Gerocilan

Leaflet included in the packaging: patient information

Gerocilan, 2.5 mg, film-coated tablets

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

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to you for a specific condition. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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 packaging and other information

1. What is Gerocilan and what is it used for

Gerocilan is a medicine 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 of 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 essential to be aware that Gerocilan does not work without sexual stimulation.
The patient and their partner should engage in foreplay, just like when the patient is not taking erectile dysfunction medication.

2. Important information before taking Gerocilan

When not to take Gerocilan:

• 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 donors of nitric oxide, 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 effect 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 in the last 90 days.
• if the patient has had a stroke in the last 6 months.
• if the patient has low blood pressure or uncontrolled high blood pressure.
• if the patient has ever had a loss of vision 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 treatment with Gerocilan, the patient should discuss it with their doctor.
The patient should remember that sexual activity is associated with a risk for patients with heart disease, as it puts an additional strain on the heart. If the patient experiences heart problems, they should inform their doctor.
The patient should inform their doctor before taking the medicine if they have any of the following conditions:

• sickle-cell anemia (abnormal shape of red blood cells).
• multiple myeloma (bone marrow cancer).
• leukemia (blood cell cancer).
• any penile deformity.
• severe liver disease.
• severe kidney disease.

It is not known if Gerocilan is effective in patients:

• who have had pelvic surgery.
• who have had their prostate removed (radical prostatectomy without nerve sparing).

If the patient experiences sudden vision loss or sudden vision disturbance while taking Gerocilan, they should stop taking the medicine and contact their doctor immediately.
Some patients taking tadalafil have reported a decrease in or loss of hearing. Although it is not known if this event is related to the use of tadalafil, if the patient experiences a decrease in or loss of hearing, they should stop taking Gerocilan and contact their doctor immediately.
Gerocilan is not intended for use in women.

Children and adolescents

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

Gerocilan and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should not take Gerocilan if they are taking nitrates.
Gerocilan may affect the action of some medicines or other medicines may affect the action of Gerocilan. The patient should tell their doctor or pharmacist if they are taking any of the following medicines:

• alpha-adrenergic receptor 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 methods of treating 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 patients should exercise caution when consuming it. For more information, patients should consult their doctor.

Fertility

When tadalafil was administered to dogs, it caused a decrease in sperm production in the testes. 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 patients should be aware of their reaction to the tablets before driving or operating machinery.

Gerocilan contains lactose:

If the patient has been diagnosed with an intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Gerocilan

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult their 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 dose is one 5 mg tablet, taken once a day, at approximately the same time each day. The doctor may change the dose to 2.5 mg, depending on the patient's response to Gerocilan.
The patient should take a 2.5 mg tablet in that case. The patient should not take Gerocilan more than once a day.
Taking Gerocilan once a day may be beneficial for men who intend to have sexual activity twice a week or more often.
Taking Gerocilan once a day allows the patient to achieve an erection after sexual stimulation at any time during the 24-hour period.
It is essential to be aware that Gerocilan does not work without sexual stimulation.
The patient and their partner should engage in foreplay, just like when the patient is not taking erectile dysfunction medication.
Consuming alcohol may affect the patient's ability to achieve an erection and may cause a temporary decrease in blood pressure. If the patient has taken Gerocilan or plans to take it, they should not consume large amounts of alcohol (blood alcohol concentration of 0.08% or higher), as this may increase the risk of dizziness when standing up.

Using a higher dose of Gerocilan than recommended

The patient should inform their doctor. Side effects may occur, as described in section 4.

Missing a dose of Gerocilan

The patient should take the missed dose as soon as they remember, but they should not take a double dose to make up for the missed tablet. The patient should not take Gerocilan more than once a day.
If the patient has any further doubts about taking the medicine, they should consult their 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 the patient experiences any of the following side effects, they should stop taking the medicine and contact their doctor immediately:

• allergic reactions, including rash (not very common).
• chest pain - the patient should not take nitrates, but they should seek medical help immediately (not very common).
• priapism, prolonged and possibly painful erections after taking Gerocilan (rare). If the patient experiences an erection that lasts for more than 4 hours, they should contact their doctor immediately.
• sudden vision loss (rare), distorted vision, blurred vision, or sudden vision disturbance (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, 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 hands, feet, or ankles, and fatigue.

Rare(occurring in less than 1 in 1000 patients)

• fainting, seizures, and transient memory loss, eyelid swelling, eye redness, sudden hearing loss, hives (itchy, red swellings on the skin), bleeding from the nose, 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 starting treatment with this medicine.
There have been reports of rare cases of partial, transient, or permanent decrease in or loss of vision 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, disorders characterized by blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac deaths.
• distorted vision, blurred vision, or sudden vision disturbance (frequency not known).

Dizziness has been reported more frequently in men over 75 years of age taking tadalafil. Diarrhea has been reported more frequently in men over 65 years of age taking tadalafil.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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 authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Gerocilan

The medicine should be stored out of sight and reach of children.
The medicine should not be used 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 storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help to protect the environment.

6. Contents of the packaging and other information

What Gerocilan 2.5 mg contains

• The active substance of the medicine is tadalafil. Each tablet contains 2.5 mg of tadalafil.
• Excipients:

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)
Red iron oxide (E 172)

What Gerocilan 2.5 mg looks like and contents of the pack

Yellow-orange, biconvex, film-coated tablet in the shape of an oval, with the inscription "T 2" on one side and smooth on the other.
PVC/PVDC/Aluminum blisters in a cardboard box. The pack contains 1, 2, 4, 8, 10, 12, 14, 20, 28, 30, 40, 50, 56, 60, 84, 90, 98, or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization 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, the patient should contact the representative of the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o.
Jana Pawła II Avenue 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