Erlis

Package Leaflet: Information for the Patient

Erlis, 20 mg, Film-Coated Tablets

Tadalafil

Read All of This Leaflet Carefully Before Taking This Medicine.

• Keep This Leaflet. You May Need to Read It Again.
• If You Have Any Further Questions, Ask Your Doctor or Pharmacist.
• This Medicine Has Been Prescribed for You. Do Not Pass It on to Others. It May Harm Them, Even if Their Symptoms Are the Same as Yours.
• If You Experience Any of the Following Side Effects, or Any Other Unlisted Side Effects, Tell Your Doctor or Pharmacist. See Section 4.

Table of Contents of the Leaflet

• 1. What Is Erlis and What Is It Used For
• 2. Important Information Before Taking Erlis
• 3. How to Take Erlis
• 4. Possible Side Effects
• 5. How to Store Erlis
• 6. Contents of the Pack and Other Information

1. What Is Erlis and What Is It Used For

Erlis Is a Medication for Adult Men with Erectile Dysfunction. This Is a Condition Where a Man Cannot Achieve or Maintain an Erection Sufficient for Sexual Activity. It Has Been Shown That Erlis Significantly Improves the Ability to Achieve an Erection Sufficient for Sexual Activity.
Erlis Contains the Active Substance Tadalafil, Which Belongs to a Group of Medicines 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 Is Improved. Erlis Does Not Help Patients Who Do Not Have Erectile Dysfunction.
It Is Important to Note That Erlis Does 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 Medication.

2. Important Information Before Taking Erlis

When Not to Take Erlis

• If You Are Allergic to Tadalafil or Any of the Other Ingredients of This Medication (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 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 Had a Loss of Vision Due to Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION), Also Known as "Eye Stroke".
• If You Are Taking Riociguat. This Is a Medication 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). It Has Been Shown That PDE5 Inhibitors, Such as Tadalafil, Enhance the Blood Pressure-Lowering Effect of This Medication. If You Are Taking Riociguat or Are Not Sure, You Should Inform Your Doctor.

Warnings and Precautions

Before Taking Erlis, You Should Discuss This with Your Doctor.
You 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 You Have Heart Problems, You Should Inform Your Doctor.
Before Taking the Medication, You Should Inform Your Doctor If You 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 Pelvic Surgery,
• 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 Vision Loss or Sudden Hearing Loss, or Distorted Vision, You Should Stop Taking This Medication and Seek Medical Attention Immediately.
In Some Patients Taking Tadalafil, a Decrease in Hearing or Sudden Hearing Loss Has Been Observed.
Although It Is Not Known If This Event Is Directly Related to the Use of Tadalafil, If You Experience a Decrease in Hearing or Sudden Hearing Loss, You Should Stop Taking Erlis and Seek Medical Attention Immediately.
Erlis Is Not Intended for Use in Women.

Children and Adolescents

Erlis Is Not Intended for Use in Children and Adolescents Under 18 Years of Age.

Erlis and Other Medications

You Should Tell Your Doctor About All Medications You Are Currently Taking or Have Recently Taken, as Well as Any Medications You Plan to Take.
You Should Not Take Erlis If You Are Taking Nitrates.
Erlis May Affect the Action of Certain Medications or Other Medications May Affect the Action of Erlis. You Should Tell Your Doctor or Pharmacist If You Are Taking:

• Alpha-Adrenergic Receptor Blockers (Used to Treat High Blood Pressure or Symptoms of an Enlarged Prostate),
• Other Medications Used to Treat High Blood Pressure,
• Riociguat,
• 5-Alpha-Reductase Inhibitors (Used to Treat an Enlarged Prostate),
• 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 Treatments for 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 Therefore, Caution Should Be Exercised When Consuming It. For More Information, You Should Consult Your Doctor.

Fertility

When Tadalafil Was 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 That This Would Lead to Infertility.

Driving and Using Machines

In Some Men Taking Erlis During Clinical Trials, Dizziness Was Reported.
Therefore, You Should Be Aware of Your Reaction to the Tablets Before Driving or Operating Machinery.

Erlis Contains Lactose and Sodium

If You Have Been Diagnosed with an Intolerance to Some Sugars, You Should Consult Your Doctor Before Taking This Medication.
The Medication Contains Less Than 1 Mmol (23 Mg) of Sodium per Film-Coated Tablet, Which Means That It Is Considered "Sodium-Free".

