Leaflet: information for the user

Vardenafilo TecniGen 20 mg film-coated tablets

Read this leaflet carefully before you start taking this medicine because 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, talk to your doctor, pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Vardenafilo TecniGen is and what it is used for

2. What you need to know before taking Vardenafilo TecniGen

3. How to take Vardenafilo TecniGen

4. Possible side effects

5. Storage of Vardenafilo TecniGen

6. Contents of the pack and additional information

This medicationcontains vardenafilo, an active ingredient in the group of medications known as phosphodiesterase type 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 achieving or maintaining an erection. This may be due to physical or psychological causes, or a combination of both. Regardless of the cause, muscle and blood vessel alterations result in insufficient blood in the penis to achieve and maintain an erection.

Vardenafilo will only act when sexually stimulated. This medication reduces the action of a natural substance in the body that prevents an erection. Vardenafilo allows for the achievement of an erection with a sufficient duration to maintain a satisfactory sexual relationship.

Do not take Vardenafilo TecniGen

- If you are allergic to vardenafil or any of the other components of this medication (listed in section 6). Signs of an allergic reaction include skin rash, itching, swelling in the face or lips, and difficulty breathing.

- If you are taking medications that contain nitrates, such as glyceryl trinitrate for angina, or that release nitric oxide, such as amyl nitrite. Taking these medications together with vardenafil may severely affect your blood pressure.

- If you are taking ritonavir or indinavir, medications for the treatment of human immunodeficiency virus (HIV) infections.

- If you are over 75 years old and taking ketoconazole or itraconazole, antifungal medications.

- If you have a severe heart or liver problem.

- If you are undergoing renal 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 diseases (such as retinitis pigmentosa).

- If you have ever experienced vision loss due to a lack of blood supply to the optic nerve, known as non-arteritic anterior ischemic optic neuropathy (NAION).

- If you are taking riociguat. This medication is used to treat pulmonary hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs caused by clots). PDE5 inhibitors, such as vardenafil, have shown to increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

Be extra cautious with Vardenafilo TecniGen

- If you have heart problems, as having sex may pose a risk to you.

- If you have irregular heartbeats (cardiac arrhythmia) or a hereditary heart disease that alters your electrocardiogram.

- If you have any physical condition that affects the shape of your penis, such as angulation, Peyronie's disease, or cavernous fibrosis.

- If you have a disease that may cause erections that do not subside (priapism), such as sickle cell anemia, multiple myeloma, and 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 dysfunction (see section: "Other medications and Vardenafilo TecniGen").

- If you experience sudden vision loss, stop taking vardenafil and consult your doctor immediately.

Children and adolescents

Vardenafilo should not be used in children or adolescents under 18 years old.

Other medications and Vardenafilo TecniGen

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Some medications may cause problems, especially the following:

- Nitrates, medications for angina or that release nitric oxide, such as amyl nitrite. Taking these medications together with vardenafil may severely affect your blood pressure. Do not take vardenafil without consulting your doctor first.

- Medications for the treatment of cardiac arrhythmias, such as quinidine, procainamide, amiodarone, or sotalol.

- Ritonavir or indinavir, medications for HIV. Do not take vardenafil without consulting your doctor first.

- Ketoconazole or itraconazole, antifungal medications.

- Erythromycin or clarithromycin, macrolide antibiotics.

- Alpha-blockers, a group of medications 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 medication for the treatment of erectile dysfunction.

Taking Vardenafilo with food, drinks, and alcohol

- You can take vardenafil with or without food, but it is recommended not to do so after a large or high-fat meal, as the effect may be delayed.

- Do not drink grapefruit juice while taking vardenafil, as it may interfere with the normal effect of the medication.

- Drinking alcoholic beverages may worsen erectile dysfunction.

Pregnancy and breastfeeding

Vardenafilo should not be used in women.

Driving and operating machinery

In some people, vardenafilo may cause dizziness or affect vision. Do not drive or operate tools or machinery if you feel dizzy or have vision problems after taking vardenafilo.

Vardenafilo TecniGen contains Yellow Orange S (E110)

This medication contains Yellow Orange S (E110). It may cause allergic reactions.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 10 mg.

Take a vardenafilo tablet 25 to 60 minutes before sexual activity. With sexual stimulation, you will be able to obtain an erection from 25 minutes and up to four or five hours after taking vardenafilo.

- Swallow the tablet with a glass of water.

Do not take vardenafilo film-coated tablets with any other vardenafilo formulation.

Do not take vardenafilo more than once a day.

If you estimate that the action of vardenafilo is too strong or weak, inform your doctor. They may suggest changing to another vardenafilo formulation with a different dose based on the effect it has on you.

If you take more Vardenafilo than you should

Taking too many vardenafilo tablets may cause more side effects or produce intense back pain.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

Like all medications, vardenafil may cause side effects, although not everyone will experience them. Most of these side effects are mild or moderate.

Some patients have experienced a decrease in vision or partial loss of vision, sudden, temporary, or permanent, in one or both eyes. Stop taking vardenafil and contact your doctor immediately.

There have also been reported cases of sudden hearing loss or decrease in hearing.

The possibility of presenting a side effect is described using 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 rhinorrhea.

-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 tactile perception.

-Drowsiness.

-Effects on vision, eye redness, effects on color vision, eye pain, and photophobia.

-Tinnitus, vertigo.

-Increased heart rate or palpitations.

-Difficulty breathing.

-Stuffy nose.

-Reflux, gastritis, abdominal pain, diarrhea, vomiting, nausea, dry mouth.(Nausea),dry mouth.

-Elevation of liver enzymes in the blood.

-Skin rashes, skin redness.

-Back pain or muscle pain; elevated muscle enzyme creatine phosphokinase in the 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.

-Syncope.

-Amnesia (memory loss).

-Seizures.

-Increased intraocular pressure (glaucoma), watery eyes, increased tear production.

-Effects on the heart (such as myocardial infarction, arrhythmia, or angina).

-Hypertension or hypotension.

-Nasal bleeding.

-Alterations in liver function test results in the blood.

-Sensitivity to sunlight.

-Painful erection.

-Chest pain.

Very rare or unknown frequency side effects:May affect fewer 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).

Reporting side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this prospectus. You can also report them directlythrough the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not dispose of medications through the drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Vardenafilo TecniGen

The active ingredient is vardenafil. Each tablet contains 20 mg of vardenafil (as trihydrate hydrochloride).

The other components are:

Tablet core:microcrystalline cellulose, crospovidone type B, anhydrous colloidal silica, magnesium stearate

Coating:hypromellose, titanium dioxide (E171), yellow iron oxide (E172), macrogol 400, yellow-orange S (E110).

Appearance of the product and content of the container

Vardenafilo TecniGen 20 mg film-coated tablets are round, biconvex, orange-colored tablets with a diameter of 10 mm.

Vardenafilo TecniGen film-coated tablets are presented in containers of 4 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

Pharmaceutical Works Polpharma S.A.

19 Pelplinska Street

83-200 Starogard Gdanski

Poland

or

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, nº 2, Abrunheira,

2710 – 089 Sintra

Portugal

Thismedicament is authorized in the member states of the European Economic Area with the following names:

Portugal – Vardenafil Pentafarma

Italy – Vardenafil TecniGen

Spain – Vardenafilo TecniGen 20 mg film-coated tablets

Last review date of this leaflet: November 2022

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