Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You might need to read it again.
- If you have further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not give this to anyone else. It could be harmful to them, even if the signs of their illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet.
1. In which case is Fildena used?
Fildena belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. Its action is to help the relaxation of the blood vessels of the penis, promoting blood flow into the penis, during sexual arousal. Fildena therefore helps to get an erection only if you have sexual stimulation.
Fildena is a treatment for men with erectile dysfunction (also known as impotence), that is when a man can not achieve or maintain an erection sufficient to guarantee sexual activity.
2. What information do you need to know before taking Fildena?
It is important not to take Fildena in the following cases:
- If you take medicines called nitrates, because the combination of effects can cause a decrease in blood pressure, which is potentially dangerous. Tell your doctor if you are taking any of these medicines that are often used for the relief of angina attacks. If in doubt, do not hesitate to consult your doctor or pharmacist.
- If you use any of the drugs known as nitric oxide donors such as amyl nitrite (known as “poppers”), as the combination may also result in a potentially dangerous decrease in your blood pressure.
- If you are allergic to sildenafil or any of the other ingredients of Fildena.
- If you have serious heart problems or liver problems.
- If you suffer from some rare hereditary eye diseases (such as retinitis pigmentosa).
- If you have recently had a stroke or heart attack, or if your blood pressure is abnormally low.
- If you have ever had vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).
Special attentions with Fildena
Inform your doctor of the following situations if you plan to take Fildena:
- You have sickle cell disease (an abnormality of red blood cells), leukemia (cancer of the blood cells)(cancer of the bone marrow).
- You have penile deformity or Peyronie’s disease.
- You have heart problems that have not been evaluated by your doctor yet.
- You have a stomach ulcer or bleeding disorders (such as hemophilia).
You should not use Fildena at the same time as another oral or local treatment for erectile dysfunction.
Fildena should not be administered to persons under 18 years of age.
Fildena and other medicines
If you are taking or have recently taken any other prescription or over-the-counter medications, talk to your doctor or pharmacist.
Fildena tablets can interact with certain medications, especially those used for angina. Thus, you should not take Fildena if you are taking any medications called nitrates because the combination of these medications can lead to a potentially dangerous decrease in your blood pressure. Always tell your doctor or pharmacist if you are taking any of these medicines that are often used for the relief of angina.
You should not take Fildena if you are taking any of the medicines known as oxide donors such as nitrite (better known as “poppers”) as this combination can also result in a potentially dangerous decrease of your blood pressure.
If you are taking medications known to be inhibitors (this is particularly the case during HIV treatment), your doctor may start your treatment with the lowest dose (25 mg).
Some patients taking alpha-blocking medication (s) for the treatment of high blood pressure or enlarged prostate may experience dizziness or drunkenness, especially when moving quickly to a sitting position. in the standing position.
These symptoms occur most often within 4 hours of taking Fildena. To reduce the likelihood of these symptoms, you should be treated with a constant daily dose of alpha-blocker before starting treatment with Fildena. Your doctor may start your treatment with Fildena at a lower dose (25 mg).
Fildena and foods
Fildena can be taken during or after meals, but the effect is slower if you take it with a high-fat meal. By the way, drinking alcohol can temporarily affect your ability to have an erection. To maximize the benefits of Fildena, it is therefore advisable to avoid drinking a lot of alcohol before taking a tablet.
Fildena, driving and using machines
Fildena can sometimes cause dizziness and affect vision. Before driving or using machines, you must know how you react to the medication.
3. How to take Fildena?
Always follow the dosage indicated by your doctor. The usual dose of initiation is 50 mg. If you are uncertain, consult your doctor or pharmacist.
Fildena should not be used more than once a day. The tablet should be swallowed whole with a glass of water about an hour before sexual intercourse. For this to be effective, there must be sexual stimulation. You will notice that Fildena works more slowly if you take it during a high-fat meal.
You took more Fildena than you should
Contact your doctor if you exceed the prescribed dose.
4. What are the possible side effects?
Like all medicines, Fildena 100 can cause side effects, although not everybody gets them. Adverse reactions reported with Fildena are generally mild to moderate and of short duration.
Cases of prolonged and sometimes painful erections have been reported after taking Fildena. If you have an erection that persists continuously for more than 4 hours, you must consult a doctor urgently. Fildena may also cause allergies: contact your doctor immediately if any of the symptoms occur after taking the tablet: difficulty breathing, dizziness, swelling of the eyelids, face, lips, throat, or sudden wheezing .
Headache is a very common side effect (may occur in more than 1 patient in 10).
Common side effects (may occur in 1 to 10 patients in 100) may occur after taking Fildena such as facial redness, indigestion, vision effects (altered color perception, decreased sensitivity to light, vision trouble), a stuffy nose and dizziness.
Other infrequent side effects (which may occur in 1 to 10 patients in 1000) may also occur. They include: vomiting, rash, bleeding in the back of the eye, eye irritation, bloodshot / red-eye eyes, eye pain, double vision, abnormal sensations in the eye, irregular or accelerated heartbeat muscle pain, drowsiness, decreased sensitivity to touch, dizziness, ringing of ears, nausea, dry mouth, chest pain and feeling tired.
Rare side effects (which may occur in 1 to 10 patients in 10,000) have also been reported: hypertension, hypotension, unconsciousness, stroke, nosebleeds, and sudden hearing loss or decrease.
Very rare side effects have been reported after marketing: very fast heartbeat, chest pain, sudden death, heart attack or temporary decrease of blood supply to certain parts of the brain. Most men who suffered from these side effects had heart problems before taking this medication. It is impossible to determine if these effects are directly related to Fildena. Cases of epileptic seizures, convulsions and severe skin reactions characterized by skin rashes, blisters and peeling skin have also been reported.
6. Additional information about Fildena
Fildena contains an active substance which is sildenafil. Each tablet contains 50 mg as Sildenafil Citrate. The other ingredients are: microcrystalline cellulose, calcium hydrogenphosphate (anhydrous), croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), lactose, triacetin, indigo-containing aluminum lake (E132).
What does Fildena look like?
Fildena tablets are blue with a rounded diamond shape. It is written “Fortune Healthcare” on one side and “Fildena 50” on the other. The tablets are presented in platelets containing 2, 4, 8 or 12 tablets in a box.