Sildenafil Teva 100 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Sildenafil Teva 100 mg Film-coated Tablets EFG

Sildenafil

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Sildenafil 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 achieve or maintain a firm erection suitable for satisfactory sexual activity.

2. What you need to know before taking Sildenafil Teva

Do not take Sildenafil 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 drop in your blood pressure. Consult your doctor if you are taking any of these medicines, which are often prescribed to relieve angina pain (or “chest pain”). If you are unsure, consult your doctor or pharmacist.

• If you are using any medicines known as nitric oxide donors such as amyl nitrate (“poppers”), as the combination may lead to a drop 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 been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

• If you have severe heart or liver problems.

• 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 sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NA-AION).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Sildenafil Teva:

• If you have sickle cell anemia (an abnormality of red blood cells), leukemia (cancer of blood cells), or multiple myeloma (cancer of bone marrow).
• If you have a penile deformity or Peyronie’s disease.
• If you have heart problems. Your doctor should carefully assess whether your heart can tolerate the additional strain of sexual activity.
• If you currently have a stomach ulcer or bleeding disorders (such as hemophilia).
• If you experience sudden partial or complete vision loss, stop taking Sildenafil Teva and contact your doctor immediately.

It is not recommended to use Sildenafil Teva simultaneously with any other treatment for erectile dysfunction.

You must not take Sildenafil Teva with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitor.

You must not take Sildenafil Teva if you do not have erectile dysfunction.

The use of Sildenafil Teva is not indicated in women.

Special considerations in patients with renal impairment or liver problems

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

Children and adolescents

The use of Sildenafil Teva is not indicated in individuals under 18 years of age.

Taking Sildenafil Teva with other medicines

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

Sildenafil Teva tablets may interact with certain medicines, especially those used to treat chest pain. In a medical emergency, you must inform your doctor, pharmacist, or nurse that you are taking Sildenafil Teva and when you took it. Do not take Sildenafil Teva with other medicines unless your doctor advises you to.

You must not take Sildenafil Teva if you are taking medicines called nitrates, as the combination of these medicines may cause a dangerous drop 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 pain (or “chest pain”).

You must not take Sildenafil Teva if you are taking medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), as the combination of these products may also cause a dangerous drop in your blood pressure.

Inform your doctor or pharmacist if you are taking riociguat.

If you are taking protease inhibitors, medicines used in the treatment of HIV, your doctor may recommend starting treatment with the lowest dose (25 mg) of Sildenafil Teva.

Some patients taking alpha-blockers, medicines used to treat high blood pressure or benign prostatic hyperplasia, may experience dizziness or lightheadedness caused by a drop in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking Sildenafil Teva with alpha-blockers. This is more likely to occur within 4 hours after taking Sildenafil Teva. To reduce the likelihood of these symptoms, you should already be on a regular daily dose of the alpha-blocker before starting Sildenafil Teva. Your doctor may advise you to start treatment with the lowest dose (25 mg) of Sildenafil Teva.

Taking Sildenafil Teva with food, drinks, and alcohol

Sildenafil Teva can be taken with or without food. However, you may notice that Sildenafil Teva takes longer to work if taken with a heavy meal.

Alcohol intake may temporarily impair your ability to achieve an erection. Therefore, to achieve the maximum benefit from the medicine, it is advisable not to consume large amounts of alcohol before taking Sildenafil Teva.

Pregnancy, breast-feeding, and fertility

The use of Sildenafil Teva is not indicated in women.

Driving and using machines

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

3. How to take Sildenafil Teva

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. The recommended starting dose is 50 mg.

Sildenafil Teva must not be taken more than once a day.

Do not take Sildenafil Teva film-coated tablets together with orally disintegrating tablets containing sildenafil.

You should take Sildenafil Teva approximately one hour before you plan to have sexual intercourse. Swallow the tablet whole with a glass of water.

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

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

If Sildenafil 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 Sildenafil Teva than you should

You may experience an increase in adverse effects and their severity. Doses higher than 100 mg 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. The adverse effects reported with Sildenafil Teva are generally of mild to moderate intensity and short duration.

If you experience any of the following serious adverse effects, stop taking Sildenafil Teva and seek immediate medical attention:

• 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 it occurs during or after sexual activity:

• 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 lasting 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

Symptoms may 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 adverse 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 flushes (symptoms include sudden sensation of heat in the upper body), indigestion, abnormal colour vision, 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, perception of flashing lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced touch sensation, dizziness, tinnitus (ringing in the ears), dry mouth, nasal blockage or congestion, swelling of the nasal mucosa (symptoms include runny nose, sneezing, and nasal congestion), pain in the upper abdomen, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in arms and legs, nosebleeds, feeling of warmth, and fatigue.

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to parts of the brain, throat tightness, mouth numbness, bleeding behind 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, pupil dilation, change in colour of the white part of the eye, penile bleeding, blood in semen, dry nose, swelling inside the nose, feeling irritable, sudden decrease or loss of hearing.

During post-marketing experience, rare cases of unstable angina (heart disease) and sudden death have been reported. It should be noted that most men who experienced these adverse effects, although not all, had pre-existing heart conditions before taking this medicine. It is not possible to determine whether these adverse effects were directly related to sildenafil.

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sildenafil Teva

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and packaging following EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from moisture.

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

6. Contents of the pack and other information

Composition of Sildenafil Teva

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

The other components are:

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

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

Appearance of the product and pack sizes

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

Manufacturers:

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 Malpica, calle C, nº 4

50016 Zaragoza

Spain

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80, 31-546 Kraków

Poland

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

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