Leaflet:information for the user

Sildenafilo Krka50mg film-coated tablets

Sildenafil citrate

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any doubts, consult your doctor/pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Sildenafilo Krka

3.How to take Sildenafilo Krka

4.Possible side effects

5Storage of Sildenafilo Krka

6.Contents of the pack and additional informationl

SildenafiloKrkacontainsthe active ingredient sildenafilo, which belongs to a group of medicinescalled phosphodiesterase type 5 (PDE5) inhibitors. It works by dilatingthe blood vessels in the penis, allowing blood to flow when sexuallystimulated.Sildenafilo will only help you achieve anerection if you are sexually stimulated.

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

Do not take Sildenafilo Krka:

-If you are allergic to sildenafil or any of the other ingredients of this medication (listed in section 6).

-If you are taking certain medications called nitrates, as the combination may 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 chest pain (or "angina"). If you are unsure, consult your doctor or pharmacist.

-If you are using any of the medications called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination may 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 clots). PDE5 inhibitors, such as sildenafil, have shown to 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 disorder (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 blood disorder), leukemia (blood 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 handle the extra strain of sexual activity.

-If you have an active stomach ulcer or bleeding problems (such as hemophilia).

-If you experience a sudden decrease or loss of vision, stop taking sildenafil and contact your doctor immediately.

Do not use sildenafil simultaneously with any other oral or local treatment for erectile dysfunction.

Do not take sildenafil with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or any other PDE5 inhibitor.

Do not take sildenafil if you do not have erectile dysfunction.

Sildenafil is not indicated for use in women.

Special considerations in patients with liver or kidney problems:

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

Children and adolescents:
Sildenafil is not indicated for use in individuals under 18 years of age.

Use of Sildenafilo Krka with other medications:

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

Medications containing sacubitril/valsartan, used to treat heart failure.

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

Do not take sildenafil if you are taking nitrates, as the combination of these medications may 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 chest pain (or "angina").

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

Inform 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 starting treatment with the lowest dose (25 mg) of sildenafil.

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 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 in the 4 hours following sildenafil intake. To reduce the likelihood of these symptoms, you should be receiving your regular daily dose of the alpha-blocker before starting sildenafil. Your doctor may recommend starting 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 take effect if taken with a large meal.

Consuming alcohol may temporarily impair your ability to achieve an erection. Therefore, to maximize the benefits of the medication, it is recommended not to consume large amounts of alcohol before taking sildenafil.

Pregnancy, breastfeeding, and fertility:

Sildenafil is not indicated for use in women.

Driving and operating machinery:

This medication may cause dizziness and affect your vision. You should know how you react to sildenafil before driving vehicles or operating 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.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The normal starting dose is 50mg.

Do not takesildenafilomore than once a day.

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

If you notice that the effect of sildenafilo is too strong or weak, inform your doctor or pharmacist.

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

If sildenafilo does not help you get an erection or if the erection does not last long enough to complete the sexual act, consult your doctor.

If you take moresildenafilothan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 56204 20 indicating the medication and the amount ingested.

You may experience an increase in adverse effects and their severity.Doses above 100mg do not increase efficacy.

Do not take more tablets than recommended by your doctor.

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

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

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

-Allergic reaction - this occurs with a low frequency (may affect up to 1 in 100 people).
The symptoms include sudden swelling of the face, lips, tongue, or throat, difficulty breathing, or a rapid heartbeat.

-Chest pain - this occurs with a low frequency.

Si appear during or after sexual intercourse:

-Position yourself in a semi-recumbent 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 must contact your doctor immediately.

-Decreased vision or loss of vision - this occurs rarely.

-Severe skin reactions - this occurs rarely.

The symptoms may include severe peeling and swelling of the skin, vesiculation of the mouth, genitals, and around the eyes, as well as fever.

-Convulsions or seizures - this occurs rarely.

Other side effects:

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

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

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/red eyes, eye pain, flashing lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced tactile sensation, vertigo, ringing in the ears, dry mouth, nasal congestion or blockage, inflammation of the nasal mucosa (including symptoms such as runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including symptoms such as heartburn), blood in urine, arm or leg pain, nosebleed, feeling of heat, and feeling tired.

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

During post-marketing experience, rare cases of unstable angina (heart disease) and sudden death have been reported. It is worth noting that most men who experienced these side effects, although not all of them, had 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system: Spanish System of Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

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 on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Sildenafilo Krka Composition

-The active ingredient is sildenafil citrate. Each film-coated tablet contains50mg of sildenafil (as citrate).

-The other components are microcrystalline cellulose, anhydrous calcium hydrogen phosphate, croscarmellose sodium, hypromellose, magnesium stearate in the tablet core, and lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin in the film coating.

Appearance of the product and contents of the package

Sildenafilo Krka50mg film-coated tablets are biconvex, oval-shaped, white to almost white film-coated tablets, engraved with “50” on one side.

Sildenafilo Krka50mgisavailable in boxes of 1,2,4, 8and 12 film-coated tablets in blisters.

Only some package sizes may be marketed.

Marketing Authorization Holder

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

Responsible for manufacturing

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

TAD Pharma GmbH, Heinz-Lohmann-Stra?e 5, 27472 Cuxhaven, Germany

For more information about this medication, please contact the local representative of the marketing authorization holder:

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

Last review date of this leaflet:May 2022

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/