Sildenafil aristo

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Package leaflet: Information for the patient

Sildenafil Aristo, 25 mg, coated tablets
Sildenafil Aristo, 50 mg, coated tablets
Sildenafilum
Please read this leaflet carefully before taking this 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 the physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse, contact your doctor.

Table of contents

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

Sildenafil Aristo contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. The medicine works by dilating blood vessels in the penis, allowing increased blood flow into the penis during sexual stimulation.
Sildenafil Aristo will help achieve an erection only during sexual stimulation.
Sildenafil Aristo is used to treat erectile dysfunction in adult men, sometimes referred to as impotence. This is the inability to achieve or maintain an erection sufficient for sexual intercourse.

2. Important information before using Sildenafil Aristo

When not to use Sildenafil Aristo:

• If the patient is allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If the patient is taking medicines called nitrates, as concomitant use may lead to a dangerous drop in blood pressure. The doctor should be informed if the patient is taking any medicines from this group, which are often used to relieve symptoms of angina (or "chest pain"). If in doubt, consult a doctor or pharmacist.
• If the patient is taking drugs that release nitric oxide, such as amyl nitrite (so-called poppers), as their concomitant use may also lead to a dangerous drop in blood pressure.
• If the patient is taking riociguat. This is a medicine 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). PDE5 inhibitors, such as Sildenafil Aristo, have been shown to enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, this should be reported to the doctor.
• If the patient has severe heart or liver disease.
• If the patient has recently suffered a stroke or heart attack, or has low blood pressure.
• If the patient has a rare inherited eye disease (such as retinitis pigmentosa, pigmentary retinal degeneration).
• If the patient has ever lost vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Before starting treatment with Sildenafil Aristo, discuss this with a doctor, pharmacist, or nurse:

• If the patient has sickle cell anemia (abnormal red blood cells), leukemia (a blood cancer), or multiple myeloma (a bone marrow cancer).
• If the patient has penile deformity or Peyronie's disease.
• If the patient has heart problems. In this case, the doctor should assess whether the heart condition allows for the additional strain associated with sexual activity.
• If the patient has stomach ulcers or bleeding disorders (such as hemophilia).
• If the patient suddenly experiences a worsening of vision or loss of vision, treatment with Sildenafil Aristo should be stopped immediately and the patient should contact a doctor without delay.

Do not use Sildenafil Aristo together with other oral or topical treatments for erectile dysfunction.
Sildenafil Aristo should not be used concurrently with arterial pulmonary hypertension (PH) therapies containing sildenafil or other PDE5 inhibitors.
Sildenafil Aristo should not be taken if erectile dysfunction has not been diagnosed.
Sildenafil Aristo is not intended for use in women.

Special recommendations for patients with kidney or liver impairment
Tell the doctor if the patient has kidney or liver disease. Patients with impaired kidney or liver function should not take a dose higher than 25 mg of sildenafil (should not use Sildenafil Aristo 50 mg tablets).

Children and adolescents
Sildenafil Aristo should not be used in patients under 18 years of age.

Sildenafil Aristo and other medicines
Tell the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.

Sildenafil Aristo coated tablets may interact with certain medicines, especially those used to treat chest pain. In an emergency requiring medical intervention, inform the doctor, pharmacist, or nurse that the patient is taking Sildenafil Aristo and when the last dose was taken. Do not take Sildenafil Aristo with other medicines without the doctor's approval.

Do not take Sildenafil Aristo if the patient is using nitrate-containing medicines, as concomitant use may lead to a dangerous drop in blood pressure. Always inform the doctor, pharmacist, or nurse if the patient is taking any medicines used to treat angina (or "chest pain").

Do not take Sildenafil Aristo if the patient is using medicines known to release nitric oxide, such as amyl nitrite (so-called poppers), as their concomitant use may cause a dangerous drop in blood pressure.

If the patient is already taking riociguat, inform the doctor or pharmacist.

If the patient is taking protease inhibitors used in the treatment of HIV infection, consult the doctor before taking Sildenafil Aristo; in such cases, treatment should be initiated with the lowest dose (25 mg) of Sildenafil Aristo.

In some patients taking alpha-blockers for high blood pressure or benign prostatic hyperplasia, dizziness or lightheadedness may occur, possibly due to a drop in blood pressure when standing up or sitting down quickly. Such symptoms may occur in some patients taking alpha-blockers and Sildenafil Aristo concomitantly. This is most likely within 4 hours after taking Sildenafil Aristo. To reduce the risk of such symptoms, the patient should be on a stable daily dose of the alpha-blocker before starting Sildenafil Aristo. The doctor may decide to initiate treatment with the lowest dose (25 mg) of Sildenafil Aristo. If symptoms of low blood pressure (dizziness, lightheadedness, feeling faint) occur, the patient should lie down or sit until symptoms resolve. Drinking water, breathing fresh air, or crossing the legs may also help. Avoid rapid standing or sitting up.

If the patient is taking ketoconazole (an antifungal medicine), erythromycin (an antibiotic), or cimetidine (a medicine for heartburn), consult the doctor before taking Sildenafil Aristo.

Inform the doctor or pharmacist if the patient is taking medicines containing sacubitril with valsartan, used in the treatment of heart failure.

Sildenafil Aristo with food, drink, and alcohol
Sildenafil Aristo may be taken with or without food. If Sildenafil Aristo is taken after a heavy meal, its effect may be delayed.
The ability to achieve an erection may be temporarily impaired after alcohol consumption.
To fully benefit from Sildenafil Aristo, significant alcohol consumption should be avoided before taking the medicine.

