SILDENAFIL TECNIGEN 50 mg FILM-COATED TABLETS

Introduction

Leaflet: Information for the user

Sildenafilo TecniGen 50 mg film-coated tablets EFG

Sildenafil citrate

Read the entire leaflet carefully before starting to take the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet:

1. What Sildenafilo TecniGen is and what it is used for.
2. Before taking Sildenafilo TecniGen.
3. How to take Sildenafilo TecniGen.
4. Possible side effects.
5. Storage of Sildenafilo TecniGen.
6. Additional information.

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

Sildenafilo TecniGen belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels of the penis, allowing blood flow when sexually stimulated. Sildenafilo TecniGen will only help you 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 called impotence. This occurs when a man cannot obtain or maintain a firm erection suitable for satisfactory sexual activity.

2. BEFORE TAKING SILDENAFILO TECNIGEN

Do not take Sildenafilo TecniGen

• If you are taking medicines called nitrates, as the combination can cause a potentially dangerous drop in 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 blood pressure.
• If you are taking medicines containing sacubitril/valsartan, used to treat heart failure.
• If you are allergic (hypersensitive) to sildenafil or any of the other components of Sildenafilo TecniGen.
• If you have a serious heart or liver problem.
• If you have suffered from a rare hereditary eye disease (such as retinitis pigmentosa).
• If you have previously experienced a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Be careful with Sildenafilo TecniGen

Tell your doctor:

• If you have sickle cell anemia (a red blood cell abnormality), leukemia (blood cell 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 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 TecniGen and contact your doctor immediately.

Sildenafilo TecniGen 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 TecniGen is not indicated in people under 18 years of age.

Special considerations in patients with kidney or liver problems

You should inform your doctor if you have kidney or liver problems. Your doctor may decide to reduce your dose.

Taking other medicines

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

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

Do not take Sildenafilo TecniGen if you are taking medicines called nitrates, as the combination of these products can cause a potentially dangerous drop in 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 TecniGen 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 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 TecniGen.

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

Using Sildenafilo TecniGen with food and drinks

Sildenafilo TecniGen can be taken with or without food. However, you may notice that Sildenafilo TecniGen 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 Sildenafilo TecniGen.

Pregnancy and breastfeeding

The use of Sildenafilo TecniGen is not indicated in women.

Driving and using machines

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

3. HOW TO TAKE SILDENAFILO TECNIGEN

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

Do not take Sildenafilo TecniGen more than once a day.

You should take Sildenafilo TecniGen approximately one hour before you plan to have sex. Swallow the tablet whole with a little water.

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

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

In the event that Sildenafilo TecniGen 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 TecniGen 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 recommended by your doctor

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 TecniGen can cause side effects, although not everyone gets them. The side effects reported in association with the use of Sildenafilo TecniGen 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 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.

There have been reports of prolonged and sometimes painful erections after taking Sildenafilo TecniGen. 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 TecniGen and contact your doctor immediately.

The most common side effect(in 1 in 10 patients) is headache.

Common side effects(between 1 and 10 in 100 patients) include: 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(between 1 and 10 in 1,000 patients) include: vomiting, skin rash, bleeding in the back of the eye, eye irritation, eye discharge/red eyes, eye pain, double vision, watery eye, abnormal sensation in the eye, irregular or rapid heartbeat, muscle pain, feeling of drowsiness, reduced sense of touch, vertigo, ringing in the ears, nausea, dry mouth, chest pain, bleeding from the penis, presence of blood in the semen and/or urine, and feeling of fatigue.

Rare side effects(between 1 and 10 in 10,000 patients) include: heart attack, high blood pressure, low blood pressure, fainting, stroke, nosebleed, and sudden decrease or loss of hearing.

Side effects reported from post-marketing experience include: palpitations, chest pain, sudden death, decreased blood flow to some parts of the brain. Most, but not all, had pre-existing heart problems before taking this medicine. It is not possible to determine if these events were directly related to Sildenafilo TecniGen. 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 consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned 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 package to protect it from moisture.

Do not use Sildenafilo TecniGen after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

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

6. ADDITIONAL INFORMATION

Composition of Sildenafilo TecniGen 50 mg

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

The other components are:

Core tablet: microcrystalline cellulose, calcium phosphate dibasic, sodium croscarmellose, and magnesium stearate.

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

Appearance of the product and packaging size

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

Sildenafilo TecniGen 50 mg is available in blisters of 1, 2, 4, or 8 tablets per pack. Only some pack sizes may be marketed.

Other presentations:

Sildenafilo TecniGen 25 mg, packs of 4 tablets. Sildenafilo TecniGen 100 mg, packs of 4 or 8 tablets.

Marketing authorization holder and manufacturer

Holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) SPAIN

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande nº 2, Abrunheira. 2710 – 089 Sintra (Portugal).

This leaflet was revised in

July 2022

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/