Gerocilan

Package Leaflet: Information for the Patient

Gerocilan, 20 mg, Film-Coated Tablets

Tadalafil
You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, you should ask your doctor, pharmacist, or nurse.
• 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, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Gerocilan and what is it used for

Gerocilan is a medicine used for adult men with erectile dysfunction. This is a condition where a man cannot achieve or maintain an erection sufficient for sexual intercourse. It has been shown that tadalafil significantly improves the ability to achieve an erection sufficient for sexual intercourse.
Gerocilan contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, Gerocilan helps to widen the blood vessels in the penis, allowing blood to flow into the penis. As a result, the erection improves. Gerocilan does not help patients who do not have erectile dysfunction.
It is important to note that Gerocilan 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.

2. Important information before taking Gerocilan

When not to take Gerocilan:

• 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"). It has been shown that tadalafil enhances the effects of these medicines. If you are taking nitrates in any form or are unsure, you should inform 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 "eye stroke".
• 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, enhance the blood pressure-lowering effect of this medicine. If you are taking riociguat or are unsure, you should inform your doctor.

Warnings and precautions

Before taking Gerocilan, you should discuss it with your doctor.
You should remember that sexual activity carries a risk for patients with heart disease, as it puts an extra strain on the heart. If you experience heart problems, you should inform your doctor.
Before taking the medicine, the patient should inform the doctor if any of the following conditions occur:

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

It is not known whether Gerocilan is effective in patients who have:

• undergone pelvic surgery.
• had their prostate removed (radical prostatectomy without nerve-sparing).

If you experience sudden worsening of vision or sudden loss of vision, or distorted vision, you should stop taking Gerocilan and contact your doctor immediately.
Some patients taking tadalafil have reported a worsening or sudden loss of hearing. Although it is not known whether this event is related to tadalafil, if you experience a worsening or sudden loss of hearing, you should stop taking Gerocilan and contact your doctor immediately.
Gerocilan is not intended for use by women.

Children and adolescents

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

Gerocilan and other medicines

You should tell your doctor about all medicines you are currently taking or plan to take.
You should not take Gerocilan if you are taking nitrates.
Gerocilan may affect the way some medicines work, or some medicines may affect the way Gerocilan works.
You should tell your doctor or pharmacist if you are taking any of the following medicines:

• alpha-blockers (used to treat high blood pressure or symptoms of an enlarged prostate).
• other medicines used to treat high blood pressure.
• riociguat.
• 5-alpha-reductase inhibitors (used to treat an enlarged prostate).
• medicines such as ketoconazole in tablets (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.

Gerocilan with food and alcohol

Information about the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Gerocilan, and caution should be exercised when consuming it.
To get more information, you should ask 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 your reaction to the tablets before driving or operating machinery.

Gerocilan contains lactose:

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Gerocilan

This medicine should always be taken exactly as prescribed by your doctor.
If you are unsure, you should ask your doctor or pharmacist.
Gerocilan 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.
The recommended starting dose is one 10 mg tablet, taken before planned sexual activity.
If your doctor finds that the 10 mg dose is too weak, you should take one 20 mg tablet according to your doctor's instructions.
Gerocilan can be taken at least 30 minutes before planned sexual activity.
Gerocilan may still be effective up to 36 hours after taking the tablet.
You should not take Gerocilan more than once a day.
Gerocilan 10 mg and 20 mg is intended for use before planned sexual activity.
It is not recommended to take the medicine continuously, on a daily basis.
It is important to note that Gerocilan 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.
Consuming large amounts of alcohol may affect your ability to achieve an erection and may temporarily lower your blood pressure.
If you have taken Gerocilan or plan to take it, you should not consume large amounts of alcohol (blood alcohol level 0.08% or higher), as this may increase the risk of dizziness when standing up.

Use of a higher than recommended dose of Gerocilan

You should inform your doctor.
Side effects may occur, as described in section 4.
If you have any further questions about the use of this medicine, you should 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, you should stop taking the medicine and contact your doctor immediately:

• allergic reactions, including rash (not very common).
• chest pain - you should not take nitrates, but you should seek medical help immediately (not very common).
• priapism, prolonged and possibly painful erections after taking Gerocilan (rare). If you experience such an erection, and it lasts continuously for more than 4 hours, you should seek medical help immediately.
• sudden loss of vision (rare), distorted vision, or sudden worsening of vision (frequency not known).

Other reported side effects:

Common(occurring in less than 1 in 10 patients)

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

Uncommon(occurring in less than 1 in 100 patients)

• dizziness, stomach pain, nausea, vomiting, acid reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erections, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of the face, feet, or ankles, and feeling tired.

Rare(occurring in less than 1 in 1,000 patients)

• fainting, seizures, and transient memory loss, swelling of the eyelids, redness of the eyes, sudden worsening or loss of hearing, hives (itchy, red bumps on the skin), bleeding from the penis, blood in semen, and increased sweating.

Heart attack and stroke have been rarely reported in men taking tadalafil.
Most of them had heart problems before taking this medicine.
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 that 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 deaths.
• distorted vision, or sudden worsening of vision (frequency not known).

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 side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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 Gerocilan

The medicine should be stored 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 month stated.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste.
You should ask your pharmacist how to dispose of medicines that are no longer required.
This will help protect the environment.

6. Contents of the pack and other information

What Gerocilan 20 mg contains

• The active substance is tadalafil.
  Each tablet contains 20 mg of tadalafil.
• excipients:

tablet core:
lactose
croscarmellose sodium
sodium lauryl sulfate
hydroxypropyl cellulose
polysorbate 80
magnesium stearate
coating:
hypromellose 2910
lactose monohydrate
titanium dioxide (E 171)
triacetin
talc
yellow iron oxide (E 172)

What Gerocilan 20 mg looks like and contents of the pack

Yellow, biconvex, film-coated tablet in the shape of an almond, with the inscription "T 20" on one side and smooth on the other.
PVC/PVDC/Aluminium blister packs in a cardboard box.
The pack contains 1, 2, 4, 8, 10, 12, 14, 20, 28, 30, 40, 50, 56, or 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria
Genepharm S.A.
Marathonos Avenue 18 Th Km.
15351 Pallini, Attiki
Greece
Combino Pharm (Malta) Ltd.
HF 60, Hal Far Industrial Estate
BBG 3000 Birzebbuga
Malta
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Estate
PLA 3000 Paola
Malta

For more information, you should contact the representative of the marketing authorisation holder:

G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
biuro@gl-pharma.pl

Date of last revision of the leaflet: 06.12.2023