SILDENAFIL TARBIS FARMA 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sildenafil Tarbis Farma 50 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What Sildenafil Tarbis Farma is and what it is used for
2. What you need to know before taking Sildenafil Tarbis Farma
3. How to take Sildenafil Tarbis Farma
4. Possible side effects
5. Storage of Sildenafil Tarbis Farma
6. Package Contents and Additional Information

1. What Sildenafil Tarbis Farma is and what it is used for

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

This medication is indicated for the treatment of erectile dysfunction in adult men, sometimes called impotence. This occurs when a man cannot achieve or maintain a firm erection suitable for satisfactory sexual activity.

2. What you need to know before taking Sildenafil Tarbis Farma

Do not take sildenafil

• If you are allergic to sildenafil or any of the other components of this medication (listed in section 6).
• If you are taking medications called nitrates, as the combination can lead to a dangerous decrease in your blood pressure. Consult your doctor if you are taking any of these medications, which are often administered to relieve angina pectoris (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
• If you are using any medications called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination can lead to a dangerous decrease 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 thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by blood clots). PDE5 inhibitors, such as sildenafil, have shown that they increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.
• If you have a serious heart or liver problem.
• If you have recently experienced a stroke or heart attack, or if you have low blood pressure.
• If you suffer from 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

Consult your doctor, pharmacist, or nurse before starting to take this medication:

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

It is not recommended to use this medication simultaneously with any other oral or local treatment for erectile dysfunction.

You should not take this medication with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or any other PDE5 inhibitor.

You should not take this medication if you do not have erectile dysfunction.

The use of this medication is not indicated in women.

Special Considerations in Patients with Renal or Hepatic Impairment

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 this medication is not indicated in persons under 18 years of age.

Use of Sildenafil with Other Medications

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

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

You should not take sildenafil if you are taking medications called nitrates, as the combination of these medications can lead to a dangerous decrease 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 angina pectoris (or "chest pain").

You should not take sildenafil if you are taking medications called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these medications can also lead to a dangerous decrease 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 in the treatment of HIV, your doctor may recommend that you start treatment with the lowest dose (25 mg) of sildenafil.

Some patients who are receiving an alpha-blocker, a medication used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness that can be caused by a decrease in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking sildenafil with alpha-blockers. This is more likely to occur within 4 hours of taking this medication. To minimize the likelihood of these symptoms, you should be receiving your daily dose of the alpha-blocker regularly before starting sildenafil. Your doctor may recommend that you start treatment with the lower dose (25 mg) of sildenafil.

Medications that contain sacubitril/valsartan, used to treat heart failure.

Use of Sildenafil with Food, Drinks, and Alcohol

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

Consuming alcohol can temporarily make it more difficult 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 sildenafil.

Pregnancy, Breastfeeding, and Fertility

The use of this medication is not indicated in women.

Driving and Using Machines

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

This Medication Contains Sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to Take Sildenafil

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. The recommended starting dose is 50 mg.

Do not take this medication more than once a day.

Do not take sildenafil film-coated tablets with sildenafil orodispersible tablets.

You should take this medication approximately one hour before you plan to have sex. Swallow the tablet whole with a glass of water.

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

Sildenafil will only help you achieve an erection if you are sexually stimulated. The time it takes for sildenafil to work varies from person to person, usually between half an hour and one hour. The effect of sildenafil can be delayed if you take it with a large meal.

In the event that sildenafil does not help you achieve an erection or if the erection is not maintained long enough to complete sexual intercourse, consult your doctor.

If You Take More Sildenafil 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 your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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 doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them. The side effects reported in association with the use of sildenafil are generally mild to moderate and short-lived.

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

• Allergic reaction - this occurs with rare frequency(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 with rare frequency.

If it occurs during or after sex:

• 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 very 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 very rarely.
• Severe skin reactions - this occurs very rarely.

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 very 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, warmth (including a sudden feeling of heat in the upper body), indigestion, abnormal color perception, blurred vision, visual impairment, 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, sensitivity to light, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced touch sensation, vertigo, ringing in the ears, dry mouth, nasal stuffiness or congestion, inflammation of the nasal mucosa (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 of warmth, and feeling of tiredness.

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 of the mouth, bleeding in the back of 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, dilation of the pupil, change in color of the white of the eye, penile bleeding, presence of blood in semen, dry nose, nasal swelling, feeling of irritability, and sudden decrease or loss of hearing.

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Sildenafil

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 stated on the packaging after CAD. The expiration date is the last day of the month indicated.

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

6. Package Contents and Additional Information

Composition of Sildenafil

The active substance is sildenafil citrate.

Each film-coated tablet contains 70.24 mg of sildenafil citrate, equivalent to 50 mg of sildenafil.

The other components are:

Core of the tablet:

Microcrystalline cellulose (E460), anhydrous calcium hydrogen phosphate (E341), sodium croscarmellose (E468), magnesium stearate (E470b).

Film coating:

Partially hydrolyzed poly(vinyl) alcohol (E1203), hypromellose 5cp (E464), titanium dioxide (E171), macrogol (E1521), talc (E553b), triacetin (E1518), aluminum lake of carmine (E132).

Appearance of the Product and Package Contents

Film-coated tablet.

Sildenafil film-coated tablets are blue, round, biconvex, with the mark 125 on one face and J on the other face with a scored line.

The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Sildenafil film-coated tablets are available in blisters of 2, 4, 8, 12, and 24 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medication is authorized in the Member States of the European Economic Area under the following names:

Netherlands: Sildenafil Amarox 50 mg, filmomhulde tabletten

Spain: Sildenafilo Tarbis Farma 50 mg comprimidos recubiertos con película EFG

Date of the Last Revision of this Package Leaflet: August 2022.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/