TADALAFIL MABO 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil MABO 10 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Tadalafil Mabo and what is it used for
2. What you need to know before you take Tadalafil Mabo
3. How to take Tadalafil Mabo
4. Possible side effects
5. Storage of Tadalafil Mabo
6. Contents of the pack and further information

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

Tadalafil Mabo is indicated for the treatment of erectile dysfunction in adult men. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil has been shown to significantly improve the ability to get a hard erect penis suitable for sexual activity.

This medicine contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, tadalafil works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result is improved erectile function. Tadalafil will not help if you do not have erectile dysfunction.

It is important to note that tadalafil is not effective if there is no sexual stimulation.You and your partner will still need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

2. What you need to know before you take Tadalafil Mabo

Do not takeTadalafil Mabo if:

• You are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• You are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used to treat angina pectoris (“chest pain”). Tadalafil has been shown to increase the effects of these medicines.
• You have a severe heart or liver problem.
• You have recently had a stroke or heart attack (within the last 90 days).
• You have low blood pressure or uncontrolled high blood pressure.
• You have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
• You are taking riociguat. This medicine 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 been shown to increase the hypotensive effects of this medicine.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

Be aware that sexual activity carries a possible risk to patients with heart problems because it puts extra strain on the heart. If you have a heart problem, tell your doctor.

Before taking the tablets, tell your doctor if you:

• Have sickle cell anemia (a disorder of the red blood cells).
• Have multiple myeloma (cancer of the bone marrow).
• Have leukemia (cancer of the blood cells).
• Have any deformation of your penis.
• Have a severe liver or kidney problem.

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

• Undergone pelvic surgery.
• Had a radical prostatectomy (removal of the prostate gland).

If you experience 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 sudden decrease or loss of hearing, stop taking this medicine and contact your doctor immediately.

Tadalafil is not intended for use by women.

Children and adolescents

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

Other medicines and Tadalafil Mabo

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take tadalafil if you are already taking nitrates (see “Do not take Tadalafil Mabo”).

Some medicines may be affected by tadalafil or may affect how well tadalafil works. Tell 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 medicines for high blood pressure.
• Riociguat.
• A 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• Medicines such as ketoconazole tablets (for the treatment of fungal infections) and protease inhibitors for the treatment of HIV or AIDS.
• Phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• Rifampicin, erythromycin, clarithromycin, or itraconazole.
• Other treatments for erectile dysfunction.

Taking Tadalafil Mabo with drinks and alcohol

Information about the effect of alcohol is in section 3.

Grapefruit juice may affect how well tadalafil works and should be taken with caution. Consult your doctor for more information.

Fertility

In dogs treated with tadalafil, a decrease in sperm production was observed. A reduction in sperm count has been observed in some men. These effects are unlikely to produce infertility.

Driving and using machines

Some men taking tadalafil during clinical trials experienced dizziness. Check carefully how you react to the tablets before driving or using machines.

Tadalafil Mabo contains lactose:

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Tadalafil Mabo contains sodium:

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

3. How to take Tadalafil Mabo

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

The tablets of Tadalafil Mabo are for oral administration only in men. Swallow the tablet whole with some water. The tablets can be taken with or without food.

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. Tadalafil Mabo tablets are for oral use.

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

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

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

It is important to note that tadalafil is not effective if there is no sexual stimulation.You and your partner will still need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Consuming large amounts of alcohol may impair your ability to get 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 Mabo than 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 medicine and the amount ingested. You may experience side effects described in section 4.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate.

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

• Allergic reactions including skin 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 for more than 4 hours, you should contact a doctor immediately.
• Sudden loss of vision (rare), distorted vision, blurred vision, or sudden loss of vision (frequency not known).

Other side effects that have been reported:

Common(seen in 1 to 10 in every 100 patients)

• Headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion, and indigestion.

Uncommon(seen in 1 to 10 in every 1,000 patients)

• 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, nosebleeds, ringing in the ears, swelling of hands, feet, or ankles, and feeling tired.

Rare(seen in 1 to 10 in every 10,000 patients)

• Fainting, seizures, and temporary memory loss, swelling of the eyelids, 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.

Additionally, the following rare side effects have been reported in men taking tadalafil that were not seen in clinical trials:

• Migraine, swelling in the face, 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, and sudden cardiac death.

In men over 75 years of age treated with tadalafil, the most frequently reported adverse event was dizziness.

In men over 65 years of age treated with tadalafil, the most frequently reported adverse event was diarrhea.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tadalafil Mabo

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Tadalafil Mabo

• The active substance is tadalafil. Each film-coated tablet contains 10 mg of tadalafil.
• The other ingredients are:

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

Coating: hypromellose 2910 (E464), lactose monohydrate, titanium dioxide (E171), triacetin, talc (E553b), yellow iron oxide (E-172), and black iron oxide (E172).

Appearance of the product and pack contents

Tadalafil Mabo 10 mg is a yellow, capsule-shaped, biconvex, film-coated tablet marked with “10” on one face and plain on the other.

It is available in blister packs of PVC/PVDC/Aluminum, in packs of 4 film-coated tablets.

Marketing authorisation holder

MABO-FARMA, S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturer

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

Date of last revision of this leaflet:November 2023

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