Erlis

Package Leaflet: Information for the Patient

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

• erectile dysfunction.This is when a man cannot get or keep a hard erection that is sufficient for satisfactory sexual activity. It has been shown that Erlis significantly improves the ability to get a hard erection sufficient for satisfactory sexual activity. After sexual stimulation, Erlis helps to relax 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.
• with symptoms of benign prostatic hyperplasia (a non-cancerous enlargement of the prostate gland).
  This is when the prostate gland enlarges with age. Symptoms include: difficulty starting to urinate, feeling like the bladder is not completely empty, and needing to urinate more often, even at night. Erlis improves blood flow and causes relaxation of the prostate and bladder muscles, which can alleviate symptoms of benign prostatic hyperplasia. It has been shown that tadalafil alleviates these urinary symptoms after 1-2 weeks of treatment.

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").

Nitrates have been shown to potentiate the hypotensive effects of tadalafil.
If you are taking nitrates in any form, or are unsure, tell 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 loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), also known as "stroke of the eye".
• 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, potentiate the blood pressure-lowering effect of this medicine. If you are taking riociguat, or are unsure, tell your doctor.

Warnings and precautions

Before taking Erlis, discuss it with your doctor.
Remember that sexual activity carries a risk for patients with heart disease, as it puts an extra strain on the heart. If you have heart problems, tell your doctor.
Benign prostatic hyperplasia and prostate cancer can have the same symptoms, so your doctor will perform a check for prostate cancer before starting treatment with Erlis for benign prostatic hyperplasia symptoms.
Erlis is not used to treat prostate cancer.
Before taking the medicine, tell your doctor if you have:

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

It is not known if Erlis is effective in patients who have:

• had pelvic surgery.
• had their prostate removed (prostatectomy), during which the nerves surrounding the prostate are cut (radical prostatectomy without nerve-sparing).

If you experience sudden loss of vision or sudden hearing loss, or if your vision is blurred, distorted, or discoloured, stop taking Erlis 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 if this event is directly related to tadalafil, if you experience a decrease in hearing or sudden hearing loss, stop taking Erlis and contact your doctor immediately.
Erlis is not intended for use by women.

Children and adolescents

Erlis is not intended for use by children and adolescents under 18 years of age.

Erlis and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Do not take Erlis if you are taking nitrates.
Erlis may affect the way some medicines work, or some medicines may affect the way Erlis works. Tell your doctor or pharmacist if you are taking:

• alpha-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 (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anti-epileptic medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Erlis with food and drink

Information on the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Erlis, so caution should be exercised when drinking it. For more information, 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

Some men taking tadalafil during clinical trials reported dizziness, so you should be aware of how you react to the tablets before driving or operating machinery.

Erlis contains lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is essentially "sodium-free".

3. How to take Erlis

This medicine should always be taken exactly as your doctor has instructed you. If you are unsure, ask your doctor or pharmacist.
Erlis tablets are 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.
Drinking alcohol may cause a temporary drop in blood pressure. If you have taken Erlis or plan to take it, you should avoid drinking large amounts of alcohol (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.

Treatment of erectile dysfunction

Recommended doseis one 5 mg tablet per day, taken at approximately the same time every day. Your doctor may adjust the dose to 2.5 mg, depending on your response to Erlis. You should take one 2.5 mg tablet.
Do not take Erlis more than once a day.
Taking Erlis once a day allows you to get an erection after sexual stimulation at any time during the 24-hour period. Taking Erlis once a day may be beneficial for men who plan to have sexual activity twice a week or more often.
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.
Drinking alcohol may affect your ability to get an erection.

Treatment of benign prostatic hyperplasia symptoms

Doseis one 5 mg tablet per day, taken at approximately the same time every day.
If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet per day.
Do not take Erlis more than once a day.

Overdose of Erlis

Inform your doctor. Side effects (see section 4) may occur.

Missed dose of Erlis

Take the dose as soon as you remember, but do not take a double dose to make up for a forgotten tablet. Do not take Erlis more than once a day.
If you have any further questions on the use of this medicine, ask 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 Erlis and contact your doctor immediately:

• allergic reactions, including skin rash (uncommon).
• chest pain - do not take nitrates, seek medical help immediately (uncommon).
• priapism - prolonged and possibly painful erections after taking Erlis (rare). If you experience such an erection, seek medical help immediately.
• sudden loss of vision (rare), blurred vision, changes in colour vision, or sudden loss of 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, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erections, palpitations, 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, eyelid swelling, eye redness, sudden loss of hearing, hives (itchy, red bumps on the skin), penile bleeding, blood in semen, 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 loss of vision or blindness in one or both eyes.
Men taking tadalafil have reported several additional rare side effects, 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.
• blurred vision, changes in colour vision, or sudden loss of vision (frequency not known).

Dizziness was reported more frequently in men over 75 years old taking tadalafil. Diarrhoea was reported more frequently in men over 65 years old taking tadalafil.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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. 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.
There are no special storage instructions 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 that month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. 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 is tadalafil. Each tablet contains 5 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, 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 film-coated tablets are light brown, elongated, biconvex tablets; approximately 8 mm x 4 mm in size.
Erlis 5 mg film-coated tablets are available in PVC/PVDC/Aluminium blisters in a carton, containing 14, 28, or 84 film-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 Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba
Date of last revision of the leaflet:January 2024