SILDENAFIL TARBIS 100 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet: Information for the Patient

Sildenafilo Tarbis 100 mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take the medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Sildenafilo Tarbis
2. What you need to know before taking Sildenafilo Tarbis
3. How to take Sildenafilo Tarbis
4. Possible side effects
5. Storing Sildenafilo Tarbis
6. Further information

1. What is Sildenafilo Tarbis and what is it used for

Sildenafilo Tarbis contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5). It works by widening the blood vessels in the penis, allowing blood to flow in when you are sexually stimulated. Sildenafilo Tarbis will only help you to get an erection if you are sexually stimulated.

Sildenafilo Tarbis is used to treat erectile dysfunction in adult men, sometimes also called impotence. This occurs when a man cannot get or maintain a firm erection of the penis, which is adequate for satisfactory sexual activity.

2. What you need to know before taking Sildenafilo Tarbis

Do not take Sildenafilo Tarbis

• If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If you are using medicines called nitrates, as the combination can cause a dangerous decrease in your blood pressure. Consult your doctor if you are using any of these medicines, which are often given to relieve angina pectoris (or "chest pain"). If you are unsure, consult 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 can cause a dangerous decrease in your blood pressure.
• If you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by blood clots). PDE5 inhibitors, such as Sildenafilo Tarbis, have shown that they increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.
• If you have a 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 previously experienced a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Sildenafilo Tarbis:

• If you have sickle cell anemia (a disorder of the red blood cells), leukemia (cancer of the blood cells), or multiple myeloma (cancer of the bone marrow).
• If you have a penis deformity or Peyronie's disease.
• If you have heart problems. Your doctor should carefully check if your heart can handle the extra strain of having sex.
• If you currently have stomach ulcers or bleeding problems (such as hemophilia).
• If you experience a sudden decrease or loss of vision, stop taking Sildenafilo Tarbis and contact your doctor immediately.

It is not recommended to take Sildenafilo Tarbis at the same time as any other oral or local treatment for erectile dysfunction.

Do not take Sildenafilo Tarbis with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or any other PDE5 inhibitor.

Do not take Sildenafilo Tarbis if you do not have erectile dysfunction.

The use of Sildenafilo Tarbis is not indicated in women.

Special considerations in patients with kidney or liver problems

You should inform your doctor if you have kidney or liver problems. Your doctor may decide to reduce your dose.

Children and adolescents

The use of Sildenafilo Tarbis is not indicated in persons under 18 years of age.

Using Sildenafilo Tarbis with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Sildenafilo Tarbis tablets may interfere with some medicines, especially those used to treat angina pectoris. In case of a medical emergency, you should inform your doctor, pharmacist, or nurse that you are taking Sildenafilo Tarbis and when you took it. Do not take Sildenafilo Tarbis with other medicines unless your doctor advises you to.

Do not take Sildenafilo Tarbis if you are taking medicines called nitrates, as the combination of these medicines can cause a dangerous decrease in your blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often used to relieve angina pectoris (or "chest pain").

Do not take Sildenafilo Tarbis if you are taking medicines called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these medicines can also cause a dangerous decrease in your blood pressure.

Tell your doctor or pharmacist if you are taking riociguat.

If you are taking medicines known as protease inhibitors, such as those used to treat HIV, your doctor may recommend that you start treatment with the lowest dose (25 mg) of Sildenafilo Tarbis.

Some patients who are taking an alpha-blocker, a medicine used to treat high blood pressure or an enlarged prostate, may experience dizziness or lightheadedness, which can be caused by a decrease in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking Sildenafilo Tarbis with alpha-blockers. This is more likely to happen within 4 hours after taking Sildenafilo Tarbis. To minimize the chance of these symptoms happening, you should be taking your daily dose of the alpha-blocker regularly before starting Sildenafilo Tarbis. Your doctor may advise you to start treatment with the lower dose (25 mg) of Sildenafilo Tarbis.

Taking Sildenafilo Tarbis with food, drinks, and alcohol

Sildenafilo Tarbis can be taken with or without food. However, you may notice that Sildenafilo Tarbis takes a little longer to work if you take it with a large meal.

Drinking alcohol can temporarily impair your ability to get an erection. Therefore, to get the maximum benefit from the medicine, it is advised not to drink large amounts of alcohol before taking Sildenafilo Tarbis.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine. The use of Sildenafilo Tarbis is not indicated in women.

Driving and using machines

Sildenafilo Tarbis can cause dizziness and affect vision. You should know how you react to Sildenafilo Tarbis before driving vehicles or using machinery.

