Package leaflet: Information for the patient

Tadalafil Aurovitas, 20 mg, coated tablets
Tadalafilum
Please read all of this leaflet carefully before taking this medicine, because 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 them, even if their symptoms are the same.
If you experience any side 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
What you need to know 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 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.
Tadalafil Aurovitas has been shown to significantly improve the ability to obtain an erection sufficient for sexual intercourse.
Tadalafil Aurovitas contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation, Tadalafil Aurovitas helps widen the blood vessels of the penis, allowing increased blood flow into the penis. This results in improved erection. Tadalafil Aurovitas does not benefit patients who do not have erectile dysfunction.
It is important to understand 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 if the patient were not taking medication for erectile dysfunction.

2. Important information before using Tadalafil Aurovitas

When not to use 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, such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina (chest pain). Tadalafil Aurovitas has been shown to enhance 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), also known 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 remember that sexual activity involves some risk in patients with heart disease, as it places additional strain on the heart. If the patient has any heart problems, they should inform their doctor.
Before taking Tadalafil Aurovitas, the patient should inform their doctor if any of the following apply:

Sickle cell anemia (abnormal shape of red blood cells).
Multiple myeloma (a cancer of the bone marrow).
Leukemia (a cancer of blood cells).
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 nerve damage (non-nerve-sparing radical prostatectomy).

If sudden worsening of vision, sudden vision loss, or distorted, blurred vision occurs during treatment with Tadalafil Aurovitas, stop taking the medicine immediately and contact a 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, discontinue 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
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not take Tadalafil Aurovitas if you are using nitrates.
Tadalafil Aurovitas may affect the action of certain medicines or other medicines may affect the action of Tadalafil Aurovitas. Inform your doctor or pharmacist if you 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 in the treatment of AIDS or HIV infection.
Phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
Rifampicin, erythromycin, clarithromycin, or itraconazole.
Other treatments for erectile dysfunction.

Tadalafil Aurovitas, food, and alcohol
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the efficacy of Tadalafil Aurovitas, and therefore caution should be exercised when consuming it. For further information, consult your doctor.
Fertility
When Tadalafil Aurovitas 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 using machines
In some men taking Tadalafil Aurovitas, dizziness has been reported during clinical trials; 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 their doctor before starting treatment with this medicine.
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 exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Tadalafil Aurovitas tablets are intended for oral use only in men.
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. If your doctor finds that the 10 mg dose is too weak, then one 20 mg tablet should be taken as directed by your doctor.
Tadalafil Aurovitas may be taken at least 30 minutes before planned sexual activity. Tadalafil Aurovitas may still be effective up to 36 hours after taking the tablet.
Do not take Tadalafil Aurovitas more than once a day. Tadalafil Aurovitas 10 mg and 20 mg is intended to be taken prior to planned sexual activity. Regular daily use is not recommended.
It is important to be aware that Tadalafil Aurovitas 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 erectile dysfunction medicines.
Drinking alcohol 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 Aurovitas, 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.
Taking more than the recommended dose of Tadalafil Aurovitas
Inform your doctor immediately. Adverse effects described in section 4 may occur.
If you have any further doubts regarding 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 using 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, seek immediate medical advice.
Sudden loss of vision (rare), distorted, blurred, or impaired central vision, or sudden decrease in vision (frequency unknown).

Other reported adverse reactions:
Common (may affect up to 1 in 10 people)

Headache, back pain, muscle pain, arm and leg pain, 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, blood in urine, prolonged erection, sensation of heart 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 penis, 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 problems 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, 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 congestion in the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
Distorted, blurred, or impaired central vision, or sudden decrease in vision (frequency unknown).

Adverse reaction: 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 adverse reactions
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions
can be reported directly to the Department of Monitoring of 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tadalafil Aurovitas

Keep this medicine out of 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 should not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. This will help protect
the environment.

6. Contents of the packaging and other information

What Tadalafil Aurovitas contains

The active substance is tadalafil. Each coated tablet contains 20 mg of tadalafil.
The other ingredients are:
Tablet core: copovidone, glyceryl macrogol hydroxystearate, lactose monohydrate, colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E 171), triacetin, talc, yellow iron oxide (E 172).

What Tadalafil Aurovitas looks like and contents of the packaging
Coated tablet.
Light yellow, oval coated tablets, marked with "20" on one side and "TL" on the other side.
Tadalafil Aurovitas coated tablets are packed in blisters made of PVC/PVDC/Aluminium, contained in a cardboard box.
Pack sizes: 2, 4, 8 and 12 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa Street 13D, unit 27
01-909 Warsaw
email: [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 countries under the following names:
Italy: Tadalafil Aurobindo
Poland: Tadalafil Aurovitas
Portugal: Tadalafil Generis