SILDENAFIL TEVA 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Sildenafilo Teva 25mg film-coated tablets EFG

Sildenafilo

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, pharmacist, or nurse.
• 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, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Sildenafilo Teva and what is it used for
2. What you need to know before taking Sildenafilo Teva
3. How to take Sildenafilo Teva
4. Possible side effects
5. Storage of Sildenafilo Teva
6. Package contents and additional information

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

Sildenafilo Teva contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to widen the blood vessels in the penis, allowing blood flow when you are sexually stimulated. Sildenafilo Teva will only help you achieve an erection if you are sexually stimulated.

Sildenafilo Teva is indicated for the treatment of erectile dysfunction in adult men, sometimes called impotence. This occurs when a man cannot obtain or maintain a firm erection sufficient for satisfactory sexual activity.

2. What you need to know before taking Sildenafilo Teva

Do not take Sildenafilo Teva

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

• If you are taking medicines called nitrates, as the combination can lead to a dangerous decrease in your blood pressure. Consult your doctor if you are taking any of these medications, which are often used to relieve angina pectoris (or "chest pain"). If you are unsure, consult your doctor or pharmacist.

• If you are using any of the medicines called nitric oxide donors, such as amyl nitrate ("poppers"), as the combination can lead to a decrease in your blood pressure.

• 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 a serious heart or liver problem.

• If you have recently had a stroke or heart attack, or if you have low blood pressure.

• If you have a rare inherited eye disease (such as retinitis pigmentosa).

• If you have previously experienced a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Sildenafilo Teva:

• If you have sickle cell anemia (a red blood cell abnormality), leukemia (blood cell cancer), or multiple myeloma (bone marrow cancer)
• If you have a penis deformity or Peyronie's disease.
• If you have heart problems. Your doctor should carefully check if your heart can withstand the extra effort of having sex.
• If you currently have a stomach ulcer or bleeding problems (such as hemophilia).
• If you experience a sudden decrease or loss of vision, stop taking Sildenafilo Teva and contact your doctor immediately.

It is not recommended to use Sildenafilo Teva at the same time as any other treatment for erectile dysfunction.

You should not take Sildenafilo Teva with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or any other PDE5 inhibitor.

You should not take Sildenafilo Teva if you do not have erectile dysfunction.

The use of Sildenafilo Teva is not indicated in women.

Special considerations in patients with kidney or liver problems

You should inform your doctor if you have kidney or liver problems. Your doctor may decide to reduce your dose.

Children and adolescents

The use of Sildenafilo Teva is not indicated in persons under 18 years of age.

Use of Sildenafilo Teva with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may use any other medication.

Sildenafilo Teva tablets may interfere with some medications, especially those used to treat chest pain. In case of a medical emergency, you should inform your doctor, pharmacist, or nurse that you are taking Sildenafilo Teva and when you took it. Do not take Sildenafilo Teva with other medications unless your doctor advises you to do so.

You should not take Sildenafilo Teva if you are taking medications called nitrates, as the combination of these medications can lead to a dangerous decrease in your blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking any of these medications, which are often used to relieve angina pectoris (or "chest pain").

You should not take Sildenafilo Teva if you are taking medications called nitric oxide donors, such as amyl nitrate ("poppers"), as the combination of these products can also lead to a dangerous decrease in your blood pressure.

Tell your doctor or pharmacist if you are taking riociguat.

If you are taking medications known as protease inhibitors, such as those used in the treatment of HIV, your doctor may recommend that you start treatment with the lowest dose (25 mg) of Sildenafilo Teva.

Some patients who take an alpha-blocker, a medication used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness that can be caused by a decrease in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking Sildenafilo Teva with alpha-blockers. This is more likely to occur within 4 hours of taking Sildenafilo Teva. To reduce the likelihood of these symptoms, you should be taking your daily dose of the alpha-blocker regularly before starting Sildenafilo Teva. Your doctor may recommend that you start treatment with the lower dose (25 mg) of Sildenafilo Teva.

Tell your doctor or pharmacist if you are taking medications that contain sacubitril/valsartan, used to treat heart failure.

Taking Sildenafilo Teva with food, drinks, and alcohol

Sildenafilo Teva can be taken with or without food. However, you may notice that Sildenafilo Teva takes a little longer to work if you take it with a large meal.

