Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Tadalafil Aurovitas (Tadalafil PUREN)
20 mg, coated tablets
Tadalafilum
Tadalafil Aurovitas and Tadalafil PUREN are different trade names for the same medicinal product.
Please read the entire leaflet carefully before taking this 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 consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform 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 adequate 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 in the penis, allowing increased blood flow into the penis. This
leads to improved erection. Tadalafil Aurovitas does not help patients who do not have erectile
dysfunction.
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 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). 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), 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 Aurovitas, 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 Aurovitas, consult a doctor.
Please remember that sexual activity involves some risk for patients with heart disease, as it places additional strain on the heart. If the patient has 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 anaemia (abnormal shape of red blood cells).
Multiple myeloma (a tumour of the bone marrow).
Leukaemia (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, during which the nerves to the prostate are cut (non-nerve-sparing radical prostatectomy).

If sudden worsening of vision or sudden vision loss occurs while taking Tadalafil Aurovitas, or if vision becomes distorted or blurred, stop taking Tadalafil Aurovitas immediately and contact a doctor without delay.
In some patients taking tadalafil, worsening or sudden loss of hearing has been observed.
Although it is not known whether this event is directly related to the use of tadalafil, if worsening or sudden loss of hearing occurs, 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
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. Tell your doctor or pharmacist if you are taking any of the following medicines:

Alpha-blockers (used to treat high blood pressure or urinary symptoms caused by 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, food, and alcohol
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 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 operating machinery
In clinical trials, some men taking Tadalafil Aurovitas reported dizziness. Therefore, patients should be aware of their individual response to the tablets before deciding to drive or operate machinery.
Tadalafil Aurovitas contains lactose monohydrate
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 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. Tablets may be taken
regardless of meals.
The recommended starting dose is one 10 mg tablet taken prior to planned sexual activity. If your doctor determines that the recommended 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 remain effective for up to 36 hours after taking the tablet.
Do not take Tadalafil Aurovitas more than once in a 24-hour period. Tadalafil Aurovitas 10 mg and 20 mg is intended for use prior to planned sexual activity. Regular, daily use is not recommended.
It is important to be aware that Tadalafil Aurovitas will 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.
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 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 Aurovitas
You should inform your doctor. 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 any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
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 rashes (uncommon).
Chest pain – do not use 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 adverse reactions:
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, 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, redness of the eyes, sudden worsening or loss of hearing, urticaria (itchy, red raised areas on the skin), rectal bleeding, 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 problems before starting treatment with this medicine.
There have been reports of rare cases of partial, transient or permanent
visual impairment or loss of vision 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 blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
Distorted, dimmed, blurred central vision or sudden worsening of vision (frequency not known). The 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, tell your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
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 the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
No special storage instructions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will 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 20 mg of tadalafil.
The other ingredients are:
Tablet core: copovidone, macrogol glycerol hydroxystearate, lactose monohydrate, colloidal silicon dioxide anhydrous, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E 171), triacetin, talc, iron oxide yellow (E 172).

What Tadalafil Aurovitas looks like and contents of the pack
Coated tablets.
Light yellow, oval coated tablets marked with "20" on one side and "TL" on the other side.
Tadalafil Aurovitas coated tablets are packed in PVC/PVDC-Aluminium blisters in a cardboard box.
Pack sizes: 2 or 4 coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Germany, the country of export:
PUREN Pharma GmbH & Co. KG
Willy-Brandt-Allee 2
81829 Munich, Germany

Manufacturers:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000, Malta
Orion Corporation Orion Pharma
Orionintie 1
02200 Espoo, Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo, Finland
Generis Farmacêutica S.A.
Rua João de Deus, nº 19, Venda Nova
2700-487 Amadora, Portugal

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

German marketing authorisation number (country of export): 94459.00.00
Parallel import authorisation number: 162/25

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