25 mg film-coated tablets
sildenafil
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 inhibitors (PDE5 inhibitors). It works by making it easier for the blood vessels in your penis to dilate so that the blood can flow in when you are sexually stimulated. Sildenafil Teva only makes it easier to get an erection if you are sexually stimulated.
Sildenafil Teva is a treatment for adult men with erectile dysfunction, better known as impotence. This means that a man cannot get, or maintain, a hard erect penis sufficient for sexual intercourse.
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, in combination with Sildenafil Teva may cause a sharp drop in blood pressure. Tell your doctor if you are taking any of these medicines, which are often given to relieve angina ( angina pectoris ) or “chest pain”. If you are not sure, ask your doctor or pharmacist.
- if you are taking medicines called nitric oxide donors such as amyl nitrite (“poppers”), a combination of such medicines with Sildenafil Teva may also lead to a sharp drop in blood pressure.
- if you take riociguat. This medicine is used to treat pulmonary arterial hypertension (ie high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (ie high blood pressure in the lungs due to blood clots). PDE5 inhibitors, such as sildenafil, have been shown to increase the antihypertensive effect of this medicine. If you are taking riociguat or if you are not sure, talk to 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 certain, rare, inherited eye diseases (such as retinitis pigmentosa ).
- if you have ever lost your sight due to non-arteritic anterior ischemic optic infarction/neuropathy (NAION).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Sildenafil Teva.
- if you have sickle cell anemia (abnormal red blood cells), leukemia (blood cell cancer), or multiple myeloma ( bone marrow cancer ).
- if you have a deformed penis or any disease of the penis such as Peyronie’s disease.
- if you have heart problems. Your doctor should carefully check if your heart can tolerate the increased effort that sexual activity entails.
- if you currently have a stomach ulcer or a bleeding disorder (such as hemophilia).
- if you experience a sudden deterioration or loss of vision, stop taking Sildenafil Teva and contact your doctor immediately.
You should not use Sildenafil Teva at the same time as any other oral or topical treatment for erectile dysfunction.
You should not use Sildenafil Teva at the same time as any treatment for pulmonary arterial hypertension (PAH) that contains 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.
Especially to take into account when it comes to patients with liver or kidney problems
You should tell your doctor if you have kidney or liver problems. Your doctor may decide that your dose should be lower.
Children and young people
Sildenafil Teva should not be given to people under 18 years of age.
Other medicines and Sildenafil Teva
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
Sildenafil Teva tablets may affect the way some medicines are used, especially those used to treat chest pain. If you become acutely ill, you should inform 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 to.
You should not take Sildenafil Teva if you are taking medicines called nitrates, as the combination of these medicines can cause a sharp drop in blood pressure. Always tell your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often given to relieve angina pectoris (or “chest pain”).
You should not take Sildenafil Teva if you are taking medicines called nitric oxide donors such as amyl nitrite (“poppers”), as a combination of such medicines with Sildenafil Teva may also lead to a sharp drop in blood pressure.
Tell your doctor or pharmacist if you are already taking riociguat.
If you are taking a so-called protease inhibitor for the treatment of HIV, your doctor may prescribe that you start with the lowest dose of Sildenafil Teva (25 mg).
Some patients taking alpha-receptor blockers for the treatment of high blood pressure or prostate enlargement may experience dizziness or fainting, which may be caused by low blood pressure when you quickly sit up or stand up. Some patients have experienced these symptoms while taking Sildenafil Teva with alpha-receptor blockers. This is most likely to happen within 4 hours of taking Sildenafil Teva. To reduce the risk of these symptoms, you should take alpha-receptor blockers regularly with a fixed daily dose before you start taking Sildenafil Teva. Your doctor may prescribe a lower dose (25 mg) of Sildenafil Teva.
Sildenafil Teva with food, drink, and alcohol
Sildenafil Teva can be taken with or without food, but if you take it with a heavy meal, it may take a little longer before it works.
