Prospect: Information for the Patient

Sildenafilo Teva 50mg Film-Coated Tablets

Sildenafilo

Read this prospect carefully before starting to take the 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, pharmacist, or nurse.

−This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

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

1.What is Sildenafil or Teva and for what it is used

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

3.How to take Sildenafilo Teva

4.Possible adverse effects

5.Storage of Sildenafilo Teva

6.Contents of the package and additional information

Sildenafilo Teva contains the active ingredient sildenafilo, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to dilate the blood vessels of the penis, allowing blood to flow when 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 referred to as impotence. This occurs when a man is unable to obtain or maintain a firm, satisfactory erection for sexual activity.

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

• If you are using any of the medications called nitric oxide donors such as amyl nitrite ("poppers"), as the combination may lead to a drop 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 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 a severe 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 disorder (such as retinitis pigmentosa).

• If you have experienced previous vision loss 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 blood disorder), leukemia (cancer of the blood cells), or multiple myeloma (cancer of the bone marrow)
• If you have a penile deformity or Peyronie's disease
• If you have heart problems. Your doctor must carefully check if your heart can handle the additional strain of sexual activity.
• If you have a current 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 simultaneously with any other treatment for erectile dysfunction.

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

Do 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 renal or hepatic impairment

You must 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 individuals under 18 years of age.

Use of Sildenafilo Teva with other medications

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

Sildenafilo Teva tablets may interact with some medications, especially those used to treat chest pain. In case of a medical emergency, you must 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 not take Sildenafilo Teva if you are taking medications called nitrates, as the combination may lead to a dangerous drop 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 chest pain (or "chest pain").

Do not take Sildenafilo Teva if you are taking medications called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination may lead to a drop in your blood pressure.

Inform your doctor or pharmacist if you are taking riociguat.

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

Some patients taking an alpha-blocker, a medication used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness caused by a drop in blood pressure when standing or sitting up quickly. Some patients have experienced these symptoms when taking Sildenafilo Teva with alpha-blockers. This is more likely to occur within 4 hours after taking Sildenafilo Teva. To reduce the likelihood of these symptoms, you should be receiving 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.

Inform 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 bit longer to take effect if you ingest it with a large meal.

Consuming alcohol may temporarily impair your ability 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 operating machinery

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. The recommended starting dose is 50mg.

Do not take Sildenafilo Teva more than once a day.

Do not take Sildenafilo Teva film-coated tablets with buccal tablets containing sildenafilo.

Take Sildenafilo Teva approximately one hour before planning to have sexual intercourse. Swallow the tablet whole with a glass of water.

If you notice that the effect of Sildenafilo Teva is too strong or too weak, inform 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 take effect varies from person to person, generally ranging from half an hour to one hour. The effect of Sildenafilo Teva may be delayed if taken with a large meal.

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

If you take more Sildenafilo Teva than you should

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

Do not take more tablets than recommended by your doctor.

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The side effects reported associated with the use of Sildenafilo Teva are generally of mild to moderate intensity and short duration.

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

• Allergic reaction - this occurs infrequently (may affect up to 1 in 100 people)

The symptoms include sudden hissing when breathing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.

• Chest pain - this occurs infrequently

If they occur during or after sexual intercourse:

-Position yourself in a semi-recumbent position and try to relax

-Do not use nitratesto treat your chest pain

• Prolonged and sometimes painful erections - this occurs rarely

If you have an erection that lasts more than 4 hours, you must contact your doctor immediately.

• Sudden decrease or loss of vision - this occurs rarely

• Severe skin reactions - this occurs rarely

The symptoms may include severe peeling and swelling of the skin, vesiculation of the mouth, genitals, and around the eyes, as well as fever.

• Seizures or attacks - this occurs rarely

Other side effects:

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

Common(mayaffect up to 1 in 10 people):nausea, flushing, warmth (among the symptoms is a sudden feeling of heat in the upper body), indigestion, abnormal color perception, blurred vision, visual deterioration, nasal congestion, and dizziness.

Uncommon(mayaffect up to 1 in 100 people):vomiting, skin rash, eye irritation, eye discharge/ red eyes, eye pain, flashing lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced tactile sensation, vertigo, ringing in the ears, dry mouth, nasal congestion or blockage, nasal mucosa inflammation (among the symptoms are sneezing, runny nose, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (among the symptoms is stomach burning), blood in urine, arm and leg pain, nosebleed, feeling of heat, and feeling tired.

Rare(may affect up to 1 in 1,000 people):syncope, stroke, heart attack, irregular heartbeat, transient decrease in blood flow to some parts of the brain, sensation of throat constriction, numbness of the mouth, bleeding in the back of the eye, double vision, visual acuity decrease, abnormal sensation in the eye, eye swelling or eyelid swelling, small particles or spots in vision, halos around lights, pupil dilation, change in the color of the white part of the eye, bleeding of the penis, blood in semen, dry nose, nasal congestion, feeling of irritability, and sudden decrease or loss of hearing

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

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://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 blister and packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Sildenafilo Teva

The active ingredient is sildenafilo. Each tablet contains 50mg of sildenafilo (as citrato).

The other components are:

Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, croscarmellose sodium, magnesium stearate.

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

Appearance of the product and packaging size

Sildenafilo Teva 50mg film-coated tablets are white, oval-shaped, engraved with “S 50” on one side and plain on the other.

Sildenafilo Teva is available in blisters containing 2, 4, 8, 12 or 24 tablets and perforated unit dose blisters containing 10 x 1 tablet.

Only some packaging sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Responsible 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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet:

The detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/