SILDENAFIL AUROVITAS 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sildenafilo Aurovitas 25 mg film-coated tablets EFG

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

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

1. What Sildenafilo Aurovitas is and what it is used for

Sildenafilo Aurovitas contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels in the penis, allowing blood to flow into the penis when you are sexually stimulated. Sildenafilo Aurovitas will only help you to get an erection if you are sexually stimulated.

Sildenafil is indicated for the treatment of erectile dysfunction in adult men, sometimes called impotence. This occurs when a man cannot get or maintain an erection that is sufficient for satisfactory sexual activity.

2. What you need to know before you take Sildenafilo Aurovitas

Do not take Sildenafilo Aurovitas

• If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If you are taking medicines called nitrates, as the combination may lead to a dangerous decrease in your blood pressure. Consult your doctor if you are taking any of these medicines, often given to relieve angina pectoris (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
• If you are using any of the medicines known as nitric oxide donors such as amyl nitrite ("poppers"), as the combination may lead to a dangerous decrease in your blood pressure.
• 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). PDE5 inhibitors, such as sildenafil, have shown that they increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.
• If you have a severe heart or liver problem.
• If you have recently had a stroke or heart attack or if you have low blood pressure.
• If you have a rare inherited eye disease (such as retinitis pigmentosa).
• If you have previously experienced a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor or pharmacist before taking Sildenafilo Aurovitas.

Tell your doctor:

• If you have sickle cell anemia (a disorder of the red blood cells), leukemia (cancer of the blood cells), or multiple myeloma (cancer of the bone marrow).
• If you have a penile deformity or Peyronie's disease.
• If you have heart problems. Your doctor should carefully check if your heart can tolerate the extra strain of having sex.
• If you have current stomach ulcer or bleeding problems (such as hemophilia).
• If you experience a sudden decrease or loss of vision, stop taking sildenafil and contact your doctor immediately.

You should not use sildenafil at the same time as any other oral or local treatment for erectile dysfunction.

You should not take sildenafil with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or any other PDE5 inhibitor.

You should not take sildenafil if you do not have erectile dysfunction.

You should not take sildenafil if you are a woman.

Special considerations in patients with kidney or liver problems

You should tell your doctor if you have kidney or liver problems. Your doctor may decide to reduce the dose.

Children and adolescents

Sildenafil should not be given to persons under 18 years of age.

Other medicines and Sildenafilo Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Medicines that contain sacubitril/valsartan, used to treat heart failure.

Sildenafil tablets may interfere with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should tell your doctor or pharmacist that you have taken sildenafil and when you took it. Do not take sildenafil with other medicines unless your doctor tells you to.

You should not take sildenafil if you are taking medicines called nitrates, as the combination may lead to a dangerous decrease in your blood pressure. Always tell your doctor or pharmacist if you are taking any of these medicines, often used to relieve angina pectoris (or "chest pain").

You should not take sildenafil if you are taking medicines called nitric oxide donors such as amyl nitrite ("poppers"), as the combination may also lead to a dangerous decrease in your blood pressure.

Tell your doctor or pharmacist if you are taking riociguat.

If you are taking medicines known as protease inhibitors, such as those used to treat HIV, your doctor may recommend that you start with the lowest dose (25 mg) of sildenafil.

Some patients who are taking alpha-blockers, a medicine used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness that can be caused by low blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking sildenafil with alpha-blockers. This is more likely to happen within 4 hours after taking sildenafil. To minimize the chance of these symptoms, you should be on a regular daily dose of your alpha-blocker before starting sildenafil. Your doctor may advise you to start with the lower dose (25 mg) of sildenafil.

Taking Sildenafilo Aurovitas with food, drinks, and alcohol

Sildenafil can be taken with or without food. However, you may notice that sildenafil takes a little longer to start working if you take it with a large meal.

Drinking alcohol may temporarily impair your ability to get an erection. Therefore, to get the maximum benefit from the medicine, it is advised not to drink large amounts of alcohol before taking sildenafil.

Pregnancy, breastfeeding, and fertility

The use of sildenafil is not indicated in women.

Driving and using machines

Sildenafil can cause dizziness and affect vision. You should know how you react to sildenafil before driving or using machines.

Sildenafilo Aurovitas contains lactose

This medicine contains lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Sildenafilo Aurovitas contains sodium

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

3. How to take Sildenafilo Aurovitas

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

The recommended initial dose is 50 mg.

