Erlis

Package Leaflet: Information for the User

Erlis, 2.5 mg, Film-Coated Tablets

Tadalafil

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 2.5 mg is a medicine for adult men with erectile dysfunction. This is a condition where a man cannot achieve or maintain an erection sufficient for satisfactory sexual performance. It has been shown that Erlis significantly improves the ability to achieve an erection sufficient for satisfactory sexual performance.
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 improves. 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 medicine (listed in section 6).
• if you are taking organic nitrates 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 enhances the effects of these medicines. If you are taking nitrates in any form, or are unsure, 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 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, enhance the blood pressure-lowering effect of this medicine. If you are taking riociguat, or are unsure, you should inform your doctor.

Warnings and precautions

Before taking Erlis, you should discuss it with your doctor.
It should be remembered 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 medicine, the patient should inform the doctor if he has:

• sickle-cell anaemia (abnormal shape of red blood cells).
• multiple myeloma (bone marrow cancer).
• leukaemia (blood cell cancer).
• any deformation of the penis.
• severe liver disease.
• severe kidney disease.

It is not known whether 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 sudden vision loss or sudden vision disturbance occurs during treatment with Erlis, or if the image is distorted, blurred, you should stop taking the medicine and contact your doctor immediately.
In some patients taking tadalafil, a decrease in hearing or sudden hearing loss has been observed.
Although it is not known whether this event is directly related to the use of tadalafil, if a decrease in hearing or sudden hearing loss occurs, you should stop taking Erlis and contact your doctor 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 medicines

You should tell your doctor about all medicines you are currently taking, or have recently taken, and about any medicines you plan to take.
You should not take Erlis if you are taking nitrates.
Erlis may affect the action of some medicines, or other medicines 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 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.

Erlis with food and alcohol

Information on the effect of alcohol is given 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 to lead to infertility.

Driving and using machines

In some men taking tadalafil during clinical trials, dizziness was reported, so 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 the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means that it is essentially "sodium-free".

3. How to take Erlis

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
The tablets of Erlis 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.
Recommended doseis one 5 mg tablet per day, taken at approximately the same time every day. Your doctor may change the dose to 2.5 mg depending on your response to Erlis. You should then take a 2.5 mg tablet.
You should not take Erlis more than once a day.
Taking Erlis once a day may be beneficial for men who intend to have sexual intercourse twice a week or more frequently.
Taking Erlis once a day allows for the achievement of an erection after sexual stimulation at any time during the 24-hour period.
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 your 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.

Take a higher dose of Erlis than recommended

You should inform your doctor. Adverse reactions described in section 4 may occur.

Miss a dose of Erlis

Take a dose as soon as you remember, but do not take a double dose to make up for a forgotten tablet. You should not take Erlis more than once a day.
If you have any further questions about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 medicine and contact your doctor immediately:

• allergic reactions, including rash (not very common).
• chest pain - do not take nitrates, seek medical help 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 contact your doctor immediately.
• sudden vision loss (rare), distorted, blurred, or decreased vision (frequency not known).

Other side effects have been reported:
Common(may affect up to 1 in 10 people)

• headache, back pain, muscle pain, pain in arms and legs, flushing, nasal congestion, 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 hearing loss, hives (itchy, red bumps on the skin), bleeding from the penis, blood in semen, and increased sweating.

Myocardial infarction and stroke have been rarely reported in men taking tadalafil. Most of them had heart problems before taking tadalafil.
There have been reports of rare cases of partial, transient, or permanent vision loss or blindness 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, eye disorders, irregular heartbeat, angina pectoris, and sudden cardiac death.
• distorted, blurred, or decreased vision (frequency not known).

Dizziness was reported more frequently in men over 75 years of age taking tadalafil. Diarrhoea 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
Aleje Jerozolimskie 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 authorisation holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Erlis

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of that month.
The packaging is marked with the expiry date and batch number after the EXP and Lot/LOT abbreviations, respectively.
There are no special precautions for storage.
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 protect the environment.

6. Contents of the pack and other information

What Erlis contains

• The active substance of Erlis is tadalafil. Each tablet contains 2.5 mg of tadalafil.
• The other ingredients are: Tablet core: lactose monohydrate (see the end of section 2), microcrystalline cellulose, povidone K-30, poloxamer 188, sodium lauryl sulfate, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate. Tablet coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171).

What Erlis looks like and contents of the pack

Erlis 2.5 mg film-coated tablets are white or almost white, round, biconvex, film-coated tablets, with a diameter of 4.9-5.3 mm.
Erlis 2.5 mg film-coated tablets are available in PVC/PVDC/Aluminium blister packs in a cardboard box, containing 28 film-coated tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation 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