Consuming alcohol can temporarily make it more difficult to achieve an erection. Therefore, to get the maximum benefit from the medication, it is recommended not to consume large amounts of alcohol before taking Sildenafilo Teva.

Pregnancy, breastfeeding, and fertility

The use of Sildenafilo Teva is not indicated in women.

Driving and using machines

Sildenafilo Teva can cause dizziness and affect vision. You should know how you react to Sildenafilo Teva before driving vehicles or using machinery.

3. How to take Sildenafilo Teva

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. The recommended starting dose is 50 mg.

Do not take Sildenafilo Teva more than once a day.

Do not take Sildenafilo Teva film-coated tablets with orodispersible tablets that contain sildenafil.

You should take Sildenafilo Teva about an hour before you plan to have sex. Swallow the tablet whole with a glass of water.

If you notice that the effect of Sildenafilo Teva is too strong or too weak, tell your doctor or pharmacist.

Sildenafilo Teva will only help you achieve an erection if you are sexually stimulated. The time it takes for Sildenafilo Teva to work varies from person to person, usually between half an hour and one hour. The effect of Sildenafilo Teva may be delayed if you take it with a large meal.

If Sildenafilo Teva does not help you achieve an erection or if the erection is not maintained long enough to complete sexual intercourse, consult your doctor.

If you take more Sildenafilo Teva than you should

You may experience an increase in side effects and their severity. Doses above 100 mg do not increase efficacy.

Do not take more tablets than your doctor recommends.

Contact your doctor if you have taken more tablets than advised.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them. The side effects reported in association with the use of Sildenafilo Teva are generally mild to moderate and short-lived.

If you experience any of the following serious side effects, stop taking Sildenafilo Teva and seek medical attention immediately:

• 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 they occur during or after sex:

• 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 that lasts more than 4 hours, you should contact your doctor immediately.

• Sudden decrease or loss of vision - this occurs rarely

• Severe skin reactions - this occurs rarely

Symptoms can 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 side effects:

Very common(may affect more than 1 in 10 people): headache

Common(may affect up to 1 in 10 people): nausea, facial flushing, feeling hot (including a sudden feeling of heat in the upper body), indigestion, abnormal color perception, blurred vision, impaired vision, nasal congestion, and dizziness.

Uncommon(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/red eyes, eye pain, flashing lights, visual clarity, sensitivity to light, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy nose, inflammation of the nasal mucosa (including symptoms such as runny nose, sneezing, and nasal congestion), pain in the upper abdomen, gastroesophageal reflux disease (including symptoms such as heartburn), blood in urine, pain in arms and legs, nosebleeds, feeling hot and feeling tired.

Rare(may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decrease in blood flow to some parts of the brain, feeling of compression in the throat, numbness of the mouth, bleeding in the back of 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, dilation of the pupil of the eye, change in color of the white of the eye, bleeding from the penis, presence of blood in the semen, dry nose, swelling inside the nose, feeling irritable, and sudden decrease or loss of hearing.

During post-marketing experience, cases of unstable angina (heart disease) and sudden death have been rarely reported. It is worth noting that most men who experienced these side effects, although not all of them, had pre-existing heart problems before taking this medication. It is not possible to determine whether these side effects were directly related to sildenafil.

Reporting side effects:

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Sildenafilo Teva

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

Do not use this medication after the expiration date stated on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Sildenafilo Teva

The active ingredient is sildenafil. Each tablet contains 25 mg of sildenafil (as citrate).

The other components are:

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

Coating: poly(vinyl alcohol), titanium dioxide (E 171), macrogol 3350, talc.

Appearance of the Product and Package Size

Sildenafilo Teva 25 mg film-coated tablets are white, oval, engraved with "S 25" on one side and flat on the other.

Sildenafilo Teva is available in blisters containing 2, 4, 8 or 12 tablets and single-dose blisters containing 10 x 1 tablet.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Manufacturer:

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13

4042 Debrecen

Hungary

TEVA UK Ltd

Brampton Road, Hampden Park, Eastbourne

East Sussex, BN22 9AG

United Kingdom

Teva Pharma, S.L.U.

Polígono Industrial Malpìca, calle C, nº 4

50016 Zaragoza

Spain

Teva Operations Poland Sp.z.o.o.

ul Mogilska 80. 31-546, Krakow,

Poland

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Detailed information on this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu/