Tadamen Med

Leaflet accompanying the packaging: patient information

Tadamen MED, 20 mg, film-coated tablets

Tadalafil

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the 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 for adult men with erectile dysfunction. This is a condition where a man cannot get or maintain an erection sufficient for sexual intercourse.
It has been shown that tadalafil significantly improves the ability to get an erection suitable for sexual intercourse.
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 widen the blood vessels in the penis, allowing blood to flow into the penis. As a result, the erection improves. Tadamen MED does not help patients who do not have erectile dysfunction.
It is important to remember that tadalafil does not work without sexual stimulation. The patient and his partner should arrange foreplay, just like when the patient is not taking erectile dysfunction medication.

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 in any form 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 enhances the effect of these medicines.

If you are taking nitrates in any form or are unsure, you should inform 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 a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), referred to 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, enhance 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 consult your doctor.
Remember that sexual activity is associated with a risk for patients with heart disease, as it puts an additional strain on the heart. If you have heart problems, you should inform your doctor.
Before taking the medicine, you should inform your doctor if you have:

• sickle cell anemia (a disorder affecting red blood cells).
• multiple myeloma (a bone marrow tumor).
• leukemia (a blood cell tumor).
• any penile deformity.
• severe liver disease.
• severe kidney disease.

It is not known whether tadalafil is effective in patients:

• after pelvic surgery.
• after total or partial removal of the prostate gland, during which the nerves of the prostate gland are cut (radical prostatectomy without nerve sparing).

If you experience sudden worsening of vision or loss of vision or blurred vision while taking Tadamen MED, you should stop taking the medicine and contact your doctor immediately.
In some patients taking tadalafil, a worsening or sudden loss of hearing has been observed.
Although it is not known whether this event is directly related to the use of tadalafil, if you experience a worsening or sudden loss of hearing, you should stop taking Tadamen MED and contact your doctor immediately.
Tadamen MED is not intended for use in women.

Children and adolescents

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

Tadamen MED and other medicines

Tell your doctor about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not take Tadamen MED if you are taking nitrates.
Tadamen MED may affect the way some medicines work, or other medicines may affect the way Tadamen MED works.
Tell your doctor or pharmacist if you are taking:

• alpha-adrenergic receptor 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 an enlarged prostate).
• medicines such as ketoconazole in tablets (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anti-epileptic medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Tadamen MED with food and alcohol

Information on 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, consult your doctor.

Fertility

When tadalafil was administered to dogs, a decrease in sperm production in the testes was observed.
A decrease in sperm concentration was observed in some men. It is unlikely to 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 diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

Tadamen MED contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially ``sodium-free''.

3. How to take Tadamen MED

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult 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.
The recommended doseis 10 mg, taken before planned sexual activity. If this dose is not effective, your doctor may increase the dose to 20 mg. You should then take one 20 mg tablet of Tadamen MED as prescribed by your doctor.
Tadalafil can be taken at least 30 minutes before planned sexual activity.
Tadalafil may still be effective up to 36 hours after taking the tablet.
Do not take Tadamen MED more than once a day.
Tadamen 10 mg and Tadamen MED 20 mg are intended for use before planned sexual activity. It is not recommended to take the medicine on a continuous, daily basis.
It is essential to remember that Tadamen MED does not work without sexual stimulation.
The patient and his partner should arrange foreplay, just like when the patient is not taking erectile dysfunction medication.
Consuming alcohol may affect your ability to get an erection and may cause a temporary decrease in blood pressure. If you have taken Tadamen MED or plan to take it, you should not consume large amounts of alcohol (blood alcohol level 0.08% or higher), as this may increase the risk of dizziness when standing up.

Taking a higher dose of Tadamen MED than recommended

Inform your doctor. Side effects described in section 4 may occur.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 the medicine and contact your doctor immediately:

• allergic reactions, including 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 experience such an erection and it lasts continuously for 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 worsening or loss of hearing, and hives (itchy, red bumps on the skin), bleeding from the penis, blood in semen, and increased sweating.

Heart attack and stroke have also been rarely reported in men taking tadalafil. Most of them had heart problems before taking this medicine.
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 additional rare side effects have been reported, which were not observed during clinical trials. These include:

• migraine, facial swelling, severe allergic reactions causing facial and throat swelling, 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 of age taking tadalafil. Diarrhea was reported more frequently in men over 65 years of age taking tadalafil.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 the 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 the month.
There are no special precautions for storing the 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 20 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. 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, 20 mg is a light yellow, round, biconvex, film-coated tablet with ``M'' embossed on one side and ``TL4'' on the other side of the tablet.
Tadamen MED, 20 mg is available in blisters in packs containing 2, 4, 8, 12, 24, 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
To obtain more detailed information, contact the marketing authorization holder:

Mylan Healthcare Sp. z o.o.

Tel: +48 22 546 64 00

Date of last revision of the leaflet: