SILEGRIA 50 mg. 4 tablets

What Silegria and what it is used
Silegria contains the active ingredient sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5). Silegria of action is to assist in the expansion of blood vessels in the penis, allowing blood to flow during sexual excitement.
Silegria will only help you to get an erection if you are sexually stimulated. You must not use Silegria if you do not have erectile dysfunction. You should not take Silegria if you are a woman.
Silegria medicine for adult men with erectile dysfunction, also called impotence. This means that man can not get, or keep a hard, erect penis suitable for sexual activity.

2. What you need to know before taking Silegria
Do not take Silegria:
if you are allergic (hypersensitive) to sildenafil or any of the other ingredients of this medicine (listed in section 6);
if you are taking medicines called nitrates, as the combination may cause a potentially dangerous decrease in your blood pressure. Tell your doctor if you are taking any of these drugs that are often prescribed to relieve angina (chest pain). If you're not sure, ask your doctor or pharmacist;
if you use any of the drugs known as nitric oxide donors such as amyl nitrite (poppers), as this combination may also lead to a potentially dangerous decrease in blood pressure;
if you have severe heart or liver problem;
if you have recently had a stroke or heart attack, or if you have low blood pressure;
if you have a rare inherited eye disease (such as retinitis pigmentosa);
if you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).
If you believe that any of the above applies to you (or you are in doubt), please tell your doctor.

Warnings and precautions:
Talk to your doctor, pharmacist or nurse before taking Silegria:
if you have sickle cell anemia (an abnormality of red blood cells), leukemia (cancer of blood cells), multiple myeloma (bone marrow cancer);
If you have a deformity of your penis or Peyronie's disease;
if you have heart problems. In this case, your doctor should carefully check whether your heart can take the additional strain, having sex;
if you currently have a stomach ulcer or problems with blood clotting (such as haemophilia).
If you experience sudden decrease or loss of vision, stop taking Silegria and tell your doctor immediately.
If you believe that any of the above applies to you (or you are in doubt), do not take Silegria and consult a doctor or pharmacist before you start taking any dose Silegria.
Silegria should not be administered concurrently with other oral or topical treatment of erectile dysfunction.
You should not take Silegria if you do not have erectile dysfunction.
You should not take Silegria if you are a woman.

Children and adolescents
Silegria should not be given to individuals under the age of 18.

Special considerations for patients with kidney or liver problems
Tell your doctor if you have kidney or liver problems. Your doctor may decide to prescribe a lower dose Silegria.

Other medicines and Silegria
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.
Tablets Silegria may interact with some drugs, particularly those used to treat chest pain. In an emergency, you should tell your doctor, pharmacist or nurse that you take and when you take Silegria. Do not take Silegria with other medicines unless your doctor has told you so.
You should not take Silegria with medicines called nitrates as the combination of them can cause a potentially dangerous decrease in your blood pressure. Always tell your doctor or pharmacist if you are taking any of these medicines often prescribed for angina (chest pain).
Do not take Silegria if you are using any of the drugs known as nitric oxide donors such as amyl nitrite (poppers), as the combination may lead to potentially dangerous decrease in your blood pressure.
If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your doctor probably will prescribe the lowest dose of 25 mg Silegria.
Some patients who were on treatment with an alpha-blocker for the treatment of high blood pressure or prostate enlargement may experience dizziness or lightheadedness, which may be caused by low blood pressure when standing up quickly or area. Some patients reported these symptoms when taking Silegria with alpha-blockers. This is most likely to occur within 4 hours after taking Silegria. You must be on a regular daily dose of alpha-blocker before taking Silegria to reduce the likelihood of these symptoms. Your doctor may prescribe a lower starting dose of 25 mg Silegria.

Silegria with food, drink and alcohol
Silegria can be taken with or without food. However, you may notice that Silegria act more slowly if taken with a heavy meal.
Intake of alcohol can temporarily impair your ability to get an erection. To get the maximum benefit from your medication, you are advised not to drink excessive amounts of alcohol before taking Silegria.

Pregnancy, lactation and fertility
Silegria is not indicated for use in women.

Driving and using machines
Silegria can cause dizziness and can affect vision. You need to know how you react to Silegria before you decide to drive or operate machinery.

