Egill

To ensure safe use of the medicine, please answer all the questions contained
in the "Patient Questionnaire" before using this medicine.
This information is available by scanning the QR code on the packaging with a smartphone
and on the website
https://www.stadapoland.pl/produkty/leki-bez-recepty/tadalafil
(see also section 6 of the patient leaflet).

Package leaflet: Information for the user

EGILL, 10 mg, coated tablets
Tadalafilum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If you have taken Egill as recommended (see section 3) and were still unable to achieve or maintain a suitable erection for satisfactory sexual intercourse, or if you feel worse, speak to your doctor or pharmacist.

Leaflet contents

1. What Egill is and what it is used for
2. Important information before taking Egill
3. How to take Egill
4. Possible side effects
5. How to store Egill
6. Contents of the package and other information

1. What Egill is and what it is used for

Egill contains the active substance tadalafil, which belongs to a group of medicines called
phosphodiesterase type 5 (PDE5) inhibitors. During sexual stimulation, tadalafil helps widen the
blood vessels in the penis, allowing increased blood flow into the penis. This results in improved
erection. Egill does not help patients who do not have erectile dysfunction.
Egill is used to treat adult men with:

• Erectile dysfunction. This is a condition where a man cannot achieve or maintain an erection sufficient for sexual intercourse. Tadalafil has been shown to significantly improve the ability to achieve this.

It is important to understand that Egill will 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.
Egill is not intended for use in women.

2. Important information before taking EGILL

When not to take EGILL:

• 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 nitrates (medicines used to treat chest pain, so-called angina pectoris) or other drugs releasing nitric oxide, such as amyl nitrite. Tadalafil may enhance their blood pressure-lowering effect and cause a sudden, dangerous drop in blood pressure. If the patient is unsure whether they are taking such a medicine, they should consult a pharmacist or doctor (see section "EGILL with other medicines");
• if the doctor has advised the patient to avoid sexual activity;
• 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, or uncontrolled heart rhythm disorders;
• if the patient has ever experienced vision loss due to non-arteritic anterior ischaemic optic neuropathy (NAION), also known as "eye stroke";
• if the patient is taking riociguat. This medicine is used to treat pulmonary arterial 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 treatment with Egill, the patient should complete the "Patient Questionnaire"
supplied with the package. If there are any doubts, the patient should discuss them with a doctor or pharmacist.
It is recommended that the patient visits a doctor within 6 months of starting treatment with Egill
to diagnose potential conditions and risk factors related to erectile dysfunction.
It should be remembered 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 or if the results of the "Patient Questionnaire" suggest possible heart disease and therefore Egill cannot be used, the patient should inform their doctor or pharmacist.
Before taking Egill, the patient should inform their doctor if any of the following apply:

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

It is not known whether Egill is effective in patients:

• after pelvic surgery;
• after total or partial removal of the prostate gland with nerve cutting (nerve-sparing radical prostatectomy).

If sudden vision deterioration or sudden vision loss occurs during treatment with tadalafil, or if vision appears distorted or dimmed, the patient should stop taking Egill immediately and contact a doctor without delay.
Some patients taking tadalafil have experienced hearing deterioration or sudden hearing loss.
Although it is not known whether this event is directly related to tadalafil use, if hearing deterioration or sudden hearing loss occurs, the patient should stop taking Egill and contact a doctor immediately.
Egill should not be used together with other oral or topical medicines used to treat erectile dysfunction.
Egill should not be used together with treatment for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors.
Do not take other medicines for erectile dysfunction or pulmonary hypertension containing sildenafil within 48 hours of taking Egill.
Egill should not be taken if erectile dysfunction has not been diagnosed.

Children and adolescents
Egill is not intended for use in children and adolescents under 18 years of age.

EGILL with other medicines
Before taking Egill, the patient should complete the "Patient Questionnaire" supplied with the package. In case of doubt, the patient should discuss this with a doctor or pharmacist. The patient should inform their doctor about all medicines currently or recently taken, as well as any medicines they plan to take.
Do not take Egill if you are using nitrates (e.g. nitroglycerin, isosorbide, molsidomine). These medicines are used, among others, to treat chest pain (angina pectoris).
Egill may affect the action of certain medicines or other medicines may affect the action of Egill. The patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• 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 (e.g. ritonavir, saquinavir) used in the treatment of AIDS or HIV infection;
• phenobarbital, phenytoin and carbamazepine (anticonvulsants);
• rifampicin, erythromycin, clarithromycin (antibiotics) or itraconazole (antifungal medicine);
• other medicines used to treat erectile dysfunction.

In some patients taking blood pressure-lowering medicines, drops in blood pressure may occur, especially when standing up or sitting down quickly. If the patient experiences symptoms of low blood pressure (dizziness, fainting, feeling faint), the first step should be to lie down or sit and wait until symptoms subside; drinking water, breathing fresh air, tensing abdominal muscles, or crossing legs may also help. The patient should avoid standing up or sitting down quickly.

