SILDENAFIL FARMALIDER 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sildenafilo Farmalider 100 mg film-coated tablets EFG

Sildenafil Citrate

Read the entire package leaflet carefully before starting to take this medication.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the Package Leaflet

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

1. What is Sildenafilo Farmalider and what is it used for

Sildenafilo Farmalider 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. Sildenafilo Farmalider will only help you achieve an erection if you are sexually stimulated. You should not take Sildenafilo Farmalider if you do not have erectile dysfunction. The use of Sildenafilo Farmalider is not indicated in women.

Sildenafilo Farmalider is indicated for the treatment of male erectile dysfunction, sometimes called impotence. This occurs when a man cannot get or maintain a firm erection, suitable for satisfactory sexual activity.

2. Before taking Sildenafilo Farmalider

Do not take Sildenafilo Farmalider

• If you are taking medicines called nitrates, as the combination can cause a potentially dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medicines, which are often used 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 nitrate ("poppers"), as the combination can cause a potentially dangerous drop in your blood pressure.
• If you are allergic (hypersensitive) to sildenafil or any of the other components of Sildenafilo Farmalider.
• If you have a serious heart or liver problem.
• If you have suffered from a rare hereditary eye disease (such as retinitis pigmentosa).
• If you have previously experienced a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Be careful with Sildenafilo Farmalider

Tell your doctor:

• If you have sickle cell anemia (an abnormality of red blood cells), leukemia (cancer of blood cells), or multiple myeloma (bone marrow cancer).
• If you have a penile deformity or Peyronie's disease.
• If you have heart problems. In this case, your doctor should carefully check if your heart can withstand the extra effort 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 Sildenafilo Farmalider and contact your doctor immediately.

Sildenafilo Farmalider should not be used simultaneously with any other oral or local treatment for erectile dysfunction.

Special considerations in children and adolescents

The use of Sildenafilo Farmalider is not indicated in persons under 18 years of age.

Special considerations in patients with renal or hepatic impairment

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

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Sildenafilo Farmalider tablets may interfere with some medicines, especially those used to treat chest pain. In case of a medical emergency, you should inform any healthcare professional that you are taking Sildenafilo Farmalider and when you took it. Do not take Sildenafilo Farmalider with other medicines unless your doctor advises you to do so.

Do not take Sildenafilo Farmalider if you are taking medicines called nitrates, as the combination of these products can cause a potentially dangerous drop in your blood pressure. Always inform your doctor or pharmacist if you are taking any of these medicines, which are often used to relieve angina pectoris (or "chest pain").

Do not take Sildenafilo Farmalider if you are taking medicines called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these products can also cause a potentially dangerous drop in your blood pressure.

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 Sildenafilo Farmalider.

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 Sildenafilo Farmalider with alpha-blockers. This is more likely to occur within 4 hours of taking Sildenafilo Farmalider. To reduce the likelihood of these symptoms, you should be taking your daily dose of the alpha-blocker regularly before starting Sildenafilo Farmalider. Your doctor may indicate that you start treatment with the lower dose (25 mg) of Sildenafilo Farmalider.

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

Use of Sildenafilo Farmalider with food and drinks

Sildenafilo Farmalider can be taken with or without food. However, you may notice that Sildenafilo Farmalider 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 recommended not to drink large amounts of alcohol before taking Sildenafilo Farmalider.

Pregnancy and breastfeeding

The use of Sildenafilo Farmalider is not indicated in women.

Driving and using machines

Sildenafilo Farmalider can cause dizziness and affect vision. You should know how you react to Sildenafilo Farmalider before driving vehicles or using machinery.

3. How to take Sildenafilo Farmalider

Follow the administration instructions of Sildenafilo Farmalider exactly as indicated by your doctor. Consult your doctor or pharmacist if you have doubts. The normal starting dose is 50 mg.

Do not take Sildenafilo Farmalider more than once a day.

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

If you think the effect of Sildenafilo Farmalider is too strong or too weak, tell your doctor or pharmacist.

