Package leaflet: Information for the patient

Tadalafil Aurovitas, 5 mg, film-coated tablets
Tadalafilum
Please read carefully the entire leaflet before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

What Tadalafil Aurovitas is and what it is used for
Important information before taking Tadalafil Aurovitas
How to take Tadalafil Aurovitas
Possible side effects
How to store Tadalafil Aurovitas
Contents of the pack and other information

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

Tadalafil Aurovitas contains the active substance tadalafil, which belongs to a group of medicines called
phosphodiesterase type 5 inhibitors.
Tadalafil Aurovitas 5 mg is used in the treatment of adult men:

With erectile dysfunction. This is a condition in which a man cannot achieve or maintain an erection sufficient for sexual intercourse. Tadalafil Aurovitas has been shown to significantly improve the ability to achieve an erection suitable for sexual activity. After sexual stimulation, Tadalafil Aurovitas helps widen the blood vessels of the penis, allowing blood to flow into the penis. As a result, erection improves. Tadalafil Aurovitas does not help patients who do not have erectile dysfunction. It is important to understand that Tadalafil Aurovitas does not work without sexual stimulation. The patient and his partner should engage in foreplay, just as they would if the patient were not taking erectile dysfunction medication.
With urinary symptoms caused by a common condition called benign prostatic hyperplasia. This is a condition in which the prostate gland enlarges with age. Symptoms include: difficulty starting urination, feeling of incomplete bladder emptying, and need to urinate more frequently, even at night. Tadalafil Aurovitas improves blood flow and causes relaxation of the muscles of the prostate and bladder, which may relieve symptoms of benign prostatic hyperplasia. It has been shown that Tadalafil Aurovitas alleviates these urinary symptoms within 1–2 weeks after starting treatment.

2. Important information before using Tadalafil Aurovitas

When not to take Tadalafil Aurovitas

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 (chest pain). It has been shown that Tadalafil Aurovitas 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 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.
If the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), sometimes referred to as "eye stroke".
If the patient is taking riociguat. This is a medicine used to treat pulmonary hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs caused by blood clots). PDE5 inhibitors such as Tadalafil Aurovitas 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 Tadalafil Aurovitas, consult a doctor.
Please note that sexual activity involves some risk for patients with heart disease, as it places additional strain on the heart. If the patient has any heart problems, they should inform their doctor.
Benign prostatic hyperplasia and prostate cancer may have similar symptoms, therefore the doctor will perform tests to rule out prostate cancer before starting treatment with Tadalafil Aurovitas for symptoms of benign prostatic hyperplasia. Tadalafil Aurovitas is not used to treat prostate cancer.
Before taking the medicine, the patient should inform their doctor 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 penile deformity.
Severe liver disease.
Severe kidney disease.

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

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

If sudden vision deterioration or sudden vision loss occurs while taking Tadalafil Aurovitas, or if vision becomes blurred or distorted, the patient should stop taking Tadalafil Aurovitas and contact a doctor immediately.
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 worsens or sudden hearing loss occurs, the patient should stop taking Tadalafil Aurovitas and contact a doctor immediately.
Tadalafil Aurovitas is not intended for use in women.
Children and adolescents
Tadalafil Aurovitas is not intended for use in children and adolescents under 18 years of age.
Tadalafil Aurovitas and other medicines
Inform the doctor about all medicines currently taken, recently taken, or planned for use.
Do not take Tadalafil Aurovitas if taking nitrates.
Tadalafil Aurovitas may affect the action of certain medicines, or other medicines may affect the action of Tadalafil Aurovitas. Inform the doctor or pharmacist if taking any of the following medicines:

Alpha-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, or itraconazole.
Other treatments for erectile dysfunction.

Tadalafil Aurovitas, alcohol and grapefruit juice
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Tadalafil Aurovitas and caution should be exercised when consuming it. For further information, consult a doctor.
Fertility
When Tadalafil Aurovitas was administered to dogs, reduced 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
In clinical trials, some men taking Tadalafil Aurovitas reported dizziness. Therefore, patients should understand how they react to the tablets before deciding to drive or operate machinery.
Tadalafil Aurovitas contains lactose
If the patient has an intolerance to certain sugars, they should consult a doctor before starting treatment.
Tadalafil Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Tadalafil Aurovitas

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Tadalafil Aurovitas tablets are intended for oral use only in men.
The tablets should be swallowed whole with a small amount of water. The tablets may be taken
regardless of meals.
Drinking alcohol may cause a temporary decrease in blood pressure. If
the patient has taken Tadalafil Aurovitas or plans to take it, he should not consume large
amounts of alcohol (blood alcohol concentration of 0.08% or higher), as this may increase the risk of
dizziness upon standing.
Treatment of erectile dysfunction
Recommended dose is one 5 mg tablet taken once daily at approximately the same time
of day. The doctor may adjust the dose to 2.5 mg depending on the patient's response to Tadalafil
Aurovitas. In such case, the 2.5 mg tablet should be used.
Tadalafil Aurovitas should not be taken more frequently than once a day.
Taking Tadalafil Aurovitas once daily enables achieving an erection following sexual
stimulation at any time within 24 hours. Taking Tadalafil Aurovitas once daily may be beneficial
for men who plan to engage in sexual activity two or more times per week.
It is important to be aware that Tadalafil Aurovitas does not work in the absence of
sexual stimulation. The patient and his partner should engage in foreplay, just as they would
when the patient is not taking erectile dysfunction medication.
Alcohol consumption may affect the patient's ability to achieve an erection.
Treatment of signs and symptoms of benign prostatic hyperplasia
Dose is one 5 mg tablet taken once daily at approximately the same time of day. If
the patient has benign prostatic hyperplasia as well as erectile dysfunction, the dose – one 5 mg tablet once daily – remains unchanged.
Tadalafil Aurovitas must not be taken more frequently than once a day.
Taking more Tadalafil Aurovitas than recommended
Inform your doctor immediately. Adverse effects described in section 4 may occur.
If you forget to take Tadalafil Aurovitas
Take the missed dose as soon as you remember, but do not take a double dose to make up for
the forgotten tablet. Do not take Tadalafil Aurovitas more frequently than once a day.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
These side effects are usually mild or moderate.
If any of the side effects listed below occur, stop taking the medicine and seek immediate medical advice:

Allergic reactions, including rash (uncommon).
Chest pain – do not take nitrates, but seek immediate medical help (uncommon).
Priapism, a prolonged and possibly painful erection after taking Tadalafil Aurovitas (rare). If such an erection occurs and lasts continuously for more than 4 hours, contact a doctor immediately;
Sudden loss of vision (rare), distorted, dimmed, blurred central vision, or sudden worsening of vision (frequency not known).

Other reported side effects:
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.

Uncommon (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, 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 tired.

Rare (may affect up to 1 in 1,000 people)

Fainting, seizures, and transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, urticaria (itchy, red skin swellings), bleeding from the penis, presence of blood in semen, and increased sweating.

Heart attack and stroke have been rarely reported in men taking Tadalafil Aurovitas.
Most of these men had pre-existing heart conditions before starting treatment with this medicine.
There have been reports of rare cases of partial, transient or permanent visual impairment or vision loss in one or both eyes.
In men taking Tadalafil Aurovitas, 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 manifesting as ocular hyperaemia, irregular heartbeat, angina pectoris, and sudden cardiac death.
Distorted, dimmed, blurred central vision or sudden worsening of vision (frequency not known).

The side effect: dizziness was reported more frequently in men over 75 years of age taking Tadalafil Aurovitas. Diarrhoea was reported more frequently in men over 65 years of age taking Tadalafil Aurovitas.
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Tadalafil Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required.
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 Tadalafil Aurovitas contains

The active substance is tadalafil. Each coated tablet contains 5 mg of tadalafil.
Other ingredients are: Tablet core: copovidone, glyceryl macrogol hydroxystearate, lactose monohydrate, colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose, magnesium stearate. Tablet coating: hypromellose 2910 (6 cp), titanium dioxide (E 171), triacetin, talc, iron oxide yellow (E 172).

What Tadalafil Aurovitas looks like and contents of the pack
Coated tablet.

Light yellow, oval coated tablets marked with "5" on one side and "TL" on the other side.
Tadalafil Aurovitas coated tablets are packed in PVC/PVDC/Aluminium blisters, in a cardboard carton.
Pack sizes: 14 and 28 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, lokal 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
2700-487 Amadora, Lisbon
Portugal

This medicinal product is authorised in the European Economic Area under the following trade names:
Italy: Tadalafil Aurobindo
Poland: Tadalafil Aurovitas
Portugal: Tadalafil Generis