SILDENAFIL AUROVIT 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sildenafil Aurovit 20 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 Sildenafil Aurovit is and what it is used for
2. What you need to know before you take Sildenafil Aurovit
3. How to take Sildenafil Aurovit
4. Possible side effects
5. Storage of Sildenafil Aurovit
6. Contents of the pack and other information

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

Sildenafil 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 widening the blood vessels in the lungs.

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

2. What you need to know before you take 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 that contain nitrates or nitric oxide donors such as amyl nitrite (“poppers”). These medicines are often given to relieve chest pain (or angina). Sildenafil can increase the effects of these medicines. You should tell your doctor if you are taking any of these medicines. If you are not sure, 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 shown that they increase the blood-pressure-lowering effect of this medicine. If you are taking riociguat, or are not sure, consult your doctor.
• If you have recently had a stroke, a heart attack, or if you have severe liver disease or very low blood pressure (<90/50 mmHg).
• If you are taking a medicine for fungal infections such as ketoconazole or itraconazole or medicines that contain ritonavir (for HIV).
• If you have previously experienced a loss of vision due to a problem with blood flow to the nerve of the eye called non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sildenafil Aurovit if:

• You have a disease due to a blockage or narrowing of a vein in the lungs rather than a blockage or narrowing of an artery.
• You have a serious heart problem.
• You have a problem with the heart's pumping chambers.
• You have high blood pressure in the blood vessels of the lungs.
• You have low resting blood pressure.
• You lose a large amount of body fluids (dehydration) that can occur when you sweat a lot or do not drink enough fluids. This can happen if you are sick with fever, vomiting, or diarrhea.
• You have a rare inherited eye disease (retinitis pigmentosa).
• You have a disorder of the red blood cells (sickle cell anemia), blood cell cancer (leukemia), bone marrow cancer (multiple myeloma), or any disease or deformity of the penis.
• You have a stomach ulcer or bleeding disorders (such as hemophilia) or nosebleeds.
• You use medicines for erectile dysfunction.

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

If you experience a reduction or loss of vision, stop takingthis medicineand 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 that lasts for more than 4 hours, stop takingthis medicineand consult your doctor immediately(see also section 4).

Special precautions in patients with kidney or liver problems

You should tell your doctor if you have kidney or liver problems, as a dose adjustment may be necessary.

Children

Sildenafil should not be given to children under 1 year of age.

Other medicines and Sildenafil Aurovit

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

• Medicines that contain nitrates or nitric oxide donors, such as amyl nitrite (“poppers”) or nicorandil (a vasodilator medicine to treat angina). These medicines are often given to relieve chest pain or angina (see section 2. What you need to know before you take Sildenafil Aurovit).
• Tell your doctor or pharmacist if you are taking riociguat.
• Treatments for pulmonary hypertension (e.g., bosentan, iloprost).
• Medicines that contain St. John's Wort (herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy).
• Medicines that inhibit blood clotting (e.g., warfarin), although they have not caused any side effects.
• Medicines that contain erythromycin, clarithromycin, telithromycin (antibiotics used to treat certain bacterial infections), saquinavir (for HIV), or nefazodone (for depression), as a dose adjustment may be necessary.
• Alpha-blocker therapy (e.g., doxazosin) for the treatment of hypertension or prostate problems, as the combination of the two medicines can cause symptoms of low blood pressure (e.g., dizziness, fainting).
• Medicines that contain sacubitril/valsartan, used to treat heart failure.

Taking Sildenafil Aurovit with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Sildenafil should not be used during pregnancy unless absolutely necessary.

Sildenafil should not be given 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 using machines

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

Sildenafil Aurovit contains lactose

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

Sildenafil Aurovit contains sodium

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

3. How to take Sildenafil Aurovit

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

Use in children

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

This medicine should only be used for cases where 20 mg three times a day is to be administered.

For administration in patients weighing 20 kg or less and in other younger patients who cannot swallow tablets, other pharmaceutical forms more suitable for their needs can be used.

If you take more Sildenafil Aurovit than you should

Do not take more medicine than your doctor tells you to.

If you have taken more sildenafil than you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

Taking more sildenafil than you should can increase the risk of known side effects.

If you forget to take Sildenafil Aurovit

If you have forgotten 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 can lead to worsening of symptoms. Do not stop taking this medicine unless your doctor tells you to. Your doctor will tell you to reduce the dose for a few days before stopping it completely.

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.

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

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

Adults

The following side effects have been reported very frequently (may affect more than 1 in 10 people): headache, facial flushing, indigestion, diarrhea, and pain in arms and legs.

The following side effects have been reported frequently (may affect up to 1 in 10 people): infection under the skin, flu-like symptoms, inflammation of the nasal passages, reduction in the number of red blood cells (anemia), fluid retention, difficulty sleeping, anxiety, migraine, tremor, sensation of tingling, sensation of burning, reduced sense of touch, bleeding in the back of the eye, changes in vision, blurred vision, and sensitivity to light, effects on color perception, eye irritation, red eyes, dizziness, bronchitis, nosebleeds, runny nose, cough, stuffy nose, stomach inflammation, gastroenteritis, heartburn, hemorrhoids, abdominal distension, dry mouth, hair loss, skin flushing, night sweats, muscle pain, back pain, and increased body temperature.

The following side effects have been reported infrequently (may affect up to 1 in 100 people): reduced visual acuity, double vision, strange sensation in the eye, bleeding from the penis, presence of blood in the semen and/or urine, and breast enlargement in men.

The following have also been reported with an unknown frequency (cannot be estimated from the available data): skin rash, sudden loss of hearing, and decreased blood pressure.

Children and adolescents

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

The following serious side effects were considered to be related to treatment and have been reported infrequently (may affect up to 1 in 100 people): allergic reaction (such as skin rash, face, lip, and tongue swelling, sneezing, difficulty breathing or swallowing), seizures, irregular heartbeat, hearing disorders, shortness of breath, inflammation of the digestive tract, and sneezing due to changes in air flow.

The following side effects have been reported very frequently (may affect more than 1 in 10 people): headache, vomiting, throat infection, fever, diarrhea, flu, and nosebleeds.

The following side effects have been reported frequently (may affect up to 1 in 10 people): nausea, increased erections, pneumonia, and runny nose.

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 to the Spanish Medicines Agency (AEMPS) at www.notificaram.es. By reporting side 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 which is stated on the carton and blister after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

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 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 ingredients are:

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

Coating:lactose monohydrate, hypromellose (2910) 15cP, titanium dioxide (E171), triacetin.

Appearance of the product and pack contents

White, round (6.6 mm in diameter), biconvex, film-coated tablets with “20” engraved on one face and smooth on the other.

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

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

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

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/).