20 mg film-coated tablets
sildenafil
What Sildenafil Teva Pharma is and what it is used for
Sildenafil Teva Pharma contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5 inhibitors).
Sildenafil Teva Pharma lowers blood pressure in the lungs by dilating the blood vessels in the lungs. Sildenafil Teva Pharma is used for treating adults and children and adolescents from 1 to 17 years of age with high blood pressure in the blood vessels of the lungs ( pulmonary arterial hypertension ).
Sildenafil contained in Sildenafil Teva Pharma may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Sildenafil Teva Pharma
Do not take Sildenafil Teva Pharma:
- if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
- if you are taking medicines that contain nitrates (such as nicorandil) or nitric oxide donors such as amyl nitrite. These drugs are often given to relieve angina (or angina pectoris ). Sildenafil Teva Pharma may cause a severe increase in the effect of these medicines. Tell your doctor if you are taking any of these medicines. If you are not sure, ask your doctor or pharmacist.
- 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 recently had a stroke, a heart attack, severe liver disease, or very low blood pressure (<90/50 mmHg).
- if you are taking medicines containing ketoconazole or itraconazole to treat fungal infections or medicines containing ritonavir (for HIV ).
- if you have ever before lost your sight due to a problem with the blood flow to the nerve in the eye called non-arteritic anterior ischemic optic infarction/neuropathy (NAION).
Warnings and cautions
Talk to your doctor before taking Sildenafil Teva Pharma if you:
- have a disease that is due to a blocked or narrowed vein in the lung, rather than a blocked or narrowed artery.
- have severe heart problems.
- have problems with the chambers of the heart.
- have high blood pressure in the blood vessels of the lungs.
- have low blood pressure at rest.
- loses a large number of body fluids ( dehydration ) which can occur if you sweat a lot or do not drink enough fluid. This can happen if you are sick with fever, vomiting, or diarrhea.
- have a rare inherited eye disease (retinitis pigmentosa).
- have abnormal red blood cells (sickle cell anemia), blood cell cancer ( leukemia ), bone marrow cancer (multiple myeloma ), and any disease of the penis or deformed penis.
- right now have stomach ulcers or a bleeding disorder (such as hemophilia ) or problems with nosebleeds.
- uses drugs for erectile dysfunction.
When used to treat male erectile dysfunction (ED), the following side effects on vision have been reported with PDE5 inhibitors, including sildenafil, with an unknown frequency: partial, sudden, temporary, or permanent visual impairment or loss of vision in one or both eyes.
If you experience sudden visual impairment or loss of vision, stop taking Sildenafil Teva Pharma and contact your doctor immediately (see also section 4).
Prolonged and sometimes painful erections have been reported in men after using sildenafil. If you get an erection that lasts longer than 4 hours, stop taking Sildenafil Teva Pharma and contact your doctor immediately (see also section 4).
Especially to take into account patients with kidney or liver problems:
You should tell your doctor if you have kidney or liver problems, as your dose may need
to be adjusted.
Children
Sildenafil Teva Pharma should not be given to children under 1 year of age.
Other medicines and Sildenafil Teva Pharma
Do not take Sildenafil Teva Pharma with (see also “Do not take Sildenafil Teva Pharma” in this section)
- drugs containing nitrates (such as nicorandil), or nitric oxide donors such as amyl nitrite.
- medicines containing riociguat.
- medicines containing ketoconazole , itraconazole or ritonavir.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines:
- Medicines containing substances such as bosentan, ambrisentan, and iloprost (used to treat pulmonary hypertension ).
- Medicines belonging to the same group as Sildenafil Teva Pharma (PDE5 inhibitors).
- Medicines containing St. John’s wort (traditional herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy ).
- Medicines containing erythromycin, clarithromycin, telithromycin ( antibiotics for the treatment of specific bacterial infections ), saquinavir (for the treatment of HIV ), or nefazodone (for depression), as your dose may need to be adjusted.
- Drugs that contain beta-blockers (a group of drugs that are used, among other things, to treat high blood pressure, heart failure, irregular heartbeat, and migraines ).
- Blood-thinning drugs (such as warfarin ), although did not show any side effects.
- Medicines that contain alpha-receptor blockers (eg doxazosin ) for the treatment of high blood pressure or prostate problems, as the combination of the two medicines can cause symptoms that lead to a decrease in your blood pressure (eg dizziness and dizziness).
Sildenafil Teva Pharma with food and drink
You should not drink grapefruit juice while you are being treated with Sildenafil Teva Pharma.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Sildenafil Teva Pharma should be used during pregnancy only when needed.
Sildenafil Teva Pharma should not be given to women of childbearing potential unless appropriate contraception is used.
