VARDENAFIL TECNIGEN 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Vardenafil TecniGen 10 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Vardenafil TecniGen and what is it used for
2. What you need to know before taking Vardenafil TecniGen
3. How to take Vardenafil TecniGen
4. Possible side effects
5. Storage of Vardenafil TecniGen
6. Package Contents and Additional Information

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

This medication contains vardenafil, an active ingredient in the group of medications 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 achieving 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 flow to the penis to achieve and maintain an erection.

Vardenafil will only work when you are sexually stimulated. This medication reduces the action of a natural substance in the body that prevents erection. Vardenafil allows you to achieve an erection with sufficient duration to maintain a satisfactory sexual relationship.

2. What you need to know before taking Vardenafil TecniGen

Do not take Vardenafil TecniGen

• If you are allergic to vardenafil or any other component of this medication (listed in section 6). Signs of an allergic reaction include skin rash, itching, swelling of the face or lips, and difficulty breathing.
• If you are taking medications that contain nitrates, such as glyceryl trinitrate for angina pectoris, or that release nitric oxide, such as amyl nitrite. Taking these medications together with vardenafil can seriously 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 serious 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 suffered 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 medication 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 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 especially careful with Vardenafil TecniGen

• If you have heart problems, as having sex can pose a risk to you.
• If you have irregular heartbeats (cardiac arrhythmia) or any inherited heart disease that affects your electrocardiogram.
• If you have any physical problem that affects the shape of your penis. For example, angulation, Peyronie's disease, or cavernous 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 (see the section: "Other medications and Vardenafil TecniGen").
• If you experience a sudden decrease or loss of vision, stop taking vardenafil and consult your doctor immediately.

Children and Adolescents

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

Other Medications and Vardenafil TecniGen

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those purchased without a prescription.

Some medications can cause problems, especially the following:

• Nitrates, medications for angina pectoris or that release nitric oxide, such as amyl nitrite. Taking these medications together with vardenafil can seriously 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 Vardenafil TecniGen 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 medication.

• Consuming 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.

3. How to Take Vardenafil TecniGen

Follow your doctor's instructions for taking this medication exactly. 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 can achieve an erection from 25 minutes to 4 or 5 hours after taking vardenafil.

• Swallow the tablet with a glass of water.

Do not take Vardenafil TecniGen 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 than you should

Taking too many vardenafil tablets can 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

4. Possible Side Effects

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

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

There have also been reports of sudden hearing loss.

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 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 disorders.
• Numbness and altered touch perception.
• Somnolence.
• Effects on vision, eye redness, effects on color vision, eye pain and discomfort, and photosensitivity.
• Ringing in the ears, vertigo.
• Fast 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, skin redness.
• 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.
• Increased intraocular pressure (glaucoma), watery eyes, increased tearing.
• Heart effects (such as myocardial infarction, altered heart rhythm, or angina).
• High or low blood pressure.
• Nosebleeds.
• Alterations in liver function test results in blood.
• Skin sensitivity to sunlight.
• Painful erection.
• Chest pain.

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).

Reporting Side Effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that is not listed in this package leaflet. You can also report them directly through the Spanish Medication Pharmacovigilance System https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Vardenafil TecniGen

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 "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any questions, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Vardenafil TecniGen

The active ingredient is vardenafil. Each tablet contains 10 mg of vardenafil (as trihydrate hydrochloride).

The other ingredients are:

Core of the tablet: microcrystalline cellulose, type B crospovidone, anhydrous colloidal silica, magnesium stearate

Coating: hypromellose, titanium dioxide (E171), yellow iron oxide (E172), macrogol 400, red iron oxide (E172)

Appearance of the Product and Package Contents

Vardenafil TecniGen 10 mg film-coated tablets EFG are round, biconvex, and light orange in color, with a diameter of 8 mm.

Vardenafil TecniGen film-coated tablets are available in packages of 2, 4, and 8 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

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

28108 Alcobendas (Madrid)

Spain

Manufacturer

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

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

Portugal – Vardenafil Pentafarma

Italy – Vardenafil TecniGen

Spain – Vardenafilo TecniGen 10 mg film-coated tablets EFG

Date of the Last Revision of this Package Leaflet:

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