Leaflet: information for the user

Sildenafilo TecniGen 50 mg film-coated tablets EFG

Sildenafil citrate

Read this leaflet carefully before you start taking the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for 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 experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 to flow when sexually stimulated. Sildenafilo TecniGen will only help to achieve an erection if you are sexually stimulated. Do 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, adequate erection for satisfactory sexual activity.

Do not take Sildenafilo TecniGen

Be especially careful with Sildenafilo TecniGen

Inform your doctor:

It is not recommended to use Sildenafilo TecniGen 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 old.

Special considerations in patients with renal or liver problems

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

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

Sildenafilo TecniGen tablets may interfere with some medications, especially those used to treat chest pain. In case of a medical emergency, you must inform any healthcare professional that you are taking Sildenafilo TecniGen and when you took it. Do not take Sildenafilo TecniGen with other medications unless your doctor advises you to.

You should not take Sildenafilo TecniGen if you are taking 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 medications, which are often used to relieve chest pain (or "chest pain").

You should not take Sildenafilo TecniGen if you are taking medications called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these products may also cause a potentially dangerous drop in your blood pressure.

If you are taking medications 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 taking an alpha-blocker, a medication used to treat high blood pressure or prostate enlargement, 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 Sildenafilo TecniGen with alpha-blockers. This is more likely to occur in the 4 hours following Sildenafilo TecniGen intake. 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 recommend that you start treatment with the lower dose (25 mg) of Sildenafilo TecniGen.

Use of Sildenafilo TecniGen with food and drinks

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

Consuming alcohol may temporarily impair your ability to achieve an erection. Therefore, to get the maximum benefit from the medication, 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 operating machinery

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

Follow exactly the administration instructions for Sildenafilo TecniGen 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.

Take Sildenafilo TecniGen approximately one hour before you plan to have sexual intercourse. Swallow the tablet whole with a little water.

If you estimate 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 it takes for Sildenafilo TecniGen to take effect varies from person to person, generally ranging from half an hour to one hour. The effect of Sildenafilo TecniGen may be delayed if taken with a large 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 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 Toxicological Information Service, phone 915 620 420 (indicating the medication and the amount ingested.

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

Like all medicines, Sildenafilo TecniGen can cause side effects, although not everyone will experience them. The reported side effects associated with the use of Sildenafilo TecniGen are generally mild to moderate in intensity and of short duration.

If you experience chest pain during or after sexual activity:

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 hissing sound while breathing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.

Prolonged and sometimes painful erections have been reported after taking Sildenafilo TecniGen. If you have an erection that lasts more than 4 hours, you must 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 or decreased visual acuity), nasal congestion, and dizziness.

Uncommon side effects(between 1 and 10 in 1000 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 of drowsiness, reduced sense of touch, vertigo, ringing in the ears, nausea, dry mouth, chest pain, bleeding from the penis, presence of blood in 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 loss or decrease in hearing.

Post-marketing experience side effects reported include: palpitations, chest pain, sudden death, decreased blood flow to some parts of the brain. Most, but not all, had heart problems before taking this medication. It is not possible to determine if these events were directly related to Sildenafilo TecniGen. Cases of seizures or crises and severe skin reactions that include rash, blisters, skin peeling, and pain requiring immediate medical attention have also been reported.

If you consider any of these side effects you are experiencing to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Keep out of reach and sight of children.

Store in the original packaging to protect it from moisture.

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

Do not dispose of medications through drains or trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Sildenafilo TecniGen 50 mg

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

The other components are:

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

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

Appearance of the product and packaging size

Sildenafilo TecniGen 50 mg tablets have a coating, are eliptical in shape and blue in color.

Sildenafilo TecniGen 50 mg is presented in blisters of 1, 2, 4 or 8 tablets per package. Some package sizes may only be marketed.

Other presentations:

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

Marketing authorization holder and responsible 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

Responsible manufacturer:

Atlantic Pharma – Produções Farmacêuticas SA

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

This leaflet has been revised in

July 2022

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/