Sildenafilo Farmalider will only help you achieve an erection if you are sexually stimulated. The time it takes for Sildenafilo Farmalider to work varies from person to person, usually between half an hour and one hour. The effect of Sildenafilo Farmalider may be delayed if you take it with a large meal.

In the event that Sildenafilo Farmalider does not help you achieve an erection or if the erection is not maintained long enough to complete sexual intercourse, consult your doctor.

If you take more Sildenafilo Farmalider 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, or call the Toxicology Information Service, phone 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, Sildenafilo Farmalider can cause side effects, although not everyone gets them. The side effects reported in association with the use of Sildenafilo Farmalider are generally mild to moderate and short-lived.

If you experience chest pain during or after having sex:

• Sit in a semi-upright position and try to relax.
• Do not use nitrates to treat your chest pain.
• Contact your doctor immediately.

All medicines, including Sildenafilo Farmalider, can cause allergic reactions. You should contact your doctor immediately if you experience any of the following symptoms after taking Sildenafilo Farmalider: sudden wheezing, difficulty breathing, or dizziness, swelling of the eyelids, face, lips, or throat.

There have been reports of prolonged and sometimes painful erections after taking Sildenafilo Farmalider. If you have an erection that lasts more than 4 hours, you should contact your doctor immediately.

If you experience a sudden decrease or loss of vision, stop taking Sildenafilo Farmalider and contact your doctor immediately.

The most common side effect(in 1 in 10 patients) is headache.

Common side effects(between 1 and 10 in 100 patients) include: facial flushing, indigestion, effects on vision (including abnormal color perception, sensitivity to light, or blurred vision or decreased visual acuity), nasal congestion, and dizziness.

Uncommon side effects(between 1 and 10 in 1,000 patients) include: vomiting, skin rash, bleeding in the back of the eye, eye irritation, eye discharge/red eyes, eye pain, blurred vision, abnormal sensation in the eye, or eye watering, irregular or rapid heartbeat, muscle pain, feeling of drowsiness, reduced sense of touch, vertigo, ringing in the ears, nausea, dry mouth, chest pain, and feeling of tiredness, and bleeding of the penis, presence of blood in the semen and/or urine.

Rare side effects(between 1 and 10 in 10,000 patients) include: high blood pressure, low blood pressure, fainting, stroke, nosebleed, and sudden decrease or loss of hearing, heart attack.

The side effects reported from post-marketing experience include: palpitations, chest pain, sudden death, or decreased blood flow to some parts of the brain. Most, but not all, of these patients had pre-existing heart problems before taking this medicine. It is not possible to determine whether these events were directly related to Sildenafilo Farmalider. There have also been reports of seizures or convulsions and severe skin reactions that cause rash, blisters, skin peeling, and pain that require immediate medical attention.

If you consider that any of these side effects that you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

5. Storage of Sildenafilo Farmalider

Keep out of the reach and sight of children.

Store in the original package to protect from moisture.

Do not use Sildenafilo Farmalider after the expiration date stated on the package. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of packages and medicines that are no longer needed. This will help protect the environment.

6. Further information

Composition of Sildenafilo Farmalider 25 mg

The active substance of Sildenafilo Farmalider is sildenafil. Each tablet contains 25 mg of sildenafil (as citrate).

The other ingredients are:

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

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

Appearance of the product and pack size

Sildenafilo Farmalider 25 mg tablets are film-coated, elliptical, and blue in color. They are engraved with "-" on one side.

Sildenafilo Farmalider is available in blisters of 1, 4, 8, and 12 tablets per pack.

Not all pack sizes may be marketed.

Other presentations:

Sildenafilo Farmalider 50 mg, packs of 1, 2, 4, 8, and 12 tablets.

Sildenafilo Farmalider 100 mg, packs of 1, 4, 8, and 12 tablets.

Marketing authorization holder and manufacturer

Holder:

Farmalider S.A

C/Aragoneses 15

28108 Alcobendas

Madrid

Manufacturer:

West Pharma - Producções de Especialidades Farmacêuticas, S.A.

Rua João de Deus, nº 11, Venda Nova. 2700 Amadora (Portugal)

This package leaflet was revised in August 2022.