Tadalafil Aurovitas

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Tadalafil Aurovitas(Tadalafil PUREN)

5 mg, coated tablets

Tadalafilum
Tadalafil Aurovitas and Tadalafil PUREN are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Tadalafil Aurovitas and what is it 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 to treat adult men:

• With erectile dysfunction.This is a condition where a man cannot achieve or maintain an erection sufficient for sexual intercourse. It has been shown that Tadalafil Aurovitas significantly improves the ability to achieve an erection sufficient for sexual intercourse. After sexual stimulation, Tadalafil Aurovitas helps to widen the blood vessels of the penis, allowing blood to flow into the penis. As a result, the erection improves. Tadalafil Aurovitas does not help patients who do not have erectile dysfunction. It is essential to be aware that Tadalafil Aurovitas does not work without sexual stimulation. The patient and his partner should arrange foreplay, just like when the patient is not taking erectile dysfunction medication.
• With symptoms of benign prostatic hyperplasia.This is a condition where the prostate gland enlarges with age. Symptoms include: difficulty starting to urinate, a feeling of incomplete emptying of the bladder, and the need to urinate more frequently, even at night. Tadalafil Aurovitas improves blood flow and causes relaxation of the prostate and bladder muscles, which may alleviate the symptoms of benign prostatic hyperplasia. It has been shown that Tadalafil Aurovitas alleviates these urinary symptoms within 1-2 weeks of starting treatment.

2. Important information before taking 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, such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina pectoris ("chest pain"). It has been shown that Tadalafil Aurovitas enhances the effect 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 had a loss of vision 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 (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 phosphodiesterase type 5 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, the patient should consult a doctor.
The patient should remember that sexual activity is associated with a certain risk for patients with heart disease, as it puts an additional strain on the heart. If the patient has heart problems, they should inform their doctor.
Benign prostatic hyperplasia and prostate cancer may have the same symptoms, so the doctor will perform a check for prostate cancer before starting Tadalafil Aurovitas for the treatment of benign prostatic hyperplasia symptoms. Tadalafil Aurovitas is not used to treat prostate cancer.
The patient should inform their doctor if they have any of the following:

• Sickle-cell anemia (abnormal shape of red blood cells).
• Multiple myeloma (bone marrow cancer).
• Leukemia (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 complete or partial removal of the prostate gland, during which the prostate nerves are cut (radical prostatectomy without nerve sparing).

If the patient experiences sudden worsening of vision or sudden loss of vision, or distorted vision, they should stop taking Tadalafil Aurovitas and immediately consult a doctor.
In some patients taking tadalafil, a 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 a worsening or sudden loss of hearing occurs, the patient should stop taking Tadalafil Aurovitas and immediately consult a doctor.
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

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Tadalafil Aurovitas should not be taken if the patient is taking nitrates.
Tadalafil Aurovitas may affect the action of some medicines, or other medicines may affect the action of Tadalafil Aurovitas. The patient should tell 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.
• Riociguat.
• 5-alpha-reductase inhibitors (used to treat benign prostatic hyperplasia).
• Medicines such as ketoconazole in tablets (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection.
• Phenobarbital, phenytoin, and carbamazepine (antiepileptic medicines).
• Rifampicin, erythromycin, clarithromycin, or itraconazole.
• Other treatments for erectile dysfunction.

Tadalafil Aurovitas with food and alcohol

Information on the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Tadalafil Aurovitas, and therefore, caution should be exercised when consuming it. For more information, the patient should consult their doctor.

Fertility

When tadalafil was administered to dogs, a decrease in sperm production in the testes occurred.
A decrease in sperm concentration was observed in some men. It is unlikely to lead to infertility.

Driving and using machines

Some men taking Tadalafil Aurovitas during clinical trials reported dizziness, so the patient should be aware of their reaction to the tablets before driving a car or operating machinery.

Tadalafil Aurovitas contains lactose monohydrate

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

Tadalafil Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Tadalafil Aurovitas

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should consult their 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 can be taken with or without food.
Consuming alcohol may cause a temporary decrease in blood pressure. If the patient has taken Tadalafil Aurovitas 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.