EGILL, food and alcohol
Information on the effect of alcohol is provided in section 3.
Do not drink grapefruit juice while taking this medicine. Grapefruit juice may increase tadalafil levels in the body and the risk of adverse effects.
For further information, please consult a doctor or pharmacist.

Fertility
Animal studies have shown reduced 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 using machines
In clinical trials, some men taking tadalafil reported dizziness. Therefore, patients should understand how they react to the tablets before deciding to drive or operate machinery.

EGILL contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

EGILL contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take EGILL

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Dosage
The recommended dose is one 10 mg tablet taken prior to sexual activity. If you feel the effect of EGILL is too strong or too weak, consult your doctor or pharmacist. Following consultation, your doctor may recommend a different dosage.

Method of administration
EGILL tablets are intended for oral use in men only. Swallow the tablet whole with a small amount of water. Tablets may be taken with or without food.
The tablet may be divided into equal doses.
EGILL may be taken at least 30 minutes before sexual activity.
EGILL may remain effective for up to 36 hours after taking the tablet.
EGILL is intended for use prior to planned sexual activity.
EGILL should be taken on an as-needed basis. Do not take more than once a week.
Do not take more than one tablet.

Important to remember
It is important to be aware that EGILL 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.

Do not take EGILL together with other oral or topical medicines used to treat erectile dysfunction.

Do not take EGILL together with treatment for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors.

Do not take any medicines containing sildenafil for erectile dysfunction or pulmonary hypertension within 48 hours of taking EGILL.

Do not take EGILL if erectile dysfunction has not been diagnosed.

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 EGILL, he should avoid consuming large amounts of alcohol (e.g. more than 900 mL of beer or 350 mL of wine), as this could increase the risk of dizziness upon standing.

Overdose of EGILL
Inform your doctor immediately. Adverse effects described in section 4 may occur.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
These effects are usually mild or moderate.
If any of the adverse effects listed below occur, stop taking the
medicine and seek medical advice immediately:

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

Other reported adverse effects
Common (may affect more than 1 in 10 people)

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

Uncommon (may affect no more than 1 in 100 people)

• dizziness
• abdominal pain
• nausea
• vomiting
• regurgitation of stomach contents into the oesophagus
• blurred vision
• eye pain
• difficulty breathing
• presence of blood in urine
• prolonged erection
• sensation of heart palpitations
• rapid heartbeat
• high blood pressure
• low blood pressure
• nosebleeds
• ringing in the ears
• swelling of hands, feet or ankles
• feeling of fatigue.

Rare (may affect no more than 1 in 1,000 people)

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

Heart attack and stroke have also been reported rarely in men taking tadalafil. Most of these men
had pre-existing heart conditions before starting treatment with this medicine.
Rarely, cases of partial, transient or permanent vision impairment or vision loss in one or both eyes have been reported.
In men taking tadalafil, several additional rare adverse effects 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
• sudden cardiac death
• distorted, dimmed, blurred central vision, or sudden worsening of vision (frequency not known).

Dizziness has been reported more frequently in men over 75 years of age taking tadalafil.
Diarrhoea has been reported more frequently in men over 65 years of age taking tadalafil.
Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not
listed in this leaflet, inform your doctor or pharmacist. Adverse effects
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 Warsaw
Tel: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
By reporting adverse effects, more information on the safety of this medicine can be collected.

5. How to store the medicine EGILL

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What the medicinal product contains EGILL

• The active substance is tadalafil. One coated tablet contains 10 mg of tadalafil.
• Other ingredients are:
  Tablet core
  Monohydrate lactose
  Sodium croscarmellose
  Sodium lauryl sulphate (E 487)
  Hydroxypropylcellulose
  Polysorbate 80
  Microcrystalline cellulose
  Magnesium stearate

Tablet coating
Hypromellose 2910
Monohydrate lactose
Titanium dioxide (E 171)
Triacetin
Yellow iron oxide (E 172)
Talc

What EGILL looks like and contents of the pack
Yellow, round, biconvex film-coated tablets with a division line on one side, white in cross-section, with a diameter of 8.1 ± 0.2 mm. The tablets can be divided into equal doses.
The medicine is available in blisters containing 2x1, 4x1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
611118 Bad Vilbel
Germany

Manufacturer/Importer:
STADA Arzneimittel AG
Stadastrasse 2-18
611118 Bad Vilbel
Germany
STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria
Clonmel Healthcare Ltd.
Waterford Road,
E91 D768 Clonmel Co. Tipperary
Ireland

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
STADA Poland Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Bulgaria Tadalafil STADA 10 mg film-coated tablets
Poland EGILL

The currently approved version of the diagnostic tool ("Patient Questionnaire") for this medicinal product is available by scanning the QR code located on the outer packaging and on the website https://www.stadapoland.pl/produkty/leki-bez-recepty/tadalafil.