SILDENAFIL KERN PHARMA 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sildenafil KERN PHARMA 50 mg film-coated tablets EFG

Sildenafil citrate

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

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, consult your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

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. Further information

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

Sildenafil Kern Pharma belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5). It works by dilating the blood vessels in 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 medicines 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 medicines, 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 of the medicines 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 non-arteritic anterior ischemic optic neuropathy (NAION).

Be careful with Sildenafil Kern Pharma

Tell your doctor:

• If you have sickle cell anemia (a blood disorder), 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 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 kidney or liver problems

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

Taking other medicines

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

Sildenafil Kern Pharma tablets may interfere with some medicines, 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 medicines unless your doctor advises you to do so.

Do not take sildenafil if you are taking medicines 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 medicines, which are often used to relieve angina pectoris (or "chest pain").

Do not take sildenafil if you are taking medicines 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 medicines 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 medicine used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness, which 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 minimize 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 medicines 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 impair your ability to achieve an erection. Therefore, to get the maximum benefit from the medicine, it is recommended not to consume large amounts of alcohol before taking sildenafil.

Pregnancy and breastfeeding

The use of sildenafil is not indicated in women.

Consult your doctor or pharmacist before using any medicine.

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 ingredients of Sildenafil Kern Pharma

This medicine may 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 instructions for administration of Sildenafil Kern Pharma exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any 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.

If 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 your doctor recommends.

Contact your doctor if you have taken more tablets than recommended. 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 medicine and the amount taken.

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

4. Possible side effects

Like all medicines, Sildenafil Kern Pharma can cause side effects, although not everybody gets them. The side effects associated with the use of sildenafil are usually mild to moderate and short-lived.

If you experience chest pain during or after having sex:

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

All medicines, 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 loss of vision, stop taking Sildenafil Kern Pharma and contact your doctor immediately.

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

Common side effects(affects 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(affects 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 tiredness, reduced sense of touch, vertigo, ringing in the ears, nausea, dry mouth, chest pain, feeling of fatigue, watery eyes, and bleeding from the penis and presence of blood in the semen and/or urine.

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

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

If you consider that any of the side effects you are experiencing is 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 expiry date stated on the packaging. The expiry date is the last day of the month indicated.

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

6. FURTHER INFORMATION

Composition of Sildenafil Kern Pharma

• The active ingredient is sildenafil. Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil.

• The other ingredients 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), indigo carmine (E132), brilliant blue FCF (E133), and tartrazine (E102).

Appearance of the product and packaging size

Sildenafil Kern Pharma 50 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 100 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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.