsions - occurs rarely.

Other side effects:

Very common(may affect more than 1 in 10 people): headache.
Common(may affect up to 1 in 10 people): nausea, sudden flushing, hot flushes (symptoms include a feeling of heat in the upper body), indigestion, color tinge to vision, blurred vision, visual disturbance, stuffy nose, and dizziness.
Uncommon(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, conjunctival hyperaemia and (or) eye discoloration, eye pain, seeing light flashes, increased light perception, sensitivity to light, lacrimation, palpitations, rapid heartbeat, hypertension, hypotension, muscle pain, somnolence, decreased tactile sensitivity, vertigo of labyrinthine origin, tinnitus, dry mouth, nasal congestion, or rhinitis (symptoms include runny nose, sneezing, and stuffy nose), abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), hematuria, limb pain, epistaxis, and feeling hot or tired.
Rare(may affect up to 1 in 1,000 people): fainting, stroke, myocardial infarction, arrhythmia, transient ischaemic attack, feeling of throat constriction, numbness of lips, retinal hemorrhage, double vision, decreased visual acuity, abnormal sensations in the eye, eye swelling or eyelid swelling, small particles or spots in the field of vision, seeing halos around light sources, pupil dilation, abnormal discoloration of the white of the eye, penile hemorrhage, presence of blood in semen, nasal dryness, nasal swelling, and sudden hearing loss or hearing impairment.
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 the 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. You should 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 storage. 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 Sildenafil Aristo is sildenafil. Each film-coated tablet contains 25 mg or 50 mg of sildenafil (as citrate).
˗
The other ingredients are:
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 rounded square shape.
Sildenafil Aristo, 50 mg:
Blue film-coated tablets of rounded square shape, scored on both sides. The tablet can be divided into equal doses.
Sildenafil Aristo, 25 mg:
Tablets are packaged in PVC/PE/PVDC/Aluminum blisters in a cardboard box.
Pack sizes: 4 or 8 film-coated tablets.
Sildenafil Aristo, 50 mg:
Tablets are packaged in PVC/PE/PVDC/Aluminum blisters in a cardboard box.
Pack sizes: 2 or 4 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Aristo Pharma Sp. z o.o.
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