Medicine guide
Sildenafil Teva
- Prescription status not stated
- Urinary and reproductive system, hormones
- Active substance
- Sildenafil
- Made by
- Teva B.V.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is 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.
From the package leaflet in EMA’s product information, p. 30 · 2022-07-04
How it works
From the US prescribing label for the same active substance (Sildenafil Citrate). It describes the substance, not this exact product.
The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation.
NO then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.
How the body breaks it down
It is eliminated predominantly by hepatic metabolism (mainly CYP3A4) and is converted to an active metabolite with properties similar to the parent, sildenafil.
How it leaves the body
After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the feces (approximately 80% of administered oral dose) and to a lesser extent in the urine (approximately 13% of the administered oral dose).
With food
When sildenafil tablets are taken with a high fat meal, the rate of absorption is reduced, with a mean delay in T max of 60 minutes and a mean reduction in C max of 29%.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-08-31
Do not take it if
- − 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).
From the package leaflet in EMA’s product information, p. 30–31.
How to take it
These directions are for this exact strength and form. Another one is different.
- 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 Sildenafil Teva 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.
- 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.
From the package leaflet in EMA’s product information, p. 32–33.
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 Sildenafil Teva and contact your doctor immediately.
- You should not use Sildenafil Teva with any other oral or local treatments for erectile dysfunction.
- You should not use Sildenafil Teva 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 Sildenafil Teva should not be given to individuals under the age of 18.
From the package leaflet in EMA’s product information, p. 31.
Pregnancy and breastfeeding
Sildenafil Teva is not indicated for use by women.
From the package leaflet in EMA’s product information, p. 32.
Other medicines
- Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
- 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 your doctor, pharmacist or nurse 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 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 Sildenafil Teva with alpha-blockers. This is most likely to happen within 4 hours after taking Sildenafil Teva. 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.
- Tell your doctor or pharmacist if you are already taking medicines containing sacubitril/valsartan, used to treat heart failure.
- Sildenafil Teva with food and drink and alcohol 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.
From the package leaflet in EMA’s product information, p. 31–32.
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.
- 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’.
From the package leaflet in EMA’s product information, p. 32.
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 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 (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.
- Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes /red eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding heartbeat, 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 sinuses, inflammation of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose), upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.
- Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing.
- 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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
From the package leaflet in EMA’s product information, p. 33–34.
How to store it
- 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.
From the package leaflet in EMA’s product information, p. 34.
Other ingredients
Relevant if you react to a dye, a preservative, lactose or gluten.
- 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
From the package leaflet in EMA’s product information, p. 34.
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Teva B.V. |
|---|---|
| Active substance | Sildenafil |
| Used in | Urinary and reproductive system, hormones |
| Classification | G04BE03 · Urinary and reproductive system, hormones |
| Generic | Yes — a generic medicine, according to the register |
| Authorised on | 2009-11-30 |
| Last updated by the regulator | 2022-07-04 |
| EMA product number | EMEA/H/C/001073 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.
MysildecardEU authorisation Viatris Limited · Sildenafil · G04BE03ViagraEU authorisation Upjohn EESV · Sildenafil · G04BE03RevatioEU authorisation Upjohn EESV · Sildenafil · G04BE03Sildenafil ActavisEU authorisation Actavis Group PTC ehf · Sildenafil · G04BE03GranpidamEU authorisation Accord Healthcare S.L.U. · Sildenafil · G04BE03VizarsinEU authorisation Krka, d.d., Novo mesto · Sildenafil · G04BE03