TADALAFIL MYLAN 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Tadalafilo Mylan 5 mg Film-Coated Tablets EFG

tadalafil

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.

• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Tadalafilo Mylan and what is it used for
2. What you need to know before taking Tadalafilo Mylan
3. How to take Tadalafilo Mylan
4. Possible side effects
5. Storage of Tadalafilo Mylan
6. Package Contents and Additional Information

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

Tadalafilo Mylan contains the active ingredient tadalafil, which belongs to a group of medications called phosphodiesterase type 5 inhibitors.

Tadalafilo Mylan 5 mg is used to treat adult men with:

• erectile dysfunction. This occurs when a man cannot obtain or maintain a firm erection sufficient for satisfactory sexual activity. Tadalafilo Mylan has been shown to significantly improve the ability to achieve a lasting erection of the penis suitable for sexual activity. After sexual stimulation, Tadalafilo Mylan acts by helping to relax the blood vessels in your penis, allowing blood flow to the penis. The result is an improvement in erectile function. Tadalafilo Mylan will not help if you do not have erectile dysfunction. It is essential to note that Tadalafilo Mylan is not effective if there is no sexual stimulation. Therefore, you and your partner should stimulate each other in the same way as you would if you were not taking a medication for erectile dysfunction.

• urinary symptoms associated with a common condition called benign prostatic hyperplasia. This occurs when the prostate gland enlarges with age. Symptoms include difficulty starting to urinate, feeling that the bladder is not completely empty, needing to urinate more frequently, even at night. Tadalafilo Mylan improves blood flow and relaxes the muscles of the prostate and bladder, which can reduce the symptoms of benign prostatic hyperplasia. Tadalafilo Mylan has been shown to improve these urinary symptoms in as little as 1-2 weeks after starting treatment.

2. What you need to know before taking Tadalafilo Mylan

Do not take Tadalafilo Mylan

• if you are allergic to tadalafil or any of the other ingredients of this medication (listed in section 6).

• if 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"). It has been seen that Tadalafilo Mylan increases the effects of these medications. If you are taking any type of nitrate or are unsure, tell your doctor.

• if you have a severe heart condition or have recently had a heart attack, within the last 90 days.
• if you have had a stroke in the last 6 months.
• if you have low blood pressure or uncontrolled high blood pressure.

• if you have ever had a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "eye infarction".

• if 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 blood clots). Phosphodiesterase type 5 inhibitors, such as Tadalafilo Mylan, have shown that they 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 Mylan.

Be aware that sexual activity carries a possible risk in patients with heart problems, due to the additional effort it entails for 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 screening before starting treatment with Tadalafilo Mylan for benign prostatic hyperplasia. Tadalafilo Mylan does not treat prostate cancer.

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

• sickle cell anemia (a red blood cell abnormality).
• multiple myeloma (bone marrow cancer).
• leukemia (blood cell cancer).
• any penile deformation.
• a severe liver problem.
• a severe kidney problem.

It is not known if Tadalafilo Mylan is effective in patients who have undergone:

• surgery in the pelvic area.

• a surgical procedure in which the prostate was completely or partially removed and the prostate nerves were cut (radical prostatectomy without preservation of neurovascular bundles).

If you experience a sudden decrease or loss of vision, stop taking Tadalafilo Mylan and contact your doctor immediately.

A sudden decrease or loss of hearing has been perceived in some patients using tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience a sudden decrease or loss of hearing, discontinue treatment with Tadalafilo Mylan and contact your doctor immediately.

Tadalafilo Mylan is not intended for use in women.

Children and Adolescents

Tadalafilo Mylan should not be used in children or adolescents under 18 years of age.

Other Medications and Tadalafilo Mylan

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Do not take Tadalafilo Mylan if you are already using nitrates.

Some medications may be affected by Tadalafilo Mylan or may affect the proper functioning of Tadalafilo Mylan. 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 for treating high blood pressure.
• riociguat.
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).

• medications such as ketoconazole tablets (for treating fungal infections) and protease inhibitors for treating AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medications).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking Tadalafilo Mylan with Drinks and Alcohol

Grapefruit juice may affect the proper functioning of Tadalafilo Mylan and should be taken with caution. Consult your doctor for more information.

Consuming alcohol may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafilo Mylan, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness when standing up.

