Product Information for the Patient

Tadalafilo Mylan 5 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 who have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

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

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

• erectile dysfunction. This is when a man cannot get or keep an erection firm enough for satisfying sexual activity. Tadalafilo Mylan has shown a significant improvement in the ability to get a lasting erection of the penis suitable for sexual activity. After sexual stimulation, Tadalafilo Mylan 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 Mylan will not help if you do not have erectile dysfunction. It is essential to inform you that Tadalafilo Mylan is not effective if there is no sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way as you would if you were not taking a medicine for erectile dysfunction.

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

Do not take Tadalafilo Mylan

• if you are allergic to tadalafil or any of the other ingredients of this medicine (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 medicines (“nitrates”) used to treat angina (chest pain). Tadalafilo Mylan has been seen to increase the effects of these medicines. If you are taking any type of nitrates or are unsure, tell your doctor.

• if you have a serious heart condition or have had a heart attack recently, within the last 90 days.
• if you have had a stroke in the last 6 months.
• if you have low or high blood pressure that is not controlled.

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

• if 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 clots). PDE5 inhibitors, such as Tadalafilo Mylan, 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

Consult your doctor before starting to take Tadalafilo Mylan.

Be aware that sexual activity can pose a possible risk for patients with heart problems, due to the additional strain it puts on 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 check 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 (an abnormality of red blood cells).
• multiple myeloma (bone marrow cancer).
• leukemia (blood cell cancer).
• any deformity of the penis.
• a serious liver problem.
• a serious kidney problem.

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

• pelvic surgery.

• surgeries 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 decrease or sudden loss of vision, stop taking Tadalafilo Mylan and immediately contact your doctor.

There has been a perceived decrease or sudden loss of hearing in some patients using tadalafil. Although it is unknown if the event is directly related to tadalafil, if you experience a decrease or sudden loss of hearing, discontinue treatment with Tadalafilo Mylan and immediately contact your doctor.

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 old.

Other medicines and Tadalafilo Mylan

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

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

Some medicines 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 medicines to treat high blood pressure.
• riociguat.
• an inhibitor of 5-alpha reductase (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/AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking Tadalafilo Mylan with beverages and alcohol

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

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

Fertility

In dogs treated, 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 Mylan during clinical trials experienced dizziness. Check carefully how you react when taking the tablets before driving or operating machines.

Tadalafilo Mylan contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, contact him before taking this medicine.

Tadalafilo Mylan contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) 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.

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 one 2.5 mg tablet.

Do not take Tadalafilo Mylan more than once a day.

Tadalafilo Mylan taken daily allows you to obtain 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.

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

If you take more Tadalafilo Mylan than you should

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

If you forgot to take Tadalafilo Mylan

Take your dose as soon as you remember, but do not take a double dose to make up for the missed dose. 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.

Like all medicines, Tadalafilo Mylan can 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 medicine and seek medical help immediately:

• allergic reactions including rashes (infrequent).
• chest pain - do not use nitrates but seek medical help immediately (infrequent).

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

Other side effects that have been reported:

Frequent(can affect up to 1 in 10 people)

• headache, back pain, muscle pain, arm and leg pain, facial flushing, nasal congestion, and indigestion.

Infrequent(can 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 heartbeat, high blood pressure, low blood pressure, nasal bleeding, ringing in the ears, swelling of the hands, feet, or ankles, and feeling tired.

Rare(can affect up to 1 in 1000 people)

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

Infarction and stroke have also been reported rarely in men taking Tadalafilo Mylan. Most of these men had some heart problems before taking this medicine.

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

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

• migraine, facial swelling, severe allergic reaction causing facial or throat swelling, severe skin eruptions, certain disorders affecting blood flow to the eyes, irregular heartbeat, angina, and sudden cardiac death.

The most common side effect reported in men over 75 years old taking Tadalafilo Mylan was dizziness. Diarrhea cases were more frequently reported in patients over 65 years old taking Tadalafilo Mylan.

Reporting side effects

If you experience any type of side effect, consult yourdoctoror pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 after “CAD” and “EXP” respectively. 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 drains or trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Tadalafilo Mylan

• The active ingredient is tadalafilo. Each tablet contains 5 mg of tadalafilo.
• The other components are:

Core 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: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172), triacetin.

Appearance of the product and contents of the package

Tadalafilo Mylan 5 mg is a yellowish clear tablet, coated with a film, round, biconvex, marked with an "M" on one face and with "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 package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Mylan S.A.S.

117 Allée des Parcs

69800 Saint-Priest

France

Responsible manufacturer

McDermott Laboratories Ltd. under the commercial name of 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

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

Last review date of this leaflet:

Other sources of information

The detailed information about this medication is available on the website of the European Medicines Agency http://www.ema.europa.eu and on the website of the Spanish Agency of Medicines and Medical Products (AEMPS, http://www.aemps.gob.es/ )