Leaflet: information for the user

Sildenafilo Farmalider 100 mg film-coated tablets EFG

Sildenafil Citrate

Read this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you think you have suffered a side effect, you can report it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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

2. What you need to know before you start taking Sildenafilo Farmalider

3. How to take Sildenafilo Farmalider

4. Possible side effects

5. Storage of Sildenafilo Farmalider

6. Contents of the pack and additional information

Sildenafilo Farmalider belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels of the penis, allowing blood to flow when sexually stimulated. Sildenafilo Farmalider will only help achieve an erection if you are sexually stimulated. Do 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 referred to as impotence. This occurs when a male is unable to obtain or maintain a firm, adequate erection for satisfactory sexual activity.

Do not take Sildenafilo Farmalider

-If you are taking certain medications called nitrates, as the combination may cause a potentially dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medications, which are often used to relieve chest pain (or "chest pain"). If you are unsure, consult your doctor or pharmacist.

-If you are using any of the medications called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination may cause a potentially dangerous drop in your blood pressure.

-If you are allergic (hypersensitive) to sildenafilo or to any of the other components of Sildenafilo Farmalider.

-If you have a serious heart or liver problem.

-If you have a rare inherited eye disease (such as retinitis pigmentosa).

-If you have previously experienced vision loss due to anterior ischemic optic neuropathy (NOIA-NA).

Be especially careful with Sildenafilo Farmalider

Inform your doctor:

-If you have sickle cell anemia (a red blood cell abnormality), leukemia (blood cancer), 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 must carefully check if your heart can handle the additional effort of having sex.

-If you have a current 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.

It is not recommended to use Sildenafilo Farmalider 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 people under 18 years old.

Special considerations in patients with renal or hepatic problems

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

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

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

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

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

If you are taking medications 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 taking an alpha-blocker, a medication used to treat high blood pressure or prostate hypertrophy, may experience dizziness or lightheadedness caused by a drop 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 in the 4 hours following Sildenafilo Farmalider intake. To reduce the likelihood of these symptoms, you should be receiving your daily dose of the alpha-blocker regularly before starting Sildenafilo Farmalider. Your doctor may recommend that you start treatment with the lower dose (25 mg) of Sildenafilo Farmalider.

Medications 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 take effect if taken with a large meal.

Consuming alcohol may temporarily impair your ability to achieve an erection. Therefore, to get the maximum benefit from the medication, it is recommended not to consume large amounts of alcohol before taking Sildenafilo Farmalider.

Pregnancy and breastfeeding

The use of Sildenafilo Farmalider is not indicated in women.

Driving and operating machinery

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

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

Do not take Sildenafilo Farmalider more than once a day..

Take Sildenafilo Farmalider approximately one hour before you plan to have sexual intercourse. Swallow the tablet whole with a little water.

If you estimate that the effect of Sildenafilo Farmalider is too strong or too weak, inform 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 take effect varies from person to person, generally ranging from half an hour to one hour. The effect of Sildenafilo Farmalider may be delayed if taken with a large meal.

If Sildenafilo Farmalider does not help you achieve an erection or if the erection does not last long enough to complete the sexual act, 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 recommended by your doctor.

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

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

Like all medications, Sildenafilo Farmalider may cause side effects, although not everyone will experience them. The reported side effects associated with the use of Sildenafilo Farmalider are generally mild to moderate in intensity and of short duration.

If you experience chest pain during or after sexual activity:

- Sit in a semi-recumbent position and try to relax.

-Do not use nitratesto treat your chest pain.

- Contact your doctor immediately.

All medications, 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 hissing sound while breathing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.

There have been reported cases of prolonged and sometimes painful erections after taking Sildenafilo Farmalider. If you have an erection that lasts more than 4 hours, you must 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, light sensitivity, or blurred or decreased visual acuity), nasal congestion, and dizziness.

Uncommon side effects(between 1 and 10 in 1000 patients) include: vomiting, skin rash, bleeding in the back of the eye, eye irritation, eye discharge/ red eyes, eye pain, double vision, abnormal sensation in the eye, watery eyes, irregular or rapid heartbeat, muscle pain, feeling of drowsiness, reduced tactile sensation, vertigo, ringing in the ears, nausea, dry mouth, chest pain, and feeling of fatigue and penile bleeding, presence of blood in semen and/or urine.

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

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

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

Keep out of reach and sight of children.

Store in the original packaging to protect it from moisture.

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Sildenafilo Farmalider 25 mg

The active ingredient of Sildenafilo Farmalider is sildenafilo. Each tablet contains 25 mg of sildenafilo (as citrato).

The other components are:

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

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

Appearance of the product and packaging size

The tablets of Sildenafilo Farmalider 25 mg have a coating, are eliptical in shape, and are blue in color. They are engraved with “-” on one face.

Sildenafilo Farmalider is presented in blisters of 1, 4, 8, 12 tablets per package.

Only some package sizes may be commercially available.

Other presentations:

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

Sildenafilo Farmalider 100 mg, packages with 1, 4, 8, and 12 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Farmalider S.A

C/Aragoneses 15

28108 Alcobendas

Madrid

Responsible for manufacturing:

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

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

This leaflet was revised in August 2022.