Erlis

Package Leaflet: Information for the Patient

Erlis, 10 mg, Film-Coated Tablets

Tadalafil

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• In Case of Any Doubts, Consult a Doctor or Pharmacist.
• This Medication has been Prescribed Specifically for You. Do Not Pass it on to Others. The Medication may Harm Others, Even if their Symptoms are the Same.
• If the Patient Experiences any Undesirable Effects, Including those Not Mentioned in this Package Leaflet, Inform a Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

• 1. What is Erlis and What is it Used for
• 2. Important Information Before Taking Erlis
• 3. How to Take Erlis
• 4. Possible Undesirable Effects
• 5. How to Store Erlis
• 6. Package Contents and Other Information

1. What is Erlis and What is it Used for

Erlis is a Medication 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 Erlis Significantly Improves the Ability to Achieve an Erection Suitable for Sexual Intercourse.
Erlis Contains the Active Substance Tadalafil, which Belongs to a Group of Medications Called Phosphodiesterase Type 5 Inhibitors. After Sexual Stimulation, Erlis Helps to Widen the Blood Vessels in the Penis, Allowing Blood to Flow into the Penis. As a Result, the Erection Improves. Erlis Does Not Help Patients who do Not Have Erectile Dysfunction.
It is Important to be Aware that Erlis 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 Erlis

When Not to Take Erlis

• If the Patient is Allergic to Tadalafil or any of the Other Ingredients of this Medication (Listed in Section 6).
• If the Patient is Taking Organic Nitrates in any Form or Other Donors of Nitric Oxide, such as Amyl Nitrite. This is a Group of Medications (``Nitrates'') Used to Treat Angina Pectoris (``Chest Pain''). It has been Shown that Tadalafil Enhances the Effect of these Medications. If the Patient is Taking Nitrates in any Form or is Not Sure, they Should Inform their Doctor.
• If the Patient has Severe Heart Disease or has had a Heart Attack in the Last 90 Days.
• If the Patient has had a Stroke in 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), Referred to as ``Eye Stroke''.
• If the Patient is Taking Riociguat. This is a Medication 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, Enhance the Blood-Pressure-Lowering Effect of this Medication. If the Patient is Taking Riociguat or is Not Sure, they Should Inform their Doctor.

Warnings and Precautions

Before Starting to Take Erlis, Discuss it with a Doctor.
It Should be Remembered that Sexual Activity is Associated with a Certain Risk in Patients with Heart Disease, as it Puts an Additional Strain on the Heart. If there are Problems with the Heart, the Doctor Should be Informed.
Before Taking the Medication, the Patient Should Inform the Doctor if they have:

• 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 Erlis 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 During the Use of Erlis, Sudden Worsening of Vision or Sudden Loss of Vision Occurs, or the Image is Distorted, Dim, the Use of this Medication Should be Stopped and a Doctor Should be Consulted Immediately.
In Some Patients Taking Tadalafil, 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 Worsening or Sudden Loss of Hearing Occurs, the Use of Erlis Should be Stopped and a Doctor Should be Consulted Immediately.
Erlis is Not Intended for Use in Women.

Children and Adolescents

Erlis is Not Intended for Use in Children and Adolescents Under the Age of 18.

Erlis and Other Medications

The Doctor Should be Informed About all Medications Currently Being Taken by the Patient or Recently Taken, as well as Medications that the Patient Plans to Take.
It is Not Allowed to Take Erlis if Nitrates are Being Taken.
Erlis may Affect the Action of Some Medications or Other Medications may Affect the Action of Erlis. The Doctor or Pharmacist Should be Informed if the Patient is Taking:

• Medications that Block Alpha-Adrenergic Receptors (Used to Treat High Blood Pressure or Symptoms of the Urinary System Caused by Benign Prostatic Hyperplasia),
• Other Medications Used to Treat High Blood Pressure,
• Riociguat,
• 5-Alpha-Reductase Inhibitors (Used to Treat Benign Prostatic Hyperplasia),
• Medications such as Ketokonazole in Tablets (Used to Treat Fungal Infections) and Protease Inhibitors Used to Treat AIDS or HIV Infection,
• Phenobarbital, Phenytoin, and Carbamazepine (Antiepileptic Medications),
• Rifampicin, Erythromycin, Clarithromycin, or Itraconazole,
• Other Methods of Treating Erectile Dysfunction.

Erlis with Food and Alcohol

Information on the Effect of Alcohol is Provided in Section 3. Grapefruit Juice may Affect the Efficacy of Erlis, and Caution Should be Exercised when Consuming it. For More Information, 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 During Clinical Trials, Dizziness was Reported, so it is Necessary to Know how the Tablets Affect the Patient Before Deciding to Drive or Operate Machines.

Erlis Contains Lactose and Sodium

If the Patient has Previously been Diagnosed with Intolerance to Some Sugars, they Should Consult a Doctor Before Taking the Medication.
The Medication Contains Less than 1 mmol (23 mg) of Sodium per Film-Coated Tablet, which Means the Medication is Considered ``Sodium-Free''.

3. How to Take Erlis

This Medication Should Always be Taken as Directed by the Doctor. In Case of Doubts, Consult a Doctor or Pharmacist.
Erlis 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. In Patients who do Not Respond to the 10 mg Dose, a 20 mg Dose can be Used.
Erlis Should be Taken at Least 30 Minutes Before Planned Sexual Activity. Erlis may Still be Effective up to 36 Hours After Taking the Tablet.
The Maximum Frequency of Taking Erlis is Once a Day. Erlis 10 mg and 20 mg is Intended for Use Before Planned Sexual Activity. It is Not Recommended to Take the Medication Continuously, on a Daily Basis.
It is Important to be Aware that Erlis Does Not Work Without Sexual Stimulation.
The Patient and their 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 Transient Decreases in Blood Pressure. If the Patient has Taken Erlis 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.

