Package leaflet: Information for the patient

Erlis, 10 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 consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of 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 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 obtain an erection adequate for sexual intercourse.
Erlis contains the active substance tadalafil, which belongs to a group of medicines known as phosphodiesterase type 5 inhibitors. Following sexual stimulation, Erlis helps widen the blood vessels of the penis, allowing increased blood flow into the penis. As a result, erection is improved. 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.

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, e.g. 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 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, they should inform their doctor.

Warnings and precautions
Before starting 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 any heart problems, they should inform their doctor.
Before taking the medicine, the patient should inform their doctor if any of the following apply:

sickle cell anemia (abnormal shape of 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:

after pelvic surgery,
after total or partial removal of the prostate gland with nerve cutting (radical prostatectomy without nerve sparing).

If sudden vision deterioration or sudden vision loss occurs during treatment with Erlis, or if vision appears distorted or dimmed, the patient should stop taking this medicine and contact their doctor immediately.
In some patients taking tadalafil, hearing deterioration 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 deterioration or sudden hearing loss occurs, the patient should stop taking Erlis and contact their 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 the patient is 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 the patient is 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 ketoconazole tablets (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, alcohol and grapefruit juice
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. A decrease in 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 their individual response 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 take Erlis

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your 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.
The recommended starting dose is one 10 mg tablet, taken before planned sexual activity. In patients for whom the 10 mg dose does not produce the desired effect, a dose of 20 mg may be used.
Erlis should be taken at least 30 minutes before planned sexual activity. Erlis may remain effective for up to 36 hours after taking the tablet.
The maximum frequency of Erlis administration is once per day. Erlis 10 mg and 20 mg are intended to be taken as needed before planned sexual activity. Regular, daily use of the medicine is not recommended.
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 if the patient were 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 dizziness upon standing.
Taking more than the recommended dose of Erlis
Inform your doctor immediately. Adverse effects described in section 4 may occur.
Missing a dose of Erlis
Take the missed dose as soon as you remember, but do not take a double dose to make up for the missed tablet. Do not take Erlis more often than once per day.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them. 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 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, 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 affect up to 1 in 10 patients)

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

Uncommon (may affect up to 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 affect up to 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), rectal 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.
There have been reports of rare cases of partial, transient or permanent reduction in vision 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 swelling of the face and throat,

severe skin rashes, disorders manifesting as ocular hyperaemia, 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 has been reported more frequently in men aged over 75 years taking tadalafil. Diarrhoea has been reported more frequently in men aged over 65 years taking tadalafil.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
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.
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.
No special storage instructions apply 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 10 mg of tadalafil.
Other ingredients are:
Tablet core: monohydrate lactose (see end of section 2), microcrystalline cellulose, povidone K-30, poloxamer 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 10 mg tablets are light orange, elongated, biconvex coated tablets with a score line on one side; size approximately 11 mm x 6 mm.
Erlis 10 mg coated tablets are available in PVC/PVDC/Aluminium blister packs in cardboard boxes containing 4 coated tablets.

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 Branch in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba