VARDENAFIL 10 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. Table of Contents of the 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. When to be particularly careful when taking Vardenafil Aristo
   4. Children and adolescents
   5. Other medicines and Vardenafil Aristo
   6. Vardenafil Aristo with food, drink, and alcohol
   7. Pregnancy and breastfeeding
   8. Driving and using machines
7. How to take Vardenafil Aristo
   1. Taking a higher dose of Vardenafil Aristo than recommended
8. Possible side effects
   1. Reporting 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 authorization holder and manufacturer
    4. Marketing authorization holder
    5. Manufacturer
    6. This medicinal product is authorized 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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the 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 achieving or maintaining an erection. This can be caused by physical or psychological factors, or a combination of both. However, regardless of the cause, the effect is the same: due to changes in the muscles and blood vessels, not enough blood flows to the penis to achieve and maintain an erection.

Vardenafil Aristo works only when a man is sexually stimulated. The medicine reduces the activity of a chemical substance in the body that causes the erection to subside. Vardenafil Aristo allows an erection to be achieved that is long enough to satisfy 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 containing nitrates, such as glyceryl trinitrate used for angina, or medicines that release nitric oxide, such as amyl nitrite. Taking these medicines with Vardenafil Aristo can seriously affect blood pressure.
• if you are taking ritonavir or indinavir, medicines used to treat HIV infection.
• if you are over 75 years old and are taking ketoconazole or itraconazole, antifungal medicines.
• if you have severe heart or liver disease.
• if you are undergoing kidney dialysis.
• if you have recently had a stroke or heart attack.
• if you have low blood pressure.
• if you or a family member have been diagnosed with a rare heart condition known as prolongation of the QT interval.
• if you have ever had a condition that caused a loss of vision due to damage to the optic nerve, such as non-arteritic anterior ischemic optic neuropathy (NAION).
• if you are taking riociguat, a medicine used to treat pulmonary hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs caused by blood clots). It has been shown that phosphodiesterase type 5 inhibitors, such as Vardenafil Aristo, increase the effect of this medicine, which can lower blood pressure.

Warnings and precautions

Before taking Vardenafil Aristo, tell your doctor or pharmacist.

When to be particularly careful when taking Vardenafil Aristo

• if you have heart problems. In this case, sex can be hazardous.
• if you have an irregular heartbeat (arrhythmia) or any congenital heart disease that affects the ECG.
• if you have conditions that affect the shape of the penis. This includes conditions such as: Peyronie's disease, cavernosal fibrosis.
• if you have conditions that can cause prolonged erections (priapism). This includes conditions such as: sickle cell anemia, multiple myeloma, leukemia.
• if you have stomach ulcers (also known as peptic ulcers).
• if you have bleeding disorders (such as hemophilia).
• if you have been treated for erectile dysfunction with any other medicine, including vardenafil in the form of orodispersible tablets (see section "Other medicines and Vardenafil Aristo").
• if you experience sudden vision loss or sudden hearing loss, 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 medicines you are taking or have recently taken, as well as any medicines you plan to take.

• medicines used to treat angina: nitrates (nitroglycerin) or medicines that release nitric oxide, such as amyl nitrite. Taking these medicines with Vardenafil Aristo can seriously affect blood pressure.
• medicines used to treat irregular heartbeat, such as: quinidine, procainamide, amiodarone, or sotalol.
• medicines used to treat HIV infection, such as ritonavir or indinavir. You should discuss this with your doctor before taking Vardenafil Aristo.
• ketoconazole or itraconazole, antifungal medicines.
• erythromycin or clarithromycin, macrolide antibiotics.
• medicines that block alpha-adrenergic receptors 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 used to treat erectile dysfunction, including vardenafil in the form of orodispersible tablets.

Vardenafil Aristo with food, drink, and alcohol

• Vardenafil Aristo can be taken with or without food - but when taken with food, it is better to avoid heavy and fatty meals, as they can delay the effect of the medicine.
• do not drink grapefruit juice while taking Vardenafil Aristo, as it may affect the medicine's effect.
• alcoholic beverages can increase the risk of erectile dysfunction.

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 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 sexual activity. 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.

Taking a higher dose of Vardenafil Aristo than recommended

In men who have taken too much Vardenafil Aristo, more side effects may occur, and severe back pain may occur. If you have taken more Vardenafil Aristo than recommended, contact your doctor.

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

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, sudden, partial, transient, or permanent decrease or loss of vision in one or both eyes has occurred. Stop taking Vardenafil Aristo and contact your doctor immediately.

There have been reports of sudden hearing loss.

In men taking vardenafil, there have been reports of sudden death, accelerated or disturbed heart rhythm, heart attack, chest pain, and cerebrovascular problems (including transient ischemic attack and stroke). Most of these men had pre-existing heart problems.

The risk of a side effect is described by the following categories:

Very common(may affect more than 1 in 10 people)

• headache

Common(may affect up to 1 in 10 people)

• dizziness
• flushing
• nasal congestion or stuffy nose
• indigestion

Uncommon(may affect up to 1 in 100 people)

• swelling of the skin and mucous membranes, including face, lips, or throat
• sleep disorders
• numbness or tingling
• drowsiness
• effects on vision, redness of the eyes, effects on color vision, eye pain, and discomfort in the eye, sensitivity to light
• ringing in the ears, dizziness of labyrinthine origin
• rapid heartbeat or palpitations
• shortness of breath
• nasal congestion
• acid reflux, gastritis, stomach pain, diarrhea, vomiting, nausea, dry mouth
• increased liver enzyme activity in the blood
• rash, skin redness
• back pain or muscle pain, increased activity in the blood of the enzyme found in muscles (creatine phosphokinase), muscle stiffness
• prolonged erections
• malaise.

Rare(may affect up to 1 in 1,000 people)

• inflammation of the eye (conjunctivitis)
• allergic reaction
• anxiety
• fainting
• memory loss (amnesia)
• seizures
• increased pressure in the eye (glaucoma), increased tearing
• effects on the heart (such as heart attack, changed heartbeat, or angina)
• increased or decreased blood pressure
• nasal bleeding
• effects on liver function tests
• skin sensitivity to sunlight
• painful erections
• chest pain
• transient ischemic attack.

Very rare or unknown frequency(may affect less than 1 in 10,000 people or frequency cannot be estimated from available data)

• blood in the urine (hematuria)
• penile bleeding
• presence of blood in the semen (hematospermia)
• sudden death
• stroke.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist, or nurse.

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, phone: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl.

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

Reporting side effects will help to gather more information on the safety of this medicine.

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 stated on the carton after "EXP". The expiry date refers to the last day of that month.

5 mg, 10 mg, and 20 mg (Aluminium/OPA/Aluminium/PVC blister): This medicine does not require any special storage conditions.

5 mg and 10 mg (Aluminium-PVC and Aluminium-PVC/PVdC blister): This medicine does not require any special storage conditions.

20 mg (Aluminium-PVC and Aluminium-PVC/PVdC blister): Do not store above 30°C.

Medicines should 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 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: Tablet core:Microcrystalline cellulose, hydroxypropylcellulose, crospovidone, type B, 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.

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

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

Vardenafil Aristo, 5 mg, is available in blisters containing 4 tablets.

Vardenafil Aristo, 10 mg and 20 mg, is available in blisters containing 4 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized in the Member States of the European Economic Area under the following names:

Austria

VARDENARISTO

Czech Republic

Estonia

Vardenafil Aristo

Vardenafil Alembic

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