Package leaflet: Information for the user

Erlis, 2.5 mg, coated tablets
Tadalafilum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific patient only. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Contents of the leaflet

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 2.5 mg is a medicine intended for adult men with erectile dysfunction. This is a condition
in which a man is unable to achieve or maintain an erection sufficient for sexual intercourse.
Erlis has been shown to significantly improve the ability to achieve an erection sufficient
for sexual intercourse.
Erlis contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation, Erlis helps widen the blood vessels of the penis, allowing increased blood flow into the penis. This results in improved erection. Erlis does not benefit patients who do not have erectile dysfunction.
It is important to understand 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 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 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, 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 medicine is 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). PDE5 inhibitors such as tadalafil have been shown to enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, they should inform their doctor.

Warnings and precautions
Before starting to take Erlis, discuss this with your doctor.
Please remember that sexual activity involves some risk for patients with heart disease, as it places additional strain on the heart. If the patient has heart problems, they should inform their doctor.
Before taking the medicine, the patient should inform the doctor if any of the following conditions are present:

sickle cell anemia (abnormally shaped red blood cells).
multiple myeloma (a bone marrow cancer).
leukemia (a blood cell cancer).
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 complete or partial removal of the prostate gland with cutting of the nerves supplying the prostate (non-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 loss or sudden hearing deterioration 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 they plan to take.
Do not take Erlis if you are taking 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 caused by 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 (anticonvulsant medicines).
rifampicin, erythromycin, clarithromycin, or itraconazole.
other treatments for erectile dysfunction.

Erlis, drinking, and alcohol
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Erlis, and therefore caution should be exercised when consuming it. For further information, consult your doctor.
Fertility
When the medicine was administered to dogs, a reduction in sperm production in the testes was observed. 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 consult 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 use Erlis

This medicine should always be taken exactly as directed by the doctor. If in doubt, consult
the 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 food or independently of meals.
The recommended dose is one 5 mg tablet once daily, taken 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 may be beneficial for men who plan to engage in sexual activity two or
more times per week.
Taking Erlis once daily allows the achievement of an erection following sexual stimulation
at any time within a 24-hour period.
It is important to be aware that Erlis does not work in the absence of sexual stimulation.
The patient and his partner should engage in foreplay, just as they would when the patient is
not taking erectile dysfunction medication.
Alcohol consumption may affect the patient's ability to achieve an erection and may cause
transient lowering of blood pressure. If the patient has taken or plans to take Erlis, he should
not consume large amounts of alcohol (blood alcohol concentration of 0.08% or higher), as this
may increase the risk of experiencing dizziness upon standing.
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 questions regarding the use of this medicine, consult the 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 seek immediate
medical advice:

allergic reactions, including rash (uncommon).
chest pain – do not use 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, seek immediate medical advice.
sudden loss of vision (rare), distorted, dimmed, blurred central vision, or sudden worsening of vision (frequency not known).

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, breathing difficulties, presence of blood in urine, prolonged duration of 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, eye redness, sudden worsening or loss of hearing, urticaria (itchy, red skin swellings), penile bleeding, presence of blood in semen, and 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 that were not observed during clinical trials. These include:

migraine, facial swelling, severe allergic reactions causing facial and throat swelling, severe skin rashes, disorders manifesting as blood congestion in the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
distorted, dimmed, blurred central vision or sudden worsening of vision (frequency not known).

The adverse reaction dizziness was reported more frequently in men aged over 75 years taking tadalafil. Diarrhoea was reported more frequently in men aged over 65 years taking tadalafil.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions of Medicinal Products at the 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 to provide more information on the safety of the 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 pack.
The expiry date refers to the last day of the stated month.
The marking on the packaging following "EXP" indicates the expiry date, and following "Lot" or "LOT" indicates the batch number.
There are no special storage instructions for this medicine.
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 2.5 mg of tadalafil.
The other ingredients 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).

What Erlis looks like and contents of the pack
Erlis 2.5 mg tablets are white or almost white, round, biconvex coated tablets,
with a diameter of 4.9–5.3 mm.
Erlis 2.5 mg coated tablets are available in PVC/PVDC/Aluminium blister packs
in a cardboard box containing 28 coated tablets.

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

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