Tadalafil Aurovitas

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Tadalafil Aurovitas(Tadalafil PUREN)

20 mg, Film-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 You by a Doctor and is Intended for Your Use Only. Do Not Give it to Others. The Medicine may Harm Another Person, even if Their Symptoms are the Same as Yours.
• If You Experience any Undesirable Effects, including those Not Mentioned in this Leaflet, You Should Inform Your 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 Undesirable 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 is a Medicine Intended for 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.
Tadalafil Aurovitas Contains the Active Substance Tadalafil, which Belongs to a Group of Medicines Called Phosphodiesterase Type 5 Inhibitors. After Sexual Stimulation, Tadalafil Aurovitas Helps to Widen the Blood Vessels in 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 Important 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 Medication for Erectile Dysfunction.

2. Important Information Before Taking Tadalafil Aurovitas

When Not to Take Tadalafil Aurovitas

• If You are Allergic to Tadalafil or any of the Other Ingredients of this Medicine (listed in Section 6).
• If You are Taking Organic Nitrates in any Form or Other Donors of Nitric Oxide, 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 You are Taking Nitrates in any Form or are Not Sure, You Should Inform Your Doctor.
• If You have Severe Heart Disease or have had a Heart Attack in the Last 90 Days.
• If You have had a Stroke in the Last 6 Months.
• If You have Low Blood Pressure or Uncontrolled High Blood Pressure.
• If You have Ever Lost Your Vision due to Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION), also Known as ``Eye Stroke''.
• If You are 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 You are Taking Riociguat or are Not Sure, You Should Inform Your Doctor.

Warnings and Precautions

Before Starting to Take Tadalafil Aurovitas, You Should Consult a Doctor.
You Should Remember that Sexual Activity is Associated with a Certain Risk in Patients with Heart Disease, as it Puts an Additional Strain on the Heart. If You have Heart Problems, You Should Inform Your Doctor.
Before Taking the Medicine, You Should Inform Your Doctor if You have any of the Following Conditions:

• Sickle-Cell Anemia (Abnormal Shape of Red Blood Cells).
• Multiple Myeloma (Bone Marrow Cancer).
• Leukemia (Blood Cell Cancer).
• Any Deformity of the Penis.
• Severe Liver Disease.
• Severe Kidney Disease.

It is Not Known if Tadalafil Aurovitas is Effective in Patients:

• After Surgical Procedures in the Pelvic Area.
• After Total or Partial Removal of the Prostate Gland, during which the Nerves of the Prostate Gland are Cut (Radical Prostatectomy without Nerve-Sparing).

If You Experience Sudden Worsening of Vision or Sudden Loss of Vision, or Distorted Vision, You 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 if this Event is Directly Related to the Use of Tadalafil, if You Experience a Worsening or Sudden Loss of Hearing, You 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

You Should Tell Your Doctor about all Medicines You are Currently Taking or Have Recently Taken, as well as any Medicines You Plan to Take.
You Should Not Take Tadalafil Aurovitas if You are Taking Nitrates.
Tadalafil Aurovitas may Affect the Action of Some Medicines or Other Medicines may Affect the Action of Tadalafil Aurovitas. You Should Tell Your Doctor or Pharmacist if You are Taking any of the Following Medicines:

• Medicines that Block Alpha-Adrenergic Receptors (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 Ketokonazole in Tablets (Used to Treat Fungal Infections) and Protease Inhibitors Used to Treat AIDS or HIV Infection.
• Phenobarbital, Phenytoin, and Carbamazepine (Anti-Epileptic Medicines).
• Rifampicin, Erythromycin, Clarithromycin, or Itraconazole.
• Other Methods of Treating 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, it Should be Consumed with Caution. For More Information, You Should Consult a Doctor.

Fertility

When Administered to Dogs, a Decrease in Sperm Production in the Testes was Observed.
A Decrease in Sperm Concentration was Observed in Some Men. It is Unlikely to Lead to Infertility.

Driving and Operating Machines

In Some Men Taking Tadalafil Aurovitas During Clinical Trials, Dizziness was Reported, so You Should be Aware of Your Reaction to the Tablets Before Deciding to Drive a Car or Operate Machines.

Tadalafil Aurovitas Contains Lactose Monohydrate

If You have an Intolerance to Some Sugars, You Should Consult a Doctor Before Taking the Medicine.

Tadalafil Aurovitas Contains Sodium

This Medicine Contains Less than 1 mmol (23 mg) of Sodium per Tablet, which Means that the Medicine is Considered ``Sodium-Free''.

3. How to Take Tadalafil Aurovitas

This Medicine Should Always be Taken as Directed by a Doctor or Pharmacist. If You are in Doubt, You Should Consult a 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.
The Recommended Initial Doseis one 10 mg Tablet, Taken Before Planned Sexual Activity. If the Doctor has Determined that the Recommended Dose of 10 mg is Too Weak, then one 20 mg Tablet Should be Taken as Directed by the Doctor.
Tadalafil Aurovitas can be Taken at Least 30 Minutes Before Planned Sexual Activity. Tadalafil Aurovitas may Still be Effective up to 36 Hours After Taking the Tablet.
You Should Not Take Tadalafil Aurovitas more than Once a Day. Tadalafil Aurovitas 10 mg and 20 mg is Intended for Use Before Planned Sexual Activity. It is Not Recommended to Take the Medicine Continuously, on a Daily Basis.
It is Important 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 Medication for Erectile Dysfunction.
Consuming Alcohol may Affect the Patient's Ability to Achieve an Erection and may Cause a Transient Decrease in Blood Pressure. If You have Taken Tadalafil Aurovitas or Plan to Take it, You 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.

