SARILEN 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sarilen 5 mg film-coated tablets EFG

vardenafil

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 Sarilen and what is it used for
2. What you need to know before taking Sarilen
3. How to take Sarilen
4. Possible side effects
5. Storage of Sarilen
6. Package contents and additional information

1. What is Sarilen and what is it used for

This medication contains vardenafil, an active substance from 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 Sarilen

Do not take Vardenafil

• 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 have ever developed a severe skin rash or peeling, blisters, and/or ulcers in the mouth after taking vardenafil.
• 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 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 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 suffered vision loss due to a nerve injury 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 careful with vardenafil

• If you have heart problems, as having a sexual relationship can pose a risk to you.
• If you have irregular heartbeats (cardiac arrhythmia) or any inherited heart disease that alters 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, including vardenafil film-coated tablets (see the section "Use of Vardenafil with other medications").
• Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with vardenafil treatment. Discontinue vardenafil treatment and seek medical attention immediately if you experience any symptoms related to these severe skin reactions described in section 4.

If you suddenly experience a decrease or loss of vision, or if your vision becomes distorted or blurred while taking vardenafil, do not take vardenafil and consult your doctor immediately.

• If you experience sudden loss of vision, do not take vardenafil and consult your doctor immediately.

Children and adolescents

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

Other medications and Vardenafil

Inform 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 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, including vardenafil orodispersible tablets.

Taking Vardenafil with food, drinks, and alcohol

• You can take vardenafil with or without food, but it is preferable not to take it 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.

• Drinking 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 Sarilen

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 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. Your doctor 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 and 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 the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

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

Some patients have experienced sudden vision loss or partial vision loss, distorted, attenuated, or blurred vision, temporarily or permanently, in one or both eyes.

There have also been reports of sudden hearing loss.

There have been reports of sudden death, rapid or altered heartbeats, heart attacks, chest pain, and cerebral circulation problems (including temporary reduction of blood flow to parts of the brain and cerebral hemorrhage) in men taking vardenafil. Most men who 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 experiencing a side effect is described by 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 disturbances.
• Numbness and altered touch perception.
• Somnolence.
• Effects on vision; eye discharge, effects on color vision, eye pain, and photosensitivity.
• Ringing in the ears; vertigo.
• Rapid 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, red skin.
• Back pain or muscle pain; elevation of muscle enzyme creatine phosphokinase in blood; muscle stiffness.
• Prolonged erection.
• General discomfort.

Rare side 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 infarction, tachycardia, or angina).
• High or low blood pressure.
• Nosebleeds.
• Alterations in 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 or unknown frequency side effects:may affect less than 1 in 10,000 people or the frequency cannot be estimated from the available data:

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

Reporting side effects

If you experience any side effects, consult your doctor, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Sarilen

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

Do not use this medication after the expiration date stated on the packaging after "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 wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Sarilen

• The active substance is vardenafil. Each film-coated tablet contains 5 mg of vardenafil (as trihydrate hydrochloride).
• The other components are: Core: microcrystalline cellulose (E460), crospovidone (E1201), magnesium stearate (E470b), and colloidal silicon dioxide (E551). Coating: titanium dioxide (E171), hypromellose (E464), macrogol 6000 (E1521), talc (E553b), yellow iron oxide (E172), red iron oxide (E172), and purified water.

Appearance of the product and package contents

Sarilen 5 mg, orange film-coated tablets. Each package contains 4 or 20 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

C/ Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

Date of the last revision of this package leaflet: February 2025

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/