3. How to take Silegria
Always take this medicine exactly as you have been told by your doctor or pharmacist. If you're not sure, ask your doctor or pharmacist.
The recommended dose is 50 mg.
Silegria not take more than once daily.
Silegria should be taken about 1 hour before you plan to have sex. Swallow the tablet whole with a glass of water.
If you feel that the effect of Silegria is too strong or too weak, talk to your doctor or pharmacist.
Silegria will only help you to get an erection during sexual stimulation. The time at which occurs the effect of Silegria is individual, but is typically between half and one hour. If you accept Silegria during a heavy meal, the effect may occur more slowly.
If Silegria will not help you get an erection, or if your erection does not last long enough to complete sexual intercourse, tell your doctor.

If you take more dose Silegria
You may experience an increase in side effects and their severity. Doses above 100 mg do not increase the efficacy.
You should not take more tablets than prescribed by your doctor.
Contact your doctor if you take more than you need.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. It is important to be aware what could be these side effects. They are usually mild to moderate and transient.

The frequency of adverse reactions is determined according to the following convention:
Very common (affecting 1 or more in every 10 patients);
common (affecting 1 or more in every 100 but less than 1 in every 10 patients);
Uncommon (affecting 1 or more in every 1000 but less than 1 in every 100 patients);
Rare (affects 1 or more per 10 000, but less than 1 out of 000 patients 1);
very rare (affects less than 1 in 10,000 patients);
not known (frequency can not be estimated from available data).
If you experience any of the following serious side effects, stop taking Silegria and seek medical advice immediately:
Chest pain during or after intercourse (they do not occur often):
borrow a semi-sitting position and try to relax;
Do not use nitrates to treat your chest pain;
Allergic reaction (which occurs rarely). Symptoms include: sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat;
Prolonged and sometimes painful erections (not known). If you have an erection that lasts more than 4 hours, immediately contact a doctor;
Sudden decrease or loss of vision (frequency not known);
Serious skin reactions (frequency not known). Symptoms may include severe peeling and swelling of skin, blisters in the mouth, genitals and around the eyes, fever;
Convulsions and seizures (not known).
Other adverse reactions:
Very common:
headache.
Common:
flushing;
indigestion;
visual disturbances (including impaired color perception, light sensitivity, blurred vision or reduced sharpness of vision);
stuffy nose;
dizziness.
Uncommon:
vomiting;
skin rash;
Bleeding in the back of the eye;
eye irritation;
bloodshot eyes / red eyes;
eye pain;
double vision;
abnormal sensation in the eye;
tearing;
irregular or rapid heartbeat;
muscle pain;
drowsiness;
reduced sense of touch;
dizziness;
ringing in the ears;
nausea;
dry mouth;
bleeding from the penis;
presence of blood in the semen and / or urine;
chest pain;
fatigue.
Rare:
high blood pressure;
low blood pressure;
loss of consciousness;
stroke;
heart attack;
irregular heartbeat;
nosebleeds;
sudden decrease or loss of hearing.
Not known:
unstable angina (heart disease);
sudden death;
temporary decreased blood flow to parts of the brain.
Most, but not all of these men had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to sildenafil.

5. How to store Silegria
Keep out of reach of children.
Do not use Silegria after the expiry date stated on the carton or blister. The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
Does not require any special storage conditions.

6. Contents of the pack and further information
What Silegria
The active substance is sildenafil 50 mg (equivalent to 70,243 mg sildenafil citrate) or sildenafil 100 mg (equivalent to 140,485 mg sildenafil citrate).
The other ingredients are cellulose microcrystalline, calcium hydrogen phosphate anhydrous, croscarmellose sodium, hypromellose, hypromellose 2910, sodium stearyl fumarate, triacetin, titanium dioxide (E 171), indigo carmine (E132).

Silegria looks like and contents of the pack
Silegria 50 mg tablets
Blue, round, biconvex film-coated tablet scored on one side, separating the "7" and "8" and plain on the other side.

Silegria 100 mg film-coated tablets
Blue, round, biconvex film-coated tablet scored on one side, separating the "8" and "8" and plain on the other side.
Silegria 50 mg or 100 mg is available in blister packs of 1 and 4 tablets.