Treatment of erectile dysfunction

Recommended doseis one 5 mg tablet, taken once a day, approximately at the same time of day. The doctor may change the dose to 2.5 mg, depending on the patient's response to Tadalafil Aurovitas. In that case, a 2.5 mg tablet should be taken.
Tadalafil Aurovitas should not be taken more than once a day.
Taking Tadalafil Aurovitas once a day allows for the achievement of an erection after sexual stimulation at any time during the 24 hours. Taking Tadalafil Aurovitas once a day may be beneficial for men who intend to engage in sexual activity twice a week or more often.
It is essential to be aware that Tadalafil Aurovitas does not work without sexual stimulation. The patient and his partner should arrange foreplay, just like when the patient is not taking erectile dysfunction medication.
Consuming alcohol may affect the patient's ability to achieve an erection.

Treatment of symptoms of benign prostatic hyperplasia

Doseis one 5 mg tablet, taken once a day, approximately at the same time of day. If the patient has benign prostatic hyperplasia and erectile dysfunction, the dose of one 5 mg tablet per day remains unchanged.
Tadalafil Aurovitas should not be taken more than once a day.

Use of a higher than recommended dose of Tadalafil Aurovitas

The patient should inform their doctor. Adverse reactions described in section 4 may occur.

Missed dose of Tadalafil Aurovitas

The patient should take the dose as soon as they remember, but they should not take a double dose to make up for the missed tablet. Tadalafil Aurovitas should not be taken more than once a day.

4. Possible side effects

Like all medicines, Tadalafil Aurovitas 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 Tadalafil Aurovitas and immediately consult a doctor:

• Allergic reactions, including rash (not very common).
• Chest pain - the patient should not take nitrates, but should immediately seek medical help (not very common).
• Priapism, prolonged and possibly painful erection after taking Tadalafil Aurovitas (rare). If such an erection occurs and lasts continuously for more than 4 hours, the patient should immediately consult a doctor;
• Sudden loss of vision (rare), distorted, blurred, or impaired 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, flushing, nasal congestion, and indigestion.

Uncommon(may affect up to 1 in 100 people)

• Dizziness, abdominal pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, 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, swelling of the eyelids, redness of the eyes, sudden worsening or loss of hearing, hives (itchy, red bumps on the skin), bleeding from the penis, blood in semen, and increased sweating.

Heart attack and stroke have been rarely reported in men taking Tadalafil Aurovitas. Most of them had heart problems before starting to take this medicine.
There have been reports of rare cases of partial, transient, or permanent loss of vision or blindness in one or both eyes.
In men taking Tadalafil Aurovitas, several additional rare side effectshave 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, eye disorders, irregular heartbeat, angina pectoris, and sudden cardiac deaths.
• Distorted, blurred, or impaired vision (frequency not known). The side effect of dizziness was reported more frequently in men over 75 years of age taking Tadalafil Aurovitas. Diarrhea was reported more frequently in men over 65 years of age taking Tadalafil Aurovitas.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Tadalafil Aurovitas

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Tadalafil Aurovitas contains

• The active substance of the medicine is tadalafil. Each coated tablet contains 5 mg of tadalafil.
• The other ingredients are: Core:copovidone, hydroxypropyl cellulose, lactose monohydrate, silicon dioxide, microcrystalline cellulose, sodium croscarmellose, magnesium stearate. Coating:hypromellose, titanium dioxide (E 171), triacetin, talc, yellow iron oxide (E 172).

What Tadalafil Aurovitas looks like and contents of the pack

Coated tablets.
Light yellow, oval, coated tablets, with "5" marked on one side and "TL" on the other side.
Tadalafil Aurovitas coated tablets are packaged in PVC/PVDC-Aluminum blisters in a cardboard box.
Pack sizes: 14 and 28 coated tablets.
For more detailed information, the patient should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the country of export:

PUREN Pharma GmbH & Co. KG
Willy-Brandt-Allee 2
81829 Munich, Germany

Manufacturer:

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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorization number in Germany, the country of export:94457.00.00

Parallel import authorization number: 146/25

This medicine is authorized in the Member States of the European Economic Area under the following names:

Italy: Tadalafil Aurobindo
Poland: Tadalafil Aurovitas
Portugal: Tadalafil Generis

Date of leaflet approval: 16.04.2025