Sildenafil Krka 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sildenafil Krka 25 mg film-coated tablets EFG

Sildenafil citrate

Read the entire 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Sildenafil Krka is and what it is used for
2. What you need to know before taking Sildenafil Krka
3. How to take Sildenafil Krka
4. Possible adverse effects
5. How to store Sildenafil Krka
6. Contents of the pack and other information

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

Sildenafilo Krka contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels in the penis, allowing blood flow into the penis 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 referred to as impotence. This occurs when a man is unable to achieve or maintain a firm erection suitable for satisfactory sexual activity.

2. What you need to know before taking Sildenafil Krka

Do not take Sildenafil Krka:

• If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If you are taking medicines called nitrates, as the combination may cause a dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medicines, which are often used to relieve angina pain (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
• If you are using any medicines known as nitric oxide donors, such as amyl nitrate ("poppers"), as the combination may cause a dangerous drop in your blood pressure.
• If you are taking riociguat. This medicine 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 Sildenafil Krka have been shown to increase the hypotensive effect of this medicine. 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 sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NA-AION).

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• If you have sickle cell anemia (an abnormality of red blood cells), leukemia (cancer of blood cells), or multiple myeloma (cancer of the bone marrow).
• If you have penile deformity or Peyronie's disease.
• If you have heart problems. Your doctor must carefully assess whether your heart can tolerate the additional strain of sexual activity.
• If you currently have a stomach ulcer or bleeding disorders (such as hemophilia).
• If you experience sudden decrease or loss of vision, stop taking sildenafil and contact your doctor immediately.

It is not recommended to use sildenafil together with any other oral or local treatments for erectile dysfunction.

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

You should not take this medicine 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.

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 individuals under 18 years of age.

Taking Sildenafil Krka with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

Sildenafil tablets may interact with certain medicines, especially those used to treat chest pain. In a medical emergency, you must inform your doctor, pharmacist, or nurse that you are taking this medicine and when you took it. Do not take sildenafil with other medicines unless advised by your doctor.

You must not take sildenafil if you are taking medicines called nitrates, as the combination of these medicines may cause a dangerous drop in your blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often used to relieve angina pain (or "chest pain").

You must not take sildenafil if you are taking medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these medicines may also cause a dangerous drop in your blood pressure.

Inform your doctor or pharmacist if you are taking riociguat.

If you are taking protease inhibitors, such as those used in the treatment of HIV, your doctor may recommend starting treatment with the lowest dose (25 mg) of sildenafil.

Some patients taking an alpha-blocker, a medicine used to treat high blood pressure or benign prostatic hyperplasia, may experience dizziness or lightheadedness, which may be caused by a drop 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 after taking sildenafil. To reduce the likelihood of these symptoms, you should be on a regular daily dose of the alpha-blocker before starting sildenafil. Your doctor may advise you to start treatment with the lowest dose (25 mg) of sildenafil.

Taking Sildenafil Krka with food, drinks, and alcohol

Sildenafil may be taken with or without food. However, you may notice that this medicine takes slightly longer to work if taken with a heavy meal.

Drinking alcohol may temporarily impair your ability to get an erection. Therefore, to achieve the maximum benefit from the medicine, it is advisable not to drink 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 medicine may cause dizziness and affect vision. You should know how you react to sildenafil before driving or operating machinery.

Sildenafil Krka contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Sildenafil Krka

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The usual starting dose is 50 mg.

Sildenafil must not be taken more than once a day.

You should take sildenafil approximately one hour before planning to have sexual intercourse. Swallow the tablet whole with a glass of water.

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

Sildenafil will only help you achieve an erection if you are sexually stimulated. The time required for sildenafil to take effect varies from person to person, usually between half an hour and one hour. The effect of sildenafil may be delayed if taken with a heavy meal.

If sildenafil 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 sildenafil than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

You may experience an increase in the frequency and severity of adverse effects. Doses higher than 100 mg do not increase efficacy.

Do not take more tablets than recommended by your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. The adverse effects reported with sildenafil are generally mild to moderate in intensity and short in duration.

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

• Allergic reaction – this occurs uncommonly (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 uncommonly

If chest pain occurs during or after sexual activity:

• • 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 lasting more than 4 hours, you must contact your doctor immediately.

• Sudden decrease or loss of vision – this occurs rarely.
• Severe skin reactions – this occurs rarely.

Symptoms may include severe skin peeling and swelling, blistering in the mouth, genital area, and around the eyes, as well as fever.

• Seizures or fits – this occurs rarely.

Other adverse effects:

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

Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flushes (including sudden sensation of heat in the upper body), indigestion, colour vision abnormalities, blurred vision, visual disturbance, nasal congestion, and dizziness.

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

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to parts of the brain, throat tightness, mouth numbness, bleeding behind the eye, double vision, reduced visual acuity, abnormal sensation in the eye, eye or eyelid swelling, small particles or spots in vision, seeing halos around lights, pupil dilation, change in colour of the white part of the eye, penile bleeding, blood in semen, dry nose, swelling inside the nose, feeling irritable, 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 should be noted that most, although not all, of the men who experienced these adverse effects had pre-existing heart conditions before taking this medicine. It is not possible to determine whether these adverse effects were directly related to sildenafil.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the national reporting system: Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

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

5. Storage of Sildenafil Krka

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

Do not use this medicine after the expiry date stated on the blister and the carton following EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sildenafil Krka

• The active substance is sildenafil citrate. Each film-coated tablet contains 25 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), triacetin in the film coating.

Appearance of the product and contents of the pack

Sildenafil Krka 25 mg film-coated tablets are biconvex, oval, white to almost white film-coated tablets, engraved with "25" on one side.

Sildenafil Krka 25 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

Manufacturer

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

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

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

Date of the most recent revision of this leaflet: May 2022

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