Galotam 25 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Galotam 25 mg film-coated tablets EFG
sildenafil
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you and should not be given to other people, 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 effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Galotam is and what it is used for
- What you need to know before taking Galotam
- How to take Galotam
- Possible adverse effects
- How to store Galotam
- Contents of the pack and other information
1. What Galotam is and what it is 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 in the penis, allowing blood flow into it 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 achieve or maintain a firm erection suitable for satisfactory sexual activity.
2. What you need to know before starting to take Galotam
Do not take Galotam
- If you are allergic to sildenafil or to any of the other components of this medicine (listed in section 6).
- If you are taking medicines 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 medicines, which are often administered to relieve angina pain (or “chest pain”). If you are unsure, consult your doctor or pharmacist.
- If you are using any medicines known as 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 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 been shown to 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 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 Galotam:
- If you have sickle cell anemia (an abnormality of red blood cells), leukemia (cancer of blood cells), or multiple myeloma (cancer of bone marrow).
- If you have penile deformity or Peyronie’s disease.
- If you have heart problems. In such cases, your doctor should carefully assess whether your heart can tolerate the additional strain of sexual activity.
- If you currently have a stomach ulcer or bleeding disorders (such as hemophilia).
- If you experience 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 oral or local treatment for erectile dysfunction.
You must not take Galotam with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or any other PDE5 inhibitor.
You must not take Galotam if you do not have erectile dysfunction.
The use of Galotam is not indicated in women.
Special considerations in patients with renal or hepatic impairment
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 individuals under 18 years of age.
Other medicines and Galotam
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription.
Galotam tablets may interact with certain medicines, especially those used to treat chest pain. In a medical emergency, you must inform any healthcare professional that you are taking Galotam and when you took it. You must 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 may 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 pain (or “chest pain”).
Do not take Galotam if you are taking medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), as the combination may also lead to a dangerous drop in your blood pressure.
Inform your doctor or pharmacist if you are taking riociguat.
If you are taking protease inhibitors, such as those used in the treatment of HIV, your doctor may recommend starting treatment with the lowest dose (25 mg) of Galotam.
Some patients receiving alpha-blockers, medicines used to treat high blood pressure or benign prostatic hyperplasia, may experience dizziness or lightheadedness, which may 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 occur within 4 hours after taking sildenafil. To reduce the likelihood of these symptoms, you should already be on a regular daily dose of an alpha-blocker before starting Galotam. Your doctor may advise you to start treatment with the lowest dose (25 mg) of Galotam.
Inform your doctor or pharmacist if you are taking medicines containing 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 slightly longer to work if taken with a heavy meal.
Alcohol consumption may temporarily impair your ability to achieve an erection.
Therefore, to achieve the maximum benefit from the medicine, it is advisable 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 may cause dizziness and affect vision. You should know how you react to Galotam before driving or operating 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 exactly the administration instructions for Galotam provided by your doctor. If in doubt, consult your doctor or pharmacist again. The recommended starting dose is 50 mg.
Galotam must not be taken more than once a day.
Do not take Galotam together with other medicines containing sildenafil.
You should 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 too weak, inform your doctor or pharmacist.
Galotam will only help you achieve an erection if you are sexually stimulated. The time Galotam takes to work varies from person to person, usually between half an hour and one hour. The effect of this medicine may be delayed if taken with a heavy meal.
If Galotam 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 Galotam than you should
You may experience an increase in the frequency and severity of side effects. Doses higher than 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Galotam may cause adverse effects, although not everyone experiences them. The adverse effects reported with sildenafil are generally mild to moderate in intensity and short in duration.
If you experience any of the following serious adverse effects, stop taking Galotam and seek immediate medical attention:
-
Allergic reaction – this occurs uncommonly (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 uncommonly
If chest pain occurs during or after sexual activity:- Sit in a semi-upright position and try to relax.
- Do not use nitrates to treat chest pain.
-
Prolonged and sometimes painful erections – this occurs rarely (may affect up to 1 in 1,000 people)
If you have an erection lasting longer than 4 hours, 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 adverse 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 sudden sensation of warmth 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 flashing lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sense of touch, vertigo, ringing in the ears, dry mouth, nasal blockage or congestion, swelling of the nasal mucosa (including runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including heartburn), blood in urine, pain in arms or legs, nosebleeds, sensation of warmth, and feeling of fatigue.
Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to parts of the brain, throat tightness, mouth numbness, bleeding behind 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, pupil dilation, change in the colour of the white part of the eye, penile bleeding, blood in semen, dry nose, swelling inside the nose, feeling irritable, 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 should be noted that most men who experienced these adverse effects, although not all, had pre-existing heart conditions before taking this medicine. It is not possible to determine whether these adverse effects were directly related to Galotam.
Reporting of adverse effects
If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products at: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Galotam
Keep this medicine out of sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be returned to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps 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 components are:
Core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, and sodium croscarmellose.
Coating: hypromellose, titanium dioxide (E-171), macrogol 6000, talc, and indigo carmine lake (E-132).
Appearance of the product and contents of the pack
Galotam 25 mg: film-coated blue, elongated tablets with imprint (25).
Packaged in packs of 4 tablets.
Marketing Authorization Holder and Manufacturer
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid, Spain
Date of the most recent revision of this leaflet: May 2024
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/