25 mg / 50 mg / 100 mg film-coated tablets
sildenafil
What Sildenafil STADA is and what it is used for
Sildenafil Stada 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 Stada only makes it easier to get an erection if you are sexually stimulated.
Sildenafil Stada 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.
Sildenafil contained in Sildenafil Stada 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 use Sildenafil STADA
Do not use Sildenafil STADA
- if you are allergic to sildenafil, peanuts or soy, or any of the other ingredients of this medicine (listed in section 6)
- if you are taking medicines called nitrates, in combination with Sildenafil Stada can lead to 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 Stada 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 Stada, 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 a rare optic nerve disease (non-arteritic anterior ischemic optic infarction/neuropathy, NAION).
Warnings and cautions
Talk to your doctor or pharmacist before taking Sildenafil Stada
- if you have sickle cell anemia (abnormal red blood cells ), leukemia (blood cell cancer), 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 Stada and contact a doctor immediately
- if you are taking a medicine called ritonavir (for the treatment of HIV ), you should not take Sildenafil Stada.
- You should not use Sildenafil Stada at the same time as any other oral (oral) or local treatment for erectile dysfunction.
You should not use Sildenafil Stada at the same time as any other oral (oral) or local treatment for erectile dysfunction.
You should not take Sildenafil Stada if you do not have erectile dysfunction.
You should not take Sildenafil Stada 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 Stada should not be used in people under 18 years of age.
Other medicines and Sildenafil STADA
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
Sildenafil Stada tablets can affect the effects of certain medicines, especially those used to treat chest pain. If you become acutely ill, you should inform your doctor or pharmacist that you have taken Sildenafil Stada and when you did. Do not take Sildenafil Stada with other medicines unless your doctor tells you to.
You should not take Sildenafil Stada 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 or pharmacist if you are taking any of these medicines, which are often given to relieve angina pectoris or “chest pain”.
You should not take Sildenafil Stada if you are taking medicines called nitric oxide donors such as amyl nitrite (“poppers”), as a combination of such medicines with Sildenafil Stada can also lead to a sharp drop in blood pressure.
Tell your doctor or pharmacist if you are already taking riociguat.
If you are taking so-called protease inhibitors for the treatment of HIV, your doctor may prescribe that you start with the lowest dose (25 mg) of Sildenafil Stada. You should not take Sildenafil Stada if you are taking the protease inhibitor ritonavir (for the treatment of HIV ).
Some patients taking alpha-receptor blockers to treat high blood pressure or prostate enlargement may experience dizziness or fainting, which may be caused by low blood pressure when sitting up or standing up quickly. Some patients have experienced these symptoms while taking sildenafil with alpha-receptor blockers. This is most likely to occur within 4 hours of taking Sildenafil Stada. To reduce the risk of these symptoms, you should take alpha-receptor blockers regularly with a fixed daily dose before you start taking Sildenafil Stada. Your doctor may prescribe a lower dose (25 mg) of Sildenafil Stada.
Sildenafil STADA with food, drink, and alcohol
Sildenafil Stada 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 Stada.
Pregnancy, breastfeeding, and fertility
Sildenafil Stada should not be used by women.
Driving and using machines
Sildenafil Stada may cause dizziness and may affect vision. You should be aware of how you react to Sildenafil Stada before driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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 STADA contains soy lecithin, nicotine, lactose, glucose, and sodium
Sildenafil Stada contains soy lecithin.
Do not use this medicine if you are allergic to peanuts or soy.
Sildenafil Stada contains neocockin
It May cause allergic reactions.
Sildenafil Stada contains lactose and glucose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Sildenafil Stada contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
How to use Sildenafil STADA
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended starting dose is 50 mg.
You should not take Sildenafil Stada more than once a day.
Do not take Sildenafil Stada film-coated tablets together with orodispersible tablets containing sildenafil.
You should take Sildenafil Stada about an 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 Stada is too strong or too weak, talk to your doctor or pharmacist.
Sildenafil Stada only gives you an erection if you are sexually stimulated. The time it takes for Sildenafil Stada to work varies from person to person, but normally it takes between half and an hour. You may notice that it takes longer for Sildenafil Stada to work if you take it with a heavy meal.
If Sildenafil Stada 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 use more Sildenafil STADA 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 prescribes.
Contact your doctor if you have taken too many tablets.
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor or hospital for risk assessment and advice.
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. The side effects reported with Sildenafil Stada are usually mild to moderate and last only a short time.
Stop using Sildenafil Stada and contact your doctor immediately if you experience any of the following severe symptoms:
- An allergic reaction – is 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 – is 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, high heartbeat, high 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, gastroesophageal reflux disease. reflux disease(symptoms include heartburn), presence of blood in the urine, pain in the arms or legs, nosebleeds, and 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 STADA
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. The expiration date is the last day of the specified month.
This medicine has 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 citrate.
One Sildenafil Stada 25 mg tablet contains 25 mg sildenafil (as citrate).
One Sildenafil Stada 50 mg tablet contains 50 mg sildenafil (as citrate).
One Sildenafil Stada1005 mg tablet contains 100 mg sildenafil (as citrate).
Other ingredients are:
- Tablet core: lactose monohydrate, microcrystalline cellulose E 460, hydroxypropylcellulose E 463, croscarmellose sodium E 468, sodium stearyl fumarate, anhydrous colloidal silica E 551
- Film coating: indigo carmine aluminum lacquer E 132, triglycerides (medium chain), hypromellose E 464, maltodextrin, polydextrose E 1200, nycockin (red) aluminum lacquer E 124, talc E 553b, titanium dioxide E 171, dextrose monohydrate, soy lecithin E 322, maltodextrin aluminum potassium silicate/titanium dioxide pigment E 555, sodium carboxymethylcellulose E 466.
What the medicine looks like and the contents of the pack
Sildenafil Stada 25 mg film-coated tablets are light blue, mother-of-pearl, round and biconvex with a diameter of approximately 8 mm.
Sildenafil Stada 50 mg film-coated tablets are light blue, mother-of-pearl, round and biconvex with a diameter of approximately 10 mm.
Sildenafil Stada 100 mg film-coated tablets are light blue, mother-of-pearl, round and biconvex with a diameter of approximately 12 mm.
The 25 mg tablets are supplied in blister packs containing 1, 2, 3, 4, 8, 12, or 24 film-coated tablets.
The 50 mg and 100 mg tablets are supplied in blister packs containing 1, 2, 3, 4, 8, 12, 24, 36, or 48 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
Pharmacodane APS
Marielundvej 46A
DK-2730 Herlev
Denmark
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark