Tadalafil inventum

Before taking the medicine, use the enclosed DIAGNOSTIC TEST!

Package leaflet: Information for the patient

Tadalafil Inventum, 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 taken exactly as described in this patient leaflet or as directed by
the physician or pharmacist.

• Keep this leaflet so that it can be read again if necessary.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after using the medicine, or if the patient feels worse, contact a doctor.

Table of contents of the leaflet

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

Tadalafil Inventum is a medicine intended for adult men with erectile dysfunction, i.e. the
inability to achieve or maintain an erection sufficient for a satisfactory sexual intercourse.
Tadalafil has been shown to significantly improve 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 (PDE5) inhibitors. Following sexual stimulation, Tadalafil Inventum helps
dilate the blood vessels of the penis, allowing blood flow into the penis. As a result, erection improves.
Tadalafil Inventum does not help patients who do not have erectile dysfunction.
Tadalafil Inventum does not work in the absence of sexual stimulation. The patient and his partner should
remember the need for sexual arousal and engage in foreplay, just as they would when the patient is not taking
a medicine for erectile dysfunction.

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, e.g. amyl nitrite. This is a group of medicines ("nitrates") used in the treatment of angina pectoris ("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). 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 Tadalafil Inventum, the patient should complete the Diagnostic Test included in the packaging. 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, as it places additional strain on the heart. If the patient has heart problems (including those indicated by the Diagnostic Test as contraindications for using Tadalafil Inventum due to heart conditions), they should inform their doctor or pharmacist.
Before taking the medicine, the patient should inform their doctor or pharmacist if any of the following apply:

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

It is not known whether Tadalafil Inventum 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 or sudden vision loss occurs during treatment with tadalafil, or if vision becomes distorted or blurred, the patient should stop taking tadalafil and contact their doctor immediately.
Some patients taking tadalafil have experienced worsening or sudden hearing loss.
Although it is not known whether this event is directly related to the use of tadalafil, if hearing worsens or sudden hearing loss occurs, the patient should stop taking Tadalafil Inventum and contact their doctor immediately.
Tadalafil Inventum should not be used together with other oral or topical medicines used to treat erectile dysfunction.
Tadalafil Inventum should not be used together with arterial pulmonary hypertension (APH) therapies using sildenafil or other PDE5 inhibitors.
For 48 hours after taking Tadalafil Inventum, the patient must not take any medicines containing sildenafil used to treat erectile dysfunction or pulmonary hypertension.
Tadalafil Inventum should not be taken if erectile dysfunction has not been diagnosed.
Tadalafil Inventum is not intended for use in women.

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

Tadalafil Inventum and other medicines
Before starting to take Tadalafil Inventum, the patient should complete the Diagnostic Test.
If in doubt, the patient should inform their doctor or pharmacist about all medicines currently or recently taken, as well as any medicines they plan to take.
Tadalafil Inventum must not be taken if the patient is using nitrates.
Tadalafil Inventum may affect the action of certain 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 urinary symptoms caused by 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 tablets or itraconazole (used to treat fungal infections) and protease inhibitors (e.g. ritonavir, saquinavir) used in the treatment of AIDS or HIV infection;
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines);
• rifampicin, erythromycin, clarithromycin (antibiotics);
• 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 the symptoms to subside. Drinking water, getting fresh air, tensing abdominal muscles, or crossing legs may also help. The patient should avoid standing up or sitting down quickly.

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

Pregnancy, breastfeeding and fertility
Tadalafil Inventum is not intended for use in women.
Fertility
When the medicine was given 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 using machines
Dizziness has been reported in some men taking tadalafil during clinical trials; therefore, patients should understand their individual response to the tablets before deciding to drive a car or operate machinery.

Tadalafil Inventum contains lactose and sodium
Lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this 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, meaning it is considered "sodium-free".

3. How to take Tadalafil Inventum

This medicine should always be taken exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your 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. Tablets may be taken with or without food.
The recommended dose is one 10 mg tablet taken prior to planned sexual activity.
If you feel the effect of Tadalafil Inventum is too strong or too weak, consult your doctor or pharmacist. After consultation, your doctor may recommend a different dosing regimen.
Tadalafil Inventum may 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 prior to planned sexual activity.
The medicine should be taken on an as-needed basis.
Do not take this medicine more than once a week.
Tadalafil Inventum must not be taken together with other oral or topical medicines used in the treatment of erectile dysfunction.
Tadalafil Inventum must not be taken simultaneously with arterial pulmonary hypertension (PAH) therapies containing sildenafil or other PDE5 inhibitors.
For 48 hours after taking Tadalafil Inventum, do not take any medicines containing sildenafil used in the treatment of erectile dysfunction or pulmonary hypertension.
Tadalafil Inventum should not be taken if erectile dysfunction has not been diagnosed.
It is important to be aware that effective treatment with Tadalafil Inventum requires sexual stimulation. The patient and his partner should remember to provide sexual stimulation, just as they would when the patient is not taking medicines 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 Tadalafil Inventum, 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 more than the recommended dose of Tadalafil Inventum
Inform your doctor immediately. Adverse effects described in section 4 may occur.
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 seek immediate medical advice:

• allergic reactions, including rash (occur in no more than 1 in 100 patients – uncommon);
• chest pain – do not take nitrates, but seek immediate medical help (occurs uncommonly);
• priapism, a prolonged and possibly 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, seek immediate medical advice;
• sudden vision loss (rare), distorted, blurred, or impaired central vision, or sudden worsening of vision (frequency not known).

Other reported adverse reactions:
Common (occur in no more than 1 in 10 patients)

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

Uncommon (occur in no more than 1 in 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, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling of fatigue.

Rare (occur in no more than 1 in 1,000 patients)

• fainting, seizures, and transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, urticaria (itchy, red skin swellings), penile 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 treatment with this medicine.
There have been reports of rare cases of partial, transient, or permanent vision loss or visual impairment in one or both eyes.
In men taking tadalafil, several additional rare adverse reactions
have been reported that were not observed during clinical trials. These include:

• migraine, facial swelling, severe allergic reactions causing swelling of the face and throat, severe skin rashes, disorders characterized by blood flow into the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death;
• distorted, blurred, or impaired central vision, or sudden worsening of vision (frequency not known).

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 effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be
reported directly to the Department of Monitoring Adverse Reactions of 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
Adverse reactions can also be reported to the responsible marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tadalafil Inventum

Keep this medicine out of the 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 stated month.
No special storage conditions apply for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Tadalafil Inventum contains

• The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.
• Other ingredients are: lactose, sodium croscarmellose, sodium lauryl sulfate, hydroxypropylcellulose, polysorbate 80, magnesium stearate; tablet coating: hypromellose 2910, monohydrate lactose, 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 a yellow, biconvex, oval, film-coated tablet with "T 10" embossed on one side.
Tadalafil Inventum is packed in blisters. One pack contains 2 or 4 film-coated tablets in a cardboard box.

Marketing Authorisation 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