Alcohol intake may temporarily reduce the ability to get an erection. To get the maximum effect from your medicine, you should not drink large amounts of alcohol before taking Sildenafil Teva.
Pregnancy, breastfeeding, and fertility
Sildenafil Teva should not be used by women.
Driving and using machines
Sildenafil Teva may cause dizziness and may affect vision. You should be aware of how you react to Sildenafil Teva before driving or using machines.
How to take Sildenafil Teva
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. 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 with sildenafil-containing orodispersible tablets.
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 have the impression that the effect of Sildenafil Teva is too strong or too weak, talk to your doctor or pharmacist.
Sildenafil Teva only gives you an erection if you are sexually stimulated. The time it takes for Sildenafil Teva to work varies from person to person, but it usually takes between half and an hour. You may notice that it takes longer for Sildenafil Teva to work if you take it with a heavy meal.
If Sildenafil Teva does not help you get an erection or if an erection does not last long enough to complete sexual intercourse, tell your doctor.
If you take more Sildenafil Teva than you should:
You may find that the side effects and their severity increase. Doses above 100 mg do not increase the effect.
Do not take more tablets than your doctor tells you to do.
Contact your doctor if you take more tablets than you should.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects reported with the use of Sildenafil Teva are usually mild to moderate and last only a short time.
Stop using Sildenafil Teva and contact your doctor immediately if you experience any of the following severe symptoms:
- An allergic reaction – less common (may affect up to 1 in 100 people)
Symptoms include sudden wheezing, difficulty breathing or dizziness, and swelling of the eyelids, face, lips, or throat. - Chest pain – less common this happens during or after intercourse:
- Get up in a semi-sitting position and try to relax
- Do not take nitrates to treat chest pain
- Prolonged and sometimes painful erections – rare (may affect up to 1 in 1,000 users)If you get such an erection that lasts longer than 4 hours, you should contact a doctor immediately.
- Sudden decrease or loss of vision – rare
- Severe skin reaction – rare symptoms include severe dandruff and swelling of the skin, blistering of the mouth, genitals, and around the eyes, and fever.
- Seizures – rare
Other side effects:
Very common (may affect more than 1 user in 10): headache
Common (may affect up to 1 in 10 people): nausea, flushing, hot flashes (symptoms may include a sudden feeling of warmth in the upper body), digestive problems, altered color vision, blurred vision, visual disturbances, nasal congestion, and dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes / red eye, eye pain, seeing flashes of light or perceiving light as very strong, photosensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, decreased sensation to the touch, dizziness, ringing in the ears, dry mouth, blocked or blocked sinuses, inflammation of the lining of the nose (symptoms include runny nose, sneezing and nasal congestion), upper abdominal pain, gastroesophageal reflux disease(symptoms include heartburn), presence of blood in the urine, pain in the arms or legs, nosebleeds, feeling hot and tired.
Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decrease in blood flow to parts of the brain, a feeling of tightness in the throat, numb mouth, bleeding in the back of the eye, double vision, decreased visual acuity, abnormal sensation in the eye, swelling in the eye or eyelid, small dots or spots in the visual field, that you see a halo around light sources, dilated pupils, discoloration of the whites of the eyes, bleeding in the penis, blood in the semen, dry nose, swelling inside the nose, irritability and sudden loss or loss of hearing.
After the drug has been marketed and used by patients, rare cases of unstable angina (a type of heart problem) and sudden death have been reported. It is worth noting that most, but not all, of the men who experienced these symptoms had heart problems before taking this medication. It is impossible to say whether these events were due to sildenafil.
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 carton and blister after EXP. or EXP. The expiration date is the last day of the specified month.
Store in the original package. Moisture sensitive.
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.