Use of a Higher than Recommended Dose of Tadalafil Aurovitas

You Should Inform a Doctor. Undesirable Effects Described in Section 4 may Occur.
If You have any Further Doubts about the Use of the Medicine, You Should Consult a Doctor or Pharmacist.

4. Possible Undesirable Effects

Like all Medicines, this Medicine can Cause Undesirable Effects, although Not Everybody gets them.
These Effects are Usually Mild or Moderate.

If You Experience any of the Following Undesirable Effects, You Should Stop Taking the Medicine and Immediately Consult a Doctor:

• Allergic Reactions, including Rashes (Uncommon).
• Chest Pain - You Should Not Take Nitrates, but You Should Immediately Seek Medical Help (Uncommon).
• Priapism, Prolonged and Possibly Painful Erection after Taking Tadalafil Aurovitas (Rare). If such an Erection Occurs and Lasts for more than 4 Hours, You Should Immediately Consult a Doctor.
• Sudden Loss of Vision (Rare), Distorted, Blurred, or Impaired Vision (Frequency Not Known).

Other Reported Undesirable Effects:
Common(may Affect up to 1 in 10 People)

• Headache, Back Pain, Muscle Pain, Pain in Arms and Legs, Flushing, Nasal Congestion, and Nausea. Uncommon(may Affect up to 1 in 100 People)
• Dizziness, Abdominal Pain, Nausea, Vomiting, Gastroesophageal Reflux, Blurred Vision, Eye Pain, Difficulty Breathing, Hematuria, Prolonged Erection, Palpitations, Tachycardia, High Blood Pressure, Low Blood Pressure, Epistaxis, Tinnitus, Edema of Hands, Feet, or Ankles, and Fatigue.

Rare(may Affect up to 1 in 1,000 People)

• Fainting, Seizures, and Transient Loss of Memory, Eyelid Edema, Eye Redness, Sudden Worsening or Loss of Hearing, Urticaria (Itchy, Red Hives on the Skin), Penile Hemorrhage, Hematospermia, and Increased Sweating.

Myocardial Infarction and Stroke have been Rarely Reported in Men Taking Tadalafil Aurovitas.
Most of them had Heart Problems Before Starting to Take this Medicine.
There are Reports of Rare Cases of Partial, Transient, or Permanent Decreased Vision or Loss of Vision in one or both Eyes.
In Men Taking Tadalafil Aurovitas, Several Additional Rare Undesirable Effectshave been Reported, which were Not Observed During Clinical Trials. These include:

• Migraine, Facial Edema, Severe Allergic Reactions Causing Facial and Throat Edema, Severe Skin Rashes, Disorders Characterized by Blood Flow to the Eyes, Irregular Heartbeat, Angina Pectoris, and Sudden Cardiac Death.
• Distorted, Blurred, or Impaired Vision (Frequency Not Known). The Undesirable 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 Undesirable Effects

If You Experience any Undesirable Effects, including those Not Mentioned in this Leaflet, You Should Inform Your Doctor, Pharmacist, or Nurse. Undesirable Effects can be Reported Directly to the Department of Monitoring of Undesirable Effects of Medicinal Products, 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 Undesirable Effects, You can Help to Gather more Information on the Safety of the Medicine.

5. How to Store Tadalafil Aurovitas

The Medicine Should be Stored in a Place that is Inaccessible to Children.
You Should Not Use this Medicine after the Expiry Date Stated on the Packaging. The Expiry Date Refers to the Last Day of the Month.
There are No Special Precautions for Storage.
Medicines Should Not be Disposed of via Wastewater or Household Waste. You Should Ask a Pharmacist how to Dispose of Medicines that are No Longer Used. This will Help to Protect the Environment.

6. Contents of the Packaging and Other Information

What Tadalafil Aurovitas Contains

• The Active Substance of the Medicine is Tadalafil. Each Film-Coated Tablet Contains 20 mg of Tadalafil.
• The Other Ingredients are: Core:Copovidone, Hydroxypropyl Glyceryl Stearate, Lactose Monohydrate, Silica Colloidal Anhydrous, 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 What the Packaging Contains

Film-Coated Tablets.
Light Yellow, Oval Film-Coated Tablets, with the Marking ``20'' on one Side and ``TL'' on the Other Side.
Tadalafil Aurovitas Film-Coated Tablets are Packaged in PVC/PVDC-Aluminum Blisters in a Cardboard Box.
Packaging Sizes: 2 or 4 Film-Coated Tablets.
For More Detailed Information, You Should Consult the Marketing Authorization Holder or the 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
Marketing Authorization Number in Germany, the Country of Export:94459.00.00

Parallel Import Authorization Number: 162/25

This Medicine is Authorized for Marketing in the Member States of the European Economic Area Under the Following Names:

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

Date of Approval of the Leaflet: 30.04.2025