Sildenafil Tarbis 100 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Sildenafil Tarbis 100 mg Film-Coated Tablets EFG

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

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

Leaflet Contents:

1. What Sildenafil Tarbis is
2. What you need to know before taking Sildenafil Tarbis
3. How to take Sildenafil Tarbis
4. Possible adverse effects
5. How to store Sildenafil Tarbis
6. Contents of the pack and other information

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

Sildenafilo Tarbis contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels in the penis, allowing blood to flow in when you are 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 achieve or maintain a firm penile erection suitable for satisfactory sexual activity.

2. What you need to know before starting to take Sildenafil Tarbis

Do not take Sildenafil Tarbis

• 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 lead to a dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medicines, which are often prescribed to relieve angina pain (or “chest pain”). If you are unsure, consult your doctor or pharmacist.
• If you are taking any nitric oxide donors such as amyl nitrate (“poppers”), as the combination may cause a dangerous drop in 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 Sildenafil Tarbis have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.
• If you have a serious 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 vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Sildenafil Tarbis:

• If you have sickle cell anemia (an abnormality of red blood cells), leukemia (cancer of blood cells), or multiple myeloma (cancer of bone marrow).
• If you have a penile deformity or Peyronie’s disease.
• If you have heart problems. Your doctor must carefully assess whether your heart can tolerate the additional strain of sexual activity.
• If you currently have a stomach ulcer or bleeding disorders (such as hemophilia).
• If you experience sudden decrease or loss of vision, stop taking Sildenafil Tarbis and contact your doctor immediately.

It is not recommended to take Sildenafil concurrently with any other oral or local treatment for erectile dysfunction.

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

You must not take Sildenafil Tarbis if you do not have erectile dysfunction.

The use of Sildenafil Tarbis is not indicated in women.

Special considerations in patients with renal impairment or liver problems

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

Children and adolescents

The use of Sildenafil Tarbis is not indicated in individuals under 18 years of age.

Taking Sildenafil Tarbis with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Sildenafil Tarbis tablets may interact with certain medicines, especially those used to treat chest pain. In a medical emergency, you must inform your doctor, pharmacist, or nurse that you are taking Sildenafil Tarbis and when you took it. You must not take Sildenafil Tarbis with other medicines unless your doctor advises you to do so.

Do not take Sildenafil Tarbis if you are taking medicines called nitrates, as combining these medicines may cause a dangerous drop 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 (or “chest pain”).

Do not take Sildenafil Tarbis if you are taking medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), as combining these medicines may also cause a dangerous drop in blood pressure.

Inform your doctor or pharmacist if you are taking riociguat.

If you are taking protease inhibitors, such as those used in the treatment of HIV, your doctor may recommend starting treatment with the lowest dose (25 mg) of Sildenafil Tarbis.

Some patients taking an alpha-blocker, a medicine used to treat high blood pressure or benign prostatic hyperplasia, may experience dizziness or lightheadedness due to a drop in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking Sildenafil Tarbis with alpha-blockers. This is more likely to occur within 4 hours after taking Sildenafil Tarbis. To reduce the likelihood of these symptoms, you should already be on a stable daily dose of the alpha-blocker before starting Sildenafil Tarbis. Your doctor may advise you to start treatment with the lowest dose (25 mg) of Sildenafil Tarbis.

Taking Sildenafil Tarbis with food, drinks, and alcohol

Sildenafil Tarbis can be taken with or without food. However, you may notice that Sildenafil Tarbis takes slightly longer to work if taken with a heavy meal.

Alcohol intake may temporarily impair the ability to achieve an erection. Therefore, to achieve the maximum benefit from the medicine, it is advised not to drink large amounts of alcohol before taking Sildenafil Tarbis.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

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

3. How to take Sildenafil Tarbis

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist.

If in doubt, consult your doctor or pharmacist again. The recommended starting dose is 50 mg.

Sildenafil Tarbis 100 mg film-coated tablets must not be taken more than once a day.

Take Sildenafil 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 Sildenafil Tarbis is too strong or too weak, inform your doctor or pharmacist.

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

The time required for Sildenafil Tarbis to take effect varies from person to person, usually between half an hour and one hour. The effect of Sildenafil Tarbis may be delayed if taken with a heavy meal.

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

If you take more Sildenafil Tarbis than you should

You may experience an increase in the frequency and severity of side effects. Doses higher than 100 mg do not increase efficacy.

In case of overdose or accidental ingestion, contact 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 about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. The adverse effects reported with Sildenafilo Tarbis are generally mild to moderate in intensity and short-lived.

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

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

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

• Chest pain – this occurs rarely.

If chest pain occurs during or after sexual activity:

• 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 lasting longer than 4 hours, you must contact your doctor immediately.

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

• Severe skin reactions – this occurs rarely.

Symptoms may include severe skin peeling and swelling, blistering in the mouth, genital area, or around the eyes, as well as fever.

• Seizures or fits – this occurs rarely.

Other adverse 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 flushes (including sudden sensation of warmth in the upper body), indigestion, abnormal colour vision, 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, perception of flashing lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sense of touch, vertigo, ringing in the ears, dry mouth, nasal blockage or congestion, swelling of the nasal mucosa (including runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including heartburn), blood in urine, pain in arms or legs, nosebleeds, sensation of warmth, and feeling of fatigue.

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to parts of the brain, sensation of tightness in the throat, numbness of the mouth, bleeding behind the eye, double vision, decreased visual acuity, abnormal sensation in the eye, eye or eyelid swelling, small particles or spots in vision, seeing halos around lights, pupil dilation, change in colour of the white part of the eye, penile bleeding, blood in semen, dry nose, swelling inside the nose, feeling irritable, 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 should be noted that most men who experienced these adverse effects, although not all, had pre-existing heart conditions before taking this medicine. It is not possible to determine whether these effects were directly related to Sildenafilo Tarbis.

Reporting of adverse effects

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

5. Storage of Sildenafil 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 stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents and additional information

Composition of Sildenafil Tarbis 100 mg film-coated tablets

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

Appearance of the product and contents of the container

Sildenafil Tarbis 100 mg film-coated tablets are blue, elongated, and printed.

Sildenafil Tarbis 100 mg film-coated tablets are available in blister packs containing 4 or 8 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization 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

Polígono Industrial Miralcampo

19200 Azuqueca de Henares - Guadalajara

Spain

Date of latest revision of this package leaflet: 04/2017.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/