Tadacontrol

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

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Leaflet attached to the packaging: information for the patient

Tadacontrol, 10 mg, film-coated tablets

Tadalafil

You should carefully read the contents of the leaflet before taking 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 you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.
• If you do not experience improvement after taking the medicine or if you feel worse, you should contact your doctor.

Table of contents of the leaflet:

• 1. What is Tadacontrol and what is it 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 is Tadacontrol and what is it used for

Tadacontrol is a medicine for adult men with erectile dysfunction. This is a condition where a man cannot achieve or maintain an erection sufficient for sexual intercourse. It has been shown that Tadacontrol significantly improves the ability to achieve an erection sufficient for sexual intercourse.
Tadacontrol contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, Tadacontrol helps to widen the blood vessels of the penis, allowing blood to flow into the penis. As a result, the erection improves. Tadacontrol does not help patients who do not have erectile dysfunction.
It is important to be aware that Tadacontrol does not work without sexual stimulation.
The patient and his partner should arrange foreplay, just like when the patient is not taking erectile dysfunction medication.
If you do not experience improvement after taking the medicine or if you feel worse, you should contact your doctor.
Before taking the medicine, you should carefully read the leaflet and review the attached "Patient Questionnaire". To use the medicine safely, you should answer all the questions in the questionnaire.

2. Important information before taking Tadacontrol

When not to take Tadacontrol

• If you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• If you are 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 you are taking nitrates in any form or are unsure, you should inform your doctor.
• If your doctor has advised you to avoid sexual activity.
• If you have severe heart disease or have had a heart attack in the last 90 days.
• If you have had a stroke in the last 6 months.
• If you have low blood pressure or uncontrolled high blood pressure, or uncontrolled heart rhythm disorders.
• If you have ever had a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), referred to as "eye stroke".
• If you are 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 Tadacontrol, enhance the blood pressure-lowering effect of this medicine. If you are taking riociguat or are unsure, you should inform your doctor.

Warnings and precautions

Before starting to take Tadacontrol, you should use the questionnaire attached to the packaging. 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 for patients with heart disease, as it puts an additional strain on the heart. If you have heart problems (including those resulting from the questionnaire that indicate you should not take Tadacontrol due to heart problems), you should inform your doctor.
Before taking the medicine, you should inform your doctor if you have any of the following conditions:

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

It is not known if Tadacontrol is effective in patients:

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

If you experience sudden worsening of vision or sudden loss of vision or distorted vision while taking tadalafil, you should stop taking tadalafil and immediately contact your doctor.
In some patients taking tadalafil, worsening or sudden loss of hearing has been observed. Although it is not known if this event is directly related to the use of tadalafil, if you experience worsening or sudden loss of hearing, you should stop taking Tadacontrol and immediately contact your doctor.
Tadacontrol is not intended for use in women.
Tadacontrol should not be used in combination with other oral or topical medicines used to treat erectile dysfunction.
Tadacontrol should not be used in combination with pulmonary arterial hypertension therapies (PAH) using sildenafil or other PDE5 inhibitors.
For 48 hours after taking Tadacontrol, you should not take medicines containing sildenafil used to treat erectile dysfunction or pulmonary hypertension.
Tadacontrol should not be taken if you do not have erectile dysfunction.

Children and adolescents

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

Tadacontrol and other medicines

Before taking Tadacontrol, you should use the questionnaire attached to the packaging. In case of 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 Tadacontrol if you are taking nitrates.
Tadacontrol may affect the action of some medicines or other medicines may affect the action of Tadacontrol. You should tell your doctor or pharmacist if you are taking any of the following medicines:

• alpha-adrenergic receptor blockers (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 used to treat AIDS or HIV infection;
• phenobarbital, phenytoin, and carbamazepine (antiepileptic medicines);
• rifampicin, erythromycin, clarithromycin (antibiotics) or itraconazole (antifungal medicine);
• other treatments for erectile dysfunction.

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

Tadacontrol with food and alcohol

Information on the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Tadacontrol, and you should exercise caution when consuming it. For more information, you should consult your doctor.

Fertility

When administered to dogs, a decrease in sperm production in the testes was observed. 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 Tadacontrol during clinical trials, dizziness was reported; therefore, you should be aware of your reaction to the tablets before deciding to drive a car or operate machines.

Tadacontrol contains lactose

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Tadacontrol

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
Tadacontrol 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 doseof the medicine is one 10 mg tablet, taken before 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 still be effective up to 36 hours after taking the tablet.
The medicine is for occasional use, as needed.

Do not take more than once a week. Do not take more than one tablet.

Tadacontrol should not be used in combination with other oral or topical medicines used to treat erectile dysfunction.
Tadacontrol should not be used in combination with pulmonary arterial hypertension therapies (PAH) using sildenafil or other PDE5 inhibitors.
For 48 hours after taking Tadacontrol, you should not take medicines containing sildenafil used to treat erectile dysfunction or pulmonary hypertension.
Tadacontrol should not be taken if you do not have erectile dysfunction.
It is essential to be aware that Tadacontrol does not work without sexual stimulation.
The patient and his partner should arrange foreplay, just like when the patient is not taking erectile dysfunction medication.
Consuming alcohol may affect your ability to achieve an erection and may cause transient lowering of blood pressure. If you have taken Tadacontrol or plan to take it, you should not consume large amounts of alcohol (blood alcohol concentration 0.08% or higher), as this may increase the risk of experiencing dizziness when standing up.
You should contact your doctor if you do not experience an erection after taking Tadacontrol or if the duration of the erection is not sufficient for sexual intercourse.

Taking a higher dose of Tadacontrol than recommended

If you have taken a dose higher than recommended, you should inform your doctor. Adverse reactions described in section 4 may occur.

Do not take more tablets than indicated in the patient leaflet.

If you have any further doubts about taking the medicine, you should consult your 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 you experience any of the following side effects, you should stop taking the medicine and immediately contact your doctor:

• allergic reactions, including skin rash (observed in 1 to 10 in 1,000 patients - uncommon);
• chest pain - you should not take nitrates, but you should immediately seek medical attention (observed uncommonly);
• priapism, prolonged and possibly painful erection after taking Tadacontrol (observed in less than 1 in 1,000 patients - rare). If you experience such an erection and it lasts continuously for more than 4 hours, you should immediately contact your doctor;
• sudden loss of vision (observed rarely), distorted, blurred, or impaired vision (frequency not known).

Other reported side effects:
Common(observed in 1 to 10 in 10 patients)

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

Uncommon(observed in 1 to 10 in 100 patients)

• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet, or ankles, and feeling tired.

Rare(observed in 1 to 10 in 1,000 patients)

• fainting, seizures, and transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, hives (itchy, red swellings on the skin surface), penile bleeding, blood in semen, and increased sweating.

Myocardial infarction and stroke have been rarely reported in men taking tadalafil. Most of them had heart problems before starting to take tadalafil.
There have been reports of rare cases of partial, transient, or permanent vision loss or blindness in one or both eyes.
In men taking tadalafil, several additional rare side effectshave 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, eye disorders, irregular heartbeat, angina pectoris, and sudden cardiac deaths.
• distorted, blurred, or impaired 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 you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tadacontrol

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Tadacontrol contains

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

What Tadacontrol looks like and contents of the pack

Film-coated tablet.
Light yellow, oval, film-coated tablets, with "10" on one side and "TL" on the other side.
Tadacontrol, film-coated tablets, are packaged in PVC/PVDC/Aluminum blisters, in cardboard boxes.
Pack size: 2 film-coated tablets.

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: medicalinformation@aurovitas.pl

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

Date of last revision of the leaflet: