1. WHAT IS SILDENAFIL 100 mg, film-coated tablet AND WHAT IT IS USED FOR?
SILDENAFIL contains the active substance sildenafil (as citrate), which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Its action consists of helping the relaxation of the blood vessels of the penis, promoting blood flow into the penis, during sexual arousal. This drug will help you get an erection only if you have sexual stimulation. This medicine is a treatment for adult men with erectile dysfunction, sometimes called impotence, which is when a man cannot achieve or maintain an erection sufficient for sexual activity.
2. BEFORE YOU TAKE SILDENAFIL pFIZER 100 mg film-coated tablets?
Do not take SILDENAFIL PFIZER 100 mg film-coated tablets
If you are allergic to sildenafil or any of the other ingredients of this medication mentioned in section 6,
If you are taking medicines called nitrates, as the combination can cause a dangerous drop in your blood pressure. Tell your doctor if you are taking any of these medicines which are often used to relieve attacks of angina pectoris (or angina). If in doubt, seek the advice of your doctor or pharmacist,
if you are using any of the medicines known as nitric oxide donors such as amyl nitrite ("poppers"), as the combination may also cause a dangerous drop in your blood pressure,
If you are taking riociguat.This medicine is used to treat pulmonary arterial hypertension (PAH) (i.e. high blood pressure in the arteries of the lungs) and chronic thromboembolic pulmonary hypertension (CHPT) (i.e. high blood pressure in the pulmonary arteries due to the presence of persistent blood clots). PDE5 inhibitors, such as SILDENAFIL PFIZER, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or if you are not sure talk to your doctor,
if you have serious heart or liver problems,
if you have recently had a stroke or heart attack or if your blood pressure is low,
If you suffer from certain rare hereditary eye diseases (such as retinitis pigmentosa),
If you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking SILDENAFIL PFIZER:
if you have sickle cell disease (an abnormality of red blood cells), leukemia (cancer of blood cells), multiple myeloma (cancer of the bone marrow),
if you have a deformity of the penis or Peyronie's disease,
if you have heart problems. Your doctor should carefully assess whether your heart can tolerate the extra strain of sexual activity.
if you currently have a stomach ulcer or a bleeding disorder (such as haemophilia),
if you notice a sudden decrease or loss of vision, stop taking this medicine and contact your doctor immediately.
You should not use this medicine at the same time as any other oral or topical treatment for erectile dysfunction.
You should not use this medicine at the same time as treatments for pulmonary arterial hypertension (PAH) containing sildenafil or other PDE5 inhibitors.
You should not take SILDENAFIL PFIZER if you do not suffer from erectile dysfunction.
You should not take SILDENAFIL PFIZER if you are a woman.
Special precautions for patients with kidney or liver problems
You should tell your doctor if you have kidney or liver problems. Your doctor may then decide to prescribe a lower dose for you.
Children and teenagers
This medicine should not be given to people under the age of 18.
Other medicines and SILDENAFIL 100 mg film-coated tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
SILDENAFIL tablets may interact with certain medications, especially those used for angina pectoris. In the event of a medical emergency, you should tell your doctor, pharmacist or nurse treating you that you have taken this medicine and when you took it. Do not take this medicine at the same time as other medicines unless your doctor tells you to.
You should not take this medicine if you are taking medicines called nitrates because the combination of these medicines can cause a dangerous drop in your blood pressure. Always tell your doctor, pharmacist or nurse if you are taking any of these medicines which are often used for the relief of attacks of angina pectoris (or angina).
You should not take this medicine if you are taking any of the medicines known as nitric oxide donors such as amyl nitrite ("poppers") as this combination can also cause a dangerous drop in your blood pressure.
Tell your doctor or pharmacist if you are already taking riociguat.
If you are taking medicines known as protease inhibitors, in particular for the treatment of HIV infection, your doctor may need to start your treatment with this medicine with the lowest dose (25 mg).
Some patients taking alpha-blocker medication for the treatment of high blood pressure or an enlarged prostate may experience dizziness or lightheadedness, which may be due to low blood pressure when switching rapidly to sitting or standing position. Some patients have experienced these symptoms when taking this medication with alpha-blockers. This most often occurs within 4 hours of taking this medication. To reduce the likelihood of these symptoms occurring, you should be treated with a constant daily dose of an alpha-blocker before starting treatment with this medicine. Your doctor may start your treatment with this medicine at a lower dose (25 mg).
SILDENAFIL 100 mg film-coated tablets with food, drink and alcohol
This medicine can be taken with or without food.
