Sildenafil Aurovit 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Sildenafilo Aurovit 20 mg film-coated tablets EFG

Read the entire 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 should not give it to other people 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 Sildenafilo Aurovit is and what it is used for
2. What you need to know before taking Sildenafilo Aurovit
3. How to take Sildenafilo Aurovit
4. Possible side effects
5. How to store Sildenafilo Aurovit
6. Contents of the pack and other information

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

Sildenafilo Aurovit contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.

Sildenafil reduces blood pressure in the lungs by dilating the blood vessels in the lungs.

Sildenafil is used to treat high blood pressure in the blood vessels of the lung (pulmonary arterial hypertension) in adults and children and adolescents aged 1 to 17 years.

2. What you need to know before taking Sildenafil Aurovit

Do not take Sildenafil Aurovit

• If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If you are taking medicines containing nitrates or nitric oxide donors such as amyl nitrite ("poppers"). These medicines are often used to relieve chest pain (or angina). Sildenafil may cause a significant increase in the effects of these medicines. You must inform your doctor if you are taking any of these medicines. If you are unsure, consult your doctor or pharmacist.
• 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 recently had a stroke, a myocardial infarction, or if you have severe liver disease or very low blood pressure (<90/50 mmHg).
• If you are taking a medicine to treat fungal infections such as ketoconazole or itraconazole, or medicines containing ritonavir (for HIV).
• If you have previously experienced vision loss due to a problem with blood flow to a nerve in the eye called non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor or pharmacist before taking Sildenafil Aurovit if:

• You have a disease caused by blockage or narrowing of a vein in the lungs rather than a blockage or narrowing of an artery.
• You have a serious heart condition.
• You have a problem with the pumping chambers of the heart.
• You have high blood pressure in the blood vessels of the lungs.
• You have low blood pressure at rest.
• You are losing a large amount of body fluids (dehydration), which may occur when you sweat excessively or do not drink enough fluids. This can happen if you are ill with fever, vomiting, or diarrhea.
• You suffer from a rare inherited eye disease (retinitis pigmentosa).
• You suffer from a red blood cell disorder (sickle cell anemia), blood cell cancer (leukemia), bone marrow cancer (multiple myeloma), or any disease or deformity of the penis.
• You currently have a stomach ulcer, bleeding disorders (such as hemophilia), or nosebleeds.
• You are using medicines for erectile dysfunction.

When PDE5 inhibitors, including sildenafil, are used to treat erectile dysfunction (ED), the following visual adverse effects have been reported with unknown frequency: decreased or sudden, temporary, or permanent partial or complete vision loss in one or both eyes.

If you experience sudden reduction or loss of vision, stop taking this medicine and consult your doctor immediately (see also section 4).

Prolonged and sometimes painful erections have been observed in men taking sildenafil. If you have an erection lasting longer than 4 hours, stop taking this medicine and consult your doctor immediately (see also section 4).

Special precautions in patients with kidney or liver problems

You must inform your doctor if you have kidney or liver problems, as dose adjustment may be necessary.

Children

Sildenafil must not be administered to children under 1 year of age.

Other medicines and Sildenafil Aurovit

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

• Medicines containing nitrates or nitric oxide donors, such as amyl nitrite ("poppers") or nicorandil (a vasodilator used to treat angina). These medicines are often used to relieve chest pain or angina (see section 2. What you need to know before taking Sildenafil Aurovit).
• Inform your doctor or pharmacist if you are taking riociguat.
• Treatments for pulmonary hypertension (e.g., bosentan, iloprost).
• Medicines containing St. John's wort (herbal remedy), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy).
• Medicines that inhibit blood coagulation (e.g., warfarin), although no adverse effects have been reported.
• Medicines containing erythromycin, clarithromycin, telithromycin (antibiotics used to treat certain bacterial infections), saquinavir (for HIV), or nefazodone (for depression), as dose adjustment may be necessary.
• Alpha-blocker therapy (e.g., doxazosin) for the treatment of hypertension or prostate problems, as the combination of these two medicines may cause symptoms of low blood pressure (e.g., dizziness, fainting).
• Medicines containing sacubitril/valsartan, used to treat heart failure.

Taking Sildenafil Aurovit with food, drinks, and alcohol

You should not drink grapefruit juice while being treated with sildenafil.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Sildenafil must not be used during pregnancy unless absolutely necessary.

Sildenafil must not be administered to women of childbearing potential unless adequate contraceptive methods are used.

Sildenafil passes into breast milk at very low levels and is not expected to harm your baby.

