Package Leaflet: Information for the User

Sildenafilo Tarbis Farma 100 mg Film-Coated Tablets EFG

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

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

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

2. What you need to know before you start taking Sildenafilo Tarbis Farma

3. How to take Sildenafilo Tarbis Farma

4. Possible side effects

5. Storage of Sildenafilo Tarbis Farma

6. Contents of the pack and additional information

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

This medicine 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, adequate erection for satisfactory sexual activity.

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 certain medications 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 medications, which are often used 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 nitrite ("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 thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by clots). Phosphodiesterase type 5 inhibitors, such as sildenafil, 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 this medication:

• 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 sudden vision loss, stop taking sildenafil and contact your doctor immediately.

This medication is not recommended to be used simultaneously with any other oral or local treatment for erectile dysfunction.

Do not take this medication with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or any other phosphodiesterase type 5 inhibitor.

Do not take this medication if you do not have erectile dysfunction.

This medication is not indicated for use in women.

Special considerations in patients with renal or hepatic problems

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

Children and adolescents

This medication is not indicated for use in individuals under 18 years of age.

Use of sildenafil with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Sildenafil 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 sildenafil and when you took it. Do not take sildenafil with other medications unless your doctor advises you to.

Do not take sildenafil if you are taking nitrates, as the combination of these medications 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 sildenafil if you are taking medications called nitric oxide donors, such as amyl nitrite ("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 sildenafil.

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 sildenafil with alpha-blockers. This is more likely to occur in the 4 hours following the dose of this medication. To reduce 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 containing 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 bit longer to take effect if you ingest it 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 sildenafil.

Pregnancy, breastfeeding, and fertility

This medication is not indicated for use in women.

Driving and operating machinery

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

This medication contains sodium

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

Follow exactly the administration instructions for this medication as indicated 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 this medication more than once a day.

Do not take sildenafil film-coated tablets with sildenafil buccal dispersible tablets.

Take this medication 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 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 take effect varies from person to person, generally ranging from 30 minutes to one hour. The effect of sildenafil may be delayed if taken with a large meal.

If sildenafil 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 than you should

You may experience an increase in adverse 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 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 sildenafil are generally of mild to moderate intensity and short duration.

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

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

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

• Chest pain - this occurs withinfrequent frequency.

If they occur during or after sexual intercourse:

-Position yourself in a semi-recumbent position and try to relax.

-Do not use nitratesto treat chest pain.

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

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

• Sudden decrease or loss of vision - this occursinfrequently.
• Severe skin reactions - this occursinfrequently.

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

• Convulsions or seizures - this occursinfrequently.

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 sudden feeling of heat in the upper body), indigestion, abnormal color perception, blurred vision, visual deterioration, nasal congestion, and dizziness.

Infrequent(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, nasal mucosa inflammation (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 pre-existing heart problems before taking this medicine. It is not possible to determine if these side effects were directly related to this medicine.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on 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 shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications.This will help protect the environment.

Composition of sildenafil

The active ingredient is sildenafil citrate.

Each film-coated tablet contains 140.48 mg of sildenafil citrate equivalent to 100 mg of sildenafil.

The other components are:

Core tablet:

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

Film coating:

Poly(vinyl alcohol) partially hydrolyzed (E1203), 5cp hypromellose (E464), titanium dioxide (E171), macrogol (E1521), talc (E553b), triacetin (E1518), aluminium lake indigo carmine (E132).

Appearance of the product and contents of the packaging

Film-coated tablet.

Sildenafil film-coated tablets are blue, round, biconvex, with the mark 126 on one face and J on the other face with a line marked.

The groove serves only to break and facilitate swallowing, but not to divide into equal doses.

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

Only some sizes of packaging may be commercially marketed.

Marketing authorization holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicine is authorized in the member states of the European Economic Area with the following names:

Netherlands:Sildenafil Amarox 100 mg, filmomhulde tabletten

Spain: Sildenafilo Tarbis Farma 100 mg film-coated tablets EFG

Last review date of this leaflet: August 2022.

Further information and updates on this medicine are available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/