Tadalafil Inventum

Before taking the medicine, use the attached DIAGNOSTIC TEST!

Leaflet attached to the packaging: patient information

Tadalafil Inventum, 10 mg, film-coated tablets

Tadalafilum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

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

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If the patient's condition does not improve or worsens after taking the medicine, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Tadalafil Inventum and what is it used for

Tadalafil Inventum 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. Tadalafil Inventum contains the active substance tadalafil, which belongs to a group of medicines called "phosphodiesterase type 5 inhibitors" (PDE5). After sexual stimulation, Tadalafil Inventum helps to widen the blood vessels of the penis, allowing blood to flow into the penis. As a result, the erection improves. Tadalafil Inventum does not help patients who do not have erectile dysfunction. Tadalafil Inventum does not work without sexual stimulation. The patient and their partner should remember to stimulate sexually and arrange foreplay, just like when the patient is not taking erectile dysfunction medication.

2. Important information before taking Tadalafil Inventum

When not to take Tadalafil Inventum:

• 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;

in case of chest pain, the patient should not take Tadalafil Inventum.

• 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 a sudden loss of vision due to non-inflammatory anterior ischemic optic neuropathy (NAION), also 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). 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 taking Tadalafil Inventum, the patient should use the diagnostic test attached to the packaging. In case of any doubts, they should discuss it with their doctor or pharmacist. The patient should remember that sexual activity carries a risk, as it puts an additional strain on the heart. If the patient has heart problems (including those resulting from the diagnostic test that prevents the use of Tadalafil Inventum due to heart problems), they should inform their 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 (abnormal shape of red blood cells);
• multiple myeloma (bone marrow cancer);
• leukemia (blood cell cancer);
• any penile deformation;
• severe liver disease;
• severe kidney disease.

It is not known whether Tadalafil Inventum is effective in patients:

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

If the patient experiences sudden vision loss or sudden vision disturbance, or the image is distorted, they should stop taking tadalafil and immediately consult their doctor. In some patients taking tadalafil, a decrease in hearing or sudden hearing loss has been observed. Although it is not known whether this event is directly related to the use of tadalafil, if the patient experiences a decrease in hearing or sudden hearing loss, they should stop taking Tadalafil Inventum and immediately consult their doctor. Tadalafil Inventum should not be used with other oral or topical medicines used to treat erectile dysfunction. Tadalafil Inventum should not be used with pulmonary arterial hypertension therapies (PAH) using sildenafil or other PDE5 inhibitors. For 48 hours after taking Tadalafil Inventum, the patient should not take medicines containing sildenafil used to treat erectile dysfunction or pulmonary hypertension. Tadalafil Inventum should not be taken if the patient does not have erectile dysfunction. Tadalafil Inventum is not intended for use in women.

Children and adolescents

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

Tadalafil Inventum and other medicines

Before taking Tadalafil Inventum, the patient should use the diagnostic test. In case of any doubts, they should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Tadalafil Inventum should not be taken if the patient is using nitrates. Tadalafil Inventum may affect the action of some medicines or other medicines may affect the action of Tadalafil Inventum. 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 symptoms of benign prostatic hyperplasia);
• other medicines used to treat high blood pressure (see: "Diagnostic test");
• riociguat;
• 5-alpha reductase inhibitors (used to treat benign prostatic hyperplasia);
• medicines such as ketoconazole in tablets or itraconazole (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);
• other methods of treating erectile dysfunction.

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

Taking Tadalafil Inventum with food and alcohol

Information about the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Tadalafil Inventum, and therefore, the patient should be cautious when consuming it. For more information, the patient should consult their doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

Tadalafil Inventum is not intended for use in women. FertilityWhen tadalafil was 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 tadalafil during clinical trials, dizziness was reported, so the patient should get to know their reaction to the tablets before deciding to drive a car or operate machinery.

Tadalafil Inventum contains lactose and sodium

Lactose

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

Sodium

The medicine contains 1.21 mg of sodium per tablet. 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 Tadalafil Inventum

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. Tadalafil Inventum 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 Tadalafil Inventum is too strong or too weak, they should consult their doctor or pharmacist. The doctor may recommend a different dosage after consultation. Tadalafil Inventum can be taken at least 30 minutes before planned sexual activity. Tadalafil Inventum may still be effective up to 36 hours after taking the tablet. Tadalafil Inventum is intended for use before planned sexual activity. The medicine should be used as needed.

Do not take the medicine more than once a week.

Tadalafil Inventum should not be used with other oral or topical medicines used to treat erectile dysfunction. Tadalafil Inventum should not be used with pulmonary arterial hypertension therapies (PAH) using sildenafil or other PDE5 inhibitors. For 48 hours after taking Tadalafil Inventum, the patient should not take medicines containing sildenafil used to treat erectile dysfunction or pulmonary hypertension. Tadalafil Inventum should not be taken if the patient does not have erectile dysfunction. It is essential to be aware that the effectiveness of Tadalafil Inventum depends on sexual stimulation. The patient and their partner should remember to stimulate sexually, just like when the patient is not taking erectile dysfunction medication. Consuming alcohol may affect the patient's ability to achieve an erection and may cause a transient decrease in blood pressure. If the patient has taken Tadalafil Inventum 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.

Taking a higher dose of Tadalafil Inventum 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 rash (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 possibly 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 consult their doctor;
• sudden vision loss (occurring in less than 1 in 1,000 patients - rare), distorted, blurred, or impaired vision (frequency not known).

Other reported side effects: Common(occurring in less than 1 in 10 patients)

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

Uncommon(occurring in less than 1 in 100 patients)

• dizziness, abdominal pain, nausea, vomiting, gastroesophageal reflux, blurred vision, eye pain, difficulty breathing, hematuria, prolonged erection, palpitations, tachycardia, high blood pressure, low blood pressure, epistaxis, tinnitus, edema of hands, feet, or ankles, and fatigue.

Rare(occurring in less than 1 in 1,000 patients)

• fainting, seizures, and transient memory loss, eyelid edema, eye redness, sudden hearing loss, urticaria (itching, red hives on the skin), penile hemorrhage, hematospermia, 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 this medicine. 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 effects have been reported, which were not observed during clinical trials. These include:

• migraine, facial edema, severe allergic reactions causing facial and throat edema, severe skin rashes, disorders characterized by blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac deaths;
• distorted, blurred, or impaired vision or sudden vision loss (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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Tadalafil Inventum

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. 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 Tadalafil Inventum contains

• The active substance of the medicine is tadalafil. Each tablet of the medicine contains 10 mg of tadalafil.
• The other ingredients are: lactose, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, tablet coating: hypromellose 2910, lactose monohydrate, titanium dioxide (E171), triacetin, talc, yellow iron oxide (E172), black iron oxide (E172).

What Tadalafil Inventum looks like and contents of the pack

Tadalafil Inventum is yellow, biconvex, oval, film-coated tablets with "T 10" embossed on one side. Tadalafil Inventum is packaged in blisters. One pack contains 2 or 4 film-coated tablets in a cardboard box.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o. ul. Partyzancka 133/151, 95-200 Pabianice, Tel. (42) 22-53-100

Importer/Manufacturer

Genepharm S.A. 18th km Marathonos Avenue, Pallini Attiki, 15351, Greece, Aflofarm Farmacja Polska Sp. z o.o. ul. Szkolna 31, 95-030 Ksawerów

Pharmapath S.A. 28is Oktovriou 1, Agia Varvara, 123 51, Greece

Date of last revision of the leaflet: