Tadamen

Before taking the medicine, use the attached "Patient Instructions"!

Leaflet attached to the packaging: patient information

Tadamen, 10 mg, coated tablets

Tadalafil

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If the patient does not improve after taking the medicine or feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

1. What is Tadamen and what is it used for

Tadamen is a medicine for adult men with erectile dysfunction, which is the inability to achieve or maintain an erection sufficient for satisfactory sexual intercourse.
It has been shown that tadalafil significantly improves the ability to achieve an erection suitable for sexual intercourse.
Tadamen contains the active substance tadalafil, which belongs to a group of medicines called "phosphodiesterase type 5 inhibitors" (PDE5). After sexual stimulation, Tadamen helps to widen the blood vessels of the penis, allowing blood to flow and leading to an erection. Tadamen does not help patients who do not have erectile dysfunction.
The condition for the effectiveness of Tadamen is sexual stimulation. The patient and their partner should remember to stimulate sexually, just like when the patient is not taking medicine for erectile dysfunction.

2. Important information before taking Tadamen

When not to take Tadamen:

• 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 to treat angina pectoris ("chest pain"). It has been shown that tadalafil enhances the effect of these medicines. If the patient is taking nitrates in any form or is unsure, they should inform their doctor.
• if the doctor has advised the patient to avoid sexual activity.
• if the patient has severe heart disease or has had a heart attack in the last 90 days.
• if the patient has had a stroke in the last 6 months.
• if the patient has low blood pressure or uncontrolled high blood pressure, or uncontrolled heart rhythm disorders.
• if the patient has ever had loss of vision due to non-inflammatory 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 tadalafil, 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 to take Tadamen, you should use the attached "Patient Instructions". In case of any doubts, you should discuss them with your doctor or pharmacist.
You should remember that sexual activity is associated with a certain risk, as it puts an additional strain on the heart. If, based on the "Patient Instructions", it is not possible to use Tadamen due to heart problems, you should inform your doctor or pharmacist.
Before taking the medicine, the patient should inform their doctor or pharmacist if they have any of the following conditions:

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

It is not known whether Tadamen is effective in patients:

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

If, during the use of Tadamen, there is a sudden worsening of vision or loss of vision or the image is distorted, blurred, the patient should stop taking Tadamen and immediately contact their doctor.
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 there is a worsening or sudden loss of hearing, the patient should stop taking Tadamen and immediately contact their doctor.
Tadamen should not be used at the same time as other oral or topical medicines used to treat erectile dysfunction.
Tadamen should not be used at the same time as therapies for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors.
For 48 hours after taking Tadamen, the patient should not take medicines containing sildenafil used to treat erectile dysfunction or pulmonary hypertension.
Tadamen should not be taken if erectile dysfunction has not been diagnosed.
Tadamen is not intended for use in women.

Children and adolescents

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

Tadamen and other medicines

Before taking Tadamen, you should use the "Patient Instructions". In case of any doubts, you should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should not take Tadamen if you are taking nitrates.
Tadamen may affect the action of some medicines or other medicines may affect the action of Tadamen. You should tell your doctor or pharmacist if you are taking any of the following medicines:

• medicines blocking α-adrenergic receptors (used to treat high blood pressure or symptoms of 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 ketoconazole in tablets (used to treat fungal infections) and protease inhibitors (e.g., ritonavir, saquinavir) used to treat AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (antiepileptic drugs).
• rifampicin, erythromycin, clarithromycin (antibiotics) or itraconazole (an antifungal medicine).
• other methods of treating erectile dysfunction.

In some patients who take blood pressure-lowering medicines, there may be a decrease in blood pressure, especially when getting up quickly or sitting down. If symptoms of low blood pressure (dizziness, fainting, feeling of impending fainting) occur, the patient should first lie down or sit down and wait for the symptoms to pass, drinking water may also help, as well as taking fresh air, tensing abdominal muscles, crossing legs. The patient should avoid getting up quickly or sitting down.

Tadamen with drinking and alcohol

Information on the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Tadamen, and therefore, it should be consumed with caution. For more information, the patient should consult their doctor or pharmacist.

Fertility

When tadalafil was administered to dogs, a decrease in sperm production in the testes occurred. 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, so the patient should get to know their reaction to the tablets before deciding to drive or operate machinery.

Tadamen contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Tadamen contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Tadamen

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. In case of any doubts, you should consult your doctor or pharmacist.
Tadamen tablets are intended 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 one 10 mg tablet, taken before planned sexual activity. If the patient feels that the effect of Tadamen is too strong or too weak, they should consult their doctor or pharmacist. The doctor may, after consultation, recommend a different dosage regimen.
Tadamen tablets are intended for oral use.
Tadamen should be taken at least 30 minutes before planned sexual activity.
Tadamen may still be effective up to 36 hours after taking the tablet.
Tadamen is intended for use before planned sexual activity.
The medicine should be used as needed. Do not use more than once a week.

Do not take more than one tablet.

Tadamen should not be used at the same time as other oral or topical medicines used to treat erectile dysfunction.
Tadamen should not be used at the same time as therapies for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors.
For 48 hours after taking Tadamen, the patient should not take medicines containing sildenafil used to treat erectile dysfunction or pulmonary hypertension.
Tadamen should not be taken if erectile dysfunction has not been diagnosed.
It is essential to be aware that the condition for the effectiveness of Tadamen is sexual stimulation. The patient and their partner should remember to stimulate sexually, just like when the patient is not taking medicine for erectile dysfunction.
Consuming alcohol may affect the patient's ability to achieve an erection and may cause transient lowering of blood pressure. If the patient has taken Tadamen or plans to take it, they should not consume large amounts of alcohol (blood alcohol concentration 0.08% or higher), as this may increase the risk of dizziness when standing up.

Using a higher dose of Tadamen than recommended

The patient should inform their doctor. Adverse reactions described in section 4 may occur. In case of any further doubts about the use of this medicine, the patient should consult their 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 any of the following side effects occur, the patient should stop taking the medicine and immediately consult their doctor:

• allergic reactions, including rashes (occurring in less than 1 in 100 patients - uncommon).
• chest pain - the patient should not take nitrates, but should immediately seek medical help (occurring in less than 1 in 100 patients - uncommon).
• priapism - prolonged and sometimes painful erection after taking tadalafil (occurring in less than 1 in 1,000 patients - rare). If such an erection occurs and lasts continuously for more than 4 hours, the patient should immediately contact their doctor.
• sudden loss of vision (occurring rarely), distorted, blurred, or unclear vision (frequency not known).

Other reported side effects:
Common(may affect up to 1 in 10 patients)

• headache, back pain, muscle pain, pain in arms and legs, flushing, nasal congestion, and nausea.

Uncommon(may affect up to 1 in 100 patients)

• dizziness, abdominal pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, prolonged erection, 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 of hearing or sudden deafness, and hives (itchy, red bumps on the skin), penile bleeding, 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 starting to take this medicine.
There have been reports of rare cases of partial, transient, or permanent loss of vision or blindness in one or both eyes.
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 characterized by blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac deaths.
• distorted, blurred, or unclear vision or sudden worsening 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 side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Tadamen

The medicine should be stored 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 month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Tadamen contains

• The active substance of Tadamen is tadalafil. Each tablet contains 10 mg of tadalafil.
• The other ingredients are: Tablet core: lactose (see section 2 "Tadamen 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 looks like and contents of the pack

Tadamen, 10 mg is a light yellow, round, biconvex, film-coated tablet with "M" embossed on one side and "TL3" on the other side of the tablet.
Tadamen, 10 mg is available in blisters in packs containing 2 tablets.

Marketing authorization holder

Viatris 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, the patient should contact the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

Tel: +48 22 546 64 00
Date of last revision of the leaflet:February 2024