SILDENAFIL QUALIGEN 100 mg CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

Sildenafilo Qualigen 100 mg Chewable 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

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

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

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

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

2. What you need to know before taking Sildenafilo Qualigen

Do not take Sildenafilo Qualigen

• If you are allergic to sildenafilo 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 potentially dangerous drop 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 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 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 Qualigen.

• 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 penis 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 and contact your doctor immediately.

Sildenafilo 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 Qualigen with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or may take any other medicine.

Sildenafilo 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 and when you took it. Do not take Sildenafilo with other medicines unless your doctor advises you to.

Do not take Sildenafilo 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 if you are taking medicines called nitric oxide donors, such as amyl nitrate ("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 in the treatment of 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 medicine used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness that can be caused by a drop in blood pressure when sitting or 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 reduce the likelihood of these symptoms, you should be taking your daily dose of the alpha-blocker regularly before starting Sildenafilo. Your doctor may advise you to start treatment with the lower dose (25 mg) of Sildenafilo.

Inform your doctor if you are taking, have recently taken, or may take medicines that contain sacubitril/valsartan, used to treat heart failure.

Taking Sildenafilo Qualigen with food, drinks, and alcohol

Sildenafilo Qualigen can be taken with or without food. However, you may notice that this medicine 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 consume large amounts of alcohol before taking this medicine.

Pregnancy, breastfeeding, and fertility

The use of Sildenafilo Qualigen is not indicated in women.

Driving and using machines

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

Sildenafilo Qualigen contains lactose, aspartame, and sodium

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

This medicine contains 8.6 mg of aspartame (E-951) per tablet, equivalent to 0.12 mg/kg.

Aspartame is a source of phenylalanine, which can be harmful in case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

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

3. How to take Sildenafilo Qualigen

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. The normal starting dose is 50 mg.

The tablet should be chewed and swallowed.

Do not take Sildenafilo Qualigen more than once a day.

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

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

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

In case Sildenafilo Qualigen 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 Qualigen 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 can cause side effects, although not everybody gets them.

The side effects associated 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-sitting position and try to relax.
• Do not use nitratesto treat your chest pain.
• Contact your doctor immediately.

All medicines, 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.

Very common side effects(may affect more than 1 in 10 people): headache.

Common side effects(may affect up to 1 in 10 people): 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(may affect up to 1 in 100 people): 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 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 tiredness, bleeding from the penis, presence of blood in the semen and/or urine.

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

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 if these events were directly related to Sildenafilo. There have also been reports of seizures or convulsions and severe skin reactions that cause rash, blisters, peeling of the skin, and pain that require immediate medical attention.

If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet.

Reporting of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines:

https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sildenafilo Qualigen

This medicine does not require any special storage temperature.

Keep in the original package to protect from light.

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

Do not use this medicine after the expiry date which is stated on the package after "EXP". The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sildenafilo Qualigen 100 mg

• The active ingredient of Sildenafilo Qualigen is sildenafilo. Each tablet contains 100 mg of sildenafilo.
• The other ingredients are: potassium polacrylate, potassium hydroxide (E-525) (to adjust pH) or hydrochloric acid (E-507) (to adjust pH), magnesium stearate (E-572), anhydrous colloidal silica, aspartame (E-951), sodium croscarmellose (E-468), lactose monohydrate, povidone K-30 (E-1201), and peppermint flavor (modified cornstarch).

Appearance of the product and pack contents

Sildenafilo Qualigen 100 mg tablets are triangular, biconvex, white, and engraved with "100" on one face.

Sildenafilo Qualigen 100 mg is available in blister packs of 1, 4, 8, and 12 tablets per pack.

Not all pack sizes may be marketed.

Other presentations:

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

Sildenafilo Qualigen 25 mg, packs of 1, 4, 8, and 12 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer:

Genepharm S.A.

18 km Marathon Avenue, 15351 Pallini Attikis

Greece

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park, Paola, PLA 3000

Malta

Date of last revision of this leaflet: April 2022

Other sources of information

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/.