Tadacontrol

Before taking the medicine, use the diagnostic tool provided (Patient Questionnaire)!

Package leaflet: Information for the patient

Tadacontrol, 10 mg, coated tablets
Tadalafilum
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as prescribed by the doctor or pharmacist.

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

Leaflet contents:

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

1. What Tadacontrol is and what it is used for

Tadacontrol 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. Tadacontrol has been shown to significantly improve the ability to achieve an erection suitable for sexual intercourse.
Tadacontrol contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. During sexual stimulation, Tadacontrol helps widen the blood vessels in the penis, allowing increased blood flow. This results in improved erection. Tadacontrol does not benefit patients who do not have erectile dysfunction.
It is important to understand that Tadacontrol will not work without 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.
If there is no improvement after using the medicine, or if you feel worse, contact your doctor.
Before using the medicine, carefully read the leaflet and review the “Patient Questionnaire” included in the package. To ensure safe use of the medicine, answer all questions contained in the questionnaire.

2. Important information before using Tadacontrol

When not to use Tadacontrol

• 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 (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), known 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 Tadacontrol, 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 Tadacontrol, the patient should complete the questionnaire included in the package. If there are any doubts, the patient should discuss them with their doctor or pharmacist.
It should be remembered that sexual activity involves some risk for patients with heart disease, as it places additional strain on the heart. If the patient has heart problems (including those indicated in the questionnaire as contraindications for using Tadacontrol due to heart issues), they should inform their doctor.
Before taking the medicine, the patient should inform their doctor if any of the following conditions apply:

• sickle cell anemia (abnormal shape of red blood cells);
• multiple myeloma (a bone marrow tumor);
• leukemia (a blood cell cancer);
• any penile deformity;
• severe liver disease;
• severe kidney disease.

It is not known whether Tadacontrol is effective in patients:

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

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

Children and adolescents
Tadacontrol is not intended for use in children and adolescents under 18 years of age.

Tadacontrol and other medicines
Before using Tadacontrol, the patient should complete the questionnaire included in the package. If in doubt, the patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Tadacontrol must not be taken if the patient is using nitrates.
Tadacontrol may affect the action of certain medicines or other medicines may affect the action of Tadacontrol. 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 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 to treat AIDS or HIV infection;
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines);
• rifampicin, erythromycin, clarithromycin (antibiotics), or itraconazole (an 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 down and wait for symptoms to subside. Drinking water, breathing fresh air, tensing abdominal muscles, or crossing legs may also help. Rapid standing or sitting should be avoided.

Tadacontrol, food, and alcohol
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Tadacontrol, and therefore caution should be exercised when consuming it. For further information, consult the doctor.

Fertility
When Tadacontrol was administered to dogs, a reduction in sperm production in the testes was observed. 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 Tadacontrol reported dizziness. Therefore, patients should understand how they react to the tablets before deciding to drive a car or operate machinery.

Tadacontrol contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.

3. How to take Tadacontrol

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Tadacontrol tablets are intended for oral use in men only. Swallow the tablet whole with a small amount of water. The tablets may be taken with or without food.
The recommended dose is one 10 mg tablet taken prior to planned sexual activity.
Your doctor may recommend a different dosing regimen after consultation.
Tadacontrol should be taken at least 30 minutes before planned sexual activity.
Tadacontrol may remain effective for up to 36 hours after taking the tablet.
This is an on-demand medicine, taken as needed.
Do not take more than once per week. Do not take more than 1 tablet.
Tadacontrol must not be used simultaneously with other oral or topical medicines used in the treatment of erectile dysfunction.
Tadacontrol must not be used concurrently with pulmonary arterial hypertension (PAH) therapies containing sildenafil or other PDE5 inhibitors.
Do not take any medicine containing sildenafil used for the treatment of erectile dysfunction or pulmonary hypertension within 48 hours after taking Tadacontrol.
Tadacontrol should not be taken if erectile dysfunction has not been diagnosed.
It is important to understand that Tadacontrol 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.
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 Tadacontrol, 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.
Contact your doctor if an erection does not occur after taking Tadacontrol, or if the duration of erection is insufficient for sexual intercourse.
Taking a higher than recommended dose of Tadacontrol
If you take more than the recommended dose, inform your doctor immediately. Adverse effects described in section 4 may occur.
Do not take more tablets than indicated in this patient leaflet.
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 (observed in 1 to 10 out of 1,000 patients – uncommon);
• chest pain – do not take nitrates, but seek immediate medical help (observed uncommonly);
• priapism, a prolonged and possibly painful erection after taking Tadacontrol (observed no more frequently than in 1 out of 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 (observed rarely), distorted, dimmed, blurred central vision or sudden worsening of vision (frequency unknown).

Other reported adverse reactions:
Common (observed in 1 to 10 out of 10 patients)

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

Uncommon (observed in 1 to 10 out of 100 patients)

• dizziness, abdominal pain, nausea, vomiting, regurgitation of stomach contents into the oesophagus, blurred vision, eye pain, difficulty breathing, presence of blood in urine, prolonged erection, sensation of palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet or ankles, and feeling of fatigue.

Rare (observed in 1 to 10 out of 1,000 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 been rarely reported in men taking tadalafil. Most of these men had
heart problems before starting tadalafil treatment.
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, a few additional rare adverse reactions 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 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, tell your doctor, pharmacist or nurse. 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.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Tadacontrol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following "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. This will help protect the environment.

6. Contents of the pack and other information

What Tadacontrol contains

• The active substance is tadalafil. Each coated tablet contains 10 mg of tadalafil.
• Other ingredients are:
  Tablet core: copovidone, glyceryl macrogol hydroxystearate, monohydrate lactose, anhydrous colloidal silicon dioxide, microcrystalline cellulose (102), sodium croscarmellose, magnesium stearate.
  Tablet coating: hypromellose 2910 (6 cp), titanium dioxide (E 171), triacetin, talc, yellow iron oxide (E 172).

What Tadacontrol looks like and contents of the pack
Coated tablet.
Light yellow, oval coated tablets, marked with “10” on one side and “TL” on the other side.
Tadacontrol, coated tablets, is packed in PVC/PVDC/Aluminium blisters, in cardboard boxes.
Pack sizes: 2 and 4 coated tablets.
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
e-mail: [email protected]
Manufacturer/Importer:
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19, Venda Nova
2700-487 Amadora
Portugal