Leaflet: information for the user

Tadalafilo MABO 5 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, ask 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 contains the active ingredient tadalafilo, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Tadalafilo Mabo is used in the treatment of adult men with:

Impotence

This occurs when a man is unable to obtain or maintain a firm erection, adequate for a satisfactory sexual activity. Tadalafilo has shown a significant improvement in the ability to obtain a lasting erection of the penis, adequate for sexual activity.

After sexual stimulation, tadalafilo acts by helping to relax the blood vessels of the penis, allowing blood to flow into the penis. The result is an improvement in erectile function. Tadalafilo will not help if you do not have impotence.

It is essential to note 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 medicine for impotence.

Urinary symptoms associated with benign prostatic hyperplasia

This occurs when the prostate gland increases in size with age. Symptoms include difficulty starting to urinate, feeling that the bladder is not fully emptied, and the need to urinate more frequently, even at night. Tadalafilo improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms of benign prostatic hyperplasia. Tadalafilo has shown to improve these urinary symptoms in as short a time as 1-2 weeks after starting treatment.

Do not take Tadalafilo Mabo if:

• You are allergic to tadalafilo or to 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 for the treatment of angina pectoris (“chest pain”). Tadalafilo has been seen to increase the effects of these medications. If you are taking any type of nitrates or are unsure, tell your doctor (See section “Taking Tadalafilo Mabo with other medications”).
• You have a severe heart disease or have had a heart attack recently, within the last 90 days.
• You have had a recent stroke, within the last 6 months.
• You have low or uncontrolled high blood pressure.
• 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 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). PDE5 inhibitors, such as tadalafilo, have shown to 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 this medication.

Be aware that sexual intercourse carries a possible risk for patients with heart problems, due to the additional effort it puts on 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 review before starting treatment with tadalafilo for benign prostatic hyperplasia. Tadalafilo does not treat prostate cancer.

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 deformity.
• Severe liver disease.
• Severe kidney disease.

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 sudden decrease or loss of vision or your vision is distorted, while taking tadalafilo, stop taking tadalafilo and contact your doctor immediately.

A sudden decrease or loss of vision 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 sudden decrease or loss of hearing, stop taking tadalafilo and contact your doctor immediately.

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 take 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 an intolerance to certain sugars, 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 of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Consuming alcohol 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.

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 one 2.5 mg tablet.

Do not take tadalafil more than once a day.

Tadalafil taken daily allows you to get an erection at any time during the 24 hours of the day, as long as there is sexual stimulation. Tadalafil taken daily may be useful for men who expect to engage in sexual activity two or more times a week.

It is essential to inform you that tadalafil 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.

Consuming alcohol may affect your ability to get 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 Tadalafilo Mabo than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

You may experience adverse effects described in section 4.

If you forgot to take Tadalafilo Mabo

Take your dose as soon as you remember, but do not take a double dose to compensate for the missed 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.

Like all medicines, Tadalafilo Mabo 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 tadalafilo (rare frequency). If you experience this type of erection, which can 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(may affect up to 1 in 10 people)

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

Infrequent(may affect up to 1 in 100 people)

• Dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nasal bleeding and tinnitus, swelling of hands, feet or ankles and feeling tired.

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

• 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 semen and increased sweating.

Also, rare cases of heart attack and stroke have been reported in men taking tadalafilo. 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 tadalafilo 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 affecting blood flow to the eyes, irregular heartbeat, angina and sudden cardiac death.
• ...

In men over 75 years old taking tadalafilo, the most frequently reported side effect was dizziness. In men over 65 years old taking tadalafilo, 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 that does not appear in this leaflet. 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 appears on the box and on the blister pack after 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 themedications that you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and the medications that you no longer need. By doing so, you will help protect the environment.

Composition of Tadalafilo Mabo

• The active ingredient is tadalafil. Each film-coated tablet contains 5 mg of tadalafil.
• The other components are:

Core:anhydrous lactose, sodium croscarmellose, sodium lauryl sulfate, hydroxypropyl cellulose, polysorbate 80, magnesium stearate.

Coating:hypromellose 2910 (E464), lactose monohydrate, titanium dioxide (E171), triacetin, talc (E553b), and yellow iron oxide (E172).

Appearance of the product and contents of the packaging

Tadalafilo Mabo 5 mg are yellow film-coated tablets, capsule-shaped, biconvex, marked with “T5” on one face and flat on the other face.

They are presented in PVC/PVDC/Aluminum blisters in packaging of 28 film-coated tablets.

Only some packaging sizes may be marketed.

Marketing Authorization Holder

MABO-FARMA, S.A.

Vía de los Poblados, 3, Building 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

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/