Tadamen med

Package leaflet: Information for the patient

Tadamen MED, 5 mg, coated tablets
Tadalafilum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• 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. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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

Tadamen MED contains the active substance tadalafil, which belongs to a group of medicines called
phosphodiesterase type 5 inhibitors.
Tadamen MED 5 mg is used in the treatment of adult men:

• with erectile dysfunction. This is a condition in which a man cannot 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 intercourse. Following sexual stimulation, Tadamen MED helps widen the blood vessels of the penis, allowing increased blood 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 Tadamen MED 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.
• with urinary symptoms caused by a common condition called benign prostatic hyperplasia. This is a condition in which the prostate gland enlarges with age. Symptoms include: difficulty starting urination, feeling of incomplete bladder emptying, and the need to urinate more frequently, even at night. Tadalafil improves blood flow and causes relaxation of the muscles in the prostate and bladder, which may relieve symptoms of benign prostatic hyperplasia. It has been shown that tadalafil alleviates these urinary symptoms within 1–2 weeks after starting treatment.

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 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 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 heart problems are present, inform the doctor.
Benign prostatic hyperplasia and prostate cancer may have similar symptoms; therefore, the doctor will perform tests to rule out prostate cancer before starting tadalafil treatment for symptoms of benign prostatic hyperplasia.
Tadalafil is not used in the treatment of prostate cancer.
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-sparing procedures (nerve-sparing radical prostatectomy).

If sudden vision deterioration or vision loss occurs during treatment with Tadamen MED, or if vision becomes blurred or distorted, discontinue use of Tadamen MED immediately and contact a doctor without delay.
In some patients taking tadalafil, hearing loss or sudden hearing deterioration 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
Inform 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.
Inform the doctor or pharmacist if the patient is taking:

• alpha-blockers (used to treat high blood pressure or urinary symptoms due to 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 therefore 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 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 consult 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 take Tadamen MED

This medicine should always be taken as directed by the physician. If in 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.
Alcohol consumption may cause a temporary decrease in blood pressure. If a patient has taken or
plans to take Tadamen MED, large amounts of alcohol (blood alcohol concentration of 0.08% or
higher) should be avoided, as this may increase the risk of dizziness upon standing.

Treatment of erectile dysfunction
The recommended dose is one 5 mg tablet taken once daily at approximately 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 should be taken.
Tadamen MED should not be taken more than once a day.
Taking Tadamen MED once daily allows an erection to occur in response to sexual stimulation
at any time within a 24-hour period.
Daily administration of Tadamen MED may be beneficial for men who plan to engage in sexual
activity two or more times per week.
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 when the patient is not
taking medication for erectile dysfunction.
Alcohol consumption may affect the patient's ability to achieve an erection.

Treatment of signs and symptoms of benign prostatic hyperplasia
The recommended dose is one 5 mg tablet taken once daily at approximately the same time
each day. If a patient has both benign prostatic hyperplasia and erectile dysfunction, the dose of
one 5 mg tablet once daily remains unchanged.
Tadamen MED must not be taken more than once a day.

Overdose 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 a
missed tablet.
Tadamen MED should not be taken more 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 may 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 consult a doctor immediately:

• 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 vision loss (rare), distorted, blurred, or dim 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, tinnitus, swelling of hands, feet or ankles, and feeling tired.

Rare (may affect up to 1 in 1000 patients)

• fainting, seizures and transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, and 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.
Partial, transient or permanent visual impairment or vision loss in one or both eyes has been rarely 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, blurred, or dim central vision or sudden worsening of vision (frequency not known).

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 reactions occur, including any not listed in this leaflet, inform your 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 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 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 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, sodium croscarmellose, 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 5 mg is a light yellow, round, biconvex coated tablet, embossed with "M" on one side and "TL" above "2" on the other side of the tablet.
Tadamen MED 5 mg is available in blister packs in packs containing 2, 4, 14, 28, 30, 56 or 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
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, contact the Marketing Authorisation Holder:
Mylan Healthcare Sp. z o.o.
Tel: +48 22 546 64 00