Leaflet: information for the user

Sildenafilo Aurovitas 100 mgfilm-coated tablets

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 Sildenafilo Aurovitas is and what it is used for

2.What you need to know before you start taking Sildenafilo Aurovitas

3.How to take Sildenafilo Aurovitas

4.Possible side effects

5.Storage of Sildenafilo Aurovitas

6.Contents of the pack and additional information

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

Sildenafilo is indicated for the treatment of erectile dysfunction in adult men, sometimes referred to as impotence. This occurs when a man is unable to obtain or maintain a firm, adequate erection for satisfactory sexual activity.

Do not take Sildenafilo Aurovitas

-If you are allergic to sildenafil or any of the other ingredients of this medication (listed in section 6).

-If you are taking certain medications called nitrates, as the combination may lead to a dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medications, which are often used to relieve chest pain (or "angina"). If you are unsure, consult your doctor or pharmacist.

-If you are using any of the medications called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination may lead to a dangerous drop in your blood pressure.

-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 clots). PDE5 inhibitors, such as sildenafil, have shown to increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.

-If you have a serious heart or liver problem.

-If you have recently had a stroke, heart attack, or have low blood pressure.

-If you have a rare inherited eye disorder (such as retinitis pigmentosa).

-If you have experienced previous vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sildenafilo Aurovitas.

Inform your doctor:

-If you have sickle cell anemia (a blood disorder), leukemia (blood cancer), or multiple myeloma (bone marrow cancer).

-If you have a penile deformity or Peyronie's disease.

-If you have heart problems. Your doctor should carefully check if your heart can handle the additional strain of sexual activity.

-If you have a 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 simultaneously with 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 inform your doctor if you have liver or kidney problems. Your doctor may decide to reduce the dose.

Children and adolescents

Sildenafil should not be administered to individuals under 18 years old.

Other medications and Sildenafilo Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Medications containing sacubitril/valsartan, used to treat heart failure

Sildenafil tablets may interact with some medications, especially those used to treat chest pain. In case of a medical emergency, you should inform your doctor or pharmacist that you have taken sildenafil and when you took it. Do not take sildenafil with other medications unless your doctor advises you to.

You should not take sildenafil if you are taking nitrates, as the combination of these medications may lead to a dangerous drop in your blood pressure. Inform your doctor or pharmacist if you are taking any of these medications, which are often used to relieve chest pain (or "angina").

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

Inform your doctor or pharmacist if you are taking riociguat.

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

Some patients taking an alpha-blocker, a medication used to treat high blood pressure or benign prostatic hyperplasia, may experience dizziness or lightheadedness caused by a drop in blood pressure when standing up or sitting down quickly. Some patients have experienced these symptoms when taking sildenafil with alpha-blockers. This is more likely to occur in the 4 hours following sildenafil intake. To reduce the likelihood of these symptoms, you should be receiving your regular daily dose of the alpha-blocker before starting sildenafil. Your doctor may recommend that you start treatment 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 bit longer to take effect if you ingest it with a large meal.

Consuming alcohol may temporarily impair your ability to achieve an erection. Therefore, to get the maximum benefit from the medication, it is recommended that you do not consume large amounts of alcohol before taking sildenafil.

Pregnancy, breastfeeding, and fertility

The use of sildenafil is not indicated in women.

Driving and operating machinery

Sildenafil may cause dizziness and affect your vision. You should know how you react to sildenafil before driving vehicles or operating machinery.

Sildenafilo Aurovitas contains lactose

This medication contains lactose monohydrate. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Sildenafilo Aurovitas contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per 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 initial dose is 50 mg.

Do not take sildenafilo more than once a day.

Do not take Sildenafilo Aurovitas film-coated tablets with sildenafilo buccal tablets.

Take sildenafilo approximately one hour before planning to have sexual intercourse. Swallow the tablet whole with a glass of water.

If you notice that the action of sildenafilo is too strong or too weak, inform your doctor or pharmacist.

Sildenafilo will only help you get an erection if you are sexually stimulated. The time it takes for sildenafilo to take effect varies from person to person, but generally ranges from 30 minutes to one hour. The effect of sildenafilo may be delayed if taken with a large meal.

If sildenafilo does not help you get an erection or if the erection does not last long enough to complete sexual intercourse, consult your doctor.

If you take moreSildenafilo Aurovitas than you should

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

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.

Do not take more tablets than recommended by your doctor.

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The side effects reported associated with the use of sildenafil are generally mild to moderate in intensity and of short duration.

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

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

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

?Chest pain – this occurs infrequently.

If it occurs during or after sexual intercourse:

-Get into a semi-sitting position and try to relax.

-Do not use nitratesto 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 must contact a doctor immediately.

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

?Severe skin reactions – this occurs rarely.

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

?Convulsions or seizures – 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, warmth (including symptoms such as sudden heat sensation in the upper body), indigestion, abnormal color perception, blurred vision, visual deterioration, nasal congestion, and dizziness.

Uncommon(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/ red eyes, eye pain, flashing lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced tactile sensation, vertigo, tinnitus in the ears, dry mouth, nasal congestion or blockage, nasal mucosa inflammation (including symptoms such as coughing, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including symptoms such as stomach burning), blood in urine, arm or leg pain, nasal bleeding, feeling of heat, and feeling tired.

Rare(may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient decrease in blood flow to some parts of the brain, sensation of throat constriction, numbness of the mouth, bleeding in the back of the eye, double vision, visual acuity decrease, abnormal sensation in the eye, eye swelling or eyelid swelling, small particles or spots in vision, halos around lights, pupil dilation, change in color of the white part of the eye, bleeding of the penis, blood in semen, dry nose, nasal swelling, feeling of irritability, and sudden decrease or loss of hearing.

During post-marketing experience, rare cases of unstable angina (heart disease) and sudden death have been reported. It is worth noting that most men who experienced these side effects, although not all of them, had heart problems before taking this medicine. It is not possible to determine if these side effects were directly related to sildenafil.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special conditions for conservation.

Do not use this medication after the expiration date that appears on the carton, blister pack, and bottle label after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Sildenafilo Aurovitas

-The active ingredient is sildenafilo. Each film-coated tablet contains 100 mg of sildenafilo (as citrato de sildenafilo).

-The other components are:

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

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

Appearance of the product and contents of the package

Film-coated tablets, white to off-white in color, biconvex, round (11.2 mm in diameter), with the mark “SL” on one face and “100” on the other face.

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

Package sizes:

Blister packs: 1, 2, 4, 8, 12, and 24 film-coated tablets.

PEAD bottles: 30, 500 film-coated tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Germany:Sildenafil PUREN 100 mg Filmtabletten

Spain:Sildenafilo Aurovitas 100 mg film-coated tablets EFG

France:SILDENAFIL ARROW LAB 100 mg, coated tablet

Italy:Sildenafil Aurobindo 100 mg film-coated tablets

Malta:Sildenafil 100 mg film-coated tablets

Netherlands:Sildenafil Aurobindo 100 mg, film-coated tablets

Last review date of this leaflet:October 2022

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