Tadamen

Before taking the medicine, consult the enclosed "Patient Information Leaflet"!

Package leaflet: Information for the patient

Tadamen, 10 mg, film-coated tablets
Tadalafil
Please read this leaflet carefully 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 a physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after using the medicine, or if you feel worse, contact your doctor.

Leaflet contents:

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

Tadamen is a medicine intended for adult men with erectile dysfunction, i.e. the inability to achieve or maintain an erection of the penis sufficient for satisfactory sexual intercourse.
Tadalafil has been shown to significantly improve 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 inhibitors). Following sexual stimulation, Tadamen helps widen the blood vessels in the penis, allowing increased blood flow and resulting in an erection. Tadamen does not help men who do not have erectile dysfunction.
For Tadamen to be effective, sexual stimulation is required. The patient and his partner should remember that sexual arousal is necessary, just as it is when the patient is not taking medication for erectile dysfunction.

2. Important information before using Tadamen

When not to use 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, 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 doctor has advised the patient to avoid sexual activity.

• 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, or uncontrolled heart rhythm disorders.

• 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 tadalafil 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 to use Tadamen, patients should read the "Patient Information Leaflet" included in the packaging. If any doubts arise, they should discuss them with their doctor or pharmacist.
It should be remembered that sexual activity involves some risk, as it places additional strain on the heart. If, according to the "Patient Information Leaflet", Tadamen should not be used due to heart problems, the patient should inform their doctor or pharmacist.
Before taking Tadamen, the patient should inform their doctor or pharmacist if any of the following conditions apply:

• sickle cell anemia (an abnormality in the shape of 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 Tadamen is effective in patients:

• after pelvic surgery.
• after total or partial removal of the prostate gland with cutting of the nerves supplying the prostate (non-nerve-sparing radical prostatectomy).

If sudden worsening of vision, vision loss, or distorted, blurred vision occurs during treatment with Tadamen, the patient should stop taking Tadamen immediately and contact their 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 loss or worsening of hearing occurs, the patient should stop taking Tadamen and contact their doctor immediately.
Tadamen should not be used together with other oral or topical medicines used to treat erectile dysfunction.
Tadamen should not be used together with arterial pulmonary hypertension (APH) therapies using sildenafil or other PDE5 inhibitors.
For 48 hours after taking Tadamen, medicines containing sildenafil used to treat erectile dysfunction or pulmonary hypertension must not be taken.
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 18 years of age.
Tadamen and other medicines
Before using Tadamen, patients should refer to the "Patient Information Leaflet". If in doubt, they should inform their doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines they plan to take.
Tadamen must not be taken if the patient is using nitrates.
Tadamen may affect the action of certain medicines or other medicines may affect the action of Tadamen. The patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• alpha-adrenergic receptor 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 ketoconazole tablets (used to treat fungal infections) and protease inhibitors (e.g. ritonavir, saquinavir) used to treat AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin (antibiotics), or itraconazole (antifungal medicine).
• other treatments for erectile dysfunction.

In some patients taking blood pressure-lowering medicines, blood pressure may drop, especially when standing up or sitting down quickly. If symptoms of low blood pressure occur (dizziness, lightheadedness, feeling faint), the patient should lie down or sit and wait for symptoms to subside. Drinking water, getting fresh air, tensing abdominal muscles, or crossing legs may also help. Rapid standing or sitting should be avoided.
Tadamen, alcohol, and grapefruit juice
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Tadamen, and therefore caution should be exercised when consuming it. For further information, patients should consult their doctor or pharmacist.
Fertility
When Tadamen was administered to dogs, a reduction in sperm production in the testes was observed.
A decrease in 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. Therefore, patients should assess their individual response to the tablets before deciding to drive or operate machinery.
Tadamen contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.
Tadamen contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to take Tadamen

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Tadamen tablets are intended for oral use and only in men. Swallow the tablet whole with a small amount of water. Tadamen tablets can be taken with or without food.
The recommended dose is one 10 mg tablet taken before planned sexual activity. If you feel that the effect of Tadamen is too strong or too weak, consult your doctor or pharmacist. After consultation, your doctor may recommend a different dosing 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 to be used prior to planned sexual activity.
The medicine should be taken on an as-needed basis. Do not use more than once a week.
Do not take more than 1 tablet.
Do not take Tadamen together with other oral or topical medicines used in the treatment of erectile dysfunction.
Do not take Tadamen simultaneously with pulmonary arterial hypertension (PAH) therapy involving sildenafil or other PDE5 inhibitors.
For 48 hours after taking Tadamen, do not take any medicines containing sildenafil used to treat erectile dysfunction or pulmonary hypertension.
Do not take Tadamen if erectile dysfunction has not been diagnosed.
It is important to be aware that Tadamen requires sexual stimulation to be effective. The patient and his partner should engage in sexual stimulation, just as they would if the patient were not taking medication for erectile dysfunction.
Drinking alcohol 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, he should avoid consuming large amounts of alcohol (blood alcohol concentration of 0.08% or higher), as this may increase the risk of dizziness upon standing.
Taking a higher than recommended dose of Tadamen
Inform your doctor. Adverse effects described in section 4 may occur.
If you have any further doubts about how to use 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 seek immediate medical advice:

• allergic reactions, including rashes (occur in no more than 1 in 100 patients – not common).
• chest pain – do not take nitrates, but seek immediate medical help (occurs not commonly).
• priapism – prolonged and sometimes painful erection after taking tadalafil (occurs in no more than 1 in 1,000 patients – rare). If such an erection occurs and lasts continuously for more than 4 hours, contact a doctor immediately.
• sudden loss of vision (occurs rarely), distorted, blurred, or dim central vision, or sudden decrease in vision (frequency unknown).

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

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

Not common (may affect up to 1 in 100 people)

• 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 1,000 people)

• fainting, seizures, and transient memory loss, eyelid swelling, eye redness, sudden worsening of hearing or sudden deafness, and urticaria (itchy, red skin welts), rectal bleeding, 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 problems before starting treatment with this medicine.
There have been reports of rare cases of partial, transient, or permanent
visual impairment or loss of vision in one or both eyes.
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, disturbances causing blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
• distorted, blurred, or dim central vision or sudden decrease in vision (frequency unknown).

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 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 for 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 authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tadamen

Keep this 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 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 no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Tadamen contains

• The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.
• The other ingredients are: Core of the tablet: lactose (see section 2 “Tadamen 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 looks like and contents of the pack
Tadamen 10 mg is a light yellow, round, biconvex coated tablet, embossed with “M” 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 Authorisation 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
For further information, please contact the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
Tel: +48 22 546 64 00