TADALAFIL FARMALTER 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Farmalter 5 mg Orodispersible Tablets EFG

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

• Keep this package 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 package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Tadalafil Farmalter and what is it used for
2. What you need to know before taking Tadalafil Farmalter
3. How to take Tadalafil Farmalter
4. Possible side effects
5. Storage of Tadalafil Farmalter
6. Package Contents and Additional Information

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

Tadalafil Farmalter contains the active ingredient tadalafil, which belongs to a group of medications called phosphodiesterase type 5 inhibitors.

Tadalafil 5 mg is used to treat adult men with:

• erectile dysfunction. 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.

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 note 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.

• urinary symptoms associated with a common condition called benign prostatic hyperplasia. This occurs when the prostate gland enlarges with age. Symptoms include difficulty starting to urinate, feeling that the bladder has not been completely emptied, needing to urinate more frequently, even at night. Tadalafil improves blood flow and relaxes the muscles of the prostate and bladder, which can reduce the symptoms of benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms within a short period, such as 1-2 weeks after starting treatment.

2. What you need to know before taking Tadalafil Farmalter

Do not take Tadalafil Farmalter

• if you are allergic to tadalafil or any of the other ingredients 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, consult your doctor.
• if you have a severe heart condition or have recently had a heart attack, within the last 90 days.
• if you have recently had a stroke, within the last 6 months.
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have ever had a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition 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 this medication.

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

Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will perform a prostate cancer screening before starting treatment with tadalafil for benign prostatic hyperplasia. Tadalafil does not treat prostate cancer.

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

• sickle cell anemia (a red blood cell abnormality).
• 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 procedure 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, or diminished 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.

Other Medications and Tadalafil Farmalter

Inform your doctor 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 Farmalter 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. Check carefully how you react when taking the tablets before driving or using machines.

Tadalafil Farmalter contains Lactose

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

Tadalafil Farmalter contains Sodium

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

Tadalafil Farmalter contains Aspartame

This medication contains 2.04 mg of aspartame in each tablet.

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

3. How to take Tadalafil Farmalter

Follow the administration instructions for this medication indicated by your doctor exactly. If in doubt, consult your doctor or pharmacist again.

Tadalafil orodispersible tablets are for oral administration only in men. The orodispersible tablet should be placed on the tongue, where it dissolves in seconds, and then can be swallowed with saliva. The tablets can be taken with or without food.

Consuming alcohol may temporarily decrease 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.

For the treatment of erectile dysfunction

The recommended doseis one 5 mg tablet once a day, approximately at the same time. Your doctor may adjust the dose to 2.5 mg based on your response to tadalafil. This will be done by taking a 2.5 mg tablet.

Do not take tadalafil more than once a day.

Tadalafil taken daily allows you to obtain an erection at any time during the 24 hours of the day, provided there is sexual stimulation. Daily tadalafil may be useful in men who anticipate having sexual activity two or more times a week.

It is essential to note 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.

For the treatment of benign prostatic hyperplasia

The doseis one 5 mg tablet once a day, approximately at the same time.

If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet once a day.

Do not take tadalafil more than once a day.

If you take more Tadalafil Farmalter 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 take the packaging and the package leaflet of the medication to the healthcare professional.

If you forget to take Tadalafil Farmalter

Take your dose as soon as you remember, but do not take a double dose to make up for forgotten doses. Do not take tadalafil more than once a day.

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 experiences 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 (frequency not known).

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 pulse, 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, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (red itchy patches on the skin), bleeding in 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.

Sudden loss of vision, partial, transient, or permanent in one or both eyes has been reported rarely.

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

• migraine, facial swelling, severe allergic reaction that causes swelling of the face or throat, severe skin rashes, certain disorders that affect blood flow to the eyes, irregular heartbeats, angina pectoris, and sudden cardiac death.
• distorted, blurred, or sudden decrease in vision (frequency not known).

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 package 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 help provide more information on the safety of this medication.

5. Storage of Tadalafil Farmalter

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

Do not use this medication after the expiration date stated on the carton and blister after "EXP". The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medications should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Tadalafil Farmalter

• The active ingredientis tadalafil. Each orodispersible tablet contains 5 mg of tadalafil.
• The other ingredients (excipients)are:

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 Farmalter 5 mg tablets are white to off-white, flat, and uncoated.

Tadalafil Farmalter 5 mg is available in blister packs in cartons of 14 or 28 orodispersible tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Italy Tadalafil Laboratori Alter

Spain Tadalafil Farmalter 5 mg orodispersible tablets EFG

Date of the last revision of this package leaflet:July 2024

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