Leaflet: information for the patient

Vardenafilo Tevagen 20 mg film-coated tablets

Vardenafilo

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 give it to others even if they have the same symptoms as you, as it may harm them.

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

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

2. What you need to know before taking Vardenafilo Tevagen

3. How to take Vardenafilo Tevagen

4. Possible side effects

5. Storage of Vardenafilo Tevagen

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 vascular 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 an erection with a sufficient duration to maintain a satisfactory sexual relationship.

Do not take Vardenafilo Tevagen

- If you are allergic to vardenafilo 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 Vardenafilo Tevagen 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 ketoconazol or itraconazol, antifungal medications.

- If you have a severe heart or liver problem.

- If you are undergoing renal dialysis.

- If you have recently experienced a cerebral ischemic accident or a heart attack.

- If you have low blood pressure, or if you have had it in the past.

- If you have a family history of degenerative eye diseases (such as retinitis pigmentosa).

- If you have ever suffered vision loss due to a lack of blood supply to the optic nerve, known as nonarteritic 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 vardenafilo, 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 Vardenafilo Tevagen.

Be extra careful with Vardenafilo Tevagen

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

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

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

- If you have a disease that may cause erections that do not go away (priapism). For example, sickle cell anemia, multiple myeloma, and leukemia.

- If you have a stomach ulcer (also known as a gastric or peptic ulcer).

- If you have bleeding disorders (such as hemophilia).

- If you are using any other treatment for erectile dysfunction, including vardenafilo tablets (see the section: "Taking Vardenafilo Tevagen with other medications").

- If you have ever experienced sudden, temporary, or permanent loss of vision in one eye, do not take vardenafilo and consult your doctor immediately.

Children and adolescents

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

Taking Vardenafilo Tevagen with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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 vardenafilo may severely affect your blood pressure.

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

- Ritonavir or indinavir, medications for HIV infections.

- Ketoconazol or itraconazol, 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 take Vardenafilo Tevagen in combination with another medication for erectile dysfunction, including vardenafilo tablets.

Taking Vardenafilo Tevagen with food, drinks, and alcohol

- You can take vardenafilo 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 vardenafilo, as it may interfere with the normal effect of the medication.

- Drinking alcoholic beverages may worsen erectile dysfunction.

Pregnancy and breastfeeding

Vardenafilo Tevagen 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 Tevagen.

Vardenafilo Tevagen contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in 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 can obtain an erection from 25 minutes to four or five hours after taking Vardenafilo.

- Swallow the tablet with a glass of water.

Do not take Vardenafilo Tevagen 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 Tevagen than you should

Taking too many vardenafilo 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 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. If you experience this, stop taking vardenafil and contact your doctor immediately.

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

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

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

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

-Headache.

Common(may affect up to 1 in 10 people)

-Dizziness.

-Facial flushing.

-Nasal congestion or rhinorrhea.

-Indigestion.

Uncommon(may affect up to 1 in 100 people)

-Swelling of the skin and mucous membranes, including facial swelling, lip swelling, or throat swelling.

-Sleep disturbances.

-Numbness and altered sensation of touch.

-Drowsiness.

-Effects on vision; subconjunctival hemorrhage, effects on color vision, eye pain, and photosensitivity.

-Tinnitus; vertigo.

-Palpitations or rapid heartbeat.

-Dyspnea.

-Blocked nose.

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

-Elevation of liver enzymes in blood.

-Dermatological reactions, skin redness.

-Back pain or muscle pain; elevated creatine phosphokinase in blood; muscle rigidity.

-Prolonged erection.

-General malaise.

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

-Ocular inflammation (conjunctivitis).

-Allergic reaction.

-Anxiety.

-Syncope.

-Amnesia (memory loss).

-Seizures.

-Glaucoma (increased intraocular pressure), watery eyes.

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

-Hypertension or hypotension.

-Nasal bleeding.

-Alterations in liver function test results in blood.

-Sensitivity to sunlight.

-Painful erection.

-Chest pain.

-Temporary decrease in blood flow to parts of the brain.

Very rare(may affect fewer than 1 in 10,000 people)or unknown frequency(frequency cannot be estimated from available data)

-Blood in urine (hematuria).

-Bleeding in the penis (hemorrhagic penile).

-Blood in semen (hematospermia).

-Sudden death.

-Cerebral hemorrhage.

Reporting of adverse reactions

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

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

Do not take 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 store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Vardenafilo Tevagen 20 mg film-coated tablets

• The active ingredient is vardenafil. Each film-coated tablet contains 20 mg of vardenafil (as hydrochloride).
• The other excipients are:

Core: microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate .

Coating: polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b), macrogol/PEG 3350 (E1521), acrylate copolymer type A, yellow iron oxide (E172), sodium bicarbonate (E500 (ii)), red iron oxide (E172).

Appearance of the product and content of the packaging

Vardenafilo Tevagen 20 mg film-coated tablets are yellowish-colored tablets of 8.5 mm, marked with “ A723 ” on one side.

The tablets are available in blisters containing 2, 4, 8, 12, 20, 24, 36 or 48 tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1st Floor

Alcobendas, 28108 Madrid (Spain)

Responsible manufacturer

Actavis Ltd.

BLB015-016, Bulebel Industrial Estate

Zejtun ZTN 3000 Malta

Last review date of this prospectus: November 2020

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