TAXIER 100 mg. 4 tablets

What is Taxier and what it is used
Taxier contains the active ingredient sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE 5). It works by helping to relax the blood vessels in the penis, allowing blood to flow during sexual arousal. Taxier will only help you to get an erection if you are sexually stimulated.
Taxier treatment for adult men with erectile dysfunction, sometimes called impotence. It means that man can not get, or keep a hard, erect penis suitable for sexual activity.

2. What you need to know before taking Taxier
Do not take Taxier:
If you are allergic 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 medicines which are often given for relief of angina pectoris (or "chest pain"). If you are unsure, ask your doctor or pharmacist;
If you use one of the drugs known as nitric oxide donors such as amyl nitrite ("poppers"), as the combination may also lead to a potentially dangerous decrease in your blood pressure;
If you have severe heart or liver problem;
If you have recently had a stroke or a 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 had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).
Warnings and Precautions
Talk to your doctor or pharmacist before taking Taxier:
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 the penis or disease Peyronie;
If you have heart problems. In this case, your doctor should carefully check whether your heart can take the additional strain of having sex;
If you currently have a stomach ulcer or problems with blood clotting (such as hemophilia);
If you experience sudden decrease or loss of vision, stop taking Taxier and immediately contact your doctor.
Taxier should not be used concurrently with other oral or topical treatment of erectile dysfunction.
You should not take Taxier if you do not have erectile dysfunction. You should not take Taxier if you are a woman.

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

Children and adolescents
Taxier should not be given to individuals under the age of 18.
Other medicines and Taxier
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Sildenafil (the active substance of the product Taxier) can be reacted with certain drugs, particularly those used to treat chest pain. In case of emergency, you should tell your doctor or pharmacist that you take Taxier and when you accepted it. Taxier not take other medicines unless your doctor tells you that you.
You should not take Taxier if you are taking medicines called nitrates as the combination of these drugs can cause a potentially dangerous decrease in your blood pressure. Always tell your doctor or pharmacist if you are taking any of these medicines which are often given for relief of angina pectoris (or "chest pain").
You should not use Taxier if you are using any of the drugs known as nitric oxide donors such as amyl nitrite ("poppers"), as the combination may also lead to a 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 will probably prescribe a start at the lowest dose (25 mg) of sildenafil.
Some patients who are treated with alpha-blocker for treatment of high blood pressure or prostate enlargement may experience dizziness or light-headedness, which may be caused by low blood pressure upon sitting or standing up quickly. Some patients have experienced these symptoms when taking sildenafil with alpha-blockers. This is most likely to occur within 4 hours after taking sildenafil. You must be on a regular daily dose of your alpha-blocker before taking Taxier to reduce the likelihood of occurrence of these symptoms. Your doctor may start you on a lower dose (25 mg) Taxier.

Taxier with food, drinks and alcohol
Taxier can be taken with or without food. However, you may notice that Taxier begins to act more slowly if you take it with a heavy meal.
Drinking 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 Taxier.

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

Driving and using machines
Taxier can cause dizziness and can affect vision. You need to know how you react to Taxier before driving or operating machinery.

3. How to take Taxier
Always take this medicine exactly as you have been told your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist. The recommended starting dose is 50 mg sildenafil.

You should not take Taxier more than once a day.
Do not take Taxier coated tablets in combination with orodispersible tablets containing sildenafil.
Taxier should be taken about one hour before you plan to have sex. Swallow the tablet whole with a glass of water.
If you feel that the effect of Taxier is too strong or too weak, talk to your doctor or pharmacist.
Taxier will only help you to get an erection during sexual stimulation. Time that appears the effect of Taxier is different in individuals, but usually is between half and one hour. If you take Taxier during a heavy meal, the effect may occur more slowly.
If Taxier not help you to get an erection, or if your erection does not last long enough to complete sexual intercourse you should tell your doctor.

If you take more dose Taxier:
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 your doctor tells you to.
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 or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Adverse reactions reported in association with use of Taxier usually mild to moderate and transient.

If you experience any of the following serious side effects, stop taking Taksner and seek medical advice immediately:
Allergic reaction (which occurs rarely) - Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips and throat;
Chest pain (they occur infrequently): If occur during or after intercourse:
Take a semi-sitting position and try to relax;
Do not use nitrates to treat your chest pain;
Prolonged and sometimes painful erections (not known). If you have an erection that lasts more than 4 hours, you should contact a physician immediately;
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;
Seizures or fits (not known).
Other side effects:
Very common (may affect more than 1 in 10 people): headache.

Common (may affect up to 1 in 10 people): facial flushing, indigestion, vision changes (including changes in the colors, light sensitivity, blurred vision or reduced sharpness of vision) stuffy nose and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, bleeding at the back of the eye, eye irritation, bloodshot eyes / red eyes, eye pain, double vision, abnormal sensation in the eye, tearing, highly palpitations, rapid heartbeat, muscle pain, drowsiness, reduced sense of touch, vertigo, ringing in the ears, nausea, dry mouth, bleeding from the penis, blood in semen and / or urine, chest pain and feeling fatigue.

Rare (may affect up to 1 in 1000 people): high blood pressure, low blood pressure, fainting, stroke, heart attack, irregular heartbeat, nosebleed and sudden decrease or loss of hearing.

Not known (from the available data can not be estimated):
Additional adverse reactions reported after placing the product on the market: Unstable angina (heart disease), sudden death, temporary reduction of blood flow to parts of the brain.

Most, but not all, of these men who received the described side effects have had heart problems before taking the drug. It is not possible to determine whether these events were directly related to sildenafil.

Adverse event reporting
If you get any side effects, tell your doctor, pharmacist or nurse. This includes any possible effects not listed in this leaflet.
You can also report side effects directly via: Drug Agency Street. "Damyan Gruev" № 8, 1303 Sofia Tel,: +359 2 8903417, website: www.bda.bg. As reported adverse reactions, you can do your bit to get more information on the safety of this medicine.

5. How to store Taxier
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater <or household waste>. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information
What Taxier
The active ingredient is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate).

Other ingredients are:
Tablet core: calcium hydrogen phosphate (anhydrous), microcrystalline cellulose (E 460), sodium croscarmellose, magnesium stearate.
The coating: yellow sepifilm 3048 / hypromellose (E464), microcrystalline cellulose, Macrogol 40 stearate, titanium dioxide (E171), quinoline yellow (E104), macrogol 6000.

Taxier looks like and contents of the pack
Taxier 100 mg tablets are yellow, round, biconvex, film-coated tablets with the number "100" on one side.