SILDENAFIL KERN PHARMA 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sildenafil KERN PHARMA 100 mg film-coated tablets EFG

Sildenafil citrate

Read the entire package leaflet carefully before starting to take the medication.

• Keep this package 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 and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you are experiencing to be serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the package leaflet:

1. What Sildenafil Kern Pharma is and what it is used for
2. Before taking Sildenafil Kern Pharma
3. How to take Sildenafil Kern Pharma
4. Possible side effects
5. Storage of Sildenafil Kern Pharma
6. Additional information

1. What SILDENAFILO KERN PHARMA is and what it is used for

Sildenafil Kern Pharma 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 you are sexually stimulated. Sildenafil Kern Pharma will only help you achieve an erection if you are sexually stimulated. You should not take Sildenafil Kern Pharma if you do not have erectile dysfunction. The use of Sildenafil Kern Pharma is not indicated in women.

Sildenafil Kern Pharma is indicated for the treatment of male erectile dysfunction, sometimes called impotence. This occurs when a man cannot obtain or maintain a firm erection sufficient for satisfactory sexual activity.

2. BEFORE TAKING SILDENAFILO KERN PHARMA

Do not take Sildenafil Kern Pharma

• If you are taking medications called nitrates, as the combination can cause a potentially dangerous drop 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 cause a potentially dangerous drop in your blood pressure.
• If you are allergic (hypersensitive) to sildenafil or any of the other components of Sildenafil Kern Pharma.
• 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 a loss of vision due to a non-arteritic anterior ischemic optic neuropathy (NAION).

Be careful with Sildenafil Kern Pharma

Tell your doctor:

• 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 penis deformity or Peyronie's disease.
• If you have heart problems. In this case, 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 decrease or loss of vision, stop taking sildenafil and contact your doctor immediately.

Sildenafil Kern Pharma should not be used simultaneously with any other oral or local treatment for erectile dysfunction.

Special considerations in children and adolescents

The use of Sildenafil Kern Pharma is not indicated in persons under 18 years of age.

Special considerations in patients with renal or hepatic impairment

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

Taking other medications

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

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

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

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

If you are taking medications known as protease inhibitors, such as those used in the treatment of 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 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 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.

Caution should be exercised when starting treatment with sildenafil in patients treated with medications containing sacubitril/valsartan, used to treat heart failure.

Using Sildenafil Kern Pharma with food and drinks

Sildenafil Kern Pharma can be taken with or without food. However, you may notice that Sildenafil Kern Pharma 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 and breastfeeding

The use of Sildenafil Kern Pharma is not indicated in women.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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

Important information about some of the components of Sildenafil Kern Pharma

This medication can cause allergic reactions because it contains Tartrazine (E-102). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. HOW TO TAKE SILDENAFILO KERN PHARMA

Follow the administration instructions of Sildenafil Kern Pharma indicated by your doctor. Consult your doctor or pharmacist if you have doubts. The normal starting dose is 50 mg.

Do not take Sildenafil Kern Pharma more than once a day.

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

If you think the effect of sildenafil is too strong or too weak, tell your doctor or pharmacist.

Sildenafil Kern Pharma 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 the event that Sildenafil Kern Pharma does not help you achieve an erection or if the erection is not maintained long enough to complete sexual intercourse, consult your doctor.

If you take more Sildenafil Kern Pharma 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.

Contact your doctor if you have taken more tablets than advised. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

4. Possible side effects

Like all medications, Sildenafil Kern Pharma can have 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 chest pain during or after having sex:

• Sit in a semi-sitting position and try to relax
• Do not use nitrates to treat your chest pain
• Contact your doctor immediately

All medications, including Sildenafil Kern Pharma, can cause allergic reactions. You should contact your doctor immediately if you experience any of the following symptoms after taking Sildenafil Kern Pharma: sudden wheezing, difficulty breathing, or dizziness, swelling of the eyelids, face, lips, or throat.

There have been reports of prolonged and sometimes painful erections after taking sildenafil. If you have an erection that lasts more than 4 hours, you should contact your doctor immediately.

If you experience a sudden decrease or loss of vision, stop taking Sildenafil Kern Pharma and contact your doctor immediately.

The most common side effect(may affect more than 1 in 10 patients) is headache.

Common side effects(may affect between 1 and 10 in 100 patients) include: facial flushing, indigestion, effects on vision (including abnormal color perception, sensitivity to light, or blurred vision or decreased visual acuity), nasal congestion, and dizziness.

Uncommon side effects(may affect between 1 and 10 in 1,000 patients) include: vomiting, skin rash, bleeding in the back of the eye, eye irritation, eye discharge/red eyes, eye pain, double vision, 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, feeling of fatigue, watery eye, bleeding from the penis, presence of blood in the semen and/or urine.

Rare side effects(may affect between 1 and 10 in 10,000 patients) include: high blood pressure, low blood pressure, fainting, stroke, nosebleed, sudden decrease or loss of hearing, heart attack.

The side effects reported from post-marketing experience include: palpitations, chest pain, sudden death, transient reduction in blood flow to some parts of the brain. Most, but not all, of these patients had pre-existing heart problems before taking this medication. It is not possible to determine if these events were directly related to sildenafil. There have also been reports of seizures or convulsions and severe skin reactions that cause rash, blisters, skin peeling, and pain that require immediate medical attention.

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

5. Storage of SILDENAFILO KERN PHARMA

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Sildenafil Kern Pharma after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Sildenafil Kern Pharma

• The active ingredient is sildenafil. Each tablet contains sildenafil citrate equivalent to 100 mg of sildenafil.

• The other components are:
  • Core of the tablet: cellulose powder, colloidal silica (anhydrous), calcium phosphate dibasic (anhydrous), sodium croscarmellose, magnesium stearate.
  • • Coating: hypromellose (E464), titanium dioxide (E171), triacetin (E1518), carmine indigo (E132), brilliant blue FCF (E133), and tartrazine (E102).

Appearance of the product and packaging size

Sildenafil Kern Pharma 100 mg film-coated tablets are blue, circular, and biconvex. Sildenafil Kern Pharma is available in blisters containing 2, 4, 8, or 12 tablets. There are also 25 mg and 50 mg packaging sizes.

Not all packaging sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Kern Pharma S.L.

Polígono Ind. Colón II. Venus, 72

08228 Terrassa (Barcelona)

Manufacturer

INDUSTRIA QUIMICA Y FARMACEÚTICA VIR S.A

C/ Laguna 66-68-70, Pol. Industrial Urtinsa II,

Alcorcon, 28923 Madrid

Spain

This package leaflet was approved in April 2013.

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