Fertility

In dogs treated with tadalafil, a decrease in sperm production by the testicles was observed. A reduction in sperm has been observed in some men. It is unlikely that these effects will produce a lack of fertility.

Driving and Using Machines

Some men who took Tadalafilo Mylan during clinical trials experienced dizziness. Carefully check how you react when taking the tablets before driving or using machines.

Tadalafilo Mylan Contains Lactose

If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medication.

Tadalafilo Mylan Contains Sodium

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

3. How to Take Tadalafilo Mylan

Follow your doctor's instructions for taking this medication exactly.

If you are unsure, consult your doctor or pharmacist again.

For the Treatment of Erectile Dysfunction

The recommended dose is 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 Tadalafilo Mylan. This will be done by taking a 2.5 mg tablet.

Do not take Tadalafilo Mylan more than once a day.

Tadalafilo Mylan taken daily allows you to achieve an erection at any time during the 24 hours of the day, as long as there is sexual stimulation. A daily dose of Tadalafilo Mylan may be useful for men who expect to have sexual activity two or more times a week.

For the Treatment of Benign Prostatic Hyperplasia

The dose is 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 Tadalafilo Mylan more than once a day.

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

If You Take More Tadalafilo Mylan Than You Should

Consult your doctor. You may experience side effects described in section 4.

If You Forget to Take Tadalafilo Mylan

Take your dose as soon as you remember, but do not take a double dose to make up for missed doses. Do not take Tadalafilo Mylan more than once a day.

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

4. Possible Side Effects

Like all medications, Tadalafilo Mylan can cause side effects, although not everyone experiences them. These effects are generally mild to moderate.

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

• allergic reactions, including rash (uncommon).
• chest pain - do not use nitrates, but seek medical help immediately (uncommon).

• priapism, a prolonged and possibly painful erection after using tadalafil (rare). If you experience this type of erection, which can last continuously for more than 4 hours, you should contact a doctor immediately.
• sudden loss of vision (rare).

Other side effects that have been reported:

Frequent(may affect up to 1 in 10 people)

• headache, back pain, muscle pain, pain in the arms and legs, facial flushing, nasal congestion, and indigestion.

Uncommon(may affect up to 1 in 100 people)

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

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

Myocardial infarction and stroke have also been reported rarely in men taking Tadalafilo Mylan. Most of these men had pre-existing heart problems before taking this medication.

Rare cases of partial, transient, or permanent loss of vision have been reported in one or both eyes.

Some additional rare side effectshave been reported in men taking Tadalafilo Mylan that were not reported during clinical trials. These include:

• migraine, facial swelling, 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, angina pectoris, and sudden cardiac death.

The most frequently reported side effect in men over 75 years of age taking Tadalafilo Mylan was dizziness. The cases of diarrhea reported corresponded more frequently to patients over 65 years of age taking Tadalafilo Mylan.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Tadalafilo Mylan

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

Do not use this medication after the expiration date stated on the box after "EXP". 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 wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Tadalafilo Mylan

• The active ingredient is tadalafil. Each tablet contains 5 mg of tadalafil.
• The other ingredients are:

Core of the tablet: anhydrous lactose (see section 2 "Tadalafilo Mylan contains lactose"), poloxamer 188, microcrystalline cellulose (pH101), povidone (K-25), 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 Package Contents

Tadalafilo Mylan 5 mg is a light yellow, film-coated, round, biconvex tablet, marked with an "M" on one face and "TL over 2" on the other face.

Tadalafilo Mylan 5 mg is available in blister packs containing 14, 28, 30, 56, 84, and 98 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Mylan S.A.S.

117 Allée des Parcs

69800 Saint-Priest

France

Manufacturer

McDermott Laboratories Ltd. trading as Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road Dublin 13

Ireland

Mylan Hungary Kft.

Mylan utca 1

Komárom, 2900

Hungary

Generics [UK] Limited

Station Close

Potters Bar, EN6 1TL

United Kingdom

Mylan UK Healthcare Limited

Building 20, Station Close

Potters Bar, EN6 1TL

United Kingdom

Mylan Germany GmbH

Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1

Bad Homburg v. d. Hoehe

Hessen, 61352,

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder.

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu and on the website of the Spanish Agency for Medicines and Health Products (AEMPS, http://www.aemps.gob.es/).