Leaflet: information for the user

Sildenafilo Qualigen 100mg chewable tablets EFG

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

Sildenafilo Qualigen 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 will only help achieve an erection if you are sexually stimulated. Do 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 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 Qualigen

• If you are allergic to sildenafilo or any of the other components of this medication (listed in section 6).
• If you are taking certain medications called nitrates, as the combination may cause a potentially hazardous decrease in your blood pressure. Consult your doctor if you are taking any of these medications, which are often used to alleviate 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 nitrate ("poppers"), as the combination may cause a potentially hazardous decrease in your blood pressure.
• If you have a severe heart or liver problem.
• If you have recently experienced a stroke or heart attack, or if you have low blood pressure.
• If you have a rare inherited eye disorder (such as retinitis pigmentosa).
• If you have previously experienced vision loss 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 (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 strain of sexual activity.
• If you have an active stomach ulcer or bleeding problems (such as hemophilia).
• If you experience sudden vision loss, stop taking sildenafilo and contact your doctor immediately.

It is not recommended to use sildenafilo 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 individuals under 18 years of age.

Special considerations in patients with renal or hepatic impairment

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

Taking Sildenafilo Qualigen with other medications

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

Sildenafilo tablets may interact with certain 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 and when you took it. Do not take Sildenafilo with other medications unless your doctor advises you to.

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

You must not take Sildenafilo if you are taking medications known as nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these products may also lead to a potentially hazardous decrease in your blood pressure.

If you are taking 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 taking an alpha-blocker, a medication used to treat high blood pressure or benign prostatic hyperplasia, may experience dizziness or lightheadedness caused by a decrease in blood pressure when sitting or standing quickly. Some patients have experienced these symptoms when taking Sildenafilo with alpha-blockers. This is more likely to occur within 4 hours after taking Sildenafilo. To reduce the likelihood of these symptoms, you should be receiving 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.

Inform your doctor if you are taking, have taken recently, or may need to take medications containing 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 medication takes a little longer to take effect if you ingest it with a large meal.

Consuming alcohol may temporarily impair your ability to achieve an erection. Therefore, to maximize the benefits of the medication, it is recommended not to consume large amounts of alcohol before taking this medication.

Pregnancy, breastfeeding, and fertility

The use of Sildenafilo Qualigen is not indicated in women.

Driving and operating machinery

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

Sildenafilo Qualigen contains lactose, aspartame, and sodium

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains 8.6 mg of aspartame (E-951) in each tablet equivalent to 0.12 mg/kg.

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

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

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

The tablet must be chewed and swallowed.

Do not take Sildenafilo Qualigen more than once a day.

Take Sildenafilo Qualigen approximately one hour before planning to have sexual intercourse.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

Sildenafilo will only help you get an erection if you are sexually stimulated. The time it takes for this medication to take effect varies from person to person, generally ranging from half an hour to one hour. The effect of this medication may be delayed if taken with a large meal.

If Sildenafilo Qualigen does not help you get an erection or if the erection does not last 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 100mg 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, Sildenafil may cause side effects, although not everyone will experience them.

The reported side effects associated with the use of Sildenafil are generally mild to moderate in intensity and of short duration.

If you experience chest pain during or after sexual activity:

• Take a semi-sitting position and try to relax.
• Do not use nitratesto treat your chest pain.
• Contact your doctor immediately.

All medications, including Sildenafil, can cause allergic reactions. You should contact your doctor immediately if you experience any of the following symptoms after taking Sildenafil: 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 Sildenafil. 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 Sildenafil 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, light sensitivity, or blurred 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 eyes, irregular or rapid heartbeat, muscle pain, feeling of drowsiness, reduced tactile sensation, vertigo, ringing in the ears, nausea, dry mouth, chest pain, feeling of fatigue, penile bleeding, presence of blood in 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, nasal bleeding, and sudden decrease or loss of hearing.

The reported 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 pre-existing heart problems before taking this medication. It is not possible to determine if these events were directly related to Sildenafil. 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 experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:

https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from light.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Sildenafilo Qualigen 100 mg

• The active ingredient of Sildenafilo Qualigen is sildenafilo. Each tablet contains 100 mg of sildenafilo.
• The other components are: potassium polacrilex, potassium hydroxide (E-525) (to adjust the pH) or hydrochloric acid (E-507) (to adjust the 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 contents of the packaging

The Sildenafilo Qualigen 100 mg tablets are triangular, biconvex, white in color, and have "100" engraved on one side.

Sildenafilo Qualigen 100 mg is presented in blisters of 1, 4, 8, and 12 tablets per package.

Only some package sizes may be commercially available.

Other presentations:

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

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

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible manufacturer:

Genepharm S.A.

18 km Marathon Avenue, 15351 Pallini Attikis

Greece

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park, Paola, PLA 3000

Malta

Last review date of this leaflet: April 2022

Other sources of information

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