3. How to take Sildenafilo Tarbis

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist.

In case of doubt, consult your doctor or pharmacist again. The recommended starting dose is 50 mg.

Do not take Sildenafilo Tarbis 100 mg film-coated tablets more than once a day.

You should take Sildenafilo Tarbis about one hour before you plan to have sex. Swallow the tablet whole with a glass of water.

If you notice that the effect of Sildenafilo Tarbis is too strong or too weak, tell your doctor or pharmacist.

Sildenafilo Tarbis will only help you to get an erection if you are sexually stimulated.

The time Sildenafilo Tarbis takes to work varies from person to person, but it normally takes between half an hour and one hour. The effect of Sildenafilo Tarbis may be delayed if you take it with a large meal.

If Sildenafilo Tarbis does not help you to get an erection, or if the erection does not last long enough to complete sexual intercourse, consult your doctor.

If you take more Sildenafilo Tarbis than you should

You may experience an increase in side effects and their severity. Doses above 100 mg do not increase efficacy.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91 562 04 20.

Do not take more tablets than recommended by your doctor.

Contact your doctor if you have taken more tablets than advised.

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. The side effects reported with the use of Sildenafilo Tarbis are usually mild to moderate and short-lived.

If you experience any of the following serious side effects, stop taking Sildenafilo Tarbis and seek medical attention immediately:

• Allergic reaction - this occurs with rarefrequency(may affect up to 1 in 100 people).

The symptoms include sudden wheezing, difficulty breathing, or dizziness, swelling of the eyelids, face, lips, or throat.

• Chest pain - this occurs with rarefrequency.

If they occur during or after intercourse:

• Sit in a semi-upright position and try to relax.
• Do not use nitrates to treat chest pain.

• Prolonged and sometimes painful erections - this occurs rarely(may affect up to 1 in 1,000 people).

If you have an erection that lasts more than 4 hours, you should contact your doctor immediately.

• Sudden decrease or loss of vision - this occurs rarely.

• Severe skin reactions - this occurs rarely.

The symptoms can include severe skin peeling and swelling, blistering of the mouth, genitals, and around the eyes, as well as fever.

• Seizures or fits - this occurs rarely.

Other side effects

Very common(may affect more than 1 in 10 people): headache.

Common(may affect up to 1 in 10 people): nausea, facial flushing, hot flush (including a feeling of warmth), indigestion, abnormal color perception, blurred vision, visual disturbance, nasal congestion, and dizziness.

Uncommon(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/ red eyes, eye pain, seeing flashes of light, increased sensitivity to light, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy nose, inflammation of the lining of the nose (including symptoms such as runny nose, sneezing, and nasal congestion), pain in the upper abdomen, gastroesophageal reflux disease (including symptoms such as heartburn), blood in urine, pain in arms or legs, nosebleeds, 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 flow to some parts of the brain, feeling of tightness in the throat, numbness in the mouth, bleeding in the back of the eye, double vision, decreased sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in the vision, seeing halos around lights, dilation of the pupil, change in color of the white of the eye, bleeding from the penis, presence of blood in the semen, dry nose, swelling inside the nose, feeling irritable, and sudden decrease or loss of hearing.

During post-marketing experience, unstable angina (heart disease) and sudden death have been reported rarely. It should be noted that most of the men who experienced these side effects, although not all of them, had pre-existing heart problems before taking this medicine. It is not possible to determine whether these side effects were directly related to Sildenafilo Tarbis.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Sildenafilo Tarbis

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Further information

Composition of Sildenafilo Tarbis 100 mg film-coated tablets

• The active substance is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate).
• The other ingredients are:
• Core of the tablet: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, magnesium stearate, sodium croscarmellose, anhydrous colloidal silica.
• Coating: hypromellose, titanium dioxide (E 171), macrogol 6000, talc, carmine indigo lake (E 132).

Appearance and packaging of the product

Sildenafilo Tarbis 100 mg film-coated tablets are blue, elongated, and engraved.

Sildenafilo Tarbis 100 mg film-coated tablets are available in blisters containing 4 or 8 tablets.

Only certain pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Holder:

Tarbis Farma, S.L.

Gran Via Carlos III, 94

08028- Barcelona

Spain

Manufacturer:

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid

Spain

Laboratorios Liconsa, S.A.

Avenida Miralcampo, 7

Miralcampo Industrial Estate

19200 Azuqueca de Henares - Guadalajara

Spain

Date of last revision of this leaflet:04/2017.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/