SILDENAFIL TECNIGEN 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sildenafilo TecniGen 100 mg film-coated tablets EFG

Sildenafil Citrate

Read all of this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

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. Storing Sildenafilo TecniGen.
6. 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 inhibitors (PDE5). It works by widening the blood vessels in the penis, allowing blood to flow in when you are sexually stimulated. Sildenafilo TecniGen will only help you to get 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 get or maintain an erection that is sufficient 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 your blood pressure. Consult your doctor if you are taking any of these medicines, which are often used 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 your 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 ingredients of Sildenafilo TecniGen.
• If you have a serious heart or liver problem.
• 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).

Be cautious when taking Sildenafilo TecniGen

Tell your doctor:

• If you have sickle cell anemia (a blood disorder), leukemia (cancer of the 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 this case, your doctor should carefully check if your heart can withstand the extra strain of having sex.
• If you currently have stomach ulcers or bleeding problems (such as hemophilia).
• If you experience a sudden loss of vision, stop taking Sildenafilo TecniGen and contact your doctor immediately.

It is not recommended to use Sildenafilo TecniGen at the same time as any other oral or local treatment for erectile dysfunction.

Special considerations in children and adolescents

The use of Sildenafilo TecniGen is not indicated in persons 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 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 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 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 (25 mg) of Sildenafilo TecniGen.

Some patients who are taking an alpha-blocker, a medicine used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness, which 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 happen within 4 hours of taking Sildenafilo TecniGen. To minimize the likelihood of these symptoms, you should be taking your daily dose of the alpha-blocker regularly before starting Sildenafilo TecniGen. Your doctor may advise you to start 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.

Drinking alcohol can temporarily impair your ability 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 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 or using machines.

3. How to TAKE SILDENAFILO TECNIGEN

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

Do not take Sildenafilo TecniGen more than once a day.

You should take Sildenafilo TecniGen about an 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 to get an erection if you are sexually stimulated. The time Sildenafilo TecniGen takes to work varies from person to person, but it normally takes between half an hour and one hour. The effect of Sildenafilo TecniGen may be delayed if you take it with a large meal.

If Sildenafilo TecniGen does not help you to get 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 side effects and their severity. Doses above 100 mg 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, telephone 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 everybody gets them. The side effects reported in association with the use of Sildenafilo TecniGen are usually 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 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 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), 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 eyes, abnormal sensation in the eye, irregular or rapid heartbeat, muscle pain, feeling sleepy, 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 tired.

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 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, 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. There have also been reports of seizures or convulsions and severe skin reactions that cause rash, blisters, peeling of the skin, and pain that require immediate medical attention.

If you think any of the side effects you are experiencing is serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. Storing SILDENAFILO TECNIGEN

Keep out of the reach and sight of children.

Store in the original package to protect from moisture.

Do not use Sildenafilo TecniGen after the expiry date stated on the packaging. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for safe disposal. If you are unsure, ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. FURTHER INFORMATION

Composition of Sildenafilo TecniGen 100 mg

The active substance of Sildenafilo TecniGen is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate).

The other ingredients 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 pack size

Sildenafilo TecniGen 100 mg film-coated tablets are elliptical and blue. They are engraved with "+" on one side.

Sildenafilo TecniGen 100 mg is available in blister packs of 4 or 8 tablets. Not all pack sizes may be marketed.

Other presentations:

Sildenafilo TecniGen 25 mg, packs of 4 tablets. Sildenafilo TecniGen 50 mg, packs of 1, 2, 4, or 8 tablets.

Marketing authorization holder and manufacturer

Marketing authorization 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 last revised in

July 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/