Product Information for the User

Tadalafilo Viatris Pharmaceuticals 10 mg Film-Coated Tablets

Tadalafilo

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

1. What you need to know before starting to take Tadalafilo Viatris Pharmaceuticals
2. How to take Tadalafilo Viatris Pharmaceuticals

1. Possible adverse effects
2. Storage of Tadalafilo Viatris Pharmaceuticals
3. Contents of the pack and additional information

Tadalafilo 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.

TadalafiloViatris Pharmaceuticalscontains the active ingredient tadalafilo, which belongs to a group of medications known as phosphodiesterase type 5 inhibitors. 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 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 take Tadalafilo Viatris Pharmaceuticals 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”). 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.

• You have a serious 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 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). 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 before starting to take tadalafilo.

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.

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

• Anemia falciforme (an abnormality of red blood cells).

• Multiple myeloma (bone marrow cancer).
• Leukemia (blood cell cancer).

• Any penile deformity.
• A serious liver problem.

• A serious kidney problem.

Tadalafilo is not known to be effective in patients who have undergone:

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

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

A sudden decrease or 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 sudden decrease or loss of hearing, stop taking tadalafilo 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

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.

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 with beverages and alcohol

Information about the effect of alcohol can be found in section 3. Grapefruit 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 contains lactose:

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

Tadalafilo contains sodium:

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

Follow exactly the administration instructions for this medication as indicated by your doctor.

If in doubt, consult your doctor or pharmacist again.

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

The recommended initial doseis one 10 mg tablet before sexual activity. If the effectof this dose is too weak, your doctor may increase the dose to 20 mg. Tadalafilo tablets are administered orally.

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

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

You should not take tadalafilo more than once a day. Tadalafilo 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.

If you take more tadalafilo than you should

Consult your doctor. 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 medications, tadalafil 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 medication and seek medical help immediately:

• allergic reactions including rashes (infrequent).
• chest pain - do not use nitrates but seek medical help immediately (infrequent).
• prolonged and possibly painful erection after taking tadalafil (rare). 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) 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, ringing in the ears, 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, hives (red patches on the skin that itch), bleeding in the penis, blood in the semen and increased sweating.

It has also been reported that rare cases of heart attack and stroke have occurred in men taking tadalafil. Most of these men had some heart problem before taking this medication.

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 that causes facial or throat swelling, severe skin rashes, certain disorders that affect blood flow to the eyes, irregular heartbeat, angina and sudden cardiac death.

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 that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medications for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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 the blister pack after “CAD” or “EXP”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Tadalafil Composition

• Theactive ingredientis tadalafil. Each tablet contains 10 mg of tadalafil.
• Theother componentsare:

Tablet core: Anhydrous lactose, poloxamer 188, microcrystalline cellulose, povidone, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, anhydrous colloidal silica.

Coating: Monohydrate lactose, hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172), triacetin

Appearance of the product and contents of the packaging

Tadalafil Yes 10 mg is a pale yellow, round, biconvex tablet with the letter “M” in relief on one face and “TL3” on the other face.

This medicine is available in blister packs with 4 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

General Aranaz 86, 28027 Madrid (Madrid)

Spain

Manufacturer:

McDermott Laboratories Ltd t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road

Dublin 13

Ireland

Or

Mylan Germany GmbH

Branch in Bad Homburg v. d.

Hoeche, Benzstrasse 1

Bad Homburg v.d. hoeche

Hessen, 61352

Germany

Or

Mylan Hungary Kft.

Mylanutca1

2900Komárom

Hungary

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

General Aranaz 86, 28027 Madrid (Madrid)

Spain

Last review date of this leaflet: September 2023

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