Sildenafil Aurovitas 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sildenafil Aurovitas 50 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Sildenafil 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 during sexual stimulation. Sildenafil Aurovitas will only help you achieve an erection if you are sexually stimulated.

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

2. What you need to know before taking Sildenafil Aurovitas

Do not take Sildenafil 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 cause a dangerous drop in blood pressure. Consult your doctor if you are taking any of these medicines, which are often prescribed to relieve angina pain (or “chest pain”). If you are unsure, consult your doctor or pharmacist.
• If you are using any nitric oxide donors such as amyl nitrite (“poppers”), as the combination may cause a dangerous drop in 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 been shown to increase the hypotensive effect of this medicine. 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 disease (such as retinitis pigmentosa).
• If you have previously experienced sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Talk to your doctor or pharmacist before taking Sildenafil Aurovitas.

Inform your doctor:

• If you have sickle cell anemia (an abnormality of red blood cells), leukemia (cancer of blood cells), or multiple myeloma (cancer of bone marrow).
• If you have penile deformity or Peyronie’s disease.
• If you have heart problems. Your doctor must carefully assess whether your heart can tolerate the additional strain of sexual activity.
• If you currently have a stomach ulcer or bleeding disorders (such as hemophilia).
• If you experience sudden decrease or loss of vision, stop taking sildenafil and contact your doctor immediately.

You must not use sildenafil together with any other oral or local treatments for erectile dysfunction.

You must not take sildenafil with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitor.

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

You must not take sildenafil if you are a woman.

Special considerations in patients with kidney or liver problems

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

Children and adolescents

Sildenafil must not be given to individuals under 18 years of age.

Other medicines and Sildenafil Aurovitas

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

Medicines containing sacubitril/valsartan, used to treat heart failure.

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

You must not take sildenafil if you are taking medicines called nitrates, as the combination may cause a dangerous drop in blood pressure. Always inform your doctor or pharmacist if you are taking any of these medicines, which are often used to relieve angina pain (or “chest pain”).

You must not take sildenafil if you are taking medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), as the combination may also cause a dangerous drop in blood pressure.

Inform your doctor or pharmacist if you are taking riociguat.

If you are taking protease inhibitors, such as those used in the treatment of HIV, your doctor may recommend starting treatment with the lowest dose (25 mg) of sildenafil.

Some patients receiving an alpha-blocker, a medicine used to treat high blood pressure or benign prostatic hyperplasia, may experience dizziness or lightheadedness caused by a drop in 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 occur within 4 hours after taking sildenafil. To reduce the likelihood of these symptoms, you should already be on a regular daily dose of the alpha-blocker before starting sildenafil. Your doctor may advise you to start treatment with the lowest dose (25 mg) of sildenafil.

Taking Sildenafil Aurovitas with food, drinks, and alcohol

Sildenafil can be taken with or without food. However, you may notice that sildenafil takes slightly longer to work if taken with a heavy meal.

Alcohol intake may temporarily impair your ability to obtain an erection. Therefore, to achieve the maximum benefit from the medicine, it is advisable not to consume large amounts of alcohol before taking sildenafil.

Pregnancy, breastfeeding, and fertility

Sildenafil is not indicated for use in women.

Driving and using machines

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

Sildenafil Aurovitas contains lactose

This medicine contains lactose monohydrate. If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.

Sildenafil 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 Sildenafil Aurovitas

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended starting dose is 50 mg.

Do not take sildenafil more than once a day.

Do not take Sildenafil Aurovitas film-coated tablets together with sildenafil orodispersible tablets.

You should take sildenafil approximately one hour before planning to have sexual intercourse. Swallow the tablet whole with a glass of water.

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

Sildenafil will only help you achieve an erection if you are sexually stimulated. The time required for sildenafil to take effect varies from person to person, but generally ranges between half an hour and one hour. The effect of sildenafil may be delayed if taken with a heavy meal.

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

If you take more Sildenafil Aurovitas than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The adverse effects reported with sildenafil are generally mild to moderate in intensity and short in duration.

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

? Allergic reaction – this occurs uncommonly (may affect up to 1 in 100 people).
Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.

? Chest pain – this occurs uncommonly.
If chest pain occurs during or after sexual activity:

• 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 lasting longer than 4 hours, contact a doctor immediately.

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

? Severe skin reactions – this occurs rarely.
Symptoms may include severe skin peeling and swelling, blistering of the mouth, genitals, and around the eyes, as well as fever.

? Seizures or fits – this occurs rarely.

Other adverse 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 flushes (including sudden sensation of heat in the upper body), indigestion, abnormal colour vision, blurred vision, visual disturbance, nasal congestion, and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, watery eyes/red eyes, eye pain, perception of flashing lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sense of touch, dizziness, tinnitus (ringing in the ears), dry mouth, nasal blockage or congestion, swelling of the nasal mucosa (including runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including heartburn), blood in urine, pain in arms or legs, nosebleeds, sensation of warmth, and feeling of fatigue.

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to parts of the brain, sensation of tightness in the throat, numbness of the mouth, bleeding behind the eye, double vision, decreased visual acuity, abnormal sensation in the eye, eye or eyelid swelling, small particles or spots in vision, seeing halos around lights, pupil dilation, change in colour of the white part of the eye, penile bleeding, blood in semen, dry nose, swelling inside the nose, feeling irritable, 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 should be noted that most men who experienced these adverse effects, although not all, had pre-existing heart conditions before taking this medicine. It is not possible to determine whether these adverse effects were directly related to sildenafil.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sildenafil Aurovitas

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the outer packaging, blister pack, and label of the bottle after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Sildenafil Aurovitas

• The active substance is sildenafil. Each film-coated tablet contains 50 mg of sildenafil (as sildenafil citrate).
• The other components are:

Tablet core: calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.

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

Appearance of the product and contents of the pack

White to off-white, biconvex, round film-coated tablets (9.6 mm in diameter), marked with "SL" on one side and "50" on the other.

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

Pack sizes:

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

HDPE bottles: 30, 1,000 film-coated tablets.

Only some 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 medicinal product is authorized in the European Economic Area (EEA) member states under the following names:

Germany: Sildenafil PUREN 50 mg Filmtabletten
Spain: Sildenafilo Aurovitas 50 mg film-coated tablets EFG
France: SILDENAFIL ARROW LAB 50 mg, comprimé pelliculé
Italy: Sildenafil Aurobindo 50 mg compresse rivestite con film
Malta: Sildenafil 50 mg film-coated tablets
Netherlands: Sildenafil Aurobindo 50 mg, filmomhulde tabletten

Date of the most recent review of this leaflet: October 2022

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