Sildenafil Teva 50 mg film-coated tablets

Sildenafil Teva belongs to a group of medicines called phosphodiesterase type 5 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. You should not take Sildenafil Teva if you do not have erectile dysfunction. You should not take Sildenafil Teva if you are a woman.

Sildenafil Teva is a treatment for 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.

Do not take Sildenafil Teva

• If you are taking medicines containing nitrates, as the combination may cause a potentially dangerous decrease in your blood pressure. Tell your doctor if you are taking any of these medicines which are often given for relief of angina pectoris (?chest pain?). If you are not certain, ask your doctor or pharmacist.
• If you are using any of the drugs known as nitric oxide donors such as amyl nitrite (?poppers?), as the combination may also lead to potentially dangerous decrease in your blood pressure.
• If you are allergic (hypersensitive) to sildenafil or any of the other ingredients of Sildenafil Teva.
• 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 because of non-arteritic anterior ischaemic optic neuropathy (NAION).

Take special care with Sildenafil Teva
Tell your doctor

• If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow) or
• If you have a deformity of your penis or Peyronie?s Disease.
• If you have problems with your heart. Your doctor should in that case carefully check whether your heart can take the additional strain of having sex.
• If you currently have a stomach ulcer, or a bleeding disorder (such as haemophilia).
• If you experience sudden decrease or loss of vision, stop taking Sildenafil Teva and contact your doctor immediately.

You should not use Sildenafil Teva with any other treatment for erectile dysfunction.

Special considerations for children and adolescents

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

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.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken other medicines, including medicines obtained without prescription.

Sildenafil Teva tablets may interfere with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should tell any health care professional treating your condition that you have taken Sildenafil Teva and when you did. Do not take Sildenafil Teva 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 products may cause a potentially dangerous decrease in your blood pressure. Always tell your doctor or pharmacist 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 is you are using any of the drugs known as nitric oxide donors such as amyl nitrite (?poppers?) as the combination may also lead to potentially dangerous decrease in your blood pressure.

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 too quickly. Certain patients have experienced these symptoms when taking Sildenafil Teva with alpha-blockers. This is most likely to occur within 4 hours after taking Sildenafil Teva. In order to reduce the likelihood that these symptoms occur, 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 (25 mg) dose of Sildenafil Teva.

Taking Sildenafil Tevawith food and drink
Sildenafil Teva 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 and breast-feeding

Sildenafil Teva is not indicated for use by women.

Driving and using machines

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

Always take Sildenafil Teva exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is 50 mg.

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

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

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

Sildenafil Teva 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 Sildenafil Teva 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 Tevathan 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.

Like all medicines, Sildenafil Teva 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 have chest pains during or after intercourse:

• Get in a semi-sitting position and try to relax
• Do not use nitrates to treat your chest pain
• Contact your doctor immediately

All medicines, including Sildenafil Teva can cause allergic reactions. You should contact your doctor immediately if you experience any of the following symptoms after taking Sildenafil Teva: sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.

Prolonged and sometimes painful erections have been reported after taking Sildenafil Teva. If you have an erection which lasts for more than 4 hours, you should contact a doctor immediately.

The following side effects have been reported at the approximate frequencies shown:

Very common affects more than 1 user in 10 Common affects 1 to 10 users in 100 Uncommon affects 1 to 10 users in 1,000 Rare affects 1 to 10 users in 10,000 Very Rare affects less than 1 user in 10,000 Not known frequency cannot be estimated from the available data

Very common:

• Headache

Common:

• facial flushing
• indigestion
• effects on vision (including colour tinge to vision, light sensitivity, blurred vision or reduced sharpness of vision)
• stuffy nose
• dizziness.

Uncommon:

• vomiting
• skin rash
• bleeding at the back of the eye
• eye irritation
• bloodshot eyes/red eyes
• eye pain
• double vision
• abnormal sensation in the eye
• irregular or rapid heartbeat
• muscle pain
• feeling sleepy
• reduced sense of touch
• vertigo
• ringing in the ears
• nausea
• dry mouth
• chest pain
• feeling tired.

