SILDENAFIL WINADOL 100 mg CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

Sildenafilo Winadol 100 mg Chewable Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• 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 experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

Contents of the Package Leaflet:

1. What is Sildenafilo Winadol and what is it used for
2. What you need to know before taking Sildenafilo Winadol
3. How to take Sildenafilo Winadol
4. Possible side effects
5. Storage of Sildenafilo Winadol
6. Package Contents and Additional Information

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

Sildenafilo Winadol belongs to a group of medications called phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels of the penis, allowing blood flow when sexually stimulated. Sildenafilo Winadol will only help you achieve an erection if you are sexually stimulated. You should not take Sildenafilo Winadol if you do not have erectile dysfunction. The use of Sildenafilo is not indicated in women.

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

2. What you need to know before taking Sildenafilo Winadol

Do not take Sildenafilo Winadol

• If you are allergic to sildenafil or any of the other components of this medication (listed in section 6).
• If you are taking medications called nitrates, as the combination can cause a potentially dangerous decrease in blood pressure. Consult your doctor if you are taking any of these medications, 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 medications called nitric oxide donors, such as amyl nitrate ("poppers"), as the combination can cause a potentially dangerous decrease in blood pressure.
• 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 had 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 or pharmacist before starting to take Sildenafilo Winadol.

• If you have sickle cell anemia (a red blood cell abnormality), leukemia (blood cell 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 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 Winadol and contact your doctor immediately.

Sildenafilo Winadol 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 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.

Taking Sildenafilo Winadol with Other Medications

Inform your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medication.

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

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

You should not take Sildenafilo if you are taking medications called nitric oxide donors, such as amyl nitrate ("poppers"), as the combination of these products can also cause a potentially dangerous decrease in 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.

Some patients who are receiving an alpha-blocker, a medication 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 standing up quickly. Some patients have experienced these symptoms when taking Sildenafilo with alpha-blockers. This is more likely to occur within 4 hours of taking Sildenafilo. To minimize the likelihood of these symptoms, you should be taking your daily dose of the alpha-blocker regularly before starting Sildenafilo. Your doctor may recommend that you start treatment with the lower dose (25 mg) of Sildenafilo.

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

Taking Sildenafilo Winadol with Food and Drinks

Sildenafilo Winadol can be taken with or without food. However, you may notice that Sildenafilo Winadol takes a little longer to work if you take it with a large meal.

Consuming alcohol can temporarily make it more difficult 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 Winadol.

Pregnancy and Breastfeeding

The use of Sildenafilo Winadol is not indicated in women.

Driving and Using Machines

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

Sildenafilo Winadol Contains Aspartame and Lactose

This medication may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

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

3. How to Take Sildenafilo Winadol

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. The normal starting dose is 50 mg.

The tablet should be chewed and swallowed.

Do not take Sildenafilo Winadol more than once a day.

You should take Sildenafilo Winadol approximately one hour before you plan to have sex.

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

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

If Sildenafilo Winadol 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 Winadol 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 Toxicology Information Service, phone 915 620 420, indicating the medication and the amount taken.

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

4. Possible Side Effects

Like all medications, Sildenafilo can cause side effects, although not everyone experiences them.

The side effects reported in association with the use of Sildenafilo 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 nitratesto treat your chest pain.
• Contact your doctor immediately.

All medications, including Sildenafilo, can cause allergic reactions. You should contact your doctor immediately if you experience any of the following symptoms after taking Sildenafilo: 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. 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 and contact your doctor immediately.

The most common side effect(may affect more than 1 in 10 people) is headache.

Common side effects(may affect up to 1 in 10 people) include: facial flushing, indigestion, effects on vision (including abnormal color perception, sensitivity to light, or blurred vision), nasal congestion, and dizziness.

Uncommon side effects(may affect up to 1 in 100 people) 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, irregular or rapid heartbeat, muscle pain, feeling of drowsiness, reduced sense of touch, vertigo, ringing in the ears, nausea, dry mouth, chest pain, feeling of fatigue, watery eyes, bleeding from the penis, presence of blood in the semen and/or urine.

Rare side effects(may affect up to 1 in 1000 people) include: high blood pressure, low blood pressure, fainting, stroke, nosebleeds, sudden decrease or loss of hearing, and heart attack.

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 medication. It is not possible to determine if these events were directly related to Sildenafilo. There have also been reports of seizures or convulsions and severe skin reactions that include rash, blisters, skin peeling, and pain that require immediate medical attention.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

5. Storage of Sildenafilo Winadol

This medication does not require any special storage temperature.

Keep in the original package to protect from light.

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

Do not use this medication after the expiration date that appears on the package, after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in the pharmacy. If you have any doubts, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Sildenafilo Winadol 100 mg

• The active ingredient of Sildenafilo Winadol is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate).

• The other components are: Potassium polacrilin, anhydrous colloidal silica, lactose monohydrate, povidone K-30, aspartame (E 951), sodium croscarmellose, peppermint flavor (composed of flavorings, maltodextrin, modified cornstarch, and pulegone), magnesium stearate, potassium hydroxide (for pH adjustment) or hydrochloric acid (for pH adjustment).

Appearance of the Product and Package Size

Sildenafilo Winadol 100 mg tablets are triangular, biconvex, white, and engraved with 100 mg on one side.

Sildenafilo Winadol is available in blisters of 1, 4, 8, and 12 tablets per package.

Only some package sizes may be marketed.

Other presentations:

Sildenafilo Winadol 25 mg, packages of 1, 4, 8, and 12 tablets.

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

Marketing Authorization Holder and Manufacturer

Holder:

Farmalider, S.A.

C/ La Granja, 1, 3ª Planta

28108 Alcobendas (Madrid)

Spain

Manufacturer:

Genepharm S.A

18thKm Marathon Avenue,

15351 Pallini, Attiki

Greece

Halmeln rds a.s.

Horná 36, Modra,

900 01 Slovakia

Date of the Last Revision of this Package Leaflet: September 2023

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