Sildenafil Qualigen 25 mg chewable tablets EFG: detailed information

Brand name Sildenafil Qualigen 25 mg chewable tablets EFG

Form tablets, chewable

Active substance / Dosage

SILDENAFIL CITRATE · 35,12 mg

Prescription type Prescription Only Medicine

ATC code

G04B G04BE G04BE03

Registration number 76923

Manufacturer Neuraxpharm Spain S.L.

Sildenafil Qualigen 25 mg chewable tablets EFG tablets, chewable

Table of Contents

Package leaflet: Information for the user
Introduction
1. What Sildenafil Qualigen is and what it is used for
2. What you need to know before taking Sildenafil Qualigen
3. How to take Sildenafil Qualigen
4. Possible adverse effects
5. Storage of Sildenafil Qualigen
6. Contents of the pack and other information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sildenafil Qualigen 25 mg chewable tablets EFG

Read the entire 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, ask your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

Contents of the leaflet

What Sildenafil Qualigen is and what it is used for
What you need to know before taking Sildenafil Qualigen
How to take Sildenafil Qualigen
Possible adverse effects
How to store Sildenafil Qualigen
Contents of the pack and other information

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

Sildenafil Qualigen belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels in the penis, allowing blood flow into it when sexually stimulated. Sildenafil will only help 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 referred to as impotence. This occurs when a man is unable to achieve or maintain a firm erection adequate for satisfactory sexual activity.

2. What you need to know before taking Sildenafil Qualigen

Do not take Sildenafil Qualigen

If you are allergic to sildenafil or to any of the other ingredients of this medicine (listed in section 6).
If you are taking medicines 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 medicines, which are often administered to relieve angina pain (or “chest pain”). If you are unsure, consult your doctor or pharmacist.
If you are using any medicines known as nitric oxide donors such as amyl nitrate (“poppers”), as the combination may 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 suffered from a rare inherited eye disease (such as retinitis pigmentosa).
If you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Talk to your doctor or pharmacist before taking Sildenafil Qualigen.

If you have sickle cell anemia (an abnormality of red blood cells), leukemia (cancer of blood cells), or multiple myeloma (cancer of the bone marrow).
If you have a penile deformity or Peyronie's disease.
If you have heart problems. In such cases, your doctor should carefully assess whether your heart can tolerate the additional strain of sexual activity.
If you currently have a stomach ulcer or bleeding disorders (such as hemophilia).
If you experience sudden decrease or loss of vision, stop taking sildenafil and contact your doctor immediately.

The use of sildenafil is not recommended together with any other oral or local treatments for erectile dysfunction.

Special considerations in children and adolescents

The use of Sildenafil is not indicated in individuals under 18 years of age.

Special considerations in patients with renal or hepatic impairment

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 need to take any other medicines.

Sildenafil tablets may interact with certain medicines, especially those used to treat chest pain. In a medical emergency, you must inform any healthcare professional that you are taking Sildenafil and when you took it. Do not take Sildenafil with other medicines unless advised by your doctor.

Do not take Sildenafil if you are taking medicines 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 medicines, which are often used to relieve angina pain (or “chest pain”).

Do not take Sildenafil if you are taking medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), as the combination of these products may also lead to 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 starting treatment with the lowest dose (25 mg) of Sildenafil.

Some patients receiving an alpha-blocker, a medicine used to treat high blood pressure or benign prostatic hyperplasia, 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 Sildenafil with alpha-blockers. This is more likely to occur within 4 hours after taking Sildenafil. To reduce the likelihood of these symptoms, you should already be on a regular daily dose of the alpha-blocker before starting Sildenafil. Your doctor may advise you to start treatment with the lowest dose (25 mg) of Sildenafil.

Inform your doctor if you are taking, have recently taken, or may need to 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 longer to work if taken with a heavy meal.

Alcohol intake may temporarily impair your ability to obtain an erection. Therefore, to achieve the maximum benefit from the medicine, it is advisable not to consume 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 may cause dizziness and affect vision. You should know how you react to Sildenafil Qualigen before driving or operating machinery.

Sildenafil Qualigen contains lactose, aspartame, and sodium

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

Aspartame contains 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 informed you of an intolerance to certain sugars, consult your doctor before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially “sodium-free”.

3. How to take Sildenafil Qualigen

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. The usual starting dose is 50 mg.

The tablet should be chewed and swallowed.

Do not take Sildenafil Qualigen more than once a day.

Take this medicine approximately one hour before you plan to have sexual intercourse.

If you feel that 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 this medicine takes to work varies from person to person, usually between half an hour and one hour. The effect of Sildenafil Qualigen may be delayed if taken with a heavy meal.

If this medicine does not help you achieve an erection or if the erection does not last long enough to complete sexual intercourse, consult your doctor.

If you take more Sildenafil Qualigen than you should

You may experience an increase in the frequency and severity of side effects. Doses higher than 100 mg do not increase effectiveness.

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 at telephone number 915 620 420 (indicating the medicine and the amount ingested).

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

4. Possible adverse effects

Like all medicines, Sildenafil can cause adverse effects, although not everyone experiences them.

Adverse effects reported with Sildenafil are generally mild to moderate in intensity and short in duration.

If you experience chest pain during or after sexual activity:

Sit in a semi-upright position and try to relax.
Do not use nitrates to 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.

Cases of prolonged and sometimes painful erections have been reported after taking Sildenafil.

If you have an erection lasting longer than 4 hours, contact your doctor immediately.

If you experience sudden decrease or loss of vision, stop taking Sildenafil and contact your doctor immediately.

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

Common adverse effects (may affect up to 1 in 10 people): facial flushing, indigestion, visual disturbances (including abnormal color vision, light sensitivity, blurred vision, or decreased visual acuity), nasal congestion, and dizziness.

Uncommon adverse effects (may affect up to 1 in 100 people): vomiting, skin rash, bleeding at the back of the eye, eye irritation, eye hemorrhage/red eyes, eye pain, double vision, abnormal sensation in the eye, watery eyes, irregular or rapid heartbeat, muscle pain, drowsiness, reduced sense of touch, vertigo, tinnitus, nausea, dry mouth, chest pain, feeling of fatigue, penile bleeding, presence of blood in semen and/or urine.

Rare adverse effects (may affect up to 1 in 1,000 people): high blood pressure, low blood pressure, fainting, stroke, heart attack, nosebleeds, and sudden decrease or loss of hearing.

Adverse effects reported from post-marketing experience include: palpitations, chest pain, sudden death, or reduced blood flow to 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. Seizures or fits and serious skin reactions characterized by rash, blisters, skin peeling, and pain requiring immediate medical attention have also been reported.

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

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines:

https://www.notificaram.es. By reporting adverse 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 packaging to protect from light.

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

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sildenafil Qualigen 25 mg

The active substance in Sildenafil Qualigen is sildenafil. Each tablet contains 25 mg of sildenafil.
The other components are: potassium polacrilin, 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 mint flavour (modified corn starch).

Appearance of the product and contents of the pack

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

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

Only certain pack sizes may be marketed.