Leaflet: information for the user

Sildenafilo KERN PHARMA 50 mg film-coated tablets EFG

Sildenafilo citrate

Read this leaflet carefully before you start taking the medicine.

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

1. What Sildenafilo Kern Pharma is and what it is used for

2. Before taking Sildenafilo Kern Pharma

3. How to take Sildenafilo Kern Pharma

4. Possible side effects

5. Storage of Sildenafilo Kern Pharma

6. Additional information

Sildenafilo Kern Pharma belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels in the penis, allowing blood to flow when sexually stimulated. Sildenafilo Kern Pharma will only help you achieve an erection if you are sexually stimulated. Do not take Sildenafilo Kern Pharma if you do not have erectile dysfunction. The use of Sildenafilo Kern Pharma is not indicated in women.

Sildenafilo 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, adequate erection for satisfactory sexual activity.

Do not take Sildenafilo Kern Pharma

• If you are taking certain medications called nitrates, as the combination may 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 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 cause a potentially dangerous drop in your blood pressure.
• If you are allergic (hypersensitive) to sildenafilo or to any of the other components of Sildenafilo 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 disorder (such as retinitis pigmentosa).
• If you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Be especially careful with Sildenafilo Kern Pharma

Inform your doctor:

• 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. In this case, your doctor must carefully check if your heart can handle the additional effort of having sex.
• If you have a stomach ulcer or bleeding problems (such as hemophilia).
• If you experience a sudden decrease or loss of vision, stop taking sildenafilo and contact your doctor immediately.

Do not use Sildenafilo Kern Pharma simultaneously with any other oral or local treatment for erectile dysfunction.

Special considerations in children and adolescents

The use of Sildenafilo Kern Pharma is not indicated in people under 18 years old.

Special considerations in patients with kidney or liver problems

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

Taking other medications

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

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

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

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

If you are taking protease inhibitors, such as those used to treat HIV, your doctor may recommend that you start treatment with the lowest dose (25 mg) of sildenafilo.

Some patients taking an alpha-blocker, a medication used to treat high blood pressure or prostate hypertrophy, may experience dizziness or lightheadedness caused by a drop in blood pressure when sitting or standing up quickly.

Some patients have experienced these symptoms when taking sildenafilo with alpha-blockers. This is more likely to occur in the 4 hours following sildenafilo intake. To reduce the likelihood of these symptoms, you should be receiving your daily dose of the alpha-blocker regularly before starting sildenafilo. Your doctor may recommend that you start treatment with the lower dose (25 mg) of sildenafilo.

Caution should be exercised when initiating treatment with sildenafilo in patients treated with sacubitril/valsartan, used to treat heart failure.

Use of Sildenafilo Kern Pharma with food and beverages

Sildenafilo Kern Pharma can be taken with or without food. However, you may notice that Sildenafilo Kern Pharma 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 get the maximum benefit from the medication, it is recommended not to consume large amounts of alcohol before taking sildenafilo.

Pregnancy and breastfeeding

The use of sildenafilo is not indicated in women.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Sildenafilo Kern Pharma may cause dizziness and affect your vision. You should know how you react to sildenafilo before driving vehicles or operating machinery.

Important information about some of the components of Sildenafilo Kern Pharma

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

Follow exactly the administration instructions for Sildenafilo Kern Pharma as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. The usual starting dose is 50 mg.

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

Take Sildenafilo Kern Pharma approximately one hour before you plan to have sexual intercourse. Swallow the tablet whole with a glass of water.

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

Sildenafilo Kern Pharma will only help you achieve an erection if you are sexually stimulated.

The time it takes for sildenafilo to take effect varies from person to person, generally ranging from half an hour to one hour. The effect of sildenafilo may be delayed if taken with a large meal.

If Sildenafilo Kern Pharma does not help you achieve an erection or if the erection does not last long enough to complete the sexual act, consult your doctor.

If you take more Sildenafilo 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 Toxicological 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.

Like all medicines, Sildenafilo Kern Pharma may cause side effects, although not everyone will experience them. The reported side effects associated with the use of sildenafilo are generally mild to moderate in intensity and of short duration.

If you experience chest pain during or after sexual activity:

- Sit in a semi-recumbent position and try to relax

-Do not use nitratesto treat your chest pain

- Contact your doctor immediately

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

There have been reported cases of prolonged and sometimes painful erections after taking sildenafilo. If you have an erection that lasts more than 4 hours, you must contact your doctor immediately.

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

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

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

Infrequent side effects(may affect between 1 and 10 in 1000 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 tactile sensation, vertigo, ringing in the ears, nausea, dry mouth, chest pain, feeling of fatigue, watery eyes, penile bleeding, and presence of blood in semen and/or urine.

Rare side effects(may affect between 1 and 10 in 10000 patients) include: high blood pressure, low blood pressure, fainting, stroke, nasal bleeding, sudden hearing loss, and heart attack.

The reported side effects from post-marketing experience include: palpitations, chest pain, sudden death, transient decrease in blood flow to some parts of the brain. Most, but not all, had heart problems before taking this medication. It is not possible to determine if these events were directly related to sildenafilo. Also, there have been reported cases of seizures or crises and severe skin reactions that include rash, blisters, skin peeling, and pain requiring immediate medical attention.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

No special storage conditions are required.

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

Do not dispose of medications through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Sildenafilo Kern Pharma

− The active ingredient is sildenafilo. Each tablet contains sildenafilo citrate equivalent to 50 mg of sildenafilo.

− The other components are:

• Tablet core: powdered cellulose, colloidal silica (anhydrous), dibasic calcium phosphate (anhydrous), croscarmellose sodium, 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

Sildenafilo Kern Pharma 50 mg tablets have a film coating, are blue in color, circular, and biconvex. Sildenafilo Kern Pharma is presented in blisters containing 2, 4, 8, or 12 tablets. There are also packaging sizes of 25 mg and 100 mg.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Kern Pharma S.L.

Polígono Ind. Colón II. Venus, 72

08228 Terrassa (Barcelona)

Responsible manufacturer

INDUSTRIA QUIMICA Y FARMACEÚTICA VIR S.A

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

Alcorcon, 28923 Madrid

Spain

This prospectus was approved in April 2013.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.