Tadalafil Mylan 5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Tadalafilo Mylan 5 mg Film-coated Tablets EFG

tadalafil

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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, 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 effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

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

Tadalafilo Mylan 5 mg is used in adult men for the treatment of:

• Erectile dysfunction. This occurs when a man is unable to achieve or maintain a firm erection suitable for satisfactory sexual activity. Tadalafilo Mylan has been shown to significantly improve the ability to achieve a durable penile erection suitable for sexual activity. Following sexual stimulation, Tadalafilo Mylan works by helping to relax the blood vessels in the penis, allowing blood to flow into the penis. The result is improved erectile function. Tadalafilo Mylan will not help you if you do not have erectile dysfunction. It is important to warn you that Tadalafilo Mylan is not effective without sexual stimulation. Therefore, you and your partner should stimulate each other in the same way as you would if you were not taking a medicine for erectile dysfunction.

• Urinary symptoms associated with a common condition called benign prostatic hyperplasia. This occurs when the prostate gland enlarges over time. Symptoms include difficulty starting to urinate, a sensation that the bladder has not emptied completely, and a need 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 been shown to improve these urinary symptoms within 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 to 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 pectoris (“chest pain”). Tadalafilo Mylan has been shown to increase the effects of these medicines. If you are taking any type of nitrate or are unsure, tell your doctor.

• if you have severe heart disease or have recently had a heart attack (within the last 90 days).

• if you have had a stroke within the last 6 months.

• if you have low blood pressure or uncontrolled high blood pressure.

• if you have ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.

• 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 blood 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

Talk to your doctor before starting to take Tadalafilo Mylan.

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.

Since benign prostatic hyperplasia and prostate cancer can have similar 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 (an abnormality of red blood cells).
• multiple myeloma (cancer of the bone marrow).
• leukemia (cancer of blood cells).
• any deformity of the penis.
• severe liver problems.
• severe kidney problems.

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

• pelvic surgery.

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

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

Sudden decrease or loss of hearing has been reported in some patients taking tadalafil. Although it is unknown whether this event is directly related to tadalafil, if you experience 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 must not be used in children or adolescents under 18 years of age.

Other medicines and Tadalafilo Mylan

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

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

Some medicines may be affected by Tadalafilo Mylan or may affect how well Tadalafilo Mylan works. 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 for treating 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) and 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 Tadalafilo Mylan with food and alcohol

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

Alcohol consumption 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 upon standing.

Fertility

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

Driving and using machines

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

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; hence, it is essentially “sodium-free”.

3. How to take Tadalafil Mylan

Follow exactly the instructions for administration of this medicine as given 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 daily, taken at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg depending on your response to Tadalafil Mylan. This will be achieved by taking one 2.5 mg tablet.

Do not take Tadalafil Mylan more than once a day.

Daily administration of Tadalafil Mylan allows you to achieve an erection at any time during the 24-hour day, provided there is sexual stimulation. A daily dose of Tadalafil Mylan may be beneficial for men who expect to have sexual activity two or more times per week.

For the treatment of benign prostatic hyperplasia

The dose is one 5 mg tablet once daily, taken at approximately the same time each day. If you have both benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet once daily.

Do not take Tadalafil Mylan more than once a day.

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

If you take more Tadalafil Mylan than you should

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

If you forget to take Tadalafil Mylan

Take your dose as soon as you remember, but do not take a double dose to make up for forgotten doses. You must not take Tadalafil Mylan more than once a day.

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

4. Possible adverse effects

Like all medicines, Tadalafilo Mylan 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 loss of vision (rare frequency).

Other adverse effects reported:

Frequent (may affect up to 1 in 10 people)

• headache, back pain, muscle aches, pain in 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, presence of blood in 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 (may affect up to 1 in 1000 people)

• 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, presence of blood in semen, and increased sweating.

Rare cases of myocardial infarction (heart attack) and stroke have also been reported in men taking Tadalafilo Mylan. Most of these men had pre-existing heart conditions before taking this medicine.

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

Some additional rare adverse effects have been reported in men taking Tadalafilo Mylan 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 pectoris, and sudden cardiac death.

The most frequently reported adverse effect in men over 75 years of age taking Tadalafilo Mylan has been dizziness. Cases of diarrhea were more frequently reported in patients over 65 years of age taking Tadalafilo Mylan.

Reporting of adverse effects

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

5. Storage of Tadalafil Mylan

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging following “CAD” and “EXP”, respectively. 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. 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 Mylan

• The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
• The other components are:

Tablet core: anhydrous lactose (see section 2 “Tadalafil Mylan contains lactose”), poloxamer 188, microcrystalline cellulose (pH101), povidone (K-25), sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, colloidal anhydrous silica.

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

Nature of the product and contents of the pack

Tadalafil Mylan 5 mg is a light yellow, film-coated, round, biconvex tablet, marked with an “M” on one side and “TL over 2” on the other.

Tadalafil 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
Branch office Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352
Germany

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder.

Date of the most recent review of this leaflet:

Other sources of information

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