PSILIBER 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Psiliber 100 mg film-coated tablets EFG

Sildenafil Citrate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Psiliber and what is it used for
2. What you need to know before you take Psiliber
3. How to take Psiliber
4. Possible side effects
5. Storage of Psiliber
6. Contents of the pack and other information

1. What is Psiliber and what is it used for

Psiliber belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5). It works by dilating the blood vessels of the penis, allowing blood flow when sexually stimulated. Psiliber will only help you to get an erection if you are sexually stimulated.

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

2. What you need to know before you take Psiliber

Do not takePsiliber

• 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 can cause a dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medicines, which are often given to relieve angina pectoris (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
• If you are using any of the medicines called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination can cause a dangerous drop 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 that they increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.
• If you are taking medicines that contain sacubitril/valsartan, used to treat heart failure.
• 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 a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

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

• If you have sickle cell anemia (a blood disorder), leukemia (cancer of the blood cells), or multiple myeloma (cancer of the bone marrow).
• If you have a penile deformity 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 use Sildenafil at the same time as any other oral or local treatment for erectile dysfunction.

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

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

The use of Sildenafil is not indicated in women.

Special considerations in patients with kidney or liver problems

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 Sildenafil is not indicated in persons under 18 years of age.

Use of Psiliber 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 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 medicines unless your doctor advises you to.

You must not take Sildenafil if you are taking medicines called nitrates, as the combination of these medicines can 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 pectoris (or "chest pain").

You must not take Sildenafil if you are taking medicines called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these medicines can also cause a dangerous drop 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 treatment with the lowest dose (25 mg) of Sildenafil.

Some patients who are receiving an alpha-blocker, a medicine used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness that can be caused by a drop 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 happen within 4 hours of taking Sildenafil. To reduce the likelihood of these symptoms, you should be taking your daily dose of the alpha-blocker regularly before starting Sildenafil. Your doctor may advise you to start treatment with the lower dose (25 mg) of Sildenafil.

Use of Psiliber with food, drinks, and alcohol

Sildenafil 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 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, breast-feeding, and fertility

The use of Sildenafil 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 machines.

Psiliber contains sodium

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

3. How to take Psiliber

Follow exactly the administration instructions 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 takeSildenafil more than once a day.

Do not take Sildenafil with other formulations of sildenafil orodispersible tablets.

You should take Sildenafil about one hour before you plan to have sex. Swallow the tablet whole with a little water.

If you think the effect of Sildenafil 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 usually takes between half an hour and one hour. The effect of sildenafil can be delayed if you take it with a large meal.

In case Sildenafil does not help you to get an erection or if the erection is not maintained long enough to complete sexual intercourse, consult your doctor.

If you take more Psiliberthan you should

You may experience an increase in side effects and their severity. Doses above 100 mg do not increase efficacy.

Do not take more tablets than your doctor recommends

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicological Information Service, telephone 915 620 420 (indicating the medicine and the amount taken.

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects associated with the use of Sildenafil are generally mild to moderate and short-lived.

If you experience any of the following serious side effects, stop takingSildenafiland 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 they occur during or after sex:

• Sit in a semi-upright position and try to relax.
• Do not use nitratesto 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 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 symptoms such as sudden feeling of heat in the upper body), indigestion, abnormal color perception, 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, flashing lights, visual clarity, sensitivity to light, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy nose, 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 fatigue.

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, decrease in visual acuity, 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 of the eye, 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 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 should be noted 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 whether these side effects were directly related to Sildenafil.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Psiliber

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to 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 Psiliber 100 mg

The active substance of Psiliber is sildenafil. Each film-coated tablet contains 100 mg of sildenafil (as citrate).

The other ingredients are:

Core tablet: microcrystalline cellulose, calcium phosphate dibasic, croscarmellose sodium, and magnesium stearate.

Film coating: polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide (E171), talc, and aluminum lake indigo carmine.

Appearance of the product and contents of the pack

Psiliber 100 mg film-coated tablets are elliptical in shape and blue in color, engraved with "+" on one side.

Psiliber 100 mg is available in blister packs of 4, 8, or 12 film-coated tablets per pack.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D.

28108 Alcobendas (Madrid)

Spain

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande nº 2, Abrunheira.

2710 – 089 Sintra

Portugal

Date of last revision of this leaflet: July 2022

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