Contents of the packaging and other information
Content declaration
The active substance is sildenafil. Each tablet contains 25 mg of sildenafil (in the form of citrate salt)
The other ingredients are:
Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen sulfate, croscarmellose sodium, magnesium stearate
Film coating: poly (vinyl alcohol), titanium dioxide (E171), macrogol 3350, and talc
What the medicine looks like and the contents of the pack
Sildenafil Teva 25 mg are white oval film-coated tablets, marked “S 25” on one side and smooth on the other.
Sildenafil Teva is available in blister packs of 2, 4, 8, and 12 tablets and perforated single dose blisters containing 10 x 1 tablet.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Teva BV
Swensen 5
2031GA Haarlem
Netherlands
Manufacturer:
TEVA Pharmaceutical Works Private Limited Company
Pallagi from 13
4042 Debrecen
Hungary
TEVA UK Ltd
Brampton Road, Hampden Park, Eastbourne
East Sussex, BN22 9AG
United Kingdom
Pharmachemie BV
Swensen 5
2031 GA Haarlem
The Netherlands
TEVA Santé SA
Rue Bellocier
89100 Sens
France
Teva Pharma, SLU
Polígono Industrial Malpìca, calle C, no.4
50016 Zaragoza
Spain
Teva Operations Poland Sp.zoo
ul Mogilska 80. 31-546, Krakow,
Poland
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienTeva Pharma Belgium NV / SA / AGTel / Tel: +32 3 820 73 73 | LithuaniaUAB “Sicor Biotech”Tel: +370 5 266 02 03 |
| BulgariaTeva Pharmaceuticals Bulgaria ЕООДTel: +359 2 489 95 82 | Luxembourg / Luxemburgratiopharm GmbHGermany / GermanyTel: +49 731 402 02 |
| Czech RepublicTeva Pharmaceuticals CR, story: +420 251 007 111 | HungaryTeva Gyógyszergyár ZrtTel .: +36 1 288 64 00 |
| DenmarkTeva Denmark A / STel: +45 44 98 55 11 | MaltaTeva Pharmaceuticals IrelandIrelandTel: +353 51 321740 |
| GermanyTEVA GmbHTel: (49) 731 402 08 | The NetherlandsTeva Nederland BVTel: +31 (0) 800 0228400 |
| EestiTeva Eesti esindus UAB Sicor Biotech Eesti subsidiaryTel: +372 611 0801 | NorwayTeva Norway ASTel: (47) 66 77 55 90 |
| GreeceTeva Αλλάς Α.Ε.:Ηλ: +30 210 72 79 099 | Austriaratiopharm Arzneimittel Vertriebs GmbHTel: +43 1 97 007 |
| SpainTeva Pharma, SLUTel: + (34) 91 387 32 80 | PolandTeva Pharmaceuticals Polska Sp. z hotel .: + (48) 22 345 93 00 |
| FranceTeva HealthTel: + (33) 1 55 91 7800 | PortugalTeva Pharma – Pharmaceutical Products LdaTel: (351) 21424 80 00 |
| CroatiaPliva Hrvatska dooTel: +385 1 37 20 000 | RomaniaTeva Pharmaceuticals SRLTel: +4021 230 65 24 |
| IrelandTeva Pharmaceuticals IrelandTel: +353 (0) 51 321740 | SloveniaPliva Ljubljana dooTel: +386 1 58 90 390 |
| Icelandratiopharm OyFinlandPuh / Tel: +358 9 180 5900 | Slovak RepublicTeva Pharmaceuticals Slovakia story: + (421) 2 5726 7911 |
| ItalyTeva Italia SrlTel: + (39) 0289179805 | Finland / Finlandratiopharm OyPhone / tel: +358 9 180 5900 |
| ΚύπροςTeva Αλλάς Α.Ε.Greece:Ηλ: +30 210 72 79 099 | SwedenTeva Sweden ABTel: + (46) 42 12 11 00 |
| LatviaUAB Sicor Biotech subsidiary LatvijāTel: +371 67 323 666 | United Kingdom |