Prospect: Information for the user

Sildenafilo Aurovit 20 mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Sildenafilo Aurovit

3.How to take Sildenafilo Aurovit

4.Possible adverse effects

5.Storage of Sildenafilo Aurovit

6.Contents of the package and additional information

Sildenafilo Aurovitcontains the active ingredient sildenafilo, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.

Sildenafiloreduces blood pressure in the lungs by dilating the blood vessels in the lungs.

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

Do not take Sildenafilo Aurovit

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

-If you are taking medications that contain nitrates or nitric oxide donors such as amyl nitrite (“poppers”). These medications are often administered to relieve chest pain (or angina). Sildenafil may increase the effects of these medications. Inform your doctor if you are taking any of these medications. If unsure, consult with your doctor or pharmacist.

-If you are taking riociguat. This medication is used to treat pulmonary hypertension (i.e., high blood pressure in the lungs) and chronic pulmonary thromboembolic 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 recently had a stroke, a heart attack, or if you have severe liver disease or very low blood pressure (<90

-If you are taking a medication to treat fungal infections such as ketoconazole or itraconazole or medications that contain ritonavir (for HIV).

-If you have previously experienced vision loss due to a problem with the blood flow of an eye nerve called non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

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

-You have a disease caused by a blockage or narrowing of a vein in the lungs instead of 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 blood pressure at rest.

-You lose a large amount of body fluids (dehydration) that can occur when you sweat a lot or do not drink enough liquids. This can happen if you are sick with fever, vomiting, or diarrhea.

-You have a rare inherited eye disease (retinitis pigmentosa).

-You have a blood disorder (sickle cell anemia), blood cancer (leukemia), bone marrow cancer (multiple myeloma), or any disease or deformity of the penis.

-You have an active stomach ulcer or bleeding disorders (such as hemophilia) or nosebleeds.

-You are using medications 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: partial or complete loss of vision in one or both eyes.

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

Special precautions in patients with kidney or liver problems

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

Children

Sildenafil should not be administered to children under 1 year.

Other medications and Sildenafilo Aurovit

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

•Medications that contain nitrates or nitric oxide donors, such as amyl nitrite (“poppers”) or nicorandil (a vasodilator medication for angina). These medications are often administered to relieve chest pain or angina (see section 2. What you need to know before starting to take Sildenafilo Aurovit).

•Inform your doctor or pharmacist if you are taking riociguat.

•Treatments for pulmonary hypertension (e.g., bosentan, iloprost).

•Medications that contain St. John's Wort (herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy).

•Medications that inhibit blood coagulation (e.g., warfarin) although no adverse effects have been reported.

•Medications 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 medications may cause symptoms of low blood pressure (e.g., dizziness, fainting).

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

Taking Sildenafilo Aurovit with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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

Sildenafil should not be used during pregnancy unless absolutely necessary.

Sildenafil should not be administered to women of childbearing age 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 operating machinery

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

Sildenafilo Aurovit contains lactose

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

Sildenafilo Aurovit contains sodium

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

Follow exactly the administration instructions for this medication as indicated 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) 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 with a weight equal to or less than 20 kg or 20 mg three times a day in children and adolescents who weigh more than 20 kg, administered with or without food. In children, higher doses than those recommended should not be used.

This medication should only be used for cases in which 20 mg three times a day should be administered.

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

If you take more Sildenafilo Aurovit than you should

You should not take more medication than your doctor indicates.

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

Taking more sildenafilo than you should may increase the risk of known side effects.

If you forgot to take Sildenafilo Aurovit

If you have forgotten to take sildenafilo, take the dose as soon as you remember and continue taking your medication at regular hours. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Sildenafilo Aurovit

Stopping treatment with sildenafilo abruptly may lead to worsening of your symptoms. Do not stop taking this medication unless your doctor tells you to. Your doctor will instruct you to reduce the dose over a few days before stopping it completely.

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

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

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

-if you experience a sudden reduction or loss of vision (unknown frequency).

-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 (unknown frequency).

Adults

The very common side effects (may affect more than 1 in 10 people) reported were headache, facial flushing, indigestion, diarrhea, and pain in arms and legs.

The common side effects (may affect up to 1 in 10 people) included: skin infection, flu-like symptoms, nasal congestion, reduced red blood cell count (anemia), fluid retention, difficulty sleeping, anxiety, migraine, tremor, tingling sensation, burning sensation, reduced sense of touch, bleeding in the back of the eye, visual disturbances, blurred vision, and light sensitivity, color perception effects, eye irritation, red or bloodshot eyes, dizziness, bronchitis, nasal bleeding, runny nose, cough, stuffy nose, stomach inflammation, gastroenteritis, burning sensation, hemorrhoids, abdominal distension, dry mouth, hair loss, skin redness, night sweats, muscle pain, back pain, and increased body temperature.

The infrequent side 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.

Also, skin eruptions, sudden decrease or loss of hearing, and reduced blood pressure have been reported with an unknown frequency (cannot be estimated from available data).

Children and adolescents

Frequent (may affect up to 1 in 10 people) severe side effects reported in children and adolescents included: pneumonia, heart failure, right heart failure, cardiac shock, high blood pressure in the lungs, chest pain, fainting, respiratory infections, bronchitis, viral infections in the stomach and intestines, urinary tract infections, and tooth perforations.

Severe side effects considered related to treatment and reported infrequently (may affect up to 1 in 100 people) included: allergic reaction (such as skin rash, facial inflammation, lip and tongue inflammation, sneezing, difficulty breathing or swallowing), convulsions, irregular heartbeat, hearing disturbances, shortness of breath, digestive tract inflammation, and sneezing due to airway obstruction.

The very common side effects (may affect more than 1 in 10 people) reported were headache, vomiting, throat infection, fever, diarrhea, flu, and nasal bleeding.

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for 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.

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

This medication does not require special storage conditions.

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

Composition of Sildenafilo Aurovit

-The active ingredient is sildenafilo. Each film-coated tablet contains 20 mg of sildenafilo (as sildenafilo citrato).

-The other components are:

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

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

Appearance of the product and contents of the package

Film-coated tablets, white in color, round (6.6 mm in diameter), biconvex, with the mark “20” on one face and smooth on the other.

Sildenafilo Aurovit film-coated tabletsare available in PVC/PVdC transparent-Aluminium blisters with 28, 30, 90, and 300 film-coated tablets.

Only some package sizes may be marketed.

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

O

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

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

Last review date of this leaflet:October 2022

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