Pregnancy, breastfeeding, and fertility
Sildenafil Aristo is not indicated for use in women.

Driving and operating machinery
Sildenafil Aristo may cause dizziness and visual disturbances. The patient should be aware of their individual response 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, meaning the medicine is considered "sodium-free".

3. How to use 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, consult your doctor or pharmacist.
The recommended starting dose is 25 mg.
If the patient has previously used sildenafil-containing medicines at a dose of 50 mg or higher, the recommended dose is 50 mg. Otherwise, Sildenafil Aristo 50 mg should only be used if the patient did not achieve the desired effect (i.e. an erection sufficient for sexual intercourse) after taking sildenafil 25 mg.
If a lower dose of sildenafil (25 mg) has enabled the patient to achieve an erection sufficient for sexual intercourse, the 50 mg dose of Sildenafil Aristo should not be used.
Sildenafil Aristo must not be taken more than once a day.
Do not take Sildenafil Aristo tablets together with orally disintegrating tablets containing sildenafil.
Sildenafil Aristo should be taken approximately one 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, inform your doctor or pharmacist.
Sildenafil Aristo will help the patient achieve an erection only during sexual stimulation.
The time needed for Sildenafil Aristo to take effect varies individually, but usually ranges between half an hour and one hour. The effect may occur later if Sildenafil Aristo is taken during or after a heavy meal.
If Sildenafil Aristo does not help achieve an erection or if the duration of erection is insufficient for sexual intercourse, inform your doctor.
Taking more than the recommended dose of Sildenafil Aristo
This may increase both the frequency and severity of adverse effects. Doses higher than 100 mg do not increase the effectiveness of the medicine.
Do not take more tablets than indicated in the patient leaflet.
If the patient has taken more tablets than recommended, they should contact their doctor.
If you have any further doubts concerning the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Adverse reactions observed with Sildenafil Aristo are usually
mild to moderate and transient.
If any of the following adverse reactions occur, stop taking Sildenafil Aristo and seek immediate medical help:

• Allergic reaction – occurs uncommonly (may occur in no more than 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 chest pain occurs during or after sexual intercourse:

  • Adopt a semi-sitting position and try to relax.
  • Do not take nitrates to relieve chest pain.

• Prolonged and sometimes painful erections – occur rarely (may occur in no more than 1 in 1,000 patients).

• If erection lasts longer than 4 hours, contact a doctor immediately.

• Sudden worsening or loss of vision – occurs rarely.

• Severe skin reactions – occur rarely.

• Symptoms may include severe skin peeling and swelling, formation of blisters in the mouth, on genital organs and around the eyes, fever.

• Seizures or convulsions – occur rarely.

Other adverse reactions:
Very common (may occur in more than 1 in 10 patients): headache.
Common (may occur in no more than 1 in 10 patients): nausea, sudden flushing of the face,
hot flushes (symptoms include feeling of warmth in the upper part of the body), indigestion,
seeing coloured halos, blurred vision, visual disturbances, stuffy nose and dizziness.
Uncommon (may occur in no more than 1 in 100 patients): vomiting, skin rash,
eye irritation, eye hyperaemia and (or) eye redness, eye pain, seeing flashes of light,
bright vision, light sensitivity, watery eyes, palpitations, rapid heartbeat,
hypertension, hypotension, muscle pain, drowsiness, reduced sense of touch,
vertigo of labyrinthine origin, tinnitus, dry mouth, blocked or stuffy sinuses,
nasal mucositis (symptoms include runny nose, sneezing and blocked nose), pain
in the upper abdomen, gastroesophageal reflux disease (symptoms include heartburn),
blood in urine, pain in hands or feet, nosebleeds, feeling of warmth and fatigue.

Rare (may occur in no more than 1 in 1,000 patients): fainting, stroke, heart attack,
irregular heartbeat, transient reduction in blood flow to part of the brain, feeling of tightness
in the throat, numbness of the lips, bleeding into the back of the eye, double vision,
reduced visual acuity, abnormal sensations inside the eye, swelling of the eyes or eyelids,
small particles or spots in the visual field, seeing halos around light sources, pupil dilation,
abnormal discolouration of the white part of the eye, rectal bleeding, blood in semen,
dry nose, nasal swelling, feeling of irritation and sudden hearing loss or deafness.

Since sildenafil has been placed on 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 adverse reactions, heart problems were already present before taking sildenafil. It is not possible to determine whether these adverse reactions were directly related to the use of sildenafil.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions to Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.

5. How to store Sildenafil Aristo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Sildenafil Aristo contains

• The active substance is sildenafil. Each film-coated tablet contains 25 mg or 50 mg of
  sildenafil (as citrate).
• Other ingredients are:
  Tablet core: microcrystalline cellulose (PH 102), calcium hydrogen phosphate, anhydrous,
  sodium croscarmellose, 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, rounded square-shaped tablets.
Sildenafil Aristo 50 mg:
Blue, film-coated, rounded square-shaped tablets, scored on both sides. The tablet can be divided into equal doses.

Sildenafil Aristo 25 mg:
Tablets are packed in blisters made of PVC/PEPVDC/Aluminium in cardboard boxes.
Pack sizes: 4 or 8 film-coated tablets.

Sildenafil Aristo 50 mg:
Tablets are packed in blisters made of PVC/PEPVDC/Aluminium in cardboard boxes.
Pack sizes: 2 or 4 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised 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 filmomhulde tabletten
Germany Sildenafil Aristo
Poland Sildenafil Aristo
Portugal Sildenafil Aristo Pharma
Slovakia Sildenafil Aristo
Italy Sildenafil Aristo Pharma