Leaflet: information for the user

Tadalafilo MABO 20 mg film-coated tablets EFG

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Tadalafilo Mabo is and what it is used for

2.What you need to know before you start taking Tadalafilo Mabo

3.How to take Tadalafilo Mabo

4.Possible side effects

5. Storage of Tadalafilo Mabo

6.Contents of the pack and additional information

Tadalafilo Mabo is indicated for the treatment of erectile dysfunction in adult men. This condition occurs when a man is unable to obtain or maintain a firm erection, suitable for a satisfactory sexual activity. Tadalafilo has demonstrated a significant improvement in the ability to obtain a lasting erection of the penis suitable for sexual activity.

This medication contains the active ingredient tadalafilo, which belongs to a group of medications called phosphodiesterase type 5 inhibitors. After sexual stimulationtadalafiloacts by helping to relax the blood vessels of your penis, allowing blood to flow into the penis. The result is an improvement in erectile function.Tadalafilowill not help if you do not have erectile dysfunction.

It is essential to inform you that tadalafilo is not effective without sexual stimulation.Therefore, you and your partner should stimulate yourselves in the same way you would without taking a medication for erectile dysfunction.

Do not takeTadalafilo Mabo if:

• You are allergic to tadalafilo or any of the other components of this medication (listed in section 6).
• 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 tadalafilo increases the effects of these medications. If you are taking any type of nitrates or are unsure, tell your doctor.
• You have a serious heart disease or have had a heart attack recently, in the last 90 days.
• You have had a recent stroke, in the last 6 months.
• You have low or high blood pressure that is not controlled.
• You have ever had vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a disease described as “eye infarction”.
• 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 clots). The PDE5 inhibitors, such as tadalafilo, have shown that they produce an increase in 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 this medication.

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

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

• Anemia falciforme (a red blood cell abnormality).
• Multiple myeloma (bone marrow cancer).
• Leukemia (blood cell cancer).
• Any penile deformity.
• A serious liver problem.
• A serious kidney problem.

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

• Pelvic surgery.
• A surgical intervention in which the prostate has been completely or partially removed and the prostate nerves have been cut (radical prostatectomy without neurovascular bundle preservation).

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

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

Tadalafilo is not intended for use in women.

Children and adolescents

Tadalafilo should not be used in children or adolescents under 18 years old.

Other medications and Tadalafilo Mabo

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

Do not take tadalafilo if you are already using nitrates (See “Do not take Tadalafilo Mabo”).

Some medications may be affected by tadalafilo or may affect the proper functioning of tadalafilo.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 to treat 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 HIV/AIDS or HIV infection.
• Phenobarbital, phenytoin, and carbamazepine (anticonvulsant medications).
• Rifampicin, erythromycin, clarithromycin, or itraconazole.
• Other treatments for erectile dysfunction.

Taking Tadalafilo Mabo with beverages and alcohol

The information about the effect of alcohol is found in section 3.

Orange juice may affect the proper functioning of tadalafilo and should be taken with caution. Consult your doctor for more information.

Fertility

In treated dogs, a decrease in sperm production by the testicles was observed. A decrease in sperm count has been observed in some men. It is unlikely that these effects will cause infertility.

Driving and operating machines

Some men who took tadalafilo during clinical trials experienced dizziness. Check carefully how you react when taking the tablets before driving or operating machines.

Tadalafilo Mabo contains lactose:

If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Tadalafilo Mabo contains sodium:

This medication contains less than 23 mg of sodium (1mmol) per tablet, which is essentially “sodium-free”.

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

Tadalafilo Mabo 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.

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.Tadalafilo Mabo tablets are administered orally.

You can initiate sexual activity at least 30 minutes after taking Tadalafilo Mabo.

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

You should not take Tadalafilo Mabo more than once a day. Tadalafilo Mabo 10 and 20 mg will be used before expected sexual activity and are not recommended for continuous daily use.

It is essential to inform you that tadalafilo is not effective without sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way as you would without taking a medication for erectile dysfunction.

Consuming alcohol may affect your ability to achieve an erection and may temporarily lower your blood pressure. If you have taken or are planning to take tadalafilo, 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 moreTadalafilo Mabothan you should

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 ingested. You may experience adverse effects described in section 4.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them. These side effects are generally mild to moderate in intensity.

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

• Allergic reactions including rashes (infrequent).
• Chest pain - do not use nitrates but seek medical help immediately (infrequent).
• Priapism, a prolonged and possibly painful erection after taking tadalafil (rare frequency). If you experience this type of erection, which may last for more than 4 hours, you must contact a doctor immediately.
• Sudden loss of vision (rare frequency), distorted, blurred, central vision blurred or sudden decrease in vision (unknown frequency).

Other side effects that have been reported:

Frequent(observed in 1 to 10 of every 100 patients)

• Headache, back pain, muscle pain, arm and leg pain, facial flushing, nasal congestion and indigestion.

Infrequent(observed in 1 to 10 of every 1,000 patients)

• 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, nasal bleeding, tinnitus, swelling of the hands, feet or ankles and feeling tired.

Rare(observed in 1 to 10 of every 10,000 patients)

• Loss of consciousness, seizures and temporary loss of memory, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red itchy patches on the skin's surface), bleeding in the penis, blood in the semen and increased sweating.

Infarction and stroke have also been reported rarely in men taking tadalafil. Most of these men had some heart problem before taking this medicine.

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

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

• Migraine, facial swelling, severe allergic reaction causing facial or throat swelling, severe skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeat, angina and sudden cardiac death.
• Distorted, blurred, central vision blurred or sudden decrease in vision (unknown frequency).

In men over 75 years old taking tadalafil, the most frequently reported side effect was dizziness.

In men over 65 years old taking tadalafil, the most frequently reported side effect was diarrhea.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appearson the packaging and the blisterafter CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tadalafilo Mabo

• The active ingredient is tadalafilo. Each coated tablet contains 10 mg of tadalafilo.
• The other components are:

Core : anhydrous lactose, sodium croscarmellose, sodium laurilsulfate, hydroxypropylcellulose, polisorbate 80, magnesium stearate.

Coating : hypromellose 2910 (E464), lactose monohydrate, titanium dioxide (E171), triacetin, talc (E553b) and yellow iron oxide (E-172).

Appearance of the product and content of the container

Tadalafilo Mabo 20 mg is a yellow-coated tablet with a film-coated capsule shape, biconvex, marked with “20” on one side and smooth on the other.

It is presented in PVC/PVDC/Aluminum blisters, in containers of 4, 8, and 12 coated tablets.

Holder of the marketing authorization

MABO-FARMA, S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Responsible for manufacturing

Genepharm S.A.

18th km Marathonos Avenue.

153 51 Pallini Attiki, Greece

or

Combino Pharm (Malta) Ltd.

HF60, Hal Far Industrial Estate

BBG3000, Malta

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park.

Paola, PLA 3000, Malta

or

Pharmapath S.A.

28is Oktovriou 1,

Agia Varvara, 123 51,

Greece

Last review date of this leaflet: November 2023

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicaments and Sanitary Products (AEMPS) http:// www.aemps.gob.es