VARDENAFIL STADA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Vardenafil STADA 5 mg film-coated tablets EFG

Vardenafil STADA 10 mg film-coated tablets EFG

Vardenafil STADA 20 mg film-coated tablets EFG

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this package leaflet, as 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Vardenafil Stada and what is it used for
2. What you need to know before you take Vardenafil Stada
3. How to take Vardenafil Stada
4. Possible side effects
5. Storage of Vardenafil Stada
6. Contents of the pack and further information

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

Vardenafil Stada contains vardenafil, an active substance from the group of medicines called phosphodiesterase 5 inhibitors, which are used to treat erectile dysfunction in adult men, a condition that consists of difficulty in achieving or maintaining an erection.

At least one in ten men has, at some point, problems getting or maintaining an erection. This can be due to physical or psychological causes, or a combination of both. Regardless of the cause, muscle and blood vessel disorders cause insufficient blood to flow to the penis to achieve and maintain an erection.

Vardenafil will only work when you are sexually stimulated. This medicine reduces the action of a natural substance in the body that prevents erection. Vardenafil allows you to achieve an erection that lasts long enough to have a satisfactory sexual relationship.

2. What you need to know before you take Vardenafil Stada

DO NOT take Vardenafil Stada

• If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6). The signs of an allergic reaction include skin rash, itching, swelling of the face or lips, and difficulty breathing.
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or sores in the mouth after taking vardenafil.
• If you are taking medicines that contain nitrates, such as glyceryl trinitrate for angina, or that release nitric oxide, such as amyl nitrite. Taking these medicines together with vardenafil can seriously affect your blood pressure.
• If you are taking ritonavir or indinavir, medicines for the treatment of human immunodeficiency virus (HIV) infections.
• If you are over 75 years old and are taking ketoconazole or itraconazole, antifungal medicines.
• If you have a serious heart or liver problem.
• If you are undergoing kidney dialysis.
• If you have recently had a stroke or heart attack.
• If you have low blood pressure or have had it in the past.
• If you have a family history of degenerative eye diseases (such as retinitis pigmentosa).
• If you have ever lost your vision due to a nerve damage caused by insufficient blood supply, known as non-arteritic anterior ischemic optic neuropathy (NAION).
• If you are taking riociguat. This medicine is used to treat pulmonary arterial 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). Phosphodiesterase 5 inhibitors, such as vardenafil, have shown that they increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Vardenafil Stada.

Be particularly cautious when taking Vardenafil Stada

• If you have heart problems, as having sex can be a risk for you.
• If you have irregular heartbeats (cardiac arrhythmia) or any inherited heart disease that affects your electrocardiogram.
• If you have any physical condition that affects the shape of your penis. For example, angulation, Peyronie's disease, or cavernosal fibrosis.
• If you have a disease that can cause erections that do not disappear (priapism). For example, sickle cell anemia, multiple myeloma, and leukemia.
• If you have a stomach ulcer (also called gastric or peptic ulcer).
• If you have bleeding disorders (such as hemophilia).
• If you are using any other treatment for erection problems, including vardenafil film-coated tablets (see section "Using Vardenafil Stada with other medicines").
• Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with vardenafil treatment. Stop taking vardenafil and seek medical attention immediately if you experience any symptoms related to these severe skin reactions described in section 4.
• If you suddenly experience a decrease or loss of vision or your vision becomes distorted or blurred while taking vardenafil, stop taking vardenafil and contact your doctor immediately.

Children and adolescents

Vardenafil should not be used in children or adolescents under 18 years of age.

Other medicines and Vardenafil Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Some medicines may cause problems, especially the following:

• Nitrates, medicines for angina, or those that release nitric oxide, such as amyl nitrite. Taking these medicines together with vardenafil can seriously affect your blood pressure.
• Medicines for the treatment of irregular heartbeats, such as quinidine, procainamide, amiodarone, or sotalol.
• Ritonavir or indinavir, medicines for HIV.
• Ketoconazole or itraconazole, antifungal medicines.
• Erythromycin or clarithromycin, macrolide antibiotics.
• Alpha-blockers, a group of medicines used to treat high blood pressure and enlarged prostate (as in benign prostatic hyperplasia).
• Riociguat.

Do not use vardenafil film-coated tablets in combination with another medicine for the treatment of erectile dysfunction, including vardenafil orodispersible tablets.

Taking Vardenafil Stada with food, drinks, and alcohol

• You can take vardenafil with or without food, but it is preferable not to do so after a heavy meal or with a high fat content, as the effect may be delayed.
• Do not drink grapefruit juice when taking vardenafil, as it may interfere with the normal effect of the medicine.
• Drinking alcoholic beverages can worsen erection problems.

Pregnancy and breastfeeding

Vardenafil should not be used in women.

Driving and using machines

In some people, vardenafil can cause dizziness or affect vision. Do not drive or operate tools or machines if you feel dizzy or have vision problems after taking vardenafil.

