Leaflet: information for the user

Sarilen 10 mg film-coated 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, and you must 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 is Sarilen and what it is 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. Contents of the pack and additional information

This medication contains vardenafil, 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 ten men have, 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.

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

Do not take Vardenafilo

- 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 have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking vardenafilo.

- 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 have a severe heart or liver problem.

- If you are undergoing renal dialysis.

- If you have recently experienced a stroke or heart attack.

- If you have low blood pressure, or if you 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 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.

Be especially careful with vardenafilo

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

- If you have irregular heartbeats (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 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 film-coated tablets (see section: "Use of Vardenafilo with other medications").

- Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with vardenafilo treatment. Discontinue vardenafilo treatment and seek immediate medical attention if you experience any of the symptoms related to these severe skin reactions described in section 4.

- If you experience sudden vision loss or partial vision loss, or if your vision becomes distorted or dark while taking vardenafilo, do not take vardenafilo and consult your doctor immediately.

Children and adolescents

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

Other medications and Vardenafilo

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

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. Do not take vardenafilo without consulting your doctor first.

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

- Ritonavir or indinavir, medications for HIV. Do not take vardenafilo 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 vardenafilo film-coated tablets in combination with another medication for erectile dysfunction, including vardenafilo buccal dispersible tablets.

Taking Vardenafilo 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 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.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of 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 will be able to obtain an erection from 25 minutes and up to four or five hours after taking vardenafilo.

- Swallow the tablet with a glass of water.

Do not take vardenafilo film-coated tablets 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 than you should

Taking too many vardenafilo tablets may 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, distorted, blurred, or distorted central vision, suddenly, temporarily, or permanently, 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 reduction of 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 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 side effects:can affect more than 1 in 10 people:

• Headache.

Common side effects:can affect up to 1 in 10 people:

• Dizziness.
• Flushing.
• Nasal congestion or runny nose.
• Indigestion.

Uncommon side effects:can 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; eye bleeding, effects on color vision, eye pain, and photosensitivity.
• Tinnitus; vertigo.
• Fast or irregular heartbeat.
• Difficulty breathing.
• Blocked nose.
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, feeling of discomfort(nausea),dry mouth.
• Elevation of liver enzymes in the blood.
• Skin rashes, red skin.
• Back pain or muscle pain; elevated muscle enzyme creatine phosphokinase in the blood; muscle stiffness.
• Prolonged erection.
• General feeling of discomfort.

Rare side effects: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, for example, 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 reduction of blood flow to parts of the brain.

Very rare or unknown frequency side effects:can affect fewer 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 semen (hematospermia).
• Sudden death.
• Cerebral hemorrhage.
• Flat, non-elevated, circular or target-shaped spots on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions can be preceded by fever and symptoms similar to the flu (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Distorted, blurred, or distorted central vision or sudden decrease in vision.

Reporting side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side 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 side 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 use this medication after the expiration date that appears on the packaging after “CAD”. 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 Sarilen

• The active ingredient is vardenafil. Each film-coated tablet contains 10 mg of vardenafil (as trihydrate hydrochloride).
• The other components are: Core: microcrystalline cellulose (E460), crospovidone (E1201), magnesium stearate (E470b), and colloidal silica (E551). Coating: titanium dioxide (E171), hypromellose (E464), macrogol 6000 (E1521), talc (E553b), yellow iron oxide (E172), and red iron oxide (E172), and purified water.

Appearance of the product and content of the packaging

Sarilen 10mg, film-coated tablets, orange in color. Each package contains 2, 4, 8 tablets.

Only some package sizes may be commercially available.

Holder of the Marketing Authorization and Responsible for Manufacturing

LABORATORIOS NORMON, S.A.

C/ Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

Last review date of this leaflet: February 2025

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