Package Insert: Information for the Patient

Sildenafilo Alter 50 mg Chewable Tablets EFG

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, 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 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 package insert. See section 4.

Sildenafilo belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels of the penis, allowing blood to flow when sexually stimulated. Sildenafilo Alter will only help achieve an erection if you are sexually stimulated.

Sildenafilo Alter 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 Alter

• If you are allergic to sildenafilo 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 nitrate ("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, 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 severe 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 disease (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 Sildenafilo Alter.

-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 Sildenafilo Alter and contact your doctor immediately.

It is not recommended to use Sildenafilo Alter simultaneously with any other oral or local treatment for erectile dysfunction.

Do not take Sildenafilo Alter with treatments for pulmonary arterial hypertension (PAH) that contain sildenafilo or any other PDE5 inhibitor.

Do not take Sildenafilo Alter if you do not have erectile dysfunction.

The use of Sildenafilo Alter is not indicated in women.

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.

Children and adolescents

The use of sildenafilo is not indicated in individuals under 18 years old.

Taking Sildenafilo Alter with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication:

-Medications that contain sacubitril/valsartan, used to treat heart failure.

Sildenafilo tablets may interact 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 sildenafilo and when you took it. Do not take sildenafilo 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 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 sildenafilo if you are taking medications called nitric oxide donors, such as amyl nitrate ("poppers"), as the combination of these products 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 sildenafilo.

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 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.

Taking Sildenafilo Alter with food, drinks, and alcohol

Sildenafilo can be taken with or without food. However, you may notice that sildenafilo takes a little 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 that you do not consume large amounts of alcohol before taking sildenafilo.

Pregnancy, breastfeeding, and fertility

The use of sildenafilo is not indicated in women.

Driving and operating machinery

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

Sildenafilo Alter contains aspartame

This medication contains 4.3 mg of aspartame in each tablet, equivalent to 0.016 mg/mg.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Sildenafilo Alter contains lactose

If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. The recommended starting dose is 50 mg.

Do not take Sildenafilo Alter more than once a day. .

Take Sildenafilo Alter approximately one hour before planning to have sexual intercourse.

The tablet must be chewed and swallowed.

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

Sildenafilo 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 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 Sildenafilo Alter 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, or call the Toxicological Information Service, phone 915 620 420 (indicating the medication and the amount ingested).

If you have any doubts 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 this medicine and seek medical attention immediately:

• Severe allergic reaction - this occurs with infrequent frequency (may affect up to 1 in 100 people).

The symptoms include sudden hissing sound while breathing, difficulty breathing or dizziness, swelling of the face, lips, or throat.

• Chest pain - this occurs with infrequent frequency.

If they occur during or after sexual intercourse:

• Take a semi-recumbent position and try to relax.
• Do not use nitrates to treat chest pain.

• Prolonged and sometimes painful erections - this occurs infrequently (may 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.

• Sudden decrease or loss of vision - this occurs infrequently.
• Severe skin reactions - this occurs infrequently.

The symptoms may include severe peeling and swelling of the skin, vesicular oral, genital, and around the eyes, as well as fever.

• Convulsions or seizures - this occurs infrequently.

Other side effects:

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

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

Uncommon(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/red eyes, eye pain, flashing lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced tactile sensation, vertigo, tinnitus, dry mouth, nasal congestion or blockage, nasal mucosa inflammation (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, nosebleed, feeling of heat, and feeling tired.

Rare(may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient decrease in blood flow to some parts of the brain, sensation of throat constriction, numbness of the mouth, posterior eye bleeding, double vision, visual acuity decrease, abnormal eye sensation, eye swelling or eyelid swelling, small particles or spots in vision, halos around lights, pupil dilation, eye color change, penile bleeding, blood in semen, dry nose, nasal interior swelling, feeling of irritability, and sudden hearing loss.

During post-marketing experience, there 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 heart problems, before taking this medicine. It is not possible to determine if these side effects were directly related to sildenafil.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting 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.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Sildenafilo Alter

• The active ingredient is sildenafilo. Each tablet contains 50 mg of sildenafilo (as citrato).
• The other components are: polacrilina potásica, hidróxido de potasio (to adjust the pH) or ácido clorhídrico (to adjust the pH), estearato de magnesio, sílice coloidal anhidra, aspartamo (E951), croscarmelosa sódica, lactosa monohidrato, povidona K-30 and mint flavor (compound by flavorings: maltodextrina, modified cornstarch, peppermint essential oil and pulegona).

Appearance of the product and content of the container

Triangular, biconvex tablets, white in color, and engraved with “50” on one face.

The tablets are presented in blisters in containers of 1, 2, 4, 8 and 12 tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization

Laboratorios Alter S.A

C/ Mateo Inurria 30

28036 Madrid

Spain

Responsible for manufacturing

Genepharm S.A.

18 kmMarathon Avenue, 15351 Pallini Attikis

Greece

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park, Paola, PLA 3000

Malta

Date of the last review of this prospectus:April 2022

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicaments and Sanitary Products (AEMPS)http://www.aemps.gob.es/.