Driving and use of machines

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

Sildenafil Aurovit contains lactose

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

Sildenafil Aurovit contains sodium

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

3. How to take Sildenafil Aurovit

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

For adults, the recommended dose is 20 mg three times a day (taken at 6 to 8-hour intervals), taken with or without food.

Use in children

For children and adolescents aged 1 to 17 years, the recommended dose is 10 mg three times a day for those weighing equal to or less than 20 kg, or 20 mg three times a day for those weighing more than 20 kg, administered with or without food. In children, doses higher than those recommended must not be used.

This medicine should only be used in cases where administration of 20 mg three times a day is required.

For administration in patients weighing equal to or less than 20 kg and in other younger patients who cannot swallow tablets, other more suitable pharmaceutical forms may be used.

If you take more Sildenafil Aurovit than you should

Do not take more medicine than your doctor has prescribed.

If you have taken more sildenafil than you should, 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.

Taking more sildenafil than recommended may increase the risk of known adverse effects.

If you forget to take Sildenafil Aurovit

If you forget to take sildenafil, take the dose as soon as you remember and continue taking your medicine at the usual times. Do not take a double dose to make up for forgotten doses.

If you stop taking Sildenafil Aurovit

Sudden interruption of treatment with sildenafil may lead to worsening of your symptoms. Do not stop taking this medicine unless instructed by your doctor. Your doctor will advise you to gradually reduce the dose over several days before stopping it completely.

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 will experience them.

If you experience any of the following adverse effects, stop taking sildenafil and inform your doctor immediately (see also section 2):

• if you experience sudden vision decrease or loss (frequency not known).
• if you have an erection that lasts continuously for more than 4 hours. Prolonged and sometimes painful erections have been reported in men after taking sildenafil (frequency not known).

Adults

Very commonly reported adverse effects (may affect more than 1 in 10 people) were headache, facial flushing, indigestion, diarrhoea, and pain in arms and legs.

Commonly reported adverse effects (may affect up to 1 in 10 people) included: skin infection, flu-like symptoms, nasal sinus inflammation, reduction in red blood cell count (anaemia), fluid retention, difficulty sleeping, anxiety, migraine, tremor, tingling sensation, burning sensation, reduced sense of touch, bleeding from the back of the eye, vision disturbances, blurred vision and light sensitivity, effects on colour perception, eye irritation, red eyes, dizziness, bronchitis, nosebleed, runny nose, cough, nasal congestion, stomach inflammation, gastroenteritis, burning sensation, haemorrhoids, abdominal distension, dry mouth, hair loss, skin redness, night sweats, muscle pain, back pain, and increased body temperature.

Uncommonly reported adverse effects (may affect up to 1 in 100 people) included: reduced visual acuity, double vision, unusual sensation in the eye, penile bleeding, presence of blood in semen and/or urine, and breast enlargement in men.

Skin rashes, sudden decrease or loss of hearing, and reduction in blood pressure have also been reported with unknown frequency (cannot be estimated from available data).

Children and adolescents

The following serious adverse effects have been frequently reported (may affect up to 1 in 10 people): pneumonia, heart failure, right-sided heart failure, cardiogenic shock, high blood pressure in the lungs, chest pain, fainting, respiratory infections, bronchitis, viral infection of the stomach and intestines, urinary tract infections, and dental perforations.

The following serious adverse effects considered related to treatment have been reported uncommonly (may affect up to 1 in 100 people): allergic reaction (such as skin rash, swelling of the face, lips and tongue, sneezing, difficulty breathing or swallowing), seizures, irregular heartbeat, hearing disturbances, shortness of breath, gastrointestinal tract inflammation, and sneezing due to airflow disturbances.

Very commonly reported adverse effects (may affect more than 1 in 10 people) were headache, vomiting, throat infection, fever, diarrhoea, flu, and nosebleed.

Commonly reported adverse effects (may affect up to 1 in 10 people) were nausea, increased erections, pneumonia, and runny nose.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Aurovit

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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 will help protect the environment.

6. Contents of the pack and other information

Composition of Sildenafil Aurovit

• The active substance is sildenafil. Each film-coated tablet contains 20 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 (2910) 15 cP, titanium dioxide (E171), triacetin.

Appearance of the product and contents of the pack

White, round (6.6 mm diameter), biconvex, film-coated tablets marked with "20" on one side and smooth on the other.

Sildenafil Aurovit film-coated tablets are available in transparent PVC/PVdC-Aluminum blister packs containing 28, 30, 90, and 300 film-coated tablets.

Only certain 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

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

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

Date of the last revision of this leaflet: October 2022

Detailed 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/).