This medicine contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Vardenafil Stada

Follow the instructions for taking this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is 10 mg.

Take a vardenafil tablet 25 to 60 minutes, approximately, before sexual activity. With sexual stimulation, you will be able to achieve an erection from 25 minutes to 4-5 hours after taking vardenafil.

Swallow the tablet with a glass of water.

DO NOT take Vardenafil Stada film-coated tabletswith any other formulation of vardenafil.

DO NOT take vardenafilmore than once a day.

If you think the effect of vardenafil is too strong or too weak, inform your doctor. He or she may suggest changing to another formulation of vardenafil with a different dose based on the effect it has on you.

If you take more Vardenafil Stada than you should

Taking too many vardenafil tablets can cause more side effects and produce intense back pain. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of these side effects are mild or moderate.

Some patients have experienced sudden loss or decrease in vision, distorted, diminished, or blurred vision, temporarily or permanently, in one or both eyes. Stop taking vardenafil and contact your doctor immediately.

Sudden loss of hearing has also been reported.

There have been reports of sudden death, rapid or altered heartbeats, heart attacks, chest pain, and cerebral circulation problems (including temporary reduction of blood flow to parts of the brain and cerebral hemorrhage) in men taking vardenafil. Most men who experienced these side effects had pre-existing heart problems before taking this medicine. It is not possible to determine if these events were directly related to vardenafil.

The possibility of presenting a side effect is described through the following categories:

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

• Headache

Common side effects (may affect up to 1 in 10 people):

• Dizziness
• Facial flushing
• Nasal congestion or runny nose
• Indigestion

Uncommon side effects (may affect up to 1 in 100 people):

• Swelling of the skin and mucous membranes, including facial, lip, or throat swelling
• Sleep disturbances
• Numbness and altered sensation of touch
• Somnolence
• Effects on vision; ocular discharge, effects on color vision, eye pain, and photosensitivity
• Tinnitus; vertigo
• Accelerated or irregular heartbeat
• Breathing difficulties
• Stuffy nose
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, feeling of discomfort (nausea), dry mouth
• Elevation of liver enzymes in blood
• Skin rashes
• Back pain or muscle pain; elevation of muscle enzyme creatine phosphokinase in blood; muscle stiffness
• Prolonged erection
• General malaise

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

• Ocular inflammation (conjunctivitis)
• Allergic reaction
• Anxiety
• Fainting
• Amnesia (memory loss)
• Seizures
• Glaucoma (increased intraocular pressure), watery eyes
• Heart effects (such as heart attack, rapid or altered heartbeats, or angina)
• High or low blood pressure
• Nosebleeds
• Alterations in liver function test results in blood
• Skin sensitivity to sunlight
• Painful erection
• Chest pain
• Temporary reduction of blood flow to parts of the brain

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

• Blood in urine (hematuria)
• Bleeding in the penis (penile hemorrhage)
• Blood in semen (hematospermia)
• Sudden death
• Cerebral hemorrhage
• Reddish, non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Distorted, diminished, or blurred vision or sudden loss of vision

Reporting side effects

If you experience any side effects, talk to your doctor, even if it is possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vardenafil Stada

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

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Vardenafil Stada

• The active substance is vardenafil.

Vardenafil Stada 5 mg: each tablet contains 5 mg of vardenafil (as trihydrate hydrochloride).

Vardenafil Stada 10 mg: each tablet contains 10 mg of vardenafil (as trihydrate hydrochloride).

Vardenafil Stada 20 mg: each tablet contains 20 mg of vardenafil (as trihydrate hydrochloride).

• The other ingredients are:

Core of the tablet: microcrystalline cellulose (E460); crospovidone type A (E1202); colloidal anhydrous silica (E551); magnesium stearate (E470b).

Film coating: polyvinyl alcohol (E1203); titanium dioxide (E171); talc (E553b); macrogol (E1521); methacrylic acid-ethyl acrylate copolymer; yellow iron oxide (E172); sodium hydrogen carbonate (E500 (ii)); red iron oxide (E172).

Appearance of the product and contents of the pack

Vardenafil Stada 5 mg are yellow, film-coated, round tablets, 6 mm in size, and engraved with "A719" on one side.

Vardenafil Stada 10 mg are yellow, film-coated, round tablets, 7 mm in size, and engraved with "A721" on one side.

Vardenafil Stada 20 mg are yellow, film-coated, round tablets, 8.5 mm in size, and engraved with "A723" on one side.

They are available in PVC/Aclar-Al blisters containing:

Vardenafil Stada 5 mg: 4, 12, or 20 tablets.

Vardenafil Stada 10 mg and Vardenafil Stada 20 mg: 2, 4, 8, 12, or 20 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastasse 2-18

Bad Vilbel 61118

Germany

or

Actavis Ltd.

BLB016, Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

or

STADA Arzneimittel GmbH

Muthgasse 36/2,

1190 Vienna

Austria

Date of last revision of this package leaflet:June 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/