SARILEN 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sarilen 20 mg film-coated tablets EFG

vardenafil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Sarilen and what is it used for
2. What you need to know before you take Sarilen
3. How to take Sarilen
4. Possible side effects
5. Storing Sarilen
6. Contents of the pack and other information

1. What is Sarilen and what is it used for

This medicine contains vardenafil, an active substance from the group of medicines 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 getting or maintaining an erection. This can be due to physical or psychological causes, or a mixture of both. Regardless of the cause, muscle and blood vessel disorders cause insufficient blood to reach the penis to achieve and maintain an erection.

Vardenafil will only work when you are sexually stimulated. This medicine 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 you take Sarilen

Do not take Vardenafil

• If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include rash, itching, swelling of the face or lips, and difficulty breathing.
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or sores in the mouth after taking vardenafil.
• If you are taking medicines that contain nitrates, such as glyceryl trinitrate for angina, or that release nitric oxide, such as amyl nitrite. Taking these medicines together with vardenafil can seriously affect your blood pressure.
• If you are taking ritonavir or indinavir, medicines for the treatment of human immunodeficiency virus (HIV) infections.
• If you are over 75 years old and are taking ketoconazole or itraconazole, antifungal medicines.
• If you have a severe heart or liver problem.
• If you are on kidney 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 loss of vision due to a nerve damage caused by insufficient blood supply, known as non-arteritic anterior ischemic optic neuropathy (NAION).
• If you are taking riociguat. This medicine 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 medicine. If you are taking riociguat or are not sure, consult your doctor.

Warnings and precautions

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

Be particularly careful with vardenafil

• 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 alters your electrocardiogram.
• If you have any physical condition that affects the shape of your penis. For example, angulation, Peyronie's disease, or cavernosal fibrosis.
• If you suffer from 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 section "Using Vardenafil with other medicines").
• 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 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 or your vision becomes distorted or blurred while taking vardenafil, do not take vardenafil and consult your doctor immediately.

Children and adolescents

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

Other medicines and Vardenafil

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

Some medicines can cause problems, especially the following:

• Nitrates, medicines for angina or that release nitric oxide, such as amyl nitrite. Taking these medicines together with vardenafil can seriously affect your blood pressure. Do not take vardenafil without consulting your doctor first.
• Medicines for the treatment of heart rhythm disorders, such as quinidine, procainamide, amiodarone, or sotalol.
• Ritonavir or indinavir, medicines for HIV. Do not take vardenafil without consulting your doctor first.
• Ketoconazole or itraconazole, antifungal medicines.
• Erythromycin or clarithromycin, macrolide antibiotics.
• Alpha-blockers, a group of medicines 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 medicine 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 medicine.

• 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 exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, 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, tell 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 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 medicine and the amount taken.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, vardenafil can cause side effects, although not everybody gets them. Most of these side effects are mild or moderate.

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

There have also been reports of sudden loss of hearing.

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 of the men who experienced these side effects had previously had heart problems before taking this medicine. It is not possible to determine if these events were directly related to vardenafil.

The possibility of presenting a side effect is described through 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 discharge, effects on color vision, eye pain, and photosensitivity.
• Ringing in the ears; vertigo.
• Rapid or altered heartbeat.
• Breathing difficulties.
• Stuffy nose.
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, feeling of discomfort (nausea), dry mouth.
• Increased liver enzymes in blood.
• Rash, red skin.
• Back pain or muscle pain; increased 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.
• Red, 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 reactions 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 of side effects

If you experience any side effects, consult your doctor, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Sarilen

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

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Sarilen

• The active substance is vardenafil. Each film-coated tablet contains 20 mg of vardenafil (as trihydrate hydrochloride).

The other ingredients 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 and packaging

Sarilen 20 mg, orange film-coated tablets. Each pack contains 2, 4, 8 tablets.

Not all pack 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 last revision of this leaflet: February 2025

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