Tadamen Med

Package Leaflet: Information for the Patient

Tadamen MED, 2.5 mg, Film-Coated Tablets

Tadalafil

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Tadamen MED and what is it used for
• 2. Important information before taking Tadamen MED
• 3. How to take Tadamen MED
• 4. Possible side effects
• 5. How to store Tadamen MED
• 6. Contents of the pack and other information

1. What is Tadamen MED and what is it used for

Tadamen MED is a medicine used to treat adult men with erectile dysfunction. This is a condition where a man cannot get or maintain an erection sufficient for satisfactory sexual activity. It has been shown that tadalafil significantly improves the ability to get an erection for sexual activity.

Tadamen MED contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, Tadamen MED helps to relax the blood vessels in the penis, allowing blood to flow into the penis. As a result, it helps to improve erectile function. Tadamen MED does not help patients who do not have erectile dysfunction.

It is important to note that tadalafil does not work without sexual stimulation. The patient and his partner should engage in foreplay, just as they would if the patient were not taking an erectile dysfunction medicine.

2. Important information before taking Tadamen MED

When not to take Tadamen MED:

• if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• if you are taking organic nitrates or other nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina pectoris (chest pain). It has been shown that tadalafil increases the effects of these medicines. If you are taking nitrates in any form, or are unsure, you should tell your doctor.
• if you have severe heart disease or have had a heart attack in 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 loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), also known as "eye stroke".
• if you are taking riociguat. This is a medicine used to treat pulmonary 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). It has been shown that phosphodiesterase type 5 inhibitors, such as Tadamen MED, increase the blood pressure-lowering effect of this medicine. If you are taking riociguat, or are unsure, you should inform your doctor.

Warnings and precautions

Before taking Tadamen MED, you should tell your doctor.

You should remember that sexual activity carries a risk for patients with heart disease, as it puts extra strain on the heart. If you have a heart condition, you should tell your doctor.

Before taking the medicine, you should tell your doctor if you have:

• sickle cell anemia (a condition affecting red blood cells).
• multiple myeloma (a cancer of the bone marrow).
• leukemia (a cancer of the blood cells).
• any deformation of the penis.
• severe liver disease.
• severe kidney disease.

It is not known if tadalafil is effective in patients who have:

• had pelvic surgery.
• had their prostate removed (prostatectomy), during which the nerves surrounding the prostate were cut (radical prostatectomy without nerve sparing).

If you experience sudden loss of vision or loss of vision, or blurred vision, you should stop taking Tadamen MED and contact your doctor immediately.

In some patients taking tadalafil, a decrease in hearing or loss of hearing has been observed.

Tadamen MED is not intended for use by women.

Children and adolescents

Tadamen MED is not intended for use by children and adolescents under 18 years of age.

Tadamen MED and other medicines

You should tell your doctor about all the medicines you are taking, or have recently taken, and those you plan to take.

You should not take Tadamen MED if you are taking nitrates.

Tadamen MED may affect the way some other medicines work, or other medicines may affect the way Tadamen MED works.

You should tell your doctor or pharmacist if you are taking:

• alpha-blockers (used to treat high blood pressure or symptoms of an enlarged prostate).
• other medicines used to treat high blood pressure.
• riociguat.
• 5-alpha reductase inhibitors (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (antiepileptic medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Tadamen MED with food and drink

Information about the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Tadamen MED, and therefore, caution should be exercised when consuming it. For more information, you should ask your doctor.

Fertility

When tadalafil was given to dogs, it caused a decrease in sperm production in the testes.

A decrease in sperm concentration was observed in some men.

It is unlikely that this will lead to infertility.

Driving and using machines

In some men taking tadalafil during clinical trials, dizziness was reported.

You should be aware of how you react to the medicine before driving or operating machinery.

Tadamen MED contains lactose

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

Tadamen MED contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to take Tadamen MED

This medicine should always be taken exactly as your doctor has instructed you.

If you are unsure, you should ask your doctor or pharmacist.

Tadamen MED tablets are for oral use only in men.

The tablets should be swallowed whole with a small amount of water.

The tablets can be taken with or without food.

Recommended doseis 5 mg, taken once a day, at approximately the same time each day.

Your doctor may adjust the dose to 2.5 mg, depending on your response to Tadamen MED.

You should not take Tadamen MED more than once a day.

Taking Tadamen MED once a day may be beneficial for men who plan to have sexual activity twice a week or more frequently.

Taking Tadamen MED once a day allows for spontaneous erections in response to sexual stimulation at any time during the 24-hour dosing period.

It is important to note that Tadamen MED does not work without sexual stimulation.

The patient and his partner should engage in foreplay, just as they would if the patient were not taking an erectile dysfunction medicine.

Consuming large amounts of alcohol may decrease your ability to get an erection and may increase the risk of dizziness when standing up.

What to do if you take more Tadamen MED than you should

You should inform your doctor.

Side effects (see section 4) may occur.

What to do if you forget to take Tadamen MED

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

Do not take Tadamen MED more than once a day.

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

4. Possible side effects

Like all medicines, Tadamen MED can cause side effects, although not everybody gets them.

These effects are usually mild or moderate.

If you experience any of the following side effects, stop taking Tadamen MED and contact your doctor immediately:

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

Other reported side effects:

Common(may affect up to 1 in 10 people)

• headache, back pain, muscle pain, pain in arms and legs, 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, prolonged erections, blood in urine, 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 transient memory loss, swelling of the eyelids, redness of the eyes, sudden loss of hearing, hives (itchy, red bumps on the skin), bleeding from the penis, blood in semen, and increased sweating.

Heart attack and stroke have also been reported rarely in men taking tadalafil. Most of these men had pre-existing heart disease.

Rarely, partial, transient, or permanent decrease in vision or loss of vision in one or both eyes has been reported.

In men taking tadalafil, several other rare side effects have been reported, which were not observed in clinical trials. These include:

• migraine, facial swelling, severe allergic reactions causing swelling of the face and throat, severe skin rashes, disorders affecting blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac deaths.
• blurred vision, or loss of vision (frequency not known).

Dizziness was reported more frequently in men over 75 years old taking tadalafil.

Diarrhea was reported more frequently in men over 65 years old taking tadalafil.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl.

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tadamen MED

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

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

There are no special storage instructions for this medicine.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required.

This will help protect the environment.

6. Contents of the pack and other information

What Tadamen MED contains

• The active substance is tadalafil. Each tablet contains 2.5 mg of tadalafil.
• The other ingredients are: Tablet core: lactose (see section 2 "Tadamen MED contains lactose"), poloxamer 188, microcrystalline cellulose (pH 101), povidone K 25, croscarmellose sodium, magnesium stearate, sodium lauryl sulfate, colloidal anhydrous silica. Film coating: lactose monohydrate, hypromellose (HPMC 2910), titanium dioxide, yellow iron oxide (E 172), triacetin.

What Tadamen MED looks like and contents of the pack

Tadamen MED, 2.5 mg, is a light yellow, round, biconvex, film-coated tablet, with "M" engraved on one side and "TL" above "1" on the other side of the tablet.

Tadamen MED, 2.5 mg, is available in blisters in packs containing 2, 4, 28, or 56 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Mylan Healthcare Sp. z o.o.

ul. Postępu 21B

02-676 Warsaw

Importer

McDermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road

Dublin 13

Ireland

Mylan Hungary Kft.

Mylan utca 1

2900 Komárom

Hungary

For further information, you should contact the marketing authorization holder:

Mylan Healthcare Sp. z o.o.

Tel: +48 22 546 64 00

Date of last revision of the leaflet: