SILDENAFIL QUALIGEN 25 mg CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

Sildenafil Qualigen 25mg 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 signs of illness 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 Package Leaflet

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

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

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

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

2. What you need to know before you take Sildenafil Qualigen

Do not take Sildenafil Qualigen

• If you are allergic to sildenafil 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 nitrite ("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 Sildenafil Qualigen.

• If you have sickle cell anemia (a blood disorder), leukemia (blood cancer), 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 stomach ulcers or bleeding problems (such as hemophilia).
• If you experience a sudden decrease or loss of vision, stop taking sildenafil and contact your doctor immediately.

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

Special Considerations in Children and Adolescents

The use of Sildenafil 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 Sildenafil Qualigen with Other Medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Sildenafil tablets may interfere with some medicines, especially those used to treat chest pain.

In the event of a medical emergency, you should inform any healthcare professional that you are taking Sildenafil and when you took it. Do not take Sildenafil with other medicines unless your doctor advises you to.

Do not take Sildenafil 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 Sildenafil 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 (25mg) of Sildenafil.

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

Tell your doctor if you are taking, have recently taken, or might take medicines containing sacubitril/valsartan, used to treat heart failure.

Taking Sildenafil Qualigen with Food, Drinks, and Alcohol

Sildenafil 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 advised not to drink large amounts of alcohol before taking this medicine.

Pregnancy, Breastfeeding, and Fertility

The use of Sildenafil Qualigen is not indicated in women.

Driving and Using Machines

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

Sildenafil Qualigen Contains Lactose, Aspartame, and Sodium

This medicine contains 2.15mg of aspartame (E-951) in each tablet, equivalent to 0.03mg/kg.

Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly. 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 less than 23mg of sodium (1mmol) per tablet; it is essentially "sodium-free".

3. How to Take Sildenafil Qualigen

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

The tablet should be chewed and swallowed.

Do not take Sildenafil Qualigen more than once a day.

You should take this medicine 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.

Sildenafil 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 Sildenafil Qualigen may be delayed if you take it with a large meal.

In case this medicine 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 Sildenafil 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 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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Sildenafil can cause side effects, although not everybody gets them.

The side effects associated with the use of Sildenafil 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 medicines, including Sildenafil, can cause allergic reactions. You should contact your doctor immediately if you experience any of the following symptoms after taking Sildenafil: 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 Sildenafil.

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 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, sensitivity to light, or blurred vision), 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 tiredness, reduced sense of touch, vertigo, ringing in the ears, nausea, dry mouth, chest pain, feeling of fatigue, 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, nosebleeds, and sudden decrease or loss of hearing.

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 Sildenafil. There have also been reports of seizures or convulsions and severe skin reactions that include 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 possible 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 side effects 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 Sildenafil 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 packaging after "EXP". The expiry date is the last day of the month shown.

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

6. Package Contents and Further Information

Composition of Sildenafil Qualigen 25mg

• The active ingredient of Sildenafil Qualigen is sildenafil. Each tablet contains 25mg of sildenafil.
• The other ingredients are: potassium polacrylate, potassium hydroxide (E-525) (for pH adjustment) or hydrochloric acid (E-507) (for pH adjustment), 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 corn starch).

Appearance of the Product and Package Contents

Sildenafil Qualigen 25mg tablets are triangular, biconvex, white, and engraved with "25" on one side.

Sildenafil Qualigen 25mg is available in blister packs of 1, 4, 8, and 12 tablets per pack.

Not all pack sizes may be marketed.

Other presentations:

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

Sildenafil Qualigen 100mg, 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 the 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/.