Patient Information Leaflet

Erlis 5 mg, coated tablets
Tadalafilum
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

What Erlis is and what it is used for
Important information before taking Erlis
How to take Erlis
Possible side effects
How to store Erlis
Contents of the pack and other information

1. What Erlis is and what it is used for

Erlis contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Erlis 5 mg is used in the treatment of adult men:

with erectile dysfunction. This is a condition in which a man cannot achieve or maintain an erection sufficient for sexual intercourse. Erlis has been shown to significantly improve the ability to achieve an erection suitable for sexual intercourse. Following sexual stimulation, Erlis helps widen the blood vessels in the penis, allowing blood to flow into it. As a result, erectile function improves. Erlis does not benefit patients who do not have erectile dysfunction. It is important to understand that Erlis does not work in the absence of sexual stimulation. The patient and his partner should engage in foreplay, just as they would if the patient were not taking medication for erectile dysfunction.
with urinary symptoms caused by a common condition called benign prostatic hyperplasia. This is a condition in which the prostate gland enlarges with age. Symptoms include: difficulty starting urination, sensation of incomplete bladder emptying, and increased frequency of urination, even at night. Erlis improves blood flow and causes relaxation of the muscles in the prostate and bladder, which may relieve symptoms of benign prostatic hyperplasia. It has been shown that tadalafil alleviates these urinary symptoms within 1–2 weeks after starting treatment.

2. Important information before using Erlis

When not to use Erlis

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 (chest pain). It has been shown that tadalafil enhances the effects of these medicines.
If the patient is taking nitrates in any form or is unsure about it, 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 experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), referred to 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 PDE5 inhibitors, such as tadalafil, enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure about it, they should inform their doctor.

Warnings and precautions
Before starting treatment with Erlis, discuss this with your doctor.
Please remember that sexual activity involves some risk in patients with heart disease, as it places additional strain on the heart. If the patient has heart problems, they should inform their doctor.
Benign prostatic hyperplasia and prostate cancer may have similar symptoms; therefore, the doctor will perform an examination to rule out prostate cancer before starting treatment with Erlis for symptoms of benign prostatic hyperplasia.
Erlis is not used to treat prostate cancer.
Before taking the medicine, the patient should inform the doctor if any of the following apply:

sickle cell anemia (abnormal shape of red blood cells).
multiple myeloma (a cancer of the bone marrow).
leukemia (a cancer of blood cells).
any deformity of the penis.
severe liver disease.
severe kidney disease.

It is not known whether Erlis is effective in patients:

who have undergone pelvic surgery.
who have undergone total or partial removal of the prostate gland with cutting of the nerves supplying the prostate (nerve-sparing radical prostatectomy).

If during treatment with Erlis there is sudden worsening of vision or sudden vision loss, or if vision becomes distorted, blurred, or dimmed, the patient should stop taking this medicine and contact a doctor immediately.
In some patients taking tadalafil, worsening or sudden hearing loss has been observed.
Although it is not known whether this event is directly related to the use of tadalafil, if hearing worsens or sudden hearing loss occurs, the patient should stop taking Erlis and contact a 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
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not take Erlis if you are using nitrates.
Erlis may affect the action of certain medicines, or other medicines may affect the action of Erlis. Tell your doctor or pharmacist if you are taking:

alpha-blockers (used to treat high blood pressure or urinary symptoms due to 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 oral ketoconazole (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, alcohol, and grapefruit juice
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Erlis, so caution should be exercised when consuming it. For further information, consult your doctor.
Fertility
When administered to dogs, the medicine caused a reduction in sperm production in the testes.
Reduced sperm concentration has been observed in some men. It is unlikely that this would lead to infertility.
Driving and operating machinery
In some men taking tadalafil during clinical trials, dizziness was reported; therefore, patients should understand how they react to the tablets before deciding to drive or operate machinery.
Erlis contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Erlis

