Sildenafil Teva 100 mg film-coated tablets

 

What is it and how is it used?

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.

What do you have to consider before using it?

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 Teva with 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.

How is it used?

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 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.

What are possible side effects?

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.

How should it be stored?

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 is it?

Sildenafil Teva is a medicine that contains the active substance sildenafil. It is available as blue, round diamond-shaped tablets (25, 50 and 100 mg).

Sildenafil Teva is a ‘generic medicine’. This means that Sildenafil Teva is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Viagra. For more information on generic medicines, see the question-and-answer document here.

What is it used for?

Sildenafil Teva is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity. For Sildenafil Teva to be effective, sexual stimulation is required.
The medicine can only be obtained with a prescription.

How is it used?

The recommended dose of Sildenafil Teva is 50 mg taken as needed about one hour before sexual activity. If Sildenafil Teva is taken with food, the onset of activity may be delayed compared with taking Sildenafil Teva without food. The dose may be increased to a maximum of 100 mg or decreased to 25 mg depending on the effectiveness and side effects. Patients with liver problems or severe kidney problems should start treatment with the 25-mg dose. The maximum recommended dosing frequency is one tablet per day.

How does it work?

The active ingredient in Sildenafil Teva, sildenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP). During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax. This allows blood to flow into the corpora, producing the erection. By blocking the breakdown of cGMP, Sildenafil Teva restores erectile function. Sexual stimulation is still needed to produce an erection.

How has it been studied?

Because Sildenafil Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Viagra. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What benefits has it shown during the studies?

Because Sildenafil Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.

What is the risk associated?

Because Sildenafil Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Sildenafil Teva has been shown to have comparable quality and to be bioequivalent to Viagra. Therefore, the CHMP’s view was that, as for Viagra, the benefit outweighs the identified risk. The Committee recommended that Sildenafil Teva be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Sildenafil Teva to Teva Pharma B.V. on 30 November 2009. The marketing authorisation is valid for five years, after which it can be renewed.

This summary was last updated in 10-2009.