Patient Information Leaflet

Tadamen MED, 2.5 mg, film-coated tablets
Tadalafilum
Please read this leaflet carefully before 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 further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet Contents:

What Tadamen MED is and what it is used for
What you need to know before taking Tadamen MED
How to take Tadamen MED
Possible side effects
How to store Tadamen MED
Contents of the pack and other information

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

Tadamen MED is a medicine intended for adult men with erectile dysfunction. This is a condition in which a man is unable to achieve or maintain an erection sufficient for sexual intercourse. Tadalafil has been shown to significantly improve the ability to achieve an erection suitable for sexual activity.
Tadamen MED contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. During sexual stimulation, Tadamen MED helps to widen the blood vessels in the penis, allowing increased blood flow into the penis. As a result, erectile function improves. Tadamen MED does not benefit men who do not have erectile dysfunction.
It is important to understand that tadalafil does not work in the absence of sexual stimulation. The patient and his partner should engage in foreplay, just as they would if the patient were not taking medication for erectile dysfunction.

2. Important information before using Tadamen MED

When not to use Tadamen MED:

if the patient is allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
if the patient is taking organic nitrates in any form or other nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used in the treatment of angina pectoris ("chest pain"). It has been shown that tadalafil enhances the effects of these medicines. If the patient is taking nitrates in any form or is unsure, they should inform their doctor.
if the patient has severe heart disease or has had a heart attack within the last 90 days.
if the patient has had a stroke within the last 6 months.
if the patient has low blood pressure or uncontrolled high blood pressure.
if the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), referred to as "eye stroke".
if the patient is 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). PDE5 inhibitors, such as Tadamen MED, have been shown to enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, they should inform their doctor.

Warnings and precautions
Before starting treatment with Tadamen MED, consult a doctor.
Please remember that sexual activity involves some risk for patients with heart disease, as it places additional strain on the heart. If the patient has any heart problems, they should inform their doctor.
Before taking the medicine, inform the doctor if the patient has:

sickle cell anemia (an abnormality affecting red blood cells).
multiple myeloma (a bone marrow tumor).
leukemia (a blood cell cancer).
any deformity of the penis.
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 with nerve-sparing techniques (radical prostatectomy without nerve preservation).

If sudden vision worsening or vision loss occurs during treatment with Tadamen MED, or if vision appears blurred or distorted, discontinue use of Tadamen MED immediately and contact a doctor without delay.
In some patients taking tadalafil, worsening or sudden hearing loss has been observed.
Although it is not known whether this event is directly related to the use of tadalafil, if hearing deterioration or sudden hearing loss occurs, discontinue use of Tadamen MED immediately and contact a doctor without delay.
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
Inform the doctor about all medicines currently used, recently used, or planned for use.
Do not take Tadamen MED if you are using nitrates.
Tadamen MED may affect the action of certain medicines, or other medicines may affect the action of Tadamen MED.
Inform the doctor or pharmacist if the patient is taking:

alpha-blockers (used to treat high blood pressure or urinary symptoms caused by benign prostatic hyperplasia).
other medicines used to treat high blood pressure.
riociguat.
5-alpha-reductase inhibitors (used to treat benign prostatic hyperplasia).
medicines such as oral ketoconazole (used to treat fungal infections) and protease inhibitors used in the treatment of AIDS or HIV infection.
phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
rifampicin, erythromycin, clarithromycin, or itraconazole.
other treatments for erectile dysfunction.

Tadamen MED, drinking, and alcohol
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Tadamen MED, and caution should be exercised when consuming it. For further information, consult a doctor.
Fertility
When administered to dogs, the medicine caused reduced sperm production in the testes. Reduced sperm concentration has been observed in some men. It is unlikely that this would lead to infertility.
Driving and operating machinery
In clinical trials, some men taking tadalafil reported dizziness. Patients should understand how they react to the medicine before deciding to drive or operate machinery.
Tadamen MED contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.
Tadamen MED contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Tadamen MED

This medicine should always be used as prescribed by the doctor. In case of doubts, consult
your doctor or pharmacist.
Tadamen MED tablets are intended for oral use only in men.
The tablets should be swallowed whole with a small amount of water. Tadamen MED tablets can be taken
regardless of meals.
The recommended dose is 5 mg taken once daily, approximately at the same time each day. The doctor
may adjust the dose to 2.5 mg depending on the patient's response to Tadamen MED. In such case, one 2.5 mg tablet of Tadamen MED should be taken.
Tadamen MED should not be taken more frequently than once a day.
Taking Tadamen MED once daily may be beneficial for men who plan to engage in sexual activity two times per week or more.
Taking Tadamen MED once daily allows achieving an erection following sexual stimulation
at any time within 24 hours.
It is important to be aware that Tadamen MED does not work in the absence of sexual stimulation.
The patient and his partner should engage in foreplay, just as they would when the patient is not
taking medication for erectile dysfunction.
Alcohol consumption may affect the patient's ability to achieve an erection and may cause
transient lowering of blood pressure. If the patient has taken or plans to take Tadamen MED,
he should not consume large amounts of alcohol (blood alcohol concentration of 0.08% or
higher), as this may increase the risk of dizziness upon standing.
Use of a higher than recommended dose of Tadamen MED
Inform your doctor immediately. Adverse effects described in section 4 may occur.
Missed dose of Tadamen MED
Take the missed dose as soon as remembered, but do not take a double dose to make up
for the missed tablet.
Do not take Tadamen MED more frequently than once a day.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
These reactions are usually mild or moderate.
If any of the adverse reactions listed below occur, stop taking the medicine
and contact a doctor immediately:

allergic reactions, including rash (uncommon).
chest pain – do not take nitrates, but seek immediate medical help (uncommon).
priapism – prolonged and sometimes painful erection after taking tadalafil (rare). If such an erection occurs and lasts continuously for more than 4 hours, contact a doctor immediately.
sudden loss of vision (rare), distorted, dimmed, blurred central vision, or sudden worsening of vision (frequency not known).

Other reported adverse reactions:
Common (may affect up to 1 in 10 patients)

headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion, and indigestion.

Uncommon (may affect up to 1 in 100 patients)

dizziness, abdominal pain, nausea, vomiting, regurgitation of stomach contents into the oesophagus, blurred vision, eye pain, difficulty breathing, prolonged erection, presence of 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 patients)

fainting, seizures, and transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, urticaria (itchy, red skin swellings), bleeding from the penis, presence of 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 conditions before starting treatment with this medicine.
Rarely, partial, transient or permanent vision loss or visual impairment
in one or both eyes has been reported.
In men taking tadalafil, several additional rare adverse reactions have been reported,
which were not observed during 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 death.
distorted, dimmed, blurred central vision or sudden worsening of vision (frequency not known).

Adverse reaction: dizziness has been reported more frequently in men over 75 years of age
taking tadalafil.
Diarrhoea has been reported more frequently in men over 65 years of age taking tadalafil.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tadamen MED

Keep this medicine out of 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 stated month.
No special storage conditions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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:
Core of the tablet: lactose (see section 2 “Tadamen MED contains lactose”), poloxamer 188, microcrystalline cellulose (pH 101), povidone K 25, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, colloidal anhydrous silica.
Coating: monohydrate lactose, 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, embossed with "M" 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 Authorisation Holder
Mylan Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warszawa
Poland

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, please contact the Marketing Authorisation Holder:
Mylan Healthcare Sp. z o.o.
Tel: +48 22 546 64 00