GALOTAM 50 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Galotam 50 mg film-coated tablets EFG

sildenafil

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine 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 experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Galotam is and what it is used for
2. What you need to know before taking Galotam
3. How to take Galotam
4. Possible side effects
5. Storage of Galotam
6. Package contents and additional information

1. What Galotam is and what it is used for

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

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

2. What you need to know before taking Galotam

Do not take Galotam

• If you are allergic (hypersensitive) to sildenafil or any of the other components of this medicine (listed in section 6).
• If you are taking medicines called nitrates, as the combination can cause a 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 dangerous drop in your blood pressure.
• If you are taking riociguat. This medicine 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 Galotam, have shown that they increase the hypotensive effect of this medicine. 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, cerebral infarction, or heart attack, or if you have low blood pressure.
• If you suffer from 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 Galotam:

• If you have sickle cell anemia (a red blood cell abnormality), leukemia (cancer of the blood cells), 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 should carefully check if your heart can withstand the extra effort of having sex.
• If you currently have a stomach ulcer or bleeding disorders (such as hemophilia).
• If you experience a sudden decrease or loss of vision, stop taking Galotam and contact your doctor immediately.

It is not recommended to use sildenafil simultaneously with any other treatment for erectile dysfunction.

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

Do not take Galotam if you do not have erectile dysfunction.

The use of Galotam is not indicated in women.

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.

Children and adolescents

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

Other medicines and Galotam

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine, including those purchased without a prescription.

Galotam 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 Galotam and when you took it. Do not take Galotam with other medicines unless your doctor advises you to do so.

Do not take Galotam if you are taking medicines called nitrates, as the combination of these products can lead to a 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 Galotam if you are taking medicines called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these 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 medicines 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 Galotam.

Some patients who are receiving an alpha-blocker, a medicine used to treat high blood pressure or prostatic hyperplasia, may experience dizziness or a feeling of fainting 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 reduce the likelihood of these symptoms, you should be receiving your daily dose of alpha-blockers regularly before starting Galotam. Your doctor may indicate that you start treatment with the lower dose (25 mg) of Galotam.

Inform your doctor or pharmacist if you are taking medicines that contain sacubitril/valsartan, used to treat heart failure.

Taking Galotam with food, drinks, and alcohol

Galotam can be taken with or without food. However, you may notice that Galotam 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 medicine, it is recommended not to consume large amounts of alcohol before taking Galotam.

Pregnancy, breastfeeding, and fertility

The use of Galotam is not indicated in women.

Driving and using machines

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

Galotam contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Galotam

Follow your doctor's instructions for taking Galotam exactly. If you are unsure, consult your doctor or pharmacist again. The recommended starting dose is 50 mg.

Do not take Galotam more than once a day.

Do not take Galotam with other medicines that contain sildenafil.

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

Swallow the tablet whole with a glass of water.

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

Galotam will only help you achieve an erection if you are sexually stimulated. The time it takes for Galotam to work varies from person to person, usually between half an hour and one hour. The effect of this medicine can be delayed if you take it with a large meal.

In case Galotam 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 Galotam 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 medicine and the amount taken.

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

4. Possible side effects

Like all medicines, Galotam can cause side effects, although not everyone gets them. The side effects reported 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 Galotam and seek medical attention immediately:

• Allergic reaction - this occurs with infrequent 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 infrequent frequency

If it occurs during or after 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 rarely(may affect up to 1 in 1000 people)

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

• Sudden decrease or loss of vision - this occurs rarely

• Severe skin reactions - this occurs rarely

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

• Seizures or fits - this occurs 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, hot flushes (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 drowsiness, reduced sense of touch, 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 the urine, pain in the arms or legs, nosebleeds, feeling of warmth, and feeling of fatigue.

Rare(may affect up to 1 in 1000 people): fainting, stroke, heart attack, irregular heartbeat, transient 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 the vision, seeing halos around lights, dilation of the pupil, change in the color of the white of the eye, penile bleeding, presence of blood in the semen, dry nose, swelling inside the nose, feeling of irritability, and sudden decrease or 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 medicine. It is not possible to determine if these side effects were directly related to Galotam.

Reporting side effects

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

5. Storage of Galotam

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

No special storage conditions are required.

Do not use this medicine after the expiration date stated on the packaging after EXP. The expiration 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 pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Additional information

Composition of Galotam

• The active ingredient is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate).
• The other ingredients are:

Core: calcium phosphate dihydrate, microcrystalline cellulose, magnesium stearate, colloidal silica, and sodium croscarmellose.

Coating: hypromellose, titanium dioxide (E-171), macrogol 6000, talc, and indigo carmine lake (E-132).

Appearance of the product and package contents

Galotam 50 mg: film-coated tablets, blue, elongated, and engraved (50).

Available in packs of 1, 2, 4, 8, and 12 tablets.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid, Spain

Date of the last revision of this leaflet:May 2024

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