GALOTAM 25 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Galotam 25 mg film-coated tablets EFG

sildenafil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Galotam and what is it used for
2. What you need to know before you take Galotam
3. How to take Galotam
4. Possible side effects
5. Storage of Galotam
6. Contents of the pack and other information

1. What is Galotam and what is it used for

Galotam contains the active substance 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 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 enough erection for satisfactory sexual activity.

2. What you need to know before you take Galotam

Do not take Galotam

• If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If you are taking medicines called nitrates, as the combination can cause a potentially dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medicines, 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 of the medicines known as 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, transient ischaemic attack, 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 ischaemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor or pharmacist before taking Galotam:

• If you have sickle cell anaemia (a disorder of the red blood cells), leukaemia (cancer of the blood cells), or multiple myeloma (cancer of the bone marrow).
• 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 strain of having sex.
• If you currently have stomach ulcers or bleeding disorders (such as haemophilia).
• If you experience a sudden loss of vision, stop taking Galotam and contact your doctor immediately.

Sildenafil should not be taken at the same time as any other oral or local treatment for erectile dysfunction.

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

You should 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

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

Galotam tablets may interfere with some medicines, especially those used to treat angina pectoris. 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.

You should 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").

You should 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.

Tell your doctor or pharmacist if you are taking riociguat.

If you are taking medicines 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 who are receiving an alpha-blocker, a medicine used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness, which can be caused by a drop 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 happen within 4 hours of taking sildenafil. To reduce the likelihood of these symptoms, you should be taking your daily dose of alpha-blockers regularly before starting Galotam. Your doctor may advise you to start treatment with the lower dose (25 mg) of Galotam.

Tell 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.

Drinking alcohol can temporarily impair your ability to get an erection.

Therefore, to get the maximum benefit from the medicine, it is advised not to drink 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 or using machines.

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 the instructions for administration of Galotam indicated by your doctor. 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 about an 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, tell 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 your doctor recommends.

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 medicine and the amount taken.

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

4. Possible side effects

Like all medicines, Galotam can cause side effects, although not everybody gets them. The side effects associated 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 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 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 1000 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 of the skin, 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, feeling hot (including a feeling of warmth or heat in the upper body), indigestion, abnormal colour vision, 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, seeing flashes of light, increased light sensitivity, sensitivity to touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy nose (including symptoms such as runny nose, sneezing, and nasal congestion), inflammation of the mucous membrane of the nose (including symptoms such as runny nose, sneezing, and nasal congestion), stomach discomfort, gastro-oesophageal reflux disease (including symptoms such as heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling hot, and feeling tired.

Rare(may affect up to 1 in 1000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decrease in blood flow to parts of the brain, feeling of pressure in the throat, numbness in the mouth, bleeding in the back of the eye, double vision, decreased sharpness of vision, abnormal sensation in the eye, eye swelling or eyelid swelling, small particles or spots in the vision, seeing halos around lights, dilation of the pupil, change in colour of the white of the eye, bleeding from the penis, presence of blood in the semen, dry nose, swelling inside the nose, feeling irritable, and sudden loss of hearing.

During post-marketing experience, unstable angina (heart disease) and sudden death have been reported rarely. It is noteworthy 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 whether these side effects were directly related to Galotam.

Reporting of side effects

If you experience any of the side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report side effects 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 expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Galotam

• The active substance is sildenafil. Each tablet contains 25 mg of sildenafil (as citrate).
• The other ingredients are:

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

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

Appearance of the product and pack contents

Galotam 25 mg: film-coated tablets, blue, elongated, and engraved (25).

It is available in packs of 4 tablets.

Marketing authorisation holder and manufacturer

LABORATORIOS NORMON, S.A.

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

Date of last revision of this leaflet:May 2024

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