Tadalafil Mabo 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Tadalafilo 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Tadalafilo MABO is and what it is used for
2. What you need to know before taking Tadalafilo MABO
3. How to take Tadalafilo MABO
4. Possible side effects
5. How to store Tadalafilo MABO
6. Contents of the pack and other information

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

Tadalafilo Mabo is indicated for the treatment of erectile dysfunction in adult men. Erectile dysfunction occurs when a man is unable to achieve or maintain a firm erection suitable for satisfactory sexual activity. Tadalafilo has been shown to significantly improve the ability to achieve a durable penile erection suitable for sexual activity.

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

It is important to warn you that tadalafil is not effective in the absence of sexual stimulation. Therefore, you and your partner should engage in sexual stimulation in the same way as you would if you were not taking a medicine for erectile dysfunction.

2. What you need to know before taking Tadalafil Mabo

Do not take Tadalafil Mabo if:

• You are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
• You are taking any type of organic nitrates or nitric oxide donors such as amyl nitrite. This group of medicines (“nitrates”) is used to treat angina (chest pain). Tadalafil has been shown to increase the effects of these medicines. If you are taking any type of nitrate or are unsure, tell your doctor.
• You have a severe heart condition or have recently had a heart attack (within the last 90 days).
• You have recently had a stroke (within the last 6 months).
• You have low blood pressure or uncontrolled high blood pressure.
• You have ever experienced vision loss 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). PDE5 inhibitors such as tadalafil have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

Be aware that sexual activity involves a potential risk for patients with heart problems, due to the additional strain placed on the heart. If you have a heart condition, consult your doctor.

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

• Sickle cell anemia (an abnormality of red blood cells).
• Multiple myeloma (a cancer of the bone marrow).
• Leukemia (a cancer of blood cells).
• Any penile deformity.
• A severe liver problem.
• A severe kidney problem.

It is not known whether tadalafil is effective in patients who have undergone:

• Pelvic surgery.
• A surgical procedure involving complete or partial removal of the prostate with cutting of the nerves supplying the prostate (radical prostatectomy without neurovascular bundle preservation).

If you experience sudden decrease or loss of vision, or if your vision becomes distorted or dimmed while taking tadalafil, stop taking tadalafil and contact your doctor immediately.

Sudden decrease or loss of hearing has been observed in some patients taking tadalafil. Although it is not known whether this 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 in women.

Children and adolescents

Tadalafil must not be used in children or 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 need to take any other medicines.

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

Some medicines may interact with tadalafil or affect how well tadalafil works. Inform your doctor or pharmacist if you are taking:

• An alpha-blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
• Other medicines to treat high blood pressure.
• Riociguat.
• A 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• Medicines such as ketoconazole tablets (for treatment of fungal infections) or protease inhibitors for treatment of AIDS or HIV infection.
• Phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• Rifampicin, erythromycin, clarithromycin, or itraconazole.
• Other treatments for erectile dysfunction.

Taking Tadalafil Mabo with food and alcohol

Information about the effect of alcohol is provided in section 3.

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

Fertility

In treated dogs, a decrease in sperm production by the testes was observed. Some men have shown reduced sperm count. These effects are unlikely to cause infertility.

Driving and use of machines

Some men who took tadalafil during clinical trials experienced dizziness. Carefully assess how you react when taking the tablets before driving or operating machinery.

Tadalafil Mabo contains lactose:

If your doctor has informed you that you have an intolerance to certain sugars, consult him 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 instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The recommended starting dose is one 10 mg tablet taken 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 administered orally.

When you take Tadalafil Mabo, you may initiate sexual activity at least 30 minutes after taking the tablet.

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

You must not take Tadalafil Mabo more than once a day. Tadalafil Mabo 10 mg and 20 mg are intended to be used prior to anticipated sexual activity and are not recommended for continuous daily use.

It is important to inform you that tadalafil is not effective in the absence of sexual stimulation. Therefore, you and your partner should engage in the same kind of sexual stimulation as you would if you were not taking a medicine for erectile dysfunction.

Alcohol consumption may affect your ability to achieve 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 upon standing.

If you take more Tadalafil Mabo than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. You may experience adverse effects described in section 4.

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

4. Possible adverse effects

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

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

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

Other adverse effects that have been reported:

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

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

Uncommon (observed in 1 to 10 out of 1,000 patients)

• 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 (observed in 1 to 10 out of 10,000 patients)

• Fainting, seizures, and transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red, itchy skin rashes), bleeding in the penis, blood in the semen, and increased sweating.

Rare cases of heart attack and stroke have also been reported in men taking tadalafil. Most of these men had pre-existing heart problems before taking this medicine.

Rarely, cases of decreased or lost vision, partial, transient or permanent, in one or both eyes have been reported.

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

• Migraine, facial swelling, severe allergic reaction causing swelling of the face or throat, severe skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeats, angina, and sudden cardiac death.
• Distorted, diminished, blurred central vision or sudden decrease in vision (frequency not known).

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

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tadalafil Mabo

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

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

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

Appearance of the product and contents of the pack

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

It is presented in PVC/PVDC/Aluminum blisters, in packs containing 4 film-coated tablets.

Marketing Authorization 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 the most recent review of this leaflet: November 2023

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