TADALAFIL MYLAN 10 mg FILM-COATED TABLETS

2. What you need to know before you take Tadalafil Mylan

Do not take Tadalafil 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 form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used to treat angina pectoris (“chest pain”). Tadalafil Mylan has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure, tell your doctor.
• if you have a severe heart or liver problem.
• if you have recently had a stroke or heart attack within the last 90 days.
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have ever had loss of vision because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischemic optic neuropathy, NAION).
• 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 due to blood clots). PDE5 inhibitors, such as Tadalafil Mylan, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor before taking Tadalafil Mylan.

Be aware that sexual activity carries a possible risk to patients with heart problems because it puts extra strain on the heart. If you have a heart problem, tell your doctor.

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

• sickle cell anaemia (a disease of the red blood cells).
• multiple myeloma (a cancer of the bone marrow).
• leukaemia (a cancer of the blood cells).
• any deformation of the penis.
• a severe kidney problem.
• a severe liver problem.

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

• undergone pelvic surgery.
• had a radical non-nerve-sparing prostatectomy.

If you experience sudden loss of vision or your vision is affected while taking Tadalafil Mylan, stop taking Tadalafil Mylan and contact your doctor immediately.

Sudden loss of hearing has been reported in some patients taking tadalafil. Although it is not known if these events are directly related to tadalafil, if you experience sudden loss of hearing, stop taking Tadalafil Mylan and contact your doctor immediately.

Tadalafil Mylan is not intended for use by women.

Children and adolescents

Tadalafil Mylan should not be used in children and adolescents under 18 years of age.

Other medicines and Tadalafil Mylan

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

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

Some medicines may be affected by Tadalafil Mylan or may affect how well Tadalafil Mylan works. Tell your doctor or pharmacist if you are using:

• an alpha-blocker (used to treat high blood pressure or problems with passing water).
• other medicines for high blood pressure.
• riociguat.
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole (for fungal infections) and protease inhibitors for the treatment of HIV or AIDS.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking Tadalafil Mylan with food and drink

Grapefruit juice may affect how Tadalafil Mylan works and should be taken with caution. Consult your doctor for more information.

Consuming large amounts of alcohol may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil 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 was observed. A reduction in sperm count has been observed in some men. These effects are unlikely to lead to infertility.

Driving and using machines

Some men taking Tadalafil Mylan during clinical trials experienced dizziness. Check carefully how you react to the tablets before driving or using machines.

Tadalafil Mylan contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Tadalafil Mylan contains sodium

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

3. How to take Tadalafil Mylan

Follow exactly the instructions of your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is one 10 mg tablet taken before sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg. Tadalafil Mylan tablets are for oral use.

When taking Tadalafil Mylan, you may initiate sexual activity from at least 30 minutes after taking the tablet.

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

Do not take Tadalafil Mylan more than once a day. Tadalafil Mylan 10 and 20 mg are intended for use before anticipated sexual activity and are not recommended for continuous daily use.

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

If you take more Tadalafil Mylan than you should

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

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

4. Possible side effects

Like all medicines, Tadalafil Mylan can cause side effects, although not everybody gets them. These effects are usually mild to moderate.

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

• allergic reactions including skin rash (uncommon).
• chest pain - do not use nitrates, but seek medical help immediately (uncommon).
• priapism, a prolonged and possibly painful erection after taking tadalafil (rare). If you have an erection that lasts more than 4 hours, contact a doctor immediately.
• sudden loss of vision (rare), blurred vision, distorted vision, or sudden loss of vision (frequency not known).

Other side effects that have been reported:

Common(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, blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet, or ankles, and feeling tired.

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

• fainting, seizures, and temporary memory loss, swelling of the eyelids, red eyes, sudden loss of hearing, hives (itchy red welts on the surface of the skin), bleeding from the penis, blood in the semen, and increased sweating.

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

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

Additional rare side effects have been reportedin men taking Tadalafil Mylan that were not seen in clinical trials:

migraine, swelling of the face, 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.

• blurred vision, distorted vision, or sudden loss of vision (frequency not known).

The most commonly reported side effect in men over 75 years old taking Tadalafil Mylan was dizziness. Cases of diarrhoea reported were more common in patients over 65 years of age taking Tadalafil Mylan.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tadalafil Mylan

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

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Tadalafil Mylan contains

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

Core of the tablet: anhydrous lactose (see section 2 “Tadalafil Mylan contains lactose”), Poloxamer 188, microcrystalline cellulose (pH101), povidone (K-25), croscarmellose sodium, magnesium stearate, sodium lauryl sulfate, colloidal anhydrous silica.

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

Appearance and packaging

Tadalafil Mylan 10 mg is a light yellow, film-coated, round, biconvex tablet, marked with an “M” on one face and “TL3” on the other face.

Tadalafil Mylan 10 mg is available in blister packs containing 4, 12, and 24 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Mylan Pharmaceuticals Limited

Damastown Industrial Park,

Mulhuddart, Dublin 15,

DUBLIN

Ireland

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

Mylan Germany GmbH

Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1

Bad Homburg v. d. Hoehe

Hessen, 61352,

Germany

For further information on this medicine, contact the local representative of the marketing authorisation holder.

Date of last revision of this package leaflet:

Other sources of information

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