SILDENAFIL TARBIS FARMA 100 mg FILM-COATED TABLETS

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

Do not take sildenafil

• 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 decrease in your blood pressure. Consult your doctor if you are taking any of these medicines, often given for chest pain (or "angina"). If you are not sure, 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 may lead to 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 sildenafil, have shown an increase in the hypotensive effect of this medicine. If you are taking riociguat or are not sure, 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

Consult your doctor, pharmacist, or nurse before taking this medicine:

• 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 deformity of the penis 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 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 take this medicine with any other oral or local treatment for erectile dysfunction.

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

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

The use of this medicine is not indicated in women.

Special considerations in patients with kidney or liver problems

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

Children and adolescents

The use of this medicine is not indicated in persons under 18 years of age.

Using sildenafil with other medicines

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

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

Do not take sildenafil if you are taking medicines called nitrates, as the combination may lead to a dangerous decrease in your blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking any of these medicines, often given for chest pain (or "angina").

Do not take sildenafil if you are taking medicines called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination may also lead to 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 with a 25 mg dose of sildenafil.

Some patients who are taking alpha-blockers, medicines used to treat high blood pressure or prostate enlargement, may experience dizziness or fainting when taking sildenafil. This is more likely to happen within 4 hours of taking sildenafil. To reduce the chance of this happening, you should be on a regular daily dose of your alpha-blocker before starting sildenafil. Your doctor may recommend that you start with a 25 mg dose of sildenafil.

Medicines containing sacubitril/valsartan, used to treat heart failure.

Using sildenafil with food, drinks, and alcohol

This medicine 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.

Drinking alcohol may 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 sildenafil.

Pregnancy, breastfeeding, and fertility

The use of this medicine is not indicated in women.

Driving and using machines

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

This medicine contains sodium

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

3. How to take sildenafil

Follow exactly the instructions of administration 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 this medicine more than once a day.

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

You should take this medicine 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 medicine is too strong or too weak, tell your doctor or pharmacist.

Sildenafil will only help you to get an erection if you are sexually stimulated. The time it takes for sildenafil to work varies from person to person, but it normally takes between 30 minutes and 1 hour. The effect of sildenafil may be delayed if you take it with a large meal.

In the event that sildenafil 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 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 medicine and the amount taken.

Do not take more tablets than your doctor recommends.

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

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 sildenafil are usually mild to moderate and do not last long.

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

• 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 this occurs 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 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, swelling of the skin, 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, hot flush (including a feeling of warmth), indigestion, abnormal color 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, seeing light flashes, increased light sensitivity, eye swelling, 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 (including symptoms such as runny nose, sneezing, and nasal congestion), inflammation of the mucous membrane of the nose (including symptoms such as runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including symptoms such as heartburn), blood present 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, eye swelling or eyelid swelling, 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 of the inside of 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 of the men who experienced these side effects, although not all, had pre-existing heart disease before taking this medicine. It is not possible to determine whether these side effects were directly related to this medicine.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of sildenafil

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 after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of sildenafil

The active substance is sildenafil citrate.

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

The other ingredients 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 and 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 score line.

The score line is only to facilitate breaking and does not divide the tablet 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands: Sildenafil Amarox 100 mg, filmomhulde tabletten

Spain: Sildenafilo Tarbis Farma 100 mg comprimidos recubiertos con película EFG

Date of last revision of this leaflet: August 2022.

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/