TADALAFIL ALTER 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Patient Information Leaflet

Tadalafil Alter 10 mg orodispersible tablets EFG

Tadalafil Alter 20 mg orodispersible tablets EFG

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

• Keep this 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 leaflet. See section 4.

Contents of the Leaflet

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

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

Tadalafil is indicated for the treatment of erectile dysfunction in adult men. This occurs when a man cannot obtain or maintain a firm erection suitable for satisfactory sexual activity. Tadalafil has been shown to significantly improve the ability to obtain a lasting erection of the penis suitable for sexual activity.

Tadalafil Alter contains the active ingredient tadalafil, which belongs to a group of medications called phosphodiesterase type 5 inhibitors. After sexual stimulation, tadalafil acts by helping to relax the blood vessels in the penis, allowing blood flow to the penis. The result is an improvement in erectile function. Tadalafil will not help if you do not have erectile dysfunction.

It is essential to warn you that tadalafil is not effective if there is no sexual stimulation. Therefore, you and your partner should stimulate each other in the same way as you would if you were not taking a medication for erectile dysfunction.

2. What you need to know before taking Tadalafil Alter

Do not take Tadalafil Alter

• if you are allergic to tadalafil or any of the other components of this medication (listed in section 6).
• if you are taking any type of organic nitrates or nitric oxide donors, such as amyl nitrite. This is a group of medications ("nitrates") used to treat angina pectoris ("chest pain"). It has been seen that tadalafil increases the effects of these medications. If you are taking any type of nitrate or are unsure, tell your doctor.
• if you have a severe heart disease or have recently suffered a heart attack, within the last 90 days.
• if you have recently suffered a stroke, within the last 6 months.
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have ever experienced loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a disease described as "eye infarction".
• 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). Phosphodiesterase type 5 inhibitors, such as tadalafil, have shown that they increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor before starting to take Tadalafil Alter.

Be aware that sexual activity carries a possible risk in patients with heart problems, due to the additional effort it requires for the heart. If you have a heart problem, consult your doctor.

Before taking the tablets, inform your doctor if you have:

• sickle cell anemia (an abnormality of red blood cells).
• multiple myeloma (bone marrow cancer).
• leukemia (blood cell cancer).
• any penile deformation.
• a severe liver problem.
• a severe kidney problem.

It is not known if tadalafil is effective in patients who have undergone:

• surgery in the pelvic area.
• a surgical intervention in which the prostate was completely or partially removed and the prostate nerves were cut (radical prostatectomy without preservation of neurovascular bundles).

If you experience a sudden decrease or loss of vision or your vision is distorted, blurred while taking tadalafil, stop taking tadalafil and contact your doctor immediately.

A sudden decrease or loss of hearing has been observed in some patients taking tadalafil. Although it is not known if this is directly related to tadalafil, if you experience a sudden decrease or loss of hearing, stop taking tadalafil and contact your doctor immediately.

Tadalafil is not intended for use in women.

Children and adolescents

Tadalafil should not be used in children or adolescents under 18 years of age.

Taking Tadalafil Alter with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Do not take tadalafil if you are already using nitrates.

Some medications may be affected by tadalafil or may affect the proper functioning of tadalafil. Inform your doctor or pharmacist if you are using:

• an alpha-blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
• other medications for high blood pressure.
• riociguat.
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• medications such as ketoconazole tablets (for the treatment of fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medications).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking Tadalafil Alter with drinks and alcohol

Information about the effect of alcohol can be found in section 3. Grapefruit juice may affect the proper functioning of tadalafil and should be taken with caution. Consult your doctor for more information.

Fertility

In dogs treated with tadalafil, a decrease in sperm production by the testicles was observed. A reduction in sperm has been observed in some men. It is unlikely that these effects will produce a lack of fertility.

Driving and using machines

Some men who took tadalafil during clinical trials experienced dizziness. Carefully check how you react when taking the tablets before driving or using machines.

Tadalafil Alter contains lactose

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

Tadalafil Alter contains sodium

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

Tadalafil Alter contains aspartame

Tadalafil Alter 10 mg contains 4.08 mg of aspartame in each tablet.

