SILDENAFIL KRKA 50 mg FILM-COATED TABLETS

Introduction

Leaflet:information for the user

Sildenafilo Krka50mg film-coated tablets EFG

Sildenafil citrate

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Sildenafilo Krka and what is it used for
2. What you need to know before taking Sildenafilo Krka
3. How to take Sildenafilo Krka
4. Possible side effects

5 Conservation of Sildenafilo Krka

1. Package contents and additional information

1. What is Sildenafilo Krka and what is it used for

Sildenafilo Krka contains the active substance sildenafil, which belongs to a group of medications called phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels of the penis, allowing blood flow when sexually stimulated. Sildenafil will only help you achieve an erection if you are sexually stimulated.

Sildenafil is indicated for the treatment of erectile dysfunction in adult men, sometimes called impotence. This occurs when a man cannot obtain or maintain a firm erection suitable for satisfactory sexual activity.

2. What you need to know before taking Sildenafilo Krka

Do not take Sildenafilo Krka:

• If you are allergic to sildenafil or any of the other components of this medication (listed in section 6).
• If you are taking medications called nitrates, as the combination can lead to a dangerous decrease in your blood pressure. Consult your doctor if you are taking any of these medications, 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 medications called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination can lead to a dangerous decrease in your blood pressure.
  • If you are taking riociguat. This medication is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by blood clots). PDE5 inhibitors, such as Sildenafilo Krka, have shown that they increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.

• 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 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

Consult your doctor or pharmacist before starting to take this medication:

• 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. 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 or temporary loss of vision, stop taking sildenafil and contact your doctor immediately.

Sildenafil should not be used simultaneously with any other oral or local treatment for erectile dysfunction. You should not take sildenafil with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or any other PDE5 inhibitor.

You should not take this medication if you do not have erectile dysfunction. The use of sildenafil is not indicated in women.

Special considerations in patients with liver or kidney problems.

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

Children and adolescentsThe use of sildenafil is not indicated in persons under 18 years of age.

Use of Sildenafilo Krka with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Medications that contain sacubitril/valsartan, used to treat heart failure.

Sildenafil tablets may interfere with some medications, especially those used to treat chest pain. In case of a medical emergency, you should inform your doctor, pharmacist, or nurse that you are taking this medication and when you took it. You should not take sildenafil with other medications unless your doctor advises you to do so.

You should not take sildenafil if you are taking medications called nitrates, as the combination of these medications can lead to a dangerous decrease in your blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking any of these medications, which are often used to relieve angina pectoris (or "chest pain").

You should not take sildenafil if you are taking medications called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these medications can also lead to a dangerous decrease in your blood pressure.

Tell your doctor or pharmacist if you are taking riociguat.

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 sildenafil.

Some patients who are receiving an alpha-blocker, a medication used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness that can be caused by a decrease 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 of taking sildenafil. To reduce the likelihood of these symptoms, you should be taking your daily dose of the alpha-blocker regularly before starting sildenafil. Your doctor may recommend that you start treatment with the lower dose (25 mg) of sildenafil.

Use of Sildenafilo Krka with food, drinks, and alcohol

Sildenafil can be taken with or without food. However, you may notice that this medication takes a little longer to work if you take it with a large meal.

Consuming alcohol can temporarily make it more difficult 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 sildenafil.

Pregnancy, breastfeeding, and fertility

The use of sildenafil is not indicated in women.

Driving and using machines

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

Sildenafilo Krka contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Sildenafilo Krka

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The usual starting dose is 50mg.

Do not takesildenafilmore than once a day.

You should take sildenafil approximately one hour before you plan to have sex. Swallow the tablet whole with a glass of water.

If you notice that the effect of sildenafil 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 it takes for sildenafil to work varies from person to person, usually between half an hour and one hour. The effect of sildenafil can be delayed if you take it with a large meal.

In case sildenafil does not help you achieve an erection or if the erection is not maintained long enough to complete the sexual act, consult your doctor.

If you take moresildenafilthan you shouldIn case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 56204 20, indicating the medication and the amount ingested.

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.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them. The side effects reported in association with the use of sildenafil are generally mild to moderate and short-lived.

If you experience any of the following serious side effects, stop taking sildenafil and seek medical attention immediately:

• Allergic reaction - this occurs rarely (may affect up to 1 in 100 people). Symptoms include sudden wheezing, difficulty breathing, or dizziness, swelling of the eyelids, face, lips, or throat.
• Chest pain - this occurs rarely.

If they occur during or after having sex:

• Sit in a semi-upright position and try to relax.
• Do not use nitrates to treat chest pain.
• Prolonged and sometimes painful erections - this occurs rarely (may affect up to 1 in 1,000 people).

If you have an erection that lasts more than 4 hours, you should contact your doctor immediately.

• Sudden or temporary loss of vision - this occurs rarely.
• Severe skin reactions - this occurs rarely.

Symptoms can include severe scaling and swelling of the skin, blistering of the mouth, genitals, and around the eyes, as well as fever.

• Seizures or fits - this occurs rarely.

Other side effects:

Very common(mayaffect more than 1 in 10 people): headache.

Common(may affect up to 1 in 10 people): nausea, facial flushing, hot flushes (including a sudden feeling of heat in the upper body), indigestion, abnormal color perception, blurred vision, impaired vision, nasal congestion, and dizziness.

Uncommon(mayaffect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/ red eyes, eye pain, flashing lights, visual clarity, sensitivity to light, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced touch sensation, vertigo, ringing in the ears, dry mouth, nasal stuffiness or congestion, inflammation of the nasal mucosa (including symptoms such as runny nose, sneezing, and nasal congestion), pain in the upper abdomen, gastroesophageal reflux disease (including symptoms such as heartburn), blood in the urine, pain in the arms or legs, nosebleeds, feeling of warmth, and feeling of fatigue.

Rare(mayaffect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient decrease in blood flow to some parts of the brain, feeling of compression in the throat, numbness of the mouth, bleeding in the back of the eye, double vision, decreased visual acuity, abnormal sensation in the eye, eye or eyelid swelling, small particles or spots in the vision, seeing halos around lights, dilation of the pupil, change in the color of the white part of the eye, penile bleeding, presence of blood in the semen, dry nose, nasal swelling, feeling of irritability, and sudden or temporary loss of hearing.

During post-marketing experience, cases of unstable angina (heart disease) and sudden death have been rarely reported. It is worth noting that most of the men who experienced these side effects, although not all of them, had pre-existing heart problems before taking this medication. It is not possible to determine if these side effects were directly related to sildenafil.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the national reporting system: Spanish Pharmacovigilance System for Human Use Medications: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Conservation of Sildenafilo Krka

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

Do not use this medication after the expiration date that appears on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. By doing so, you will help protect the environment.

6. Package contents and additional information

Composition of Sildenafilo Krka

• The active substance is sildenafil citrate. Each film-coated tablet contains 50 mg of sildenafil (as citrate).
• The other components are microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose, hypromellose, magnesium stearate in the tablet core, and lactose monohydrate, hypromellose, titanium dioxide (E171), and triacetin in the film coating.

Appearance of the product and package contents

Sildenafilo Krka 50 mg film-coated tablets are biconvex, oval, white to almost white, and engraved with "50" on one side.

Sildenafilo Krka 50 mg is available in packs of 1, 2, 4, 8, and 12 film-coated tablets in blisters.

Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d. Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia.

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

Date of the last revision of this leaflet:May 2022

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/