TADALAFIL Aurovitas 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Aurovitas 20 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to use 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, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What Tadalafil Aurovitas 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 sufficient for satisfactory sexual activity. Tadalafil has shown a significant improvement in the ability to achieve a lasting erection of the penis suitable for sexual activity.

Tadalafil Aurovitas 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 Aurovitas

Do not takeTadalafil Aurovitas

• 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 vision loss 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 or pharmacist before starting to take Tadalafil Aurovitas.

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.

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

• Sickle cell anemia (an abnormality of red blood cells).
• Multimple 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 has been completely or partially removed and the prostate nerves have been 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 the event 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 Aurovitas

Tell 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 symptoms associated with benign prostatic hyperplasia).
• Other medications for treating 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 Aurovitas with Drinks and Alcohol

Information on 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. In some men, a reduction in sperm has been observed. 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 Aurovitas 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 Aurovitas contains Sodium

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

3. How to take Tadalafil Aurovitas

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

Tadalafil Aurovitas tablets are for oral administration only in men. Swallow the tablet whole with a little water. The tablets can be taken with or without food.

The recommended initial doseis one 10 mg tablet before sexual activity. However, you have been given a dose of one 20 mg tablet because your doctor has decided that the recommended dose of 10 mg is too weak.

You can take the Tadalafil Aurovitas tablet at least 30 minutes before sexual activity.

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

Do not take Tadalafil Aurovitas more than once a day. Tadalafil Aurovitas 10 mg 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.

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.

If you take more Tadalafil Aurovitas than you should

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

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 taken. It is recommended to take the package and package 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, central blurred vision, 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, 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, eyelid swelling, red eyes, sudden decrease or loss of hearing, hives (red itchy rashes on the skin surface), 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.

Rarely, cases of decreased or lost 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 notified during clinical trials. These include:

• Migraine, facial swelling, severe allergic reaction that causes facial or throat swelling, severe skin rashes, certain disorders that affect blood flow to the eyes, irregular heartbeats, angina pectoris, and sudden cardiac death.
• Distorted, blurred, central blurred vision, 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 Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tadalafil Aurovitas

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

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

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, 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 Aurovitas

• The active ingredient is tadalafil. Each film-coated tablet contains 20 mg of tadalafil.
• The other components are:

Tablet core:Copovidone, macrogolglyceride hydroxystearate, lactose monohydrate, anhydrous colloidal silica, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Tablet coating:Hypromellose, titanium dioxide (E171), talc (E553b), yellow iron oxide (E172), triacetin.

Appearance of the product and package contents

Yellow, oval, film-coated tablets with "58" on one face and "L" on the other.

Tadalafil Aurovitas is available in PVC/PVdC transparent-Aluminum blister packs.

Blister pack sizes: 2, 4, 8, 12, 24, 28, and 56 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19, Venda Nova

2700-487 Amadora

Portugal

Or

Orion Corporation Orion Pharma

Orionintie 1, Espoo

FI-02200

Finland

Or

Orion Corporation Orion Pharma

Joensuunkatu 7, Salo

FI-24100

Finland

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

Date of the last revision of this package leaflet: December 2023

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