VARDENAFIL 20 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Vardenafil Aristo, 5 mg, film-coated tablets
3. Vardenafil Aristo, 10 mg, film-coated tablets
4. Vardenafil Aristo, 20 mg, film-coated tablets
   1. Contents of the Package Leaflet
5. What is Vardenafil Aristo and what is it used for
6. Important information before taking Vardenafil Aristo
   1. When not to take Vardenafil Aristo
   2. Warnings and precautions
   3. Children and adolescents
   4. Other medicines and Vardenafil Aristo
   5. Vardenafil Aristo with food, drink, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
7. How to take Vardenafil Aristo
   1. If you take more Vardenafil Aristo than you should
8. Possible side effects
   1. Reporting of side effects
9. How to store Vardenafil Aristo
10. Contents of the pack and other information
    1. What Vardenafil Aristo contains
    2. What Vardenafil Aristo looks like and contents of the pack
    3. Marketing Authorisation Holder and Manufacturer
    4. Marketing Authorisation Holder
    5. Manufacturer
    6. This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the User

Vardenafil Aristo, 5 mg, film-coated tablets

Vardenafil Aristo, 10 mg, film-coated tablets

Vardenafil Aristo, 20 mg, film-coated tablets

(Vardenafil)
Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

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

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

Vardenafil Aristo contains vardenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. These medicines are used to treat erectile dysfunction in adult men, a condition that affects a man's ability to achieve or maintain an erection.

At least one in ten men has problems getting or keeping an erection. This can be caused by physical or psychological factors, or a combination of both. However, regardless of the cause, the result is the same: due to changes in the muscles and blood vessels, not enough blood flows into the penis to make it hard and keep it hard.

Vardenafil Aristo only works when a man is sexually stimulated. The medicine reduces the activity of a chemical that naturally occurs in the body and causes the erection to fade. Vardenafil Aristo allows an erection to last long enough for the patient to achieve full satisfaction during sexual intercourse.

2. Important information before taking Vardenafil Aristo

When not to take Vardenafil Aristo

• if you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction include: rash, itching, swelling of the face or lips, difficulty breathing.
• if you are taking medicines called nitrates, as the combination of these medicines with Vardenafil Aristo may seriously affect your blood pressure.
• if you are taking riociguat, 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). It has been shown that phosphodiesterase type 5 inhibitors, such as Vardenafil Aristo, enhance the blood pressure-lowering effect of this medicine.
• if you have severe heart disease or liver disease.
• if you have had a stroke or heart attack recently.
• if you have low blood pressure.
• if you have a family history of degenerative eye disorders (such as pigmentary retinal degeneration).
• if you have ever had a condition that caused loss of vision due to damage to the optic nerve, known as non-arteritic anterior ischemic optic neuropathy.

Warnings and precautions

Before taking Vardenafil Aristo, tell your doctor or pharmacist if you have any medical conditions, especially if you have:

• heart problems. In this case, sex can be dangerous.
• irregular heartbeat (arrhythmia) or any congenital heart disease that affects the ECG.
• conditions that affect the shape of the penis. These include conditions such as: Peyronie's disease, cavernosal fibrosis.
• diseases that can cause prolonged erections (priapism). These include: sickle cell anemia, multiple myeloma, leukemia.
• stomach ulcers (also called peptic ulcers).
• bleeding disorders (such as hemophilia).
• if you have taken any other treatment for erectile dysfunction, including a medicine containing vardenafil in the form of orodispersible tablets.
• if you experience sudden worsening of vision or sudden loss of vision, stop taking Vardenafil Aristo and contact your doctor immediately.

Children and adolescents

Vardenafil Aristo is not intended for use in children and adolescents under 18 years of age.

Other medicines and Vardenafil Aristo

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including:

• medicines for angina pectoris: nitrates or nitric oxide donors, such as amyl nitrite.
• medicines for heart rhythm disorders, such as: quinidine, procainamide, amiodarone, or sotalol.
• medicines for HIV infection, such as: ritonavir or indinavir.
• ketoconazole or itraconazole, antifungal medicines.
• erythromycin or clarithromycin, macrolide antibiotics.
• alpha-blockers, used to treat high blood pressure and enlarged prostate (benign prostatic hyperplasia).
• riociguat.

Do not take Vardenafil Aristo film-coated tablets with any other medicines for erectile dysfunction, including a medicine containing vardenafil in the form of orodispersible tablets.

Vardenafil Aristo with food, drink, and alcohol

• Vardenafil Aristo can be taken with or without food - but if taken with food, it is better to avoid fatty meals as they may delay the effect of the medicine.
• do not drink grapefruit juice while taking Vardenafil Aristo, as it may affect the medicine's action.
• alcoholic drinks can make erectile dysfunction worse.

Pregnancy and breastfeeding

Vardenafil Aristo is not intended for use in women.

Driving and using machines

Vardenafil Aristo may cause dizziness or visual disturbances in some people. If you experience dizziness or visual disturbances after taking Vardenafil Aristo, do not drive or operate machinery.

3. How to take Vardenafil Aristo

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose is 10 mg.

Take a Vardenafil Aristo tablet about 25 to 60 minutes before you plan to have sex. After sexual stimulation, you can achieve an erection between 25 minutes and 4-5 hours after taking the medicine.

Swallow the tablet with a glass of water.

Do not take Vardenafil Aristo more than once a day.

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

If you take more Vardenafil Aristo than you should

If you take more Vardenafil Aristo than you should, you may experience more side effects. Contact your doctor.

4. Possible side effects

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

Most of the side effects are mild or moderate.

In some patients, Vardenafil Aristo has been associated with:

• headache
• dizziness
• flushing
• nasal congestion
• indigestion

If you experience any of these side effects, tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

5. How to store Vardenafil Aristo

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

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

Store Vardenafil Aristo in the original package in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Vardenafil Aristo contains

• The active substance is vardenafil. Each tablet contains 5 mg or 10 mg or 20 mg of vardenafil (as vardenafil hydrochloride trihydrate).
• The other ingredients are: Core:microcrystalline cellulose, hydroxypropylcellulose, crospovidone, colloidal anhydrous silica, magnesium stearate Coating:Opadry beige 03F570025 Coating material composition (coating): Hypromellose (6 mPas), titanium dioxide (E 171), macrogol 6000, yellow iron oxide (E 172), tartrazine (E 102), orange yellow FCF (E 110), red iron oxide (E 172)

What Vardenafil Aristo looks like and contents of the pack

Vardenafil Aristo, 5 mg, are light orange to orange, round, film-coated tablets with "L" embossed on one side and "05" on the other side.

Vardenafil Aristo, 10 mg, are light orange to orange, round, film-coated tablets with "480" embossed on one side and smooth on the other side.

Vardenafil Aristo, 20 mg, are light orange to orange, round, film-coated tablets with "481" embossed on one side and smooth on the other side.

Vardenafil Aristo is available in blisters containing 4 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Aristo Pharma Sp. z o.o.

ul. Baletowa 30

02-867 Warsaw

Manufacturer

Aristo Pharma GmbH

Wallenroder Straße 8–10

13435 Berlin

Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Austria: VARDENARISTO

Czech Republic: Vardenafil Aristo

Estonia: Vardenafil Aristo

Spain: Vardenafilo Aristo

Germany: VARDENARISTO

Poland: Vardenafil Aristo

Portugal: Vardenafil Aristo

United Kingdom: Vardenafil Aristo

Italy: Vardenafil Aristo

Date of last revision of the leaflet:August 2021