SILDENAFIL ALTER 50 mg CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the Patient

Sildenafil Alter 50 mg Chewable Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• 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 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Sildenafil Alter is and what it is used for
2. What you need to know before taking Sildenafil Alter
3. How to take Sildenafil Alter
4. Possible side effects
5. Storage of Sildenafil Alter
6. Package Contents and Additional Information

1. What Sildenafil Alter is and what it is used for

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

Sildenafil Alter is indicated for the treatment of erectile dysfunction in adult men, sometimes called impotence. This occurs when a man cannot get or maintain a firm erection suitable for satisfactory sexual activity.

2. What you need to know before taking Sildenafil Alter

Do not take Sildenafil Alter

• If you are allergic to sildenafil or any of the other ingredients of this medication (listed in section 6).
• If you are taking medications called nitrates, as the combination can lead to a dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medications, which are often given 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 nitrate ("poppers"), as the combination can lead to a dangerous drop 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 blood clots). PDE5 inhibitors, such as sildenafil, have shown that they increase the hypotensive effect of this medication. 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 a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Sildenafil Alter.

• If you have sickle cell anemia (a blood disorder), leukemia (cancer of the blood cells), or multiple myeloma (cancer of the bone marrow).
• If you have a penis deformity or Peyronie's disease.
• If you have heart problems. Your doctor should carefully check if your heart can withstand the extra strain of having sex.
• If you currently have stomach ulcers or bleeding problems (such as hemophilia).
• If you experience a sudden loss of vision, stop taking Sildenafil Alter and contact your doctor immediately.

It is not recommended to use Sildenafil Alter at the same time as any other oral or local treatment for erectile dysfunction.

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

You should not take Sildenafil Alter if you do not have erectile dysfunction.

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

Taking Sildenafil Alter with Other Medications

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

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

Sildenafil 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. You should not take sildenafil with other medications unless your doctor advises you to do so.

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

You should not take sildenafil if you are taking medications called nitric oxide donors, such as amyl nitrate ("poppers"), as the combination of these products can also lead to a dangerous drop 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 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 decrease 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.

Taking Sildenafil Alter with Food, Drinks, and Alcohol

Sildenafil can be taken with or without food. However, you may notice that sildenafil takes a little longer to work if you take it with a large meal.

Consuming alcohol can temporarily make it more difficult to get 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, Breastfeeding, and Fertility

The use of sildenafil is not indicated in women.

Driving and Using Machines

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

Sildenafil 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 case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

Sildenafil Alter contains Lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to Take Sildenafil Alter

Follow the administration instructions of this medication indicated by your doctor or pharmacist exactly. If you are unsure, consult your doctor or pharmacist again. The recommended starting dose is 50 mg.

You should not take Sildenafil Alter more than once a day.

You should take Sildenafil Alter approximately one hour before you plan to have sex.

The tablet should be chewed and swallowed.

If you notice that the action 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 it takes for sildenafil to work varies from person to person, usually between half an hour and one hour. The effect of sildenafil may be delayed if you take it with a large meal.

In case sildenafil 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 Alter than you should

You may experience an increase in side effects and their severity. Doses above 100 mg do not increase efficacy.

You should 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 Toxicology 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.

4. Possible Side Effects

Like all medications, this medication can cause 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 any of the following serious side effects, stop taking this medication and seek medical attention immediately:

• Allergic reaction - this occurs with rare frequency(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 with rare frequency.

If it occurs during or after having sex:

• Sit in a semi-upright position and try to relax.
• Do not use nitratesto treat chest pain.

• Prolonged and sometimes painful erections - this occurs very rarely(may affect up to 1 in 1,000 people).

If you have an erection that lasts more than 4 hours, you should contact your doctor immediately.

• Sudden loss of vision - this occurs very rarely.
• Severe skin reactions - this occurs very rarely.

Symptoms can include severe skin peeling and swelling, blistering of the mouth, genitals, and around the eyes, as well as fever.

• Seizures or fits - this occurs very rarely.

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 a sudden feeling of heat in the upper body), indigestion, abnormal color perception, 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, flashing lights, visual clarity, sensitivity to light, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of tiredness, reduced touch sensation, vertigo, ringing in the ears, dry mouth, blocked or stuffy nose, inflammation of the nasal mucosa (including symptoms such as runny nose, sneezing, and nasal congestion), pain in the upper abdomen, gastroesophageal reflux disease (including symptoms such as heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling of heat, and feeling of fatigue.

Rare(may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decrease in blood flow to some parts of the brain, feeling of compression in the throat, numbness of the mouth, bleeding in the back of the eye, double vision, decreased visual acuity, abnormal sensation in the eye, eye or eyelid swelling, small particles or spots in vision, seeing halos around lights, dilation of the pupil, change in color of the white of the eye, bleeding from the penis, presence of blood in semen, dry nose, swelling inside the nose, feeling of irritability, and sudden loss of hearing.

During post-marketing experience, unstable angina (heart disease) and sudden death have been rarely reported. It is worth noting that most men who experienced these side effects, although not all of them, had pre-existing heart problems before taking this medication. It is not possible to determine if these side effects were directly related to sildenafil.

Reporting Side Effects:

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Sildenafil Alter

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

This medication does not require any special storage temperature.

Keep it in the original package to protect it from light.

Do not use this medication after the expiration date that appears on the package after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Sildenafil Alter

• The active ingredient is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate).
• The other ingredients are: potassium polacrylate, potassium hydroxide (for pH adjustment) or hydrochloric acid (for pH adjustment), magnesium stearate, anhydrous colloidal silica, aspartame (E951), sodium croscarmellose, lactose monohydrate, povidone K-30, and peppermint flavor (composed of flavorings: maltodextrin, modified corn starch, peppermint essential oil, and pulegone).

Appearance of the Product and Package Contents

Triangular, biconvex tablets, white in color, and engraved with "50" on one side.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Alter S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Genepharm S.A.

18 km Marathon Avenue, 15351 Pallini Attikis

Greece

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park, Paola, PLA 3000

Malta

Date of Last Revision of this Package Leaflet:April 2022

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/