FEXION 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Fexion 50 mg film-coated tablets EFG

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

1. What is Fexion and what is it used for

Fexion contains the active substance sildenafil, which 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 you are sexually stimulated. Fexion will only help you to get an erection if you are sexually stimulated.

Fexion 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 Fexion

Do not take Fexion

• 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 decrease 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 not sure, 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 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 that they increase the hypotensive effect of this medicine. If you are taking riociguat or are not sure, 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 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 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 penile deformity or Peyronie's disease.
• If you have heart problems. Your doctor should carefully check if your heart can withstand the extra strain of having sex.
• If you have current stomach ulcers or bleeding problems (such as hemophilia).
• If you experience a sudden decrease or loss of vision, stop taking Fexion and contact your doctor immediately.

It is not recommended to use this medicine at the same time as any other oral or local treatment for erectile dysfunction.

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

You should not take sildenafil 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 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.

Other medicines and Fexion

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 should inform your doctor, pharmacist, or nurse that you are taking this medicine and when you took it. Do not take sildenafil with other medicines unless your doctor advises you to.

You should not take sildenafil if you are taking medicines called nitrates, as the combination of these medicines can cause a dangerous decrease 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 should 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 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 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 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 happen within 4 hours of taking sildenafil.

In order 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 recommend that you start treatment with the lower dose (25 mg) of sildenafil.

Caution should be exercised when starting treatment with sildenafil in patients treated with medicines containing sacubitril/valsartan, used to treat heart failure.

Using Fexion with food, drinks, and alcohol

Fexion 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 can temporarily impair your ability to get an erection. Therefore, to get the maximum benefit from the medicine, it is recommended not to drink large amounts of alcohol before taking this medicine.

Pregnancy, breastfeeding, 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.

Fexion contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Fexion contains sodium

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

3. How to take Fexion

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist again.

The recommended starting dose is 50 mg.

Do not take Fexion more than once a day.

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

If this medicine does not help you to get an erection, or if the erection is not maintained for long enough to complete sexual intercourse, consult your doctor.

If you take more Fexion than 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 immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

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 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 taking sildenafil 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 they occur 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, hot flush (including symptoms such as a 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 tiredness, 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 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 in the mouth, bleeding in the back of the eye, double vision, decrease in 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 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, unstable angina (heart disease) and sudden death have been reported rarely. It should be noted that most of the 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 this medicine.

Reporting of side effects

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

5. Storage of Fexion

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

This medicine does not require any special storage conditions.

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 stated.

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 Fexion

• The active substance of Fexion is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate).
• The other ingredients are: Core of the tablet:microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, and anhydrous dibasic calcium phosphate. Coating of the tablet: Opadry II 31K60715 Blue (lactose monohydrate, hypromellose, titanium dioxide (E-171), triacetin, and aluminum lake with carmine (E-132)).

Appearance of the product and contents of the pack

The film-coated tablets are pale blue to blue, capsule-shaped, engraved with "SL50" on one face and smooth on the other.

They are available in aluminum/PVC blisters containing 4, 8, or 12 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and

MABO-FARMA, S.A.

Calle Rejas 2, 1st floor

28821 Coslada (Madrid).

Manufacturer

Basic Pharma Manufacturing B.V.

Burgemeester Lemmensstraat 352,

Geleen, 6163JT, Netherlands

Or

Netpharmalab Consulting Services

Carretera de Fuencarral 22,

Alcobendas, 28108 Madrid

Date of last revision of this leaflet:April 2022

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