Rare:

• high blood pressure
• low blood pressure
• fainting
• stroke
• nosebleed
• sudden decrease or loss of hearing

Additional side effects reported from post-marketing experience include: pounding heartbeat, chest pain, sudden death, heart attack or temporary decreased blood flow to parts of the brain. Most, but not all, of these men had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to sildenafil.Cases of convulsions or seizures and serious skin reactions characterised by rash, blisters, peeling skin and pain which require immediate medical attention have also been reported.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet please tell your doctor.

Keep out of the reach and sight of children.

Do not use Sildenafil Teva after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.

Store in the original package, in order 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. These measures will help to protect the environment.

What Sildenafil Teva contains

The active substance is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate).

The other ingredients are:
Tablet core: microcrystalline cellulose, calcium hydrogen phosphate anhydrous, 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
Sildenafil Teva 50 mg are white, oval-shaped film-coated tablets, engraved with ?S 50? on one side, and plain on the other side.
Sildenafil Teva is available in blister packs of 2, 4, 8 and 12 tablets, and perforated unit dose blisters containing 10 x 1 tablet.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma B.V.
Computerweg 10, 3542 DR Utrecht
The Netherlands

Manufacturer:
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13
4042 Debrecen
Hungary

TEVA Pharmaceutical Works Private Limited Company

Táncsics Mihály út 82

2100 Gödöll-

Hungary

TEVA UK Ltd

Brampton Road, Hampden Park, Eastbourne

East Sussex
BN22 9AG

United Kingdom

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

TEVA Santé Sa

Rue Bellocier

89107 Sens

France

Teva Pharma, S.L.U.

Polígono Industrial Malpìca, calle C,no.4

50016 Zaragoza

Spain

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

BelgiëBelgiqueBelgien Teva Pharma Belgium N.V.S.A. TelTél 32 3 820 73 73 LuxembourgLuxemburg Teva Pharma Belgium S.A. TélTel 32 3 820 73 73

Te 359 2 489 95 82 Magyarország Teva Magyarország Zrt Tel. 36 1 288 64 00

eská republika Teva Pharmaceuticals CR, s.r.o. Tel 420 251 007 111 Malta Teva .. el 30 210 72 79 099

Danmark Teva Denmark AS Tlf 45 44 98 55 11 Nederland Teva Nederland B.V. Tel 31 0 800 0228400

Deutschland Teva GmbH Tel 49 351 834 0 Norge Teva Sweden AB Tlf 46 42 12 11 00

Österreich Teva GmbH Tel 49 351 834 0 Eesti Teva Eesti esindus UAB Sicor Biotech Eesti filiaal Tel 372 611 2409

Teva .. 30 210 72 79 099 Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel. 48 22 345 93 00

España Teva Pharma, S.L.U. Tél 34 91 387 32 80 Portugal Teva Pharma - Produtos Farmacêuticos Lda Tel 351 214 235 910

France Teva Santé Tél 33 1 55 91 7800 România Teva Pharmaceuticals S.R.L Tel 4021 230 65 24

Ireland Teva Pharmaceuticals Ireland Tel 353 042 9395 892 Slovenija Pliva Ljubljana d.o.o. Tel 386 1 58 90 390

Ísland Teva UK Limited Sími 44 1323 501 111. Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Tel 421 2 5726 7911

Italia Teva Italia S.r.l. Tel 39 0289179805 SuomiFinland Teva Sweden AB PuhTel 46 42 12 11 00

Teva .. 30 210 72 79 099 Sverige Teva Sweden AB Tel 46 42 12 11 00

Latvija UAB Sicor Biotech filile Latvij Tel 371 67 784 980 United Kingdom Teva UK Limited Tel 44 1323 501 111

Lietuva

UAB ?Sicor Biotech?
Tel: +370 5 266 02 03

This leaflet was last approved in