Package Insert: Information for the Patient

Sildenafilo Tarbis 100 mg Film-Coated Tablets

Read this package insert carefully before starting to take the medicationbecause it contains important information for you

• Keep this package insert as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

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

Sildenafilo Tarbis is indicated for the treatment of erectile dysfunction in adult men, sometimes referred to as impotence. This occurs when a man is unable to obtain or maintain a firm erection of the penis, suitable for a satisfactory sexual activity.

Do not take Sildenafilo Tarbis

• If you are allergic to sildenafil or any of the other components of this medication (listed in section 6).
• If you are using medications called nitrates, as the combination may lead to a dangerous drop in your blood pressure. Consult your doctor if you are using any of these medications, which are often administered to relieve chest pain (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
• If you are using any of the medications called nitric oxide donors such as amyl nitrate ("poppers"), as the combination may lead to a dangerous drop in your blood pressure.
• If you are taking riociguat. This medication is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic pulmonary thromboembolic hypertension (i.e., high blood pressure in the lungs caused by clots). PDE5 inhibitors, such as Sildenafilo Tarbis, have shown to increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.
• If you have a severe heart or liver problem.
• If you have recently experienced a stroke or heart attack, or if you have low blood pressure.
• If you have a rare inherited eye disorder (such as retinitis pigmentosa).
• If you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

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

• If you have sickle cell anemia (a blood disorder), leukemia (blood cancer), or multiple myeloma (bone marrow cancer)
• If you have a penile deformity or Peyronie's disease.
• If you have heart problems. Your doctor must carefully check if your heart can handle the additional strain of sexual activity.
• If you have a stomach ulcer 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 simultaneously with 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 renal or hepatic impairment

You must 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 individuals under 18 years old.

Use of Sildenafilo Tarbis with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Sildenafilo Tarbis tablets may interact with some medications, especially those used to treat chest pain. In case of a medical emergency, you must inform your doctor, pharmacist, or nurse that you are taking Sildenafilo Tarbis and when you took it. Do not take Sildenafilo Tarbis with other medications unless your doctor advises you to.

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

Do not take Sildenafilo Tarbis if you are taking medications called nitric oxide donors, such as amyl nitrate ("poppers"), as the combination may also lead to a dangerous drop in your blood pressure.

Inform your doctor or pharmacist if you are taking riociguat.

If you are taking medications 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 taking an alpha-blocker, a medication used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness caused by a drop in blood pressure when standing or sitting up quickly. Some patients have experienced these symptoms when taking Sildenafilo Tarbis with alpha-blockers. This is more likely to occur within 4 hours after taking Sildenafilo Tarbis. To reduce the likelihood of these symptoms, you should be receiving your daily dose of the alpha-blocker regularly before starting Sildenafilo Tarbis. Your doctor may recommend that you 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 take effect if taken with a large meal.

Consuming alcohol may temporarily impair your ability to achieve an erection. Therefore, to get the maximum benefit from the medication, it is recommended not to consume large amounts of alcohol before taking Sildenafilo Tarbis.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.

If in 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.

Take Sildenafilo Tarbis approximately one hour before planning to have sexual intercourse. Swallow the tablet whole with a glass of water.

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

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

The time it takes for Sildenafilo Tarbis to take effect varies from person to person, generally ranging from half an hour to one hour. The effect of Sildenafilo Tarbis may be delayed if taken with a large meal.

If Sildenafilo Tarbis does not help you achieve an erection or if the erection does not last long enough to complete the sexual act, 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 Toxicological Information Service. Phone 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 other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The side effects reported associated with the use of Sildenafilo Tarbis are generally of mild to moderate intensity and short duration.

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

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

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

• Chest pain - this occurs withlowfrequency.

If it occurs during or after sexual intercourse:

- Sit in a semi-recumbent position and try to relax.

-Do not use nitratesto treat chest pain.

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

If you have an erection that lasts more than 4 hours, you must contact your doctorimmediately.

• Sudden decrease or loss of vision - this occursrarely.

• Severe skin reactions - this occursrarely.

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

• Convulsions or seizures - this occursrarely.

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, warmth (including symptoms such as sudden feeling of heat in the upper body), indigestion, abnormal color perception, blurred vision, visual deterioration, nasal congestion and dizziness.

Uncommon(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/ red eyes, eye pain, flashing lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced tactile sensation, vertigo, ringing in the ears, dry mouth, nasal congestion or blockage, inflammation of the nasal mucosa (including symptoms such as runny nose, sneezing and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including symptoms such as heartburn), blood in urine, arm or leg pain, nasal bleeding, feeling of heat and feeling tired.

Rare(may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient decrease in blood flow to some parts of the brain, sensation of throat constriction, numbness of the mouth, bleeding in the back of the eye, double vision, visual acuity decrease, abnormal sensation in the eye, eye swelling or eyelid swelling, small particles or spots in vision, halos around lights, pupil dilation, change in color of the white part of the eye, bleeding of the penis, blood in semen, dry nose, nasal swelling, feeling of irritability and sudden decrease or loss of hearing.

During post-marketing experience, rare cases of unstable angina (heart disease) and sudden death have been reported. It is worth noting that most men who experienced these side effects, although not all of them, had heart problems before taking this medicine. It is not possible to determine if these side effects were directly related toSildenafilo Tarbis.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in Appendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Sildenafilo Tarbis 100 mg Film-Coated Tablets

• The active ingredient is sildenafilo. Each tablet contains 100 mg of sildenafilo (as citrato).
• The other components are:
• Tablet core: calcium dihydrogen phosphate, microcrystalline cellulose, magnesium stearate, croscarmellose sodium, anhydrous colloidal silica.
• Film coating: hypromellose, titanium dioxide (E 171), polyethylene glycol 6000 (macrogol 6000), talc, carmine lake (E 132).

Appearance of the Product and Contents of the Package

Sildenafilo Tarbis 100 mg Film-Coated Tablets are blue, elongated, and printed.

Sildenafilo Tarbis 100 mg Film-Coated Tablets are presented in a blister pack containing 4 or 8 tablets.

Possible commercialization of only some package sizes.

Marketing Authorization Holder and Responsible Manufacturer:

Marketing Authorization Holder:

Tarbis Farma, S.L.

Gran Via Carlos III, 94

08028 Barcelona

Spain

Responsible Manufacturer:

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid

Spain

Laboratorios Liconsa, S.A.

Avenida Miralcampo, 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares - Guadalajara

Spain

Last Review Date of this Leaflet: 04/2017. .

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/