Fexion 100 mg film-coated tablets EFG
SpainTable of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Fexion 100 mg film-coated tablets EFG
(Sildenafil)
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet Contents
- What Fexion is and what it is used for
- What you need to know before taking Fexion
- How to take Fexion
- Possible side effects
- How to store Fexion
- Contents of the pack and other information
1. What Fexion is and what it is used for
Fexion contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels in the penis, allowing blood flow into it when you are sexually stimulated. Fexion will only help you achieve an erection if you are sexually stimulated.
Fexion is indicated for the treatment of erectile dysfunction in adult men, sometimes referred to as impotence. This occurs when a man is unable to achieve or maintain a firm erection suitable for satisfactory sexual activity.
2. What you need to know before taking 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 may lead to a dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medicines, which are often used to relieve angina pain (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
- If you are using any medicines known as nitric oxide donors, such as amyl nitrate ("poppers"), as the combination may 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 been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, 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 sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking this medicine:
- If you have sickle cell anemia (an abnormality of red blood cells), leukemia (cancer of blood cells), or multiple myeloma (cancer of bone marrow).
- If you have penile deformity or Peyronie's disease.
- If you have heart problems. Your doctor should carefully assess whether your heart can tolerate the additional strain of sexual activity.
- If you currently have a stomach ulcer or bleeding disorders (such as hemophilia).
- If you experience sudden decrease or loss of vision, stop taking Fexion and contact your doctor immediately.
It is not recommended to use this medicine simultaneously with any other oral or local treatment for erectile dysfunction.
You must not take sildenafil with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitor.
You must not take sildenafil if you do not have erectile dysfunction. This medicine is not intended for use in women.
Special considerations in patients with kidney or liver problems
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 recommended in individuals under 18 years of age.
Other medicines and Fexion
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Sildenafil tablets may interact with certain medicines, especially those used to treat chest pain. In a medical emergency, you must 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 advised by your doctor.
Do not take sildenafil if you are taking medicines called nitrates, as the combination of these medicines may 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 pain (or "chest pain").
Do not take sildenafil if you are taking medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), as the combination may also cause a dangerous drop in your blood pressure.
Inform your doctor or pharmacist if you are taking riociguat.
If you are taking protease inhibitors, medicines used in the treatment of HIV, your doctor may recommend starting treatment with the lowest dose (25 mg) of sildenafil.
Some patients receiving an alpha-blocker, a medicine used to treat high blood pressure or benign prostatic hyperplasia, may experience dizziness or feeling faint, which may 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 occur within 4 hours after taking sildenafil.
To reduce the likelihood of these symptoms, you should already be on a regular daily dose of the alpha-blocker before starting sildenafil. Your doctor may advise you to start treatment with the lowest dose (25 mg) of sildenafil.
Caution is advised when initiating sildenafil treatment in patients taking medicines containing sacubitril/valsartan, used to treat heart failure.
Taking Fexion with food, drinks, and alcohol
Fexion can be taken with or without food. However, you may notice that sildenafil takes slightly longer to work if taken with a heavy meal.
Drinking alcohol may temporarily impair your ability to get an erection. Therefore, to achieve the maximum benefit from the medicine, it is advisable not to drink large amounts of alcohol before taking this medicine.
Pregnancy, breastfeeding, and fertility
Sildenafil is not indicated for use 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.
Fexion contains lactose
This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him 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 instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended starting dose is 50 mg.
Fexion must not be taken more than once a day.
You should take this medicine approximately one hour before you plan to have sexual intercourse. Swallow the tablet whole with a glass of water.
If you notice that the effect of this medicine 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 required for sildenafil to take effect varies from person to person, usually ranging between half an hour and one hour. The effect of sildenafil may be delayed if taken with a heavy meal.
If this medicine 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 Fexion than you should
You may experience an increase in the frequency and severity of adverse effects. Doses higher than 100 mg do not increase efficacy.
You must not take more tablets than recommended by your doctor.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The adverse effects reported with the use of sildenafil are generally mild to moderate in intensity and short in duration.
If you experience any of the following serious adverse effects, stop taking sildenafil and seek immediate medical attention:
- Allergic reaction – this occurs uncommonly (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 uncommonly.
If chest pain occurs during or after sexual activity:
-
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 rarely (may affect up to 1 in 1,000 people).
If you have an erection lasting longer than 4 hours, you must contact your doctor immediately.
-
Sudden decrease or loss of vision – this occurs rarely.
-
Severe skin reactions – this occurs rarely.
Symptoms may include severe skin peeling and swelling, blistering in the mouth, genital area, and around the eyes, as well as fever.
- Seizures or fits – this occurs rarely.
Other adverse effects:
Very common (may affect more than 1 in 10 people): headache.
Common (may affect up to 1 in 10 people): nausea, facial flushing, flushing (symptoms include sudden sensation of heat in the upper body), indigestion, abnormal colour 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, perception of flashing lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sense of touch, vertigo, tinnitus (ringing in the ears), dry mouth, blocked or stuffy nose, swelling of the nasal mucosa (symptoms include runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in arms or legs, nosebleeds, sensation of warmth, and feeling of fatigue.
Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to parts of the brain, sensation of tightness in the throat, numbness of the mouth, bleeding behind 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, pupil dilation, change in the colour of the white part of the eye, penile bleeding, blood in semen, dry nose, swelling inside the nose, 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 should be noted that most men who experienced these adverse effects, although not all, had pre-existing heart conditions before taking this medicine. It is not possible to determine whether these adverse effects were directly related to this medicine.
Reporting of adverse effects
If you experience any adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Fexion Storage
Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater drains or in household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Fexion
- The active substance in Fexion is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate).
- The other components are: Tablet core: microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate and dibasic calcium phosphate (anhydrous). Tablet coating: Opadry II 31K60715 Blue (lactose monohydrate, hypromellose, titanium dioxide (E-171), triacetin and aluminium lake with indigo carmine (E-132)).
Appearance of the product and contents of the pack
The coated tablets are pale blue to blue in colour, capsule-shaped, engraved with "SL100" on one side and smooth on the other.
It is presented in aluminium/PVC blisters containing 4, 8 or 12 tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
MABO-FARMA, S.A.
Calle Rejas 2, planta 1
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 the most recent review of this leaflet: April 2022
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/