However, you may notice that this medication works slower if you take it with a high-fat meal.
Drinking alcohol can temporarily affect your ability to get an erection. To get the maximum benefit from your medicine, you are advised not to drink a lot of alcohol before taking this medicine.
Pregnancy, lactation and fertility
This medication is not indicated for women.
Driving and using machines
This medication can cause dizziness and may affect vision. Before driving or using machines, you should know how you react to this medicine
SILDENAFIL PFIZER 100 mg film-coated tablets contain lac Your doctor has informed you of an intolerance to certain sugars, such as lactose, contact him before taking this medicine.
SILDENAFIL 100 mg film-coated tablets contain sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, i.e. essentially 'sodium free'.
3. HOW TO TAKE SILDENAFIL PFIZER 100 mg film-coated tablets?
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt. The recommended starting dose is 50 mg.
You should not use SILDENAFIL PFIZER more than once a day.
You should take this medicine about an hour before you plan to have sex. Swallow the tablet whole with a glass of water.
If you feel that the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist.
This drug will help you get an erection only if you have sexual stimulation. The time it takes for this medicine to work varies from person to person, it is normally half an hour to an hour. You may find that this medication works more slowly if you take it with a high fat meal.
If this medicine does not give you an erection, or if your erection is not long enough to allow you to have full intercourse, talk to your doctor.
If you take more SILDENAFIL PFIZER 100 mg film-coated tablets than you should
You may experience an increase in the number of side effects and their severity. Doses above 100 mg do not increase the effectiveness of the product.
Do not take more tablets than your doctor has told you.
Contact your doctor if you take more tablets than you should.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everyone gets them.
The side effects reported with this drug are usually mild to moderate and of short duration.
If you experience any of the serious side effects listed below, stop taking SILDENAFIL PFIZER 100 mg film-coated tablets and contact your doctor immediately:
an allergic reaction this is uncommon (may affect up to 1 in 100 people)
Symptoms may include: sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.
chest pain this is uncommon
If it happens during or after sex:
o Get into a semi-sitting position and try to relax.
o Do not take nitrates to relieve your chest pain.
Prolonged sometimes painful erections this is rare (may affect up to 1 in 1,000 people)
If you have an erection that persists continuously for more than 4 hours, you should contact a doctor immediately.
Sudden decrease in vision this is rare
Serious skin reactions this is rare
Symptoms may include: severe peeling and swelling of the skin, blisters in the mouth, genital area and around the eyes, and fever.
Convulsions or epileptic seizures this is rare
Other side effects
Very common (may affect more than 1 in 10 people): headache.
Common (may affect up to 1 in 10 people): nausea, flushing of the face, flushing (symptoms may include: sudden feeling of warmth in the upper body), indigestion, disturbances in color perception, blurred vision, visual disturbance, stuffy nose and dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, rash, eye irritation, bloodshot eyes/red eyes, eye pain, seeing flashes of light, increased brightness, sensitivity to light , watery eyes, palpitations, fast heartbeat, high blood pressure, low blood pressure, muscle aches, drowsiness, decreased sensitivity to touch, dizziness, ringing in the ears, dry mouth, blocked or clogged sinuses, inflammation of the nasal lining (symptoms runny nose, sneezing and stuffy nose), upper abdominal pain, gastroesophageal reflux disease (symptoms may include: heartburn), blood in the urine, pain in arms or legs , nosebleed, feeling hot and feeling tired.
Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decrease in blood supply to parts of the brain, tightness in your throat, numb mouth, bleeding in the back of the eye, double vision, decreased visual acuity, abnormal sensations in the eye, swelling of the eye or eyelid, small particles or dots in front of the eyes, seeing halos around the lights, dilation of the pupil of the eye, change in the color of the white of the eye, bleeding from the penis, presence of blood in the semen, nasal dryness, swelling of the inside of the nose, feeling of irritability and decrease or sudden hearing loss.
In post-marketing experience, rare cases of unstable angina (heart disease) and sudden death have been reported. It should be noted that most, but not all, men who experienced these side effects had heart problems before taking this drug. It is not possible to determine whether these events were directly related to this medicinal product.
5. HOW TO STORE SILDENAFIL 100 mg film-coated tablets?
Store at a temperature not exceeding 30°C.
Store in the original packaging, away from humidity.
Keep this medication out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box and blister after EXP. The expiration date refers to the last day of that month
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What SILDENAFIL 100 mg contains, film-coated tablet
The active substance is:
Sildenafil (as citrate) 100mg