Leaflet: information for the patient

Vardenafilo Teva 10 mg buccal tablets EFG

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 Teva is and what it is used for

2. What you need to know before taking Vardenafilo Teva

3. How to take Vardenafilo Teva

4. Possible side effects

5. Storage of Vardenafilo Teva

6. Contents of the pack and additional information

This medicationcontains vardenafilo, an active ingredient from 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 every 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 Teva

- If you are allergic to vardenafilo or any of the other components of this medication (listed in section 6). Signs of 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 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 experienced 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 arterial 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 this medication.

• 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 subside (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 film-coated tablets (see the section: “Using Vardenafilo Teva 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 Teva should not be used in children or adolescents under 18 years old.

Other medications and Vardenafilo Teva

Inform your doctor or pharmacist if you are using, have used recently, or may need to use 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 use vardenafilo buccal tablets in combination with another medication for erectile dysfunction, including vardenafilo film-coated tablets.

Taking Vardenafilo Teva with food, drinks, and alcohol

- You can take Vardenafilo Teva with or without food, but do not take it without any liquid.

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

- Drinking alcoholic beverages may worsen erectile dysfunction.

Pregnancy and breastfeeding

Vardenafilo Teva should not be used in women.

Driving and operating machines

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

Vardenafilo Teva contains aspartame and sodium

This medication contains 1.8 mg of aspartame per buccal tablet. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. 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.

- Do not remove the buccodispersable tablet from the blister until you are ready to take it. With dry hands, press the blister gently to release the tablet into your hand. Do not break the tablet.

- Place the buccodispersable tablet whole in your mouth, on top of your tongue, where it will dissolve in seconds, and then swallow with saliva. The buccodispersable tablet should be taken without any type of liquid.

Do not take Vardenafilo Tevawith any other vardenafilo formulation.

Do not take Vardenafilo Tevamore than once a day.

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

If you take more Vardenafilo Teva 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 medicines, vardenafil can 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.

Cases of sudden decrease or loss of hearing have also 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) have been reported in men taking vardenafil. Most men who have experienced these side effects already had heart problems before taking this medication. It is not possible to determine if these events were directly related to vardenafil.

The possibility of presenting an adverse effect is described using the following categories:

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

-Headache.

Common(can affect up to 1 in 10 people)

-Dizziness.

-Facial flushing.

-Nasal congestion or discharge.

-Indigestion.

Uncommon(can 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.

-Drowsiness.

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

-Tinnitus; vertigo.

-Palpitations or rapid heartbeat.

-Difficulty breathing.

-Stuffy nose.

-Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, feeling of discomfort(nausea),dry mouth.

-Elevation of liver enzymes in the blood.

-Skin eruptions, red skin.

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

-Prolonged erection.

-General feeling of discomfort.

Rare(can 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 myocardial infarction, tachycardia, or angina).

-High or low blood pressure.

-Nasal bleeding.

-Alterations in liver function test results in the blood.

-Sensitivity to sunlight.

-Painful erection.

-Chest pain.

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

Very rare(can affect fewer than 1 in 10,000 people)or Unknown frequency(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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use https://www.notificaram.es. By reporting adverse 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.

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

This medication does not require special storage conditions.

Medications 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 Teva 10 mg buccal tablets

• The active ingredient is vardenafil. Each buccal tablet contains 10 mg of vardenafil (as vardenafil hydrochloride trihydrate).
• The other componentsare:

microcrystalline cellulose, sodium carboxymethyl starch (potato starch), anhydrous colloidal silica, magnesium stearate, aspartame (E951), peppermint flavor, and sodium stearoylfumarate.

Appearance of the product and contents of the packaging

Vardenafilo Teva 10 mg buccal tablets are round, flat tablets of white or off-white color.

Each package contains blisters of 4 and 8 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva B.V.

Swensweg 5 Haarlem

2031GA Netherlands

Manufacturer

Chanelle Medical Unlimited Company,

Dublin Road, Loughrea, H62 FH90,

Ireland

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park, Paola PLA 3000,

Malta

Local representative

Teva Pharma, S.L.U.

c/Anabel Segura, 11 Edificio Albatros B 1ª planta

Alcobendas 28108 Madrid

Spain

Last revision date of thisleaflet: November 2020

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

You can access detailed and updated information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the carton. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/83049/P_83049.html