25 mg, 50 mg, and 100 mg film-coated tablets
sildenafil
What Sildenafil Actavis is and what it is used for
Sildenafil Actavis 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 Actavis only makes it easier to get an erection if you are sexually stimulated.
Sildenafil Actavis 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 Actavis
Do not take Sildenafil Actavis
- If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
- If you are taking medications called nitrates, in combination with Sildenafil Actavis 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 pectoris or “chest pain”. If you are not sure, ask your doctor or pharmacist.
- If you are taking medicines known as nitric oxide donors such as amyl nitrite (“poppers”), a combination of such medicines with Sildenafil Actavis 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 Actavis, 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 Actavis:
- 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 sudden deterioration or loss of vision, stop taking Sildenafil Actavis and contact your doctor immediately.
You should not use Sildenafil Actavis at the same time as any other ( oral or topical) treatment for erectile dysfunction.
You should not use Sildenafil Actavis 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 Actavis unless you have erectile dysfunction.
You should not take Sildenafil Actavis if you are a woman.
Especially to take into account when it comes to patients with kidney or liver 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 Actavis should not be given to people under 18 years of age.
Other medicines and Sildenafil Actavis
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
Sildenafil Actavis tablets may affect the effects of certain medicines, especially those used to treat chest pain. If you become acutely ill, you should inform the person treating your condition that you took Sildenafil Actavis and when you did. Do not take Sildenafil Actavis with other medicines unless your doctor tells you to.
You should not take Sildenafil Actavis if you are taking medicines called nitrates, as they in combination can cause a potentially dangerous 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 Actavis if you are taking medicines called nitric oxide donors such as amyl nitrite (“poppers”), as these two in combination can cause a potentially dangerous 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 (25 mg) of Sildenafil Actavis.
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 with alpha-receptor blockers. This is most likely to happen within 4 hours of taking Sildenafil Actavis. To reduce the risk of these symptoms, you should take alpha-receptor blockers regularly with a fixed daily dose before you start taking Sildenafil Actavis. Your doctor may prescribe a lower dose (25 mg) of Sildenafil Actavis.
Talk to your doctor or pharmacist if you are already taking medicines containing sacubitril/valsartan, which are used to treat heart failure.
Sildenafil Actavis with food, drink, and alcohol
Sildenafil Actavis 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 Actavis.
Pregnancy, breastfeeding, and fertility
Sildenafil Actavis should not be used by women.
Driving and using machines
Sildenafil Actavis may cause dizziness and may affect vision. You should be aware of how you react to Sildenafil Actavis before driving or using machines.
Sildenafil Actavis contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, ie essentially ‘sodium-free’.
How to take Sildenafil Actavis
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 Actavis more than once a day.
You should take Sildenafil Actavis 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 Actavis is too strong or too weak, talk to your doctor or pharmacist.
Sildenafil Actavis only gives you an erection if you are sexually stimulated. The time it takes for Sildenafil Actavis 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 Actavis to work if you take it with a heavy meal.
If Sildenafil Actavis 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 Actavis 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 are usually mild to moderate and last only a short time.
Stop using Sildenafil Actavis and contact your doctor immediately if you experience any of the following severe symptoms:
- An allergic reaction – uncommon (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
- If 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 are rare (may affect up to 1 in 1,000 people)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 eyes, eye pain, seeing flashes of light or perceiving light as very strong, photosensitivity, watery eyes, palpitations, rapid heartbeat, loud blood pressure, low blood pressure, muscle pain, drowsiness, decreased sensation, 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, reflux esophagus symptoms include heartburn), blood in urine, pain in 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. they took this medicine. It is impossible to say whether these events were due to sildenafil.
How to store Sildenafil Actavis
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.
Do not store above 30 ° C.
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, 50 mg, or 100 mg of sildenafil (as citrate).
- The active substance is sildenafil. Each tablet contains 25 mg of sildenafil (as citrate).
- The active substance is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate).
- The active substance is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate).
- The other ingredients are lactose monohydrate, microcrystalline cellulose, povidone K29-32, croscarmellose sodium, magnesium stearate, hypromellose, and titanium dioxide (E171), macrogol 6000, indigo carmine aluminum lacquer (E132).
What the medicine looks like and the contents of the pack
Film-coated tablet
Sildenafil Actavis 25 mg film-coated tablets are blue, elliptical, and biconvex, 10.0 x 5.0 mm, marked “SL25” on one side.
Sildenafil Actavis 50 mg film-coated tablets are blue, elliptical, and biconvex, 13.0 x 6.5 mm, marked “SL50” on one side.
Sildenafil Actavis 100 mg film-coated tablets are blue, elliptical, and biconvex, 17.0 x 8.5 mm, marked “SL100” on one side.
The tablets are supplied in blister packs containing 1, 2, 4, 8, 12, or 24 tablets.
Some pack sizes may not be marketed in your country.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Actavis Group PTC EHF.
Reykjavíkurvegur 76-78
IS-220 Hafnarfjörður
Iceland
Manufacturer
Actavis Ltd.
BLB 015-016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
For further information on this medicine, please contact the local representative of the Marketing Authorization Holder:
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