SILDENAFIL TEVA 25 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Sildenafil Teva 25 mg film-coated tablets

Package leaflet: Information for the patient

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 signs of illness 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.

• 1. What SildenafilTeva is and what it is used for

• 2. What you need to know before you take Sildenafil Teva

• 3. How to take Sildenafil Teva

• 4. Possible side effects

• 5. How to store Sildenafil Teva

• 6. Contents of the pack and other information

Fq 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 relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited. Sildenafil Teva will only help you to get an erection if you are sexually stimulated.

Sildenafil Teva is a treatment for adult men with erectile dysfunction, sometimes known as impotence. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.

^2 What you need to know before you take 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 fall in your blood pressure. Tell your doctor if you are taking any of these medicines which are often given for relief of angina pectoris (or “chest pain”). If you are not certain, ask 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 also lead to a dangerous fall 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 secondary to blood clots). PDE5 inhibitors, such as sildenafil, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure, tell your doctor.

• – If you have a severe heart or liver problem.

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

• – If you have certain rare inherited eye diseases (such as retinitis pigmentosa ).

• – If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION).

Warnings and precautions

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

• – If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow)

• – If you have a deformity of your penis or Peyronie’s Disease.

• – If you have problems with your heart. Your doctor should carefully check whether your heart can take the additional strain of having sex.

• – If you currently have a stomach ulcer, or a bleeding problem (such as haemophilia).

• – If you experience sudden decrease or loss of vision, stop taking SildenafilTeva and contact your doctor immediately.

You should not use SildenafilTeva with any other oral or local treatments for erectile dysfunction.

You should not use SildenafilTeva with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.

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

You should not take Sildenafil Teva if you are a woman.

Special considerations for patients with kidney or liver problems

You should tell your doctor if you have kidney or liver problems. Your doctor may decide on a lower dose for you.

Children and adolescents

SildenafilTeva should not be given to individuals under the age of 18.

Other medicines and Sildenafil Teva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

SildenafilTeva tablets may interfere with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should tell your doctor, pharmacist or nurse that you have taken SildenafilTeva and when you did. Do not take SildenafilTeva with other medicines unless your doctor tells you that you can.

You should not take Sildenafil Teva if you are taking medicines called nitrates, as the combination of these medicines may lead to a dangerous fall in your blood pressure. Always tell your doctor, pharmacist or nurse if you are taking any of these medicines that are often used for the relief of angina pectoris (or “chest pain”).

You should not take Sildenafil Teva if you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood pressure.

Tell your doctor or pharmacist if you are already taking riociguat.

If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your doctor may start you on the lowest dose (25 mg) of Sildenafil Teva.

Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or light-headedness, which may be caused by low blood pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking SildenafilTeva with alpha-blockers. This is most likely to happen within 4 hours after taking SildenafilTeva. To reduce the chance that these symptoms might happen, you should be on a regular daily dose of your alpha-blocker before you start Sildenafil Teva. Your doctor may start you on a lower dose (25 mg) of Sildenafil Teva.

Sildenafil Teva with food and drink and alcohol

SildenafilTeva can be taken with or without food. However, you may find that Sildenafil Teva takes longer to start working if you take it with a heavy meal.

Drinking alcohol can temporarily impair your ability to get an erection. To get the maximum benefit from your medicine, you are advised not to drink excessive amounts of alcohol before taking Sildenafil Teva.

Pregnancy, breast-feeding and fertility SildenafilTeva is not indicated for use by women.

Driving and using machines

SildenafilTeva can cause dizziness and can affect vision. You should be aware of how you react to Sildenafil Teva before you drive or use machinery.

Sildenafil Teva contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

F^ How to take Sildenafil Teva

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended starting dose is 50 mg.

You should not take Sildenafil Teva more than once a day.

Do not take Sildenafil Teva film-coated tablets in combination with sildenafil-containing orodispersible tablets.

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

If you feel that the effect of Sildenafil Teva is too strong or too weak, talk to your doctor or pharmacist.

SildenafilTeva will only help you to get an erection if you are sexually stimulated. The amount of time Sildenafil Teva takes to work varies from person to person, but it normally takes between half an hour and one hour. You may find that SildenafilTeva takes longer to work if you take it with a heavy meal.

If Sildenafil Teva does not help you to get an erection, or if your erection does not last long enough for you to complete sexual intercourse you should tell your doctor.

If you take more Sildenafil Teva than you should:

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

You should not take more tablets than your doctor tells you to.

Contact your doctor if you take more tablets than you should.

If you have any further questions on the use of this medicine, 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 Sildenafil Teva are usually mild to moderate and of a short duration.

If you experience any of the following serious side effects stop taking Sildenafil Teva and seek medical help immediately:

• An allergic reaction -this occurs uncommonly (may affect up to 1 in 100 people) Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.
• Chest pains – this occurs uncommonly If this occurs during or after intercourse

• – Get in a semi-sitting 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 which lasts for more than 4 hours, you should contact a doctor immediately.

• A sudden decrease or loss of vision – this occurs rarely
• Serious skin reactions – this occurs rarely. Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals and around the eyes, fever.
• Seizures or fits – this occurs rarely

How to store Sildenafil 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 refers to the last day of that month.

Store in the original package, in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

rg Contents of the pack and other information

What Sildenafil Teva contains

The active substance is sildenafil. Each tablet contains 25 mg of sildenafil (as the citrate salt).

The other ingredients are:

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

Film coat: poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc.

What Sildenafil Teva looks like and contents of the pack

SildenafilTeva 25 mg are white, oval-shaped film-coated tablets, engraved with ‘S 25’ on one side, and plain on the other side.

SildenafilTeva is available in blister packs of 2, 4, 8 and 12 tablets, and perforated unit dose blisters containing 10 × 1 tablet.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva B.V.

Swensweg 5 2031GA Haarlem

The Netherlands

Manufacturer:

Teva Operations Poland Sp.z.o.o. ul Mogilska 80. 31–546, Krakow, Poland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom

Teva UK Limited

Tel: +44 1977628500

This leaflet was last revised in 01/2021

Detailed information on this medicine is available on the European Medicines Agency web site:

From post-marketing experience cases of unstable angina (a heart condition) and sudden death have been reported rarely. Of note, most, but not all, of the men who experienced these side effects had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to sildenafil.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via theYellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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