Patient Information Leaflet

Tadamen MED, 20 mg, coated tablets
Tadalafilum
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents:

What Tadamen MED is and what it is used for
Important information 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.
It has been shown that tadalafil significantly improves the ability to achieve 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. Following sexual stimulation, Tadamen MED helps widen the blood vessels of the penis, allowing blood to flow into the penis. As a result, erectile function improves. Tadamen MED does not benefit patients 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 when the patient is 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, e.g. amyl nitrite. This is a group of medicines ("nitrates") used to treat angina (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). It has been shown that PDE5 inhibitors, such as Tadamen MED, 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 in patients with heart disease, as it places additional strain on the heart. If there are any heart problems, inform the 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 cancer).
leukemia (a blood cell cancer).
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 with nerve damage (nerve-sparing radical prostatectomy).

If sudden vision deterioration or vision loss occurs during treatment with Tadamen MED,
or if vision becomes distorted or blurred, discontinue use of Tadamen MED immediately and
contact a doctor without delay.
In some patients taking tadalafil, hearing deterioration or sudden hearing loss has been observed.
Although it is not known whether this event is directly related to tadalafil use, 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
Tell the doctor about all medicines currently used, recently used, or planned for use.
Do not take Tadamen MED if taking nitrates.
Tadamen MED may affect the action of certain medicines, or other medicines may affect
the action of Tadamen MED.
Tell 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, food 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 a reduction in 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
During clinical trials, some men taking tadalafil reported dizziness. Patients should understand their response to the medicine before deciding to drive or operate machinery.
Tadamen MED contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, they should
consult a 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 exactly as directed by a physician. In case of doubt, consult
your doctor or pharmacist.
Tadamen MED tablets are intended for oral use in men only.
The tablets should be swallowed whole with a small amount of water. Tadamen MED tablets may be
taken with or without food.
The recommended starting dose is 10 mg, taken prior to planned sexual activity. If this dose is
not sufficient, the doctor may increase the dose to 20 mg. In such case, one 20 mg tablet of Tadamen MED
should be taken as directed by the physician.
Tadalafil may be taken at least 30 minutes before planned sexual activity.
Tadalafil may remain effective for up to 36 hours after taking the tablet.
Tadamen MED should not be taken more than once a day.
Tadamen 10 mg and Tadamen MED 20 mg are intended for use prior to planned sexual activity.
Regular, daily use of the medicine is not recommended.
It is important to understand that Tadamen MED will 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 medicines 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 reactions described in section 4 may occur.
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 experiences them.
These reactions are usually mild or moderate.
If any of the adverse reactions listed below occur, stop using the medicine
and seek immediate medical advice:

allergic reactions, including rashes (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 unknown).

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

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

Uncommon (may affect 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, tinnitus, swelling of hands, feet or ankles, and feeling of fatigue.

Rare (may affect 1 in 1000 patients)

fainting, seizures and transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, urticaria (itchy, red skin swellings), rectal bleeding, presence of blood in semen, and increased sweating.

Heart attack and stroke have also been rarely reported 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 impairment or vision loss in one or both eyes has been
reported in patients taking tadalafil.
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 unknown).

Adverse reaction: dizziness was reported more frequently in men over 75 years of age
taking tadalafil. Diarrhoea was reported more frequently in men over 65 years of age
taking tadalafil.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Reactions of Medicinal Products
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 apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer 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 20 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 20 mg is a light yellow, round, biconvex 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 pack sizes containing 2, 4, 8, 12, 24 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
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