Taking More than the Recommended Dose of Erlis

Inform a Doctor. Undesirable Effects Described in Section 4 may Occur.

Missing a Dose of Erlis

Take the Dose as Soon as Remembered, but Do Not Take a Double Dose to Make up for the Missed Tablet. Do Not Take Erlis more than Once a Day.
In Case of Further Doubts About the Use of this Medication, Consult a Doctor or Pharmacist.

4. Possible Undesirable Effects

Like all Medications, this Medication can Cause Undesirable Effects, although Not Everyone will Experience them. These Effects are Usually Mild or Moderate.

If any of the Following Undesirable Effects Occur, Stop Taking the Medication and Consult a Doctor Immediately:

• Allergic Reactions, Including Rashes (Uncommon).
• Chest Pain - Do Not Take Nitrates, Seek Medical Help Immediately (Uncommon).
• Priapism - Prolonged and Possibly Painful Erection After Taking Erlis (Rare). If such an Erection Occurs and Lasts Continuously for more than 4 Hours, Consult a Doctor Immediately.
• Sudden Loss of Vision (Rare), Distorted, Dim, or Blurred Vision (Frequency Not Known).

Other Undesirable Effects have been Reported:
Common(May Occur in Less than 1 in 10 Patients)

• Headache, Back Pain, Muscle Pain, Pain in the Arms and Legs, Flushing, Nasal Congestion, and Nausea.

Uncommon(May Occur in Less than 1 in 100 Patients)

• Dizziness, Abdominal Pain, Nausea, Vomiting, Reflux, Blurred Vision, Eye Pain, Difficulty Breathing, Blood in the Urine, Prolonged Erection, Palpitations, Rapid Heartbeat, High Blood Pressure, Low Blood Pressure, Nosebleeds, Ringing in the Ears, Swelling of the Hands, Feet, or Ankles, and Feeling of Fatigue.

Rare(May Occur in Less than 1 in 1000 Patients)

• Fainting, Seizures, and Transient Loss of Memory, 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 the Semen, and Increased Sweating.

Myocardial Infarction and Stroke have been Rarely Reported in Men Taking Tadalafil. Most of them had Heart Problems Before Starting to Take Tadalafil.
There have been Reports of Rare Cases of Partial, Transient, or Permanent Decreased Vision or Loss of Vision in one or both Eyes.
In Men Taking Tadalafil, Several Additional Rare Undesirable 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, Disorders Characterized by Blood Flow to the Eyes, Irregular Heartbeat, Angina Pectoris, and Sudden Cardiac Death.

• Distorted, Dim, or Blurred Vision or Sudden Worsening of Vision (Frequency Not Known).

Dizziness was Reported more Frequently in Men Over 75 Years Old Taking Tadalafil. Diarrhea was Reported more Frequently in Men Over 65 Years Old Taking Tadalafil.

Reporting Undesirable Effects

If any Undesirable Effects Occur, Including those Not Mentioned in this Package Leaflet, Inform a Doctor or Pharmacist. Undesirable Effects can be Reported Directly to the Department of Monitoring of Undesirable Effects of Medicinal Products, the 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
Undesirable Effects can also be Reported to the Marketing Authorization Holder.
Reporting Undesirable Effects will Help to Gather more Information on the Safety of the Medication.

5. How to Store Erlis

The Medication Should be Stored in a Place that is Inaccessible to Children.
Do Not Use this Medication After the Expiration Date Stated on the Carton and Blister.
The Expiration Date Stated on the Packaging is the Last Day of the Specified Month.
The Entry on the Packaging after the Abbreviation EXP Indicates the Expiration Date, and after the Abbreviation Lot/LOT Indicates the Batch Number.
There are No Special Precautions for Storing the Medication.
Medications Should Not be Disposed of in the Drain or Household Waste. Ask a Pharmacist how to Dispose of Medications that are No Longer Needed. This will Help Protect the Environment.

6. Package Contents and Other Information

What Erlis Contains

• The Active Substance of Erlis is Tadalafil. Each Tablet Contains 10 mg of Tadalafil.
• Other Ingredients are: Tablet Core: Lactose Monohydrate (See End of Section 2), Microcrystalline Cellulose, Povidone K-30, Poloxamer Type 188, Sodium Lauryl Sulfate, Croscarmellose Sodium, Colloidal Anhydrous Silica, Magnesium Stearate. Tablet Coating: Polyvinyl Alcohol, Macrogol 3350, Talc, Titanium Dioxide (E 171), Yellow Iron Oxide (E 172), Red Iron Oxide (E 172).

What Erlis Looks Like and What the Package Contains

Erlis 10 mg Film-Coated Tablets are Light Orange, Prolonged, Convex on both Sides, Film-Coated Tablets with a Score Line on one Side; Size Approximately 11 mm x 6 mm.
Erlis 10 mg Film-Coated Tablets are Available in Blisters of PVC/PVDC/Aluminum in a Cardboard Box, Containing 4 Film-Coated Tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Polpharma S.A. Pharmaceutical Works
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Manufacturer/Importer

Polpharma S.A. Pharmaceutical Works
Pelplińska 19, 83-200 Starogard Gdański
Pharmacare Premium Ltd,
HHF003 Hal Far Industrial Estate,
BBG3000, Birzebbugia, Malta
Polpharma S.A. Pharmaceutical Works
Production Plant in Nowa Dęba
Metalowca 2, 39-460 Nowa Dęba
Date of Last Revision of the Package Leaflet:January 2024