Tadalafil Alter 20 mg contains 8.16 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

3. How to take Tadalafil Alter

Follow the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The orodispersible tablets of tadalafil are for oral administration only in men. They will be administered in a single dose and can be taken with or without food. The orodispersible tablet should be placed on the tongue where it dissolves and can be swallowed without water.

The recommended initial doseis one 10 mg tablet before sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg.

Dose 10 mg: the score line is only for breaking the tablet if you find it difficult to swallow it whole.

When taking tadalafil, you can initiate sexual activity at least 30 minutes after taking it.

Tadalafil may still be effective up to 36 hours after taking the tablet.

Do not take tadalafil more than once a day. Tadalafil 10 and 20 mg will be used before expected sexual activity and are not recommended for continuous daily use.

It is essential to warn you that tadalafil is not effective if there is no sexual stimulation. Therefore, you and your partner should stimulate each other in the same way as you would if you were not taking a medication for erectile dysfunction.

Alcohol consumption may affect your ability to have an erection and may temporarily lower your blood pressure. If you have taken or are planning to take tadalafil, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness when standing up.

If you take more Tadalafil Alter than you should

Consult your doctor. You may experience side effects described in section 4.

In case of overdose or accidental ingestion, you can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the leaflet of the medication to the healthcare professional.

If you have any other questions 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 will experience them. These effects are generally mild to moderate.

If you experience any of the following side effects, stop using the medication and seek medical help immediately:

• allergic reactions, including rash (uncommon).
• chest pain - do not use nitrates, but seek medical help immediately (uncommon).
• priapism, a prolonged and possibly painful erection after taking tadalafil (rare). If you experience this type of erection, which can last continuously for more than 4 hours, you should contact a doctor immediately.
• sudden loss of vision (rare), distorted, blurred, or sudden decrease in vision (unknown frequency).

Other side effects that have been reported:

Common(may affect up to 1 in 10 people)

• headache, back pain, muscle pain, pain in the arms and legs, facial flushing, nasal congestion, and indigestion.

Uncommon(may affect up to 1 in 100 people)

• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in the urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of the hands, feet, or ankles, and feeling tired.

Rare(may affect up to 1 in 1,000 people)

• fainting, seizures, and transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, hives (red itchy patches on the skin), bleeding from the penis, blood in the semen, and increased sweating.

Myocardial infarction and stroke have also been reported rarely in men taking tadalafil. Most of these men had pre-existing heart problems before taking this medication.

Rarely, cases of sudden loss of vision, partial, transient, or permanent in one or both eyes have been reported.

Some additional rare side effectshave been reported in men taking tadalafil that were not observed during clinical trials. These include:

• migraine, facial swelling, severe allergic reaction that causes swelling of the face or throat, severe skin rash, certain disorders that affect blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
• distorted, blurred, or sudden decrease in vision (unknown frequency).

In men over 75 years of age treated with tadalafil, the most frequently reported side effect was dizziness. In men over 65 years of age treated with tadalafil, the most frequently reported side effect was diarrhea.

Reporting side effects

If you experience any 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 Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tadalafil Alter

Keep this medication out of sight and reach of children.

Store below 30°C. Store in the original packaging to protect it from moisture.

Do not use this medication after the expiration date shown on the box and blister. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Tadalafil Alter

• The active ingredientis tadalafil.

Tadalafil Alter 10 mg: each orodispersible tablet contains 10 mg of tadalafil.

Tadalafil Alter 20 mg: each orodispersible tablet contains 20 mg of tadalafil.

• The other ingredientsare:

Lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, sodium croscarmellose, sodium lauryl sulfate, aspartame (E-951), ethyl vanillin, magnesium stearate.

Appearance of the product and package contents

Tadalafil Alter 10 mg: orodispersible tablets, white to off-white, round, biconvex, with a non-functional score line on one side, approximately 8 mm in diameter.

Tadalafil Alter 20 mg: orodispersible tablets, white to off-white, round, biconvex, without score line, approximately 11 mm in diameter.

Tadalafil Alter 10 mg is available in PCTFE/PVC-Aluminum blisters in packs of 4 orodispersible tablets.

Tadalafil Alter 20 mg is available in PCTFE/PVC-Aluminum blisters in packs of 4 and 8 orodispersible tablets.

Marketing authorization holder and manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of the last revision of this leaflet:June 2024

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