You should not take sildenafil more than once a day.

Do not take Sildenafilo Aurovitas film-coated tablets with the orodispersible tablets of sildenafil.

You should take sildenafil about one hour before you plan to have sex. Swallow the tablet whole with a glass of water.

If you notice that the effect of sildenafil is too strong or too weak, tell your doctor or pharmacist.

Sildenafil will only help you to get an erection if you are sexually stimulated. The time it takes for sildenafil to work varies from person to person, but it normally takes between half an hour and one hour. The effect of sildenafil may be delayed if you take it with a large meal.

In the event that sildenafil does not help you to get an erection or if the erection does not last long enough to complete sexual intercourse, consult your doctor.

If you take more Sildenafilo Aurovitas than you should

You may experience an increase in side effects and their severity. Doses above 100 mg do not increase efficacy.

In the event of an overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

You should not take more tablets than your doctor recommends.

Contact your doctor if you have taken more tablets than recommended.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects reported in association with the use of sildenafil are, in general, mild to moderate and usually short-lived.

If you experience any of the following serious side effects, stop taking sildenafil and seek medical attention immediately:

? Allergic reaction – this occurs uncommonly (may affect up to 1 in 100 people).

The symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.

? Chest pain – this occurs uncommonly.

If they occur during or after sex:

• Sit in a semi-upright position and try to relax.
• Do not use nitrates to treat your chest pain.

? Prolonged and sometimes painful erections – this occurs rarely (may affect up to 1 in 1,000 people).

If you have an erection that lasts more than 4 hours, you should contact a doctor immediately.

? Sudden decrease or loss of vision – this occurs rarely.

? Severe skin reactions – this occurs rarely.

The symptoms can include severe skin peeling and swelling of the skin, blistering of the mouth, genitals, and around the eyes, as well as fever.

? Seizures or fits – this occurs rarely.

Other side effects:

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

Common(may affect up to 1 in 10 people): nausea, facial flushing, hot flush (including a sudden feeling of heat in the upper body), indigestion, abnormal color perception, blurred vision, visual disturbance, nasal congestion, and dizziness.

Uncommon(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/red eyes, eye pain, seeing flashes of light, increased light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy nose, inflammation of the lining of the nose (including symptoms such as runny nose, sneezing, and nasal congestion), pain in the upper abdomen, gastroesophageal reflux disease (including symptoms such as heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling hot, and feeling tired.

Rare(may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decrease in blood flow to some parts of the brain, feeling of pressure in the throat, numbness in the mouth, bleeding in the back of the eye, double vision, decreased sharpness of vision, abnormal sensation in the eye, eye swelling or eyelid swelling, small particles or spots in the vision, seeing halos around lights, dilation of the pupil of the eye, change in color of the white of the eye, bleeding from the penis, presence of blood in the semen, dry nose, swelling inside the nose, feeling irritable, and sudden decrease or loss of hearing.

During post-marketing experience, unstable angina (heart disease) and sudden death have been reported rarely. It should be noted that most of the men who experienced these side effects, although not all of them, had pre-existing heart problems before taking this medicine. It is not possible to determine whether these side effects were directly related to sildenafil.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sildenafilo Aurovitas

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton, blister, and label of the bottle after EXP. The expiry date is the last day of the month stated.

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 further information

Composition of Sildenafilo Aurovitas

• The active substance is sildenafil. Each film-coated tablet contains 25 mg of sildenafil (as sildenafil citrate).
• The other ingredients are:

Core of the tablet: calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

Coating: lactose monohydrate, hypromellose 15cP, titanium dioxide (E171), triacetin.

Appearance and packaging of the product

White to off-white, biconvex, round (7.1 mm diameter) film-coated tablets, marked with "SL" on one face and "25" on the other.

Sildenafilo Aurovitas film-coated tablets are available in blister packs and high-density polyethylene (HDPE) bottles.

Pack sizes:

Blister pack: 2, 4, 8, 12, and 24 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Sildenafil PUREN 25 mg film-coated tablets

Spain: Sildenafilo Aurovitas 25 mg film-coated tablets EFG

France: SILDENAFIL ARROW LAB 25 mg, film-coated tablet

Italy: Sildenafil Aurobindo 25 mg film-coated tablets

Netherlands: Sildenafil Aurobindo 25 mg, film-coated tablets

Date of last revision of this leaflet: October 2022

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