Package Insert: Information for the Patient

Galotam 25 mg Film-Coated Tablets EFG

sildenafil

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication 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 experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Galotam contains the active ingredient sildenafilo, which 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. 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 referred to as impotence. This occurs when a man is unable to obtain or maintain a firm, adequate erection for satisfactory sexual activity.

Do not take Galotam

• If you are allergic to sildenafil or any of the other components of this medication (listed in section 6).
• If you are taking 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 "angina"). 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 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 clots). PDE5 inhibitors, such as Galotam, 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, cerebral infarction, 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).

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 (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 an active 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.

Galotam is not recommended to be used simultaneously with any other oral or local 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.

Galotam is not indicated for use in women.

Special considerations in patients with renal or hepatic problems

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

Children and adolescents

Galotam is not indicated for use in individuals under 18 years of age.

Other medications and Galotam

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Galotam tablets may interact 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 Galotam and when you took it. Do not take Galotam with other medications unless your doctor advises you to.

Do not take Galotam if you are taking medications called nitrates, as the combination 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 "angina").

Do not take Galotam if you are taking medications called nitric oxide donors such as amyl nitrite ("poppers"), as the combination may cause 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 Galotam.

Some patients taking an alpha-blocker, a medication used to treat high blood pressure or benign prostatic hyperplasia, may experience dizziness or lightheadedness caused by a drop in blood pressure when standing or sitting up quickly. Some patients have experienced these symptoms when taking sildenafil with alpha-blockers. This is more likely to occur within 4 hours after taking sildenafil. To reduce the likelihood of these symptoms, you should be receiving your regular daily dose of alpha-blockers before starting Galotam. Your doctor may recommend that you start treatment with the lower dose (25 mg) of Galotam.

Inform your doctor or pharmacist if you are takingmedications 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 bit 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 Galotam.

Pregnancy, breastfeeding, and fertility

Galotam is not indicated for use in women.

Driving and operating machinery

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

Galotam contains sodium

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

Follow exactly the administration instructions for Galotam indicated by your doctor.In case of doubt, 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 medications that contain sildenafil.

Take Galotam approximately one hour before planning to have sexual intercourse.

Swallow the tablet whole with a glass of water.

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

Galotam will only help you get an erection if you are sexually stimulated. The time it takes for Galotam to take effect varies from person to person, generally ranging from 30 minutes to one hour. The effect of this medication may be delayed if taken with a large meal.

If Galotam does not help you get an erection or if the erection does not last 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 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 medication, ask your doctor or pharmacist.

Like all medications, Galotam may cause side effects, although not everyone will experience them. The reported side effects associated with the use of sildenafil are generally mild to moderate in intensity and of short duration.

If you experience any of the following severe side effects, stop taking Galotam and seek medical attention immediately:

• Allergic reaction - this occurs withinfrequent frequency(may affect up to 1 in 100 people)

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

• Chest pain - this occurs withinfrequent frequency

If it occurs during or after sexual intercourse:

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

• Prolonged and sometimes painful erections - this occursinfrequently(may affect up to 1 in 1000 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 occursinfrequently

• Severe skin reactions - this occursinfrequently

The symptoms may include severe peeling and swelling of the skin, vesiculation of the mouth, genitals, and around the eyes, as well as fever.

• Convulsions or seizures - this occursinfrequently

Other side effects:

Very common(may affect more than1 in 10 people): headache.

Common(may affect up to1 in 10 people): nausea, facial flushing,heat sensation (including sudden feeling of heat in the upper body),indigestion, abnormal color perception, blurred vision, visual deterioration, nasal congestion, and dizziness.

Infrequent(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/ red eyes, eye pain, flashing lights vision, visual clarity, light sensitivity,, watery eyes,palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced tactile sensation, vertigo, ringing in the ears, 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 1000 people):syncope, stroke, heart attack, irregular heartbeat, transient decrease in blood flow to some parts of the brain, sensation of throat constriction, numbness of the mouth, bleeding in the back of the eye, double vision, visual acuity decrease, abnormal sensation in the eye, eye swelling or eyelid swelling, small particles or spots in vision, halos around lights, pupil dilation, change in color of the white part of the eye, bleeding of the penis, blood in semen, dry nose, nasal congestion, swelling of the inside of the nose, feeling of irritability, and sudden decrease or loss of hearing.

During post-marketing experience, rare cases of unstable angina (heart disease) and sudden death have been 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 Galotam.

Reporting side effects

If you experience any type of side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, Website:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date shown 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 in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Galotam

• The active ingredient is sildenafilo. Each tablet contains 25 mg of sildenafilo (as citrato).
• The other components are:

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

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

Appearance of the product and contents of the packaging

Galotam 25 mg: film-coated tablets, blue in color, elongated and with printing (25).

It is presented in packs of 4 tablets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon, S.A.

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

Last review date of this prospectus:May 2024

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