SILDENAFIL TEVA 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Sildenafilo Teva 100mg film-coated tablets EFG

Sildenafilo

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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

Sildenafilo Teva is indicated for the treatment of erectile dysfunction in adult men, also known as impotence. This occurs when a man cannot get or maintain an erection that is sufficient for satisfactory sexual activity.

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

Do not take Sildenafilo Teva

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

• If you are taking medicines called nitrates, as the combination may lead to a dangerous decrease in your blood pressure. Consult your doctor if you are taking any of these medicines, 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 known as nitric oxide donors, such as amyl nitrite ("poppers"), as the combination may lead to a decrease in your blood pressure.

• 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 hypotensive effect of this medicine. 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 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 disorder of the red blood cells), leukemia (cancer of the blood cells), or multiple myeloma (cancer of the bone marrow)
• If you have a deformity of the penis or Peyronie's disease.
• If you have heart problems. Your doctor should carefully check if your heart can withstand the extra strain of having sex.
• If you have currently stomach ulcers 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.

Sildenafilo Teva should not be used simultaneously with 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 medicines

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Sildenafilo Teva tablets may interfere with some medicines, 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 medicines unless your doctor advises you to.

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

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

Inform your doctor or pharmacist if you are taking riociguat.

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

Some patients who take an alpha-blocker, a medicine used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness, which 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 happen within 4 hours after taking Sildenafilo Teva. To minimize the likelihood of these symptoms, you should be taking your daily dose of the alpha-blocker regularly before starting Sildenafilo Teva. Your doctor may advise you to start with the lower dose (25 mg) of Sildenafilo Teva.

Inform your doctor or pharmacist if you are taking medicines 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 large amounts of alcohol may temporarily impair your ability to get an erection. Therefore, to get the maximum benefit from the medicine, it is advised not to drink 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 or using machines.

3. How to take Sildenafilo Teva

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist. In case of doubt, 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 one 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 to get an erection if you are sexually stimulated. The time Sildenafilo Teva takes to work varies from person to person, but it normally takes between 30 minutes and 1 hour. The effect of Sildenafilo Teva may be delayed if you take it with a large meal.

In the event that Sildenafilo Teva does not help you to get 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 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 recommended.

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. The side effects reported in association with the use of Sildenafilo Teva are usually mild to moderate and of 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 with rare frequency(may affect up to 1 in 100 people)

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

• Chest pain - this occurs with rare frequency

If they occur during or after sex:

- Sit in a semi-upright position and try to relax

- Do not use nitratesto treat your chest pain

• Prolonged and sometimes painful erections - this occurs very 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 very rarely.

• Severe skin reactions - this occurs very rarely

The 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 very 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, hot flush (including a sudden feeling of heat in the upper body), indigestion, abnormal color perception, blurred vision, visual disturbance, 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 present 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, decrease in visual acuity, abnormal sensation in the eye, eye or eyelid swelling, small particles or spots in the 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 reported rarely. It is noteworthy that most men who experienced these side effects, although not all of them, had pre-existing heart problems before taking this medicine. It is not possible to determine whether these side effects were directly related to sildenafil.

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects 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 medicine.

5. Storage of Sildenafilo Teva

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 blister and carton after EXP. The expiry date is the last day of the month stated.

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

Sildenafil Teva Composition

The active ingredient is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate).

The other ingredients are:

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

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

Product Appearance and Package Size

Sildenafil Teva 100 mg film-coated tablets are white, oval, engraved with “S 100” on one side and flat on the other.

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

Only some pack 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 further 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/