VARDENAFIL 5 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 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. When to take special care with 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 more Vardenafil Aristo than you should
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 you.

• 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 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 achieving or maintaining an erection. This can be due to 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 in the body that causes erections to go away. Vardenafil Aristo allows an erection to last long enough for a man to have successful 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 for angina, or medicines that release nitric oxide, such as amyl nitrite. Taking these medicines with Vardenafil Aristo can seriously affect your 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 having kidney dialysis.
• if you have recently had a stroke or heart attack.
• if you have low blood pressure.
• if you have a family history of degenerative eye disorders (such as retinitis pigmentosa).
• if you have ever had a condition that resulted in vision loss due to damage to the optic nerve, known as non-arteritic anterior ischemic optic neuropathy.
• 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 are taking riociguat or are unsure, inform your doctor.

Warnings and precautions

Before taking Vardenafil Aristo, tell your doctor or pharmacist.

When to take special care with Vardenafil Aristo

• if you have heart problems. In this case, sex can be hazardous.
• if you have irregular heartbeats (arrhythmias) or any congenital heart disease that affects your ECG.
• if you have conditions that affect the shape of your penis. These include conditions such as Peyronie's disease, cavernosal fibrosis.
• if you have conditions that can cause prolonged erections (priapism). These include 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 taken any other treatment for erectile dysfunction, including vardenafil-containing orodispersible tablets (see section "Other medicines and Vardenafil Aristo").
• 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 those you have bought without a prescription.

• medicines used to treat angina: nitrates or nitric oxide donors, such as amyl nitrite. Taking these medicines with Vardenafil Aristo can seriously affect your blood pressure. Talk to your doctor before taking Vardenafil Aristo.
• medicines used to treat irregular heartbeats, such as quinidine, procainamide, amiodarone, or sotalol.
• medicines used to treat HIV infection, such as ritonavir or indinavir. Talk to 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-containing 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 by women.

Driving and using machines

Vardenafil Aristo may cause dizziness or affect vision in some people. If you experience dizziness or vision changes after taking Vardenafil Aristo, do not drive or operate machinery. Vardenafil Aristo film-coated tablets contain tartrazine (E102) and sunset yellow FCF (E110), which may cause allergic reactions.

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 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, talk to your doctor.

Taking more Vardenafil Aristo than you should

If you take more Vardenafil Aristo than you should, you may experience more side effects. In case of overdose, 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. Some patients have reported a sudden, partial, temporary, or permanent decrease or loss of vision in one or both eyes. Stop taking Vardenafil Aristo and contact your doctor immediately. There have been reports of sudden hearing loss. Men taking vardenafil have reported the following side effects: sudden death, rapid or irregular heartbeat, heart attack, chest pain, and stroke. Most of these men had heart problems before taking this medicine. It is not known whether these events were directly related to vardenafil. 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
• indigestion

Uncommon(may affect up to 1 in 100 people)

• swelling of the skin and mucous membranes, including swelling of the face, lips, or throat
• sleep disorders
• numbness and 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 due to inner ear problems
• rapid heartbeat or palpitations
• shortness of breath
• nasal congestion
• acid reflux, stomach inflammation, abdominal pain, diarrhea, vomiting, nausea, dry mouth
• increased liver enzyme activity in the blood
• rash, redness of the skin
• back pain or muscle pain, increased activity in the blood of an enzyme found in muscles (creatine phosphokinase), muscle stiffness
• prolonged erections
• feeling unwell.

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, irregular heartbeat, or angina)
• increased or decreased blood pressure
• nosebleeds
• effects on liver function tests
• skin sensitivity to sunlight
• painful erections
• chest pain
• temporary reduction in blood flow to parts of the brain

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)
• bleeding from the penis
• 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. You can also report side effects directly to the Department of Drug 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. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide 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 which is 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 blisters): This medicine does not require any special storage conditions. 5 mg and 10 mg (Aluminium-PVC and Aluminium-PVC/PVdC blisters): This medicine does not require any special storage conditions. 20 mg (Aluminium-PVC and Aluminium-PVC/PVdC blisters): 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. 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: 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, iron oxide yellow (E 172), tartrazine (E 102), sunset yellow FCF (E 110), iron oxide red (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 are 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