SILDENAFIL TEVAGEN 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet:Information for the Patient

Sildenafilo Tevagen 20 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication,as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Sildenafilo Tevagen is and what it is used for
2. What you need to know before taking Sildenafilo Tevagen
3. How to take Sildenafilo Tevagen
4. Possible side effects

5 Conservation of Sildenafilo Tevagen

1. Contents of the pack and additional information

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

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

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

2. What you need to know before taking Sildenafilo Tevagen

Do not takeSildenafilo Tevagen:

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

• if you are taking medicines that contain nitrates (such as nicorandil) or nitric oxide donors, such as amyl nitrite ("poppers"). These medications are often given to relieve chest pain (or angina pectoris). Sildenafilo Tevagen may increase the effects of these medications. You should inform your doctor if you are taking any of these medications. If you are unsure, consult your doctor or pharmacist.
• 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 blood clots). PDE5 inhibitors, such as sildenafil, have shown that they 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 (<90/50 mmHg).
• 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 blood flow in a nerve of the eye called non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

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

• you have a disease due to obstruction or narrowing of a vein in the lungs instead of obstruction 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 suffer from a rare inherited eye disease (retinitis pigmentosa).
• you suffer from an abnormality of red blood cells (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 or bleeding disorders (such as hemophilia) or nosebleeds.
• you take medications 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 sudden loss of vision in one or both eyes.

If you experience a reduction or sudden loss of vision, stop taking Sildenafilo Tevagenand inform your doctor immediately(see also section 4).

Prolonged and sometimes painful erections have been reported in men taking sildenafil. If you have an erection that lasts for more than 4 hours, stop taking Sildenafilo Tevagenand 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

Sildenafilo Tevagen should not be administered to children under 1 year of age.

Taking Sildenafilo Tevagen with other medications

Do not take Sildenafilo Tevagen with(see also "Do not take Sildenafilo Tevagen" in this section)

• Medications that contain nitrates (such as nicorandil) or nitric oxide donors, such as amyl nitrite ("poppers").
• Medications that contain riociguat.
• Medications that contain ketoconazole, itraconazole, or ritonavir.

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

• Medications that contain substances such as bosentan, ambrisentan, iloprost (for pulmonary hypertension).
• Medications that belong to the same group as sildenafil (PDE5 inhibitors).
• 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 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.

Medications that contain beta-blockers (a group of medications used to treat hypertension, heart failure, irregular heartbeat, migraine),

anticoagulant medications (such as warfarin), although these did not result in any adverse effects.

• Medications that contain alpha-blockers (such as doxazosin) for the treatment of hypertension or prostate problems, as the combination of the two medications can cause symptoms of reduced blood pressure (such as dizziness, fainting).
• Medications that contain sacubitril/valsartan (medications used to treat heart failure).

Taking Sildenafilo Tevagen with food and beverages

You should not drink grapefruit juice when being treated with Sildenafilo Tevagen.

Pregnancy and breastfeeding

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. Sildenafilo Tevagen should not be used during pregnancy unless absolutely necessary.

Sildenafilo Tevagen 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 using machines

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

Sildenafilo Tevagen contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per film-coated tablet; this is, essentially, "sodium-free".

3. How to take Sildenafilo Tevagen

Follow the administration instructions of this medication 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) taken with or without food.

Use in children and adolescents

For children and adolescents from 1 to 17 years, the recommended dose is 10 mg three times a day for children and adolescents = 20 kg or 20 mg three times a day in children and adolescents > 20 kg, administered with or without food. In children, doses higher than those recommended should not be used. This medication should only be used for cases where 20 mg three times a day should be administered. For administration in patients = 20 kg and in other younger patients who cannot swallow tablets, other pharmaceutical forms more suitable for their needs may be used.

If you take more Sildenafilo Tevagen than you should

You should not take more medication than your doctor indicates.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

If you forget to take Sildenafilo Tevagen

If you have forgotten to take Sildenafilo Tevagen, take the dose as soon as you remember and continue taking your medication at the usual times. Do not take a double dose to make up for forgotten doses.

If you stop taking Sildenafilo Tevagen

Sudden interruption of treatment with Sildenafilo Tevagen may lead to worsening of symptoms. Do not stop taking Sildenafilo Tevagen unless your doctor indicates it. Your doctor will indicate how to reduce the dose over a few days before stopping it completely.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

If you suffer from any of the following side effects, stop taking Sildenafilo Tevagen and inform your doctor immediately (see also section 2):

• if you experience a reduction or sudden loss of vision (unknown frequency).
• if you have an erection that lasts for more than 4 hours. Prolonged and sometimes painful erections have been reported in men taking sildenafil (unknown frequency).

Adults

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

The common side effects (may affect up to 1 in 10 people) are: skin infection, flu-like symptoms, nasal congestion, reduction in 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, vision changes, 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 uncommon side effects (may affect up to 1 in 100 people) included reduced visual acuity, double vision, abnormal sensation in the eye, penile bleeding, presence of blood in semen and/or urine, and gynecomastia in men.

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

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, cardiogenic shock, high blood pressure in the lungs, chest pain, dizziness, respiratory infection, bronchitis, viral gastroenteritis, urinary tract infections, and tooth perforation.

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

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

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Conservation of Sildenafilo Tevagen

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 after EXP. 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 wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and additional information

Composition of Sildenafilo Tevagen

• The active substance is sildenafil. Each film-coated tablet contains 20 mg of sildenafil (as citrate).
• The other excipients are:

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

Coating: hypromellose, macrogol 6000, talc, titanium dioxide (E171).

Appearance of the product and contents of the pack

Sildenafilo Tevagen 20 mg film-coated tablets are white or almost white, approximately 6.5 mm in size, biconvex, round, marked with "20" on one side and smooth on the other.

Sildenafilo Tevagen 20 mg film-coated tablets EFG are available in blister packs or unit-dose blister packs of 30, 90, 90x1, or 300 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

c/ Anabel Segura, 11 Edificio Albatros B, 1ª Planta

Alcobendas 28108 Madrid (Spain)

Manufacturer

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80, Kraków 31-546

Poland

or

Merckle GmbH

Ludwig-Merckle-Strasse 3, Blaubeuren, 89143

Germany

or

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25, Zagreb 10000

Croatia

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

Date of the last revision of this package leaflet:January 2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.es