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt,
consult a doctor or pharmacist.
Erlis tablets are intended for oral use in men only. The tablets should be swallowed whole,
with a small amount of water. Erlis tablets may be taken with or without food.
Alcohol consumption may cause a temporary decrease in blood pressure. If a patient has taken
Erlis or plans to take it, large amounts of alcohol should be avoided (blood alcohol concentration
of 0.08% or higher), as this may increase the risk of dizziness upon standing.
Treatment of erectile dysfunction
Recommended dose: one 5 mg tablet taken once daily at approximately the same time each day.
The doctor may adjust the dose to 2.5 mg depending on the patient's response to Erlis. In such case,
the 2.5 mg tablet should be used.
Erlis should not be taken more than once a day.
Taking Erlis once daily allows achieving an erection following sexual stimulation at any time
within 24 hours. Daily use of Erlis may be beneficial for men who plan to engage in sexual activity
twice a week or more frequently.
It is important to understand that Erlis does not work in the absence of sexual stimulation.
The patient and his partner should engage in foreplay, just as they would if the patient were not
taking medication for erectile dysfunction.
Alcohol consumption may affect the patient's ability to achieve an erection.
Treatment of symptoms of benign prostatic hyperplasia
Dose: one 5 mg tablet taken once daily at approximately the same time each day.
If a patient has benign prostatic hyperplasia as well as erectile dysfunction, the dose remains
unchanged at one 5 mg tablet once daily.
Erlis must not be taken more than once a day.
Use of a higher than recommended dose of Erlis
Inform the doctor immediately. Adverse effects described in section 4 may occur.
Missed dose of Erlis
Take the missed 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.
If there are any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone. These reactions are usually mild or moderate.
If any of the adverse reactions listed below occur, stop taking the medicine and contact a doctor immediately:

allergic reactions, including rash (uncommon).
chest pain – do not take nitrates; seek immediate medical help (uncommon).
priapism – prolonged and possibly painful erection after taking Erlis (rare). If such an erection occurs and lasts continuously for more than 4 hours, contact a doctor immediately.
sudden loss of vision (rare), distorted, blurred, or dim central vision, or sudden worsening of vision (frequency unknown).

Other adverse reactions reported:
Common (may occur in less than 1 in 10 patients)

headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion, indigestion.

Uncommon (may occur in less than 1 in 100 patients)

dizziness, abdominal pain, nausea, vomiting, regurgitation of stomach contents into the oesophagus (reflux), blurred vision, eye pain, difficulty breathing, presence of blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling tired.

Rare (may occur in less than 1 in 1000 patients)

fainting, seizures and transient memory loss, eyelid swelling, redness of the eyes, sudden worsening or loss of hearing, urticaria (itchy, red skin swellings), rectal bleeding, presence of blood in semen, increased sweating.

Myocardial infarction and stroke have been rarely reported in men taking tadalafil. Most of these men had pre-existing heart conditions before starting tadalafil treatment.
There have been reports of rare cases of partial, transient or permanent visual impairment or vision loss in one or both eyes.
In men taking tadalafil, several additional rare adverse reactions have been reported, which were not observed during clinical trials. These include:

migraine, facial swelling, severe allergic reactions causing swelling of the face and throat, severe skin rashes, disorders manifesting as blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
distorted, blurred, or dim central vision, or sudden worsening of vision (frequency unknown).

The adverse reaction 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 of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Erlis

Keep this medicine out of sight and reach of children.
No special storage conditions apply for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the stated month.
The label on the packaging shows the expiry date after the abbreviation EXP and the batch number after the abbreviation Lot/LOT.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Erlis contains

The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
Other components are:
Tablet core: monohydrate lactose (see end of section 2), microcrystalline cellulose, povidone K-30, poloxamer type 188, sodium lauryl sulfate, sodium croscarmellose, 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 contents of the pack
Erlis 5 mg tablets are light brown, elongated, biconvex coated tablets; size approximately 8 mm x 4 mm.
Erlis 5 mg coated tablets are available in PVC/PVDC/Aluminum foil blisters packed in cardboard boxes containing 14, 28 or 84 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer/Importer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
Pharmacare Premium Ltd,
HHF003 Hal Far Industrial Estate,
BBG3000, Birzebbugia, Malta
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Site in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba