Vardenafil Stada 20 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

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

At least one in ten men will, at some point, experience problems achieving or maintaining an erection. This may be due to physical or psychological causes, or a combination of both. Regardless of the cause, disturbances in the muscles and blood vessels result in insufficient blood 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 enables you to achieve an erection of sufficient duration to allow satisfactory sexual intercourse.

2. What you need to know before taking 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). Signs of an allergic reaction include 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 mouth sores after taking vardenafil.
• If you are taking medicines containing nitrates, such as glyceryl trinitrate for angina pectoris, or those that release nitric oxide, such as amyl nitrite. Taking these medicines together with vardenafil may seriously affect your blood pressure.
• If you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus (HIV) infections.
• If you are over 75 years old and are taking ketoconazole or itraconazole, antifungal medicines.
• If you have severe heart or liver problems.
• If you are undergoing renal dialysis.
• If you have recently suffered 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 experienced sudden vision loss due to optic 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). PDE5 inhibitors such as vardenafil have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

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

Take special care with Vardenafil Stada

• If you have heart problems, as having sexual intercourse may pose a risk to you.
• If you have irregular heartbeats (cardiac arrhythmia) or an inherited heart condition that affects your electrocardiogram.
• If you have a physical condition affecting the shape of your penis. For example, curvature, Peyronie’s disease, or cavernosal fibrosis.
• If you have a medical condition that may cause prolonged erections (priapism). For example, sickle cell anemia, multiple myeloma, or leukemia.
• If you have a stomach ulcer (also known as gastric or peptic ulcer).
• If you have bleeding disorders (such as hemophilia).
• If you are using any other treatment for erectile problems, including vardenafil film-coated tablets (see section: “Use of 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 treatment with vardenafil and seek immediate medical attention if you experience any of the symptoms related to these severe skin reactions described in section 4.
• If you experience sudden decrease or loss of vision, or if your vision becomes distorted or darkened while taking vardenafil, stop taking vardenafil and contact your doctor immediately.

Children and adolescents

Vardenafil must 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 need to take any other medicines, including those obtained without a prescription.

Some medicines may cause problems, especially the following:

• Nitrates, medicines for angina pectoris, or those that release nitric oxide, such as amyl nitrate. Taking these medicines together with vardenafil may seriously affect your blood pressure.
• Medicines used to treat cardiac arrhythmias, 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 (such as benign prostatic hyperplasia).
• Riociguat.

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

Taking Vardenafil Stada with food, drinks, and alcohol

• You may take vardenafil with or without food, but it is preferable not to take it after a heavy or high-fat meal, 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 alcohol may worsen erectile problems.

Pregnancy and breastfeeding

Vardenafil must not be used in women.

Driving and using machines

In some people, vardenafil may cause dizziness or affect vision. Do not drive or operate tools or machinery 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 exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 10 mg.

Take one vardenafil tablet approximately 25 to 60 minutes before sexual activity. With sexual stimulation, you may achieve an erection from 25 minutes up to four or five hours after taking vardenafil.

Swallow the tablet with a glass of water.

Do not take vardenafil film-coated tablets together with any other formulation of vardenafil.

Do not take vardenafil more than once a day.

If you feel the effect of vardenafil is too strong or too weak, inform your doctor. Your doctor may suggest switching to another formulation of vardenafil with a different dose, depending on its effect on you.

If you take more Vardenafil Stada than you should

Taking too many vardenafil tablets may lead to an increased occurrence of adverse effects and cause severe back pain. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. Most of these adverse effects are mild or moderate.

Some patients have experienced decreased or partial loss of vision, sudden, temporary or permanent blurred, dimmed or distorted central vision, in one or both eyes. Stop taking vardenafil and contact your doctor immediately.

Sudden decrease or loss of hearing has also been reported.

Cases of sudden death, rapid or irregular heartbeat, heart attack, chest pain, and cerebral circulation problems (including temporary reduction of blood flow to parts of the brain and cerebral hemorrhage) have been reported in men taking vardenafil. Most men who experienced these side effects already had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to vardenafil.

The likelihood of experiencing an adverse effect is described using the following categories:

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

• Headache

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

• Dizziness
• Facial flushing
• Runny or stuffy nose
• Indigestion

Uncommon adverse 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 sense of touch
• Drowsiness
• Visual disturbances; eye discharge, color vision changes, eye pain, and light sensitivity
• Ringing in the ears; dizziness
• Rapid pulse or palpitations
• Difficulty breathing
• Nasal congestion
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, feeling of discomfort (nausea), dry mouth
• Increased liver enzymes in blood
• Skin rashes
• Back pain or muscle pain; increased blood levels of the muscle enzyme creatine phosphokinase; muscle stiffness
• Prolonged erection
• General malaise

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

• Eye inflammation (conjunctivitis)
• Allergic reaction
• Anxiety
• Fainting
• Amnesia (memory loss)
• Seizures
• Glaucoma (increased intraocular pressure), watery eyes
• Effects on the heart (such as heart attack, tachycardia or angina)
• High or low blood pressure
• Nosebleeds
• Abnormal 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 adverse effects or adverse effects with unknown frequency (may affect fewer than 1 in 10,000 people or frequency cannot be estimated from available data):

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 which is stated on the carton and blister after “EXP”. The expiry date refers to the last day of the indicated month.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Vardenafil Stada

• The active substance is vardenafil.

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

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

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

• The other components are:

Tablet core: 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 round, film-coated, light yellow tablets, 6 mm in diameter, marked with "A719" on one side.

Vardenafil Stada 10 mg are round, film-coated, light yellow tablets, 7 mm in diameter, marked with "A721" on one side.

Vardenafil Stada 20 mg are round, film-coated, light yellow tablets, 8.5 mm in diameter, marked with "A723" on one side.

Packaged 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.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastasse 2-18

61118 Bad Vilbel

Germany

or

Actavis Ltd.

BLB016, Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

or

STADA Arzneimittel GmbH

Muthgasse 36/2,

1190 Vienna

Austria

Date of the most recent revision of this leaflet: June 2025

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