Sildenafil Tecnigen 50 mg film-coated tablets EFG: detailed information

Brand name Sildenafil Tecnigen 50 mg film-coated tablets EFG

Form tablets, film-coated

Active substance / Dosage

SILDENAFIL CITRATE · 70,24 mg

Prescription type Prescription Only Medicine

ATC code

G04B G04BE G04BE03

Registration number 71745

Manufacturer Tecnimede Espana Industria Farmaceutica S.A.

Sildenafil Tecnigen 50 mg film-coated tablets EFG tablets, film-coated

Table of Contents

Package leaflet: Information for the user
Introduction
1. What SILDENAFILO TECNIGEN is and what it is used for
2. BEFORE TAKING SILDENAFIL TECNIGEN
3. HOW TO TAKE SILDENAFILO TECNIGEN
4. Possible adverse effects
5. Storage of SILDENAFILO TECNIGEN
6. ADDITIONAL INFORMATION

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sildenafilo TecniGen 50 mg film-coated tablets EFG

Sildenafil citrate

Read the entire leaflet carefully before you start taking this medicine.

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 must not be given to other people, even if they have the same symptoms as you, since it could harm them.
If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet:

What Sildenafilo TecniGen is and what it is used for.
Before you take Sildenafilo TecniGen.
How to take Sildenafilo TecniGen.
Possible side effects.
How to store Sildenafilo TecniGen.
Further information.

1. What SILDENAFILO TECNIGEN is and what it is used for

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

Sildenafilo TecniGen 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. BEFORE TAKING SILDENAFIL TECNIGEN

Do not take Sildenafil TecniGen

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 chest pain (or “angina”). 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 are taking medicines containing sacubitril/valsartan, used to treat heart failure.
If you are allergic (hypersensitive) to sildenafil or to any of the other components of Sildenafil TecniGen.
If you have a serious heart or liver problem.
If you have a rare inherited eye disease (such as retinitis pigmentosa).
If you have previously experienced sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Take special care with Sildenafil TecniGen

Inform your doctor:

If you have sickle cell anemia (an abnormality of red blood cells), leukemia (cancer of blood cells), or multiple myeloma (cancer of 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 TecniGen and contact your doctor immediately.

It is not recommended to use Sildenafil TecniGen simultaneously with any other oral or local treatment for erectile dysfunction.

Special considerations in children and adolescents

The use of Sildenafil TecniGen 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 other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Sildenafil TecniGen 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 TecniGen and when you took it. Do not take Sildenafil TecniGen with other medicines unless your doctor advises you to do so.

Do not take Sildenafil TecniGen 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 (or “chest pain”).

Do not take Sildenafil TecniGen 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 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 TecniGen.

Some patients taking alpha-blockers, medicines used to treat high blood pressure or benign prostatic hyperplasia, may experience dizziness or lightheadedness caused by a drop in blood pressure when sitting down or standing up quickly. Some patients have experienced these symptoms when taking Sildenafil TecniGen with alpha-blockers. This is more likely to occur within 4 hours after taking Sildenafil TecniGen. To reduce the likelihood of these symptoms, you should already be on a regular daily dose of the alpha-blocker before starting Sildenafil TecniGen. Your doctor may advise you to start treatment with the lowest dose (25 mg) of Sildenafil TecniGen.

Use of Sildenafil TecniGen with food and drinks

Sildenafil TecniGen may be taken with or without food. However, you may notice that Sildenafil TecniGen takes slightly longer to take effect if taken with a large meal.

Alcohol consumption may temporarily impair the 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 Sildenafil TecniGen.

Pregnancy and breastfeeding

The use of Sildenafil TecniGen is not indicated in women.

Driving and operating machinery

Sildenafil TecniGen may cause dizziness and affect vision. You should know how you react to Sildenafil TecniGen before driving or operating machinery.

3. HOW TO TAKE SILDENAFILO TECNIGEN

Follow exactly the administration instructions for Sildenafilo TecniGen as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. The normal starting dose is 50 mg.

Do not take Sildenafilo TecniGen more than once a day.

You should take Sildenafilo TecniGen approximately one hour before planning to have sexual intercourse. Swallow the tablet whole with some water.

If you find that the effect of Sildenafilo TecniGen is too strong or too weak, inform your doctor or pharmacist.

Sildenafilo TecniGen will only help you achieve an erection if you are sexually stimulated. The time required for Sildenafilo TecniGen to take effect varies from person to person, usually ranging between half an hour and one hour. The effect of Sildenafilo TecniGen may be delayed if taken with a heavy meal.

If Sildenafilo TecniGen 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 Sildenafilo TecniGen 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 those 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 medication 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, Sildenafilo TecniGen may cause adverse effects, although not everyone experiences them. The adverse effects reported with the use of Sildenafilo TecniGen 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 Sildenafilo TecniGen, can cause allergic reactions. You should contact your doctor immediately if you experience any of the following symptoms after taking Sildenafilo TecniGen: 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 Sildenafilo TecniGen. If you have an erection lasting longer than 4 hours, you must contact your doctor immediately.

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

The most common adverse effect (in 1 out of every 10 patients) is headache.

Frequent adverse effects (in 1 to 10 out of every 100 patients) include: facial flushing, indigestion, visual disturbances (including abnormal color vision, light sensitivity, blurred vision, or decreased visual acuity), nasal congestion, and dizziness.

Uncommon adverse effects (in 1 to 10 out of every 1000 patients) include: vomiting, skin rashes, bleeding at the back of the eye, eye irritation, eye hemorrhage/red eyes, eye pain, double vision, watery eyes, abnormal sensation in the eye, irregular or rapid heartbeat, muscle pain, drowsiness, reduced sense of touch, vertigo, tinnitus, nausea, dry mouth, chest pain, penile bleeding, presence of blood in semen and/or urine, and feeling of fatigue.

Rare adverse effects (in 1 to 10 out of every 10,000 patients) include: heart attack, high blood pressure, low blood pressure, fainting, stroke, nosebleeds, and sudden decrease or loss of hearing.

Adverse effects reported from post-marketing experience include: palpitations, chest pain, sudden death, reduced blood flow to certain areas 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 Sildenafilo TecniGen. Cases of seizures or convulsions and serious skin reactions characterized by rash, blistering, skin peeling, and pain requiring immediate medical attention have also been reported.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of SILDENAFILO TECNIGEN

Keep out of the reach and sight of children.

Store in the original container to protect it from moisture.

Do not use Sildenafilo TecniGen after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or in household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This way, you will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Sildenafil TecniGen 50 mg

The active substance of Sildenafil TecniGen is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate).

The other components are:

Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose, and magnesium stearate.

Film coating: polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide (E171), talc, and indigo carmine aluminum lake.

Appearance of the medicinal product and pack sizes

Sildenafil TecniGen 50 mg tablets are film-coated, elliptical in shape, and blue in color.

Sildenafil TecniGen 50 mg is available in blister packs containing 1, 2, 4, or 8 tablets per package. Only certain pack sizes may be marketed.