Leaflet:information for the user

Sildenafilo Krka100mg 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 are unsure about anything, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do 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 male is unable to obtain or maintain a firm, adequate erection for satisfactory sexual activity.

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 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 "chest pain"). 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 Sildenafilo Krka, 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 experienced 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 additional strain of sexual activity.

- If you have a 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 any other medication for treating high blood pressure in the lungs (pulmonary arterial hypertension) that contains sildenafil or any other PDE5 inhibitor.

Do not take this medication if you do not have erectile dysfunction.

The use of sildenafil is not indicated in women.

Considerations for 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:
The use of sildenafil is not indicated in people under 18 years old.

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 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 "chest pain").

Do not take sildenafil if you are taking medications called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination 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 that you start 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 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 bit longer to take effect if you ingest it 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 sildenafil.

Pregnancy, breastfeeding, and fertility:

The use of sildenafil is not indicated 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 takesildenafiloapproximately one hour before you plan to have sexual relations. Swallowthe entire tablet with a glass of water.

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

Sildenafilowill only help you get an erection if you are sexuallystimulated. The time it takes for sildenafiloto take effect varies from person to person,usually ranging from half an hour to one hour. The effect ofsildenafilomay be delayed ifyou take it with a large meal.

If sildenafilodoes not help you get an erection or if the erectiondoes 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 anyother 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 (can affect up to 1 in 100 people).
The symptoms may include sudden onset of shortness of breath, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.

-Chest pain- this occurs with a low frequency.

Si appear during or aftermaintaining sexual relations:

-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 occursrarely(can 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 occursrarely.

-Severe skin reactions - this occursrarely.

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 occursrarely.

Other side effects:

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

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

Uncommon (can affect up to 1 in 100 people): vomiting,skin rash, eye irritation, eye discharge/red eyes, eye pain, flashing lights,visual clarity, light sensitivity,tearful 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 blockage or congestion,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, nasal bleeding, feeling of heat and feeling of fatigue.

Rare (can 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 from the penis, blood in semen, dry nose, nasal swelling, sensation ofirritability and sudden decrease or loss of hearing.

During post-marketing experiencethere have been rare cases of unstable angina (heart disease) and sudden death. It is worth noting that most men who experienced these side effects, although not all of them, had pre-existing heart problems when they took this medicine. It is not possible to determine if these side effects were directly related to sildenafil.

Reporting of side effects:

Ifyou experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appearin this prospectus. You can also report them directly through the national notification system:www.notificaRAM.es.

Byreporting side effects, you can contribute to providing more information on the safety of this medicine.

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.

Composition of Sildenafilo Krka

- The active ingredient is sildenafil citrate. Each film-coated tablet contains 100 mg 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 packaging

Sildenafilo Krka 100 mg film-coated tablets are biconvex, oval, white to almost white, and marked with “100” on one side.

Sildenafilo Krka 100 mg is available in packs of 1, 4, 8 and 12 film-coated tablets in blisters.

Only some pack 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

You can obtain more information about this medicinal product by contacting 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 medicinal product, please consult the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/