Tadalafil Viatris Pharmaceuticals 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tadalafil Viatris Pharmaceuticals 10 mg film-coated tablets EFG

Tadalafil

Read the entire 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 should not give it to others, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Tadalafil Viatris Pharmaceuticals is and what it is used for

2. What you need to know before taking Tadalafil Viatris Pharmaceuticals

3. How to take Tadalafil Viatris Pharmaceuticals

4. Possible side effects

5. How to store Tadalafil Viatris Pharmaceuticals

6. Contents of the pack and other information

1. What Tadalafilo Viatris Pharmaceuticals is and what it is used for

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

Tadalafilo Viatris Pharmaceuticals 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 penis. The result is improved erectile function. Tadalafil 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 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 Viatris Pharmaceuticals

Do not take Tadalafil Viatris Pharmaceuticals 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 is a group of medicines (“nitrates”) used to treat angina pectoris (“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 disease 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 before starting to take tadalafil.

Be aware that sexual activity carries 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 deformity of the penis.

• severe liver problems.

• severe kidney problems.

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

• pelvic surgery.

• a surgical procedure in which the prostate has been completely or partially removed and the nerves to the prostate have been cut (radical prostatectomy without neurovascular bundle preservation).

If you experience a 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. However, it is not known whether this event is directly related to tadalafil. If you experience sudden decrease or loss of hearing, stop taking tadalafil 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

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.

Some medicines may be affected by tadalafil or may 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 for high blood pressure.

• riociguat.

• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).

• medicines such as ketoconazole tablets (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection.

• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).

• rifampicin, erythromycin, clarithromycin, or itraconazole.

• other treatments for erectile dysfunction.

Taking tadalafil with food and alcohol

Information about the effect of alcohol is provided in section 3. Grapefruit juice may affect how tadalafil works and should be consumed with caution. Consult your doctor for further information.

Fertility

In treated dogs, a reduction in sperm production by the testes was observed. Some men have shown reduced sperm counts. It is unlikely that these effects would lead to infertility.

Driving and using 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 contains lactose:

If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Tadalafil contains sodium:

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

3. How to take Tadalafil Viatris Pharmaceuticals

Follow exactly the instructions for use of this medicine provided by your doctor.

If in doubt, consult your doctor or pharmacist again.

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

The recommended starting dose is one 10 mg tablet taken prior to sexual activity. If this dose is not effective enough, your doctor may increase the dose to 20 mg. Tadalafil tablets are administered orally.

After taking tadalafil, you may initiate sexual activity at least 30 minutes later.

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

You must not take tadalafil more than once a day. The 10 mg and 20 mg tadalafil tablets are to be taken 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 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 this may increase the risk of dizziness upon standing.

If you take more tadalafil than you should

Contact your doctor. 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, tadalafil 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 must contact a doctor immediately.

• sudden vision loss (rare frequency), distorted vision, dimmed vision, blurred central vision, or sudden decrease in vision (frequency not known).

Other adverse effects reported:

Frequent (observed in 1 to 10 out of every 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 every 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, tinnitus (ringing in the ears), swelling of the hands, feet or ankles, and feeling tired.

Rare (observed in 1 to 10 out of every 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 from 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 reported 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 heartbeat, angina, and sudden cardiac death. distorted, dimmed, blurred central vision or sudden decrease in vision (frequency not known).

In men over 75 years of age receiving tadalafil, the most frequently reported adverse effect was dizziness. In men over 65 years of age receiving tadalafil, the most frequently reported adverse effect was diarrhoea.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tadalafil Viatris Pharmaceuticals

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

Do not use this medicine after the expiry date stated on the carton and blister after “CAD” or “EXP”. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of tadalafil

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

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

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

Appearance of the product and contents of the pack

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

This medicine is available in blister packs containing 4 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer:

Mylan Germany GmbH

Zweigniederlassung Bad Homburg v. d.

Hoeche, Benzstrasse 1

Bad Homburg v.d. Hoeche

Hessen, 61352

Germany

Or

Mylan Hungary Kft.

Mylan utca 1

2900 Komárom

Hungary

Date of the most recent review of this leaflet: September 2023

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