Sildenafil passes into breast milk in very small amounts and is not expected to harm the baby.
Driving and using machines
Sildenafil Teva Pharma may cause dizziness and impair vision. You should be aware of how you react to the medicine before driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Sildenafil Teva Pharma contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
How to take Sildenafil Teva Pharma
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
For adults, the recommended dose is 20 mg three times daily (taken at 6 to 8-hour intervals) with or without food.
Use for children and adolescents
For children and adolescents between 1 year and 17 years of age, the recommended dose is either 10 mg three times daily for children and adolescents weighing 20 kg or less or 20 mg three times daily for children and adolescents weighing more than 20 kg. Taken with or without food. Higher doses should not be used in children.
This medicine should only be used when administering 20 mg 3 times daily. Other forms of medicine are more suitable for the treatment of patients weighing 20 kg or less, as well as for younger patients who can not swallow tablets.
If you take more Sildenafil Teva Pharma than you should
Do not take more medicines than your doctor tells you to do. Taking more Sildenafil Teva Pharma than you should increase the risk of known side effects.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to take Sildenafil Teva Pharma
If you forget to take Sildenafil Teva Pharma, take a dose as soon as you remember. Then continue to take your medicine at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Sildenafil Teva Pharma
Sudden discontinuation of Sildenafil Teva Pharma may worsen your symptoms. Do not stop taking Sildenafil Teva Pharma unless your doctor tells you to. Your doctor may ask you to reduce your dose for a few days before stopping completely.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop taking Sildenafil Teva Pharma and contact your doctor immediately (see also section 2):
- if you experience a sudden deterioration or loss of vision (no known frequency).
- if you have an erection that lasts longer than 4 hours. Prolonged and sometimes painful erections have been reported in men after taking sildenafil (no known frequency).
Adults
The side effects reported as very common (may affect more than 1 user in 10) were: headache, flushing, digestive problems, diarrhea, and pain in the arms and legs.
Side effects reported as common (may affect up to 1 in 10 people) were: subcutaneous infection, flu-like symptoms, sinusitis, decreased red blood cell count ( anemia ), fluid retention in the body, difficulty sleeping, anxiety, migraines, tremors, numbness and tingling, burning sensation, decreased sensitivity of the skin, bleeding at the back of the eye, effects on vision, blurred vision and light shading, effect on color vision, eye irritation, bloodshot eyes / red eyes, dizziness, tracheal cataracts, nosebleeds, runny nose, cough, nasal congestion, stomach – intestinal inflammation, heartburn, hemorrhoids, distended abdomen, dry mouth, hair loss, reddening of the skin, night sweats, muscle aches, back pain, and increased body temperature.
Side effects that were reported as uncommon (may affect up to 1 in 100 people) were: decreased visual acuity, double vision, abnormal sensation in the eyes, bleeding in the penis, presence of blood in semen and/or urine, and breast enlargement in men.
Skin rash and sudden loss or loss of hearing and decreased blood pressure have also been reported with an unknown frequency (frequency cannot be calculated from the available data).
Children and young people
The following serious side effects have been reported commonly (may affect up to 1 in 10 people): pneumonia, heart failure, right ventricular failure, heart-related shock, high blood pressure in the lungs, chest pain, fainting, respiratory tract infection, tracheal inflammation, viral and intestinal viral infection caries.
The following serious side effects were considered treatment-related and have been reported as uncommon (may affect up to 1 in 100 people): allergic reactions (such as rash, swelling of the face, lips, and tongue, wheezing, difficulty breathing and swallowing), convulsions, irregular heartbeat, hearing loss, shortness of breath, inflammation of the stomach and intestines, wheezing due to obstructed airflow.
Side effects reported as very common (may affect more than 1 in 10 people) were: headache, vomiting, throat infection, fever, diarrhea, flu, and nosebleeds.
Side effects reported as common (may affect up to 1 in 10 people) were: nausea, increased erection, pneumonia, and runny nose.
How to store Sildenafil Teva Pharma
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 after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
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 20 mg of sildenafil (citrate).
- Other ingredients are Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, croscarmellose sodium, and magnesium stearate.Film coating: hypromellose, macrogol 6000, talc, titanium dioxide (E171).
What the medicine looks like and the contents of the pack
Sildenafil Teva Pharma film-coated tablets are white to off-white (approximately 6.5 mm), biconvex and round, debossed with “20” on one side and unmarked on the other side.
Sildenafil Teva Pharma film-coated tablets are supplied in PVC / PVdC aluminum blisters or perforated unit dose blisters of 30, 90, 90×1, or 300 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Teva Pharma BV
Swensen 5
Haarlem
2031GA
Netherlands