3. How to Take Erlis

This Medication Should Always Be Taken Exactly as Prescribed by Your Doctor.
If You Are Uncertain, You Should Consult Your 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.
For Patients Who Do Not Achieve the Desired Effect with a 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 Note That Erlis Does 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 Medication.
Consuming Alcohol May Affect the Patient's Ability to Achieve an Erection and May Cause a Temporary Decrease in Blood Pressure.
If You Have Taken Erlis 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.

What to Do If You Take More Erlis Than You Should

You Should Inform Your Doctor.
Side Effects May Occur, as Described in Section 4.

What to Do If You Miss a Dose of Erlis

You Should Take the Missed Dose as Soon as You Remember, but Do Not Take a Double Dose to Make Up for the Missed Tablet.
You Should Not Take Erlis More Than Once a Day.
If You Have Any Further Questions on the Use of This Medication, You Should Consult Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medicines, This Medication Can Cause Side Effects, Although Not Everybody Gets Them.
These Effects Are Usually Mild or Moderate.

If You Experience Any of the Following Side Effects, Stop Taking the Medication and Seek Medical Attention Immediately:

• Allergic Reactions, Including Rashes (Not Very Common).
• Chest Pain - Do Not Take Nitrates, Seek Medical Attention Immediately (Not Very Common).
• Priapism - Prolonged and Possibly Painful Erection After Taking Erlis (Rare).
  If Such an Erection Occurs and Lasts Continuously for More Than 4 Hours, You Should Seek Medical Attention Immediately.
• Sudden Vision Loss (Rare), Distorted, Blurred, or Impaired Central Vision or Sudden Decrease in Vision (Frequency Not Known).

Other Side Effects Have Been Reported:
Common(May Affect Up to 1 in 10 Patients)

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

Uncommon(May Affect Up to 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 Affect Up to 1 in 1,000 Patients)

• Fainting, Seizures, and Transient Memory Loss, Swelling of the Eyelids, Redness of the Eyes, Sudden Decrease or Loss of Hearing, Hives (Itchy, Red Bumps on the Skin), Penile Bleeding, Blood in the Semen, and Increased Sweating.

Heart Attack 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 Decrease in Vision or Loss of Vision in One or Both Eyes.
In Men Taking Tadalafil, 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, Disorders Characterized by Blood Flow to the Eyes, Irregular Heartbeat, Angina Pectoris, and Sudden Cardiac Death.

• Distorted, Blurred, or Impaired Central Vision or Sudden Decrease in Vision (Frequency Not Known).

Dizziness Was Reported More Frequently in Men Over 75 Years of Age Taking Tadalafil.
Diarrhea Was Reported More Frequently in Men Over 65 Years of Age Taking Tadalafil.

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Listed in This Leaflet, You Should Inform Your Doctor or Pharmacist.
Side Effects Can Be Reported Directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side Effects Can Also Be Reported to the Marketing Authorization Holder.
Reporting Side Effects Will Help to Gather More Information on the Safety of This Medication.

5. How to Store Erlis

The Medication Should Be Stored Out of Sight and Reach of Children.
Do Not Use This Medication After the Expiration Date Stated on the Carton and Blister.
The Expiration Date Refers to the Last Day of the Month.
The Abbreviation "EXP" on the Packaging Indicates the Expiration Date, and "Lot/LOT" Indicates the Batch Number.
There Are No Special Precautions for Storage of the Medication.
Medicines Should Not Be Disposed of via Wastewater or Household Waste.
You Should Ask Your Pharmacist How to Dispose of Medicines No Longer Required.
This Will Help to Protect the Environment.

6. Contents of the Pack and Other Information

What Erlis Contains

• The Active Substance Is Tadalafil.
  Each Tablet Contains 20 Mg of Tadalafil.
• The Other Ingredients Are: Tablet Core: Lactose Monohydrate (See End of Section 2), Microcrystalline Cellulose, Povidone K-30, Poloxamer 188, Sodium Lauryl Sulfate, Croscarmellose Sodium, Silica Colloidal Anhydrous, Magnesium Stearate.
  Tablet Coating: Polyvinyl Alcohol, Macrogol 3350, Talc, Titanium Dioxide (E 171), Iron Oxide Yellow (E 172), Iron Oxide Red (E 172).

What Erlis Looks Like and Contents of the Pack

Erlis 20 Mg Film-Coated Tablets Are Light Pink, Prolonged, Convex, Film-Coated Tablets with a Score Line on One Side; Approximate Size 15 Mm x 7 Mm.
Erlis 20 Mg Film-Coated Tablets Are Available in Blisters of PVC/PVDC/Aluminum in a Carton, Containing 2, 4, 8, or 12 Film-Coated Tablets.
Not All Pack Sizes May Be Marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

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

Manufacturer/Importer

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