Gerocilan

Leaflet included in the packaging: patient information

Gerocilan, 10 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.
• If you have 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 undesirable effects, including any undesirable effects not mentioned 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 undesirable 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 intended 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 important to be aware that Gerocilan does not work without sexual stimulation.
The patient and their 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 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, 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 phosphodiesterase type 5 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 be aware 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 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 whether Gerocilan is effective in patients:

• who have had pelvic surgery.
• who have had a prostatectomy, in which the nerves of the prostate are cut (radical prostatectomy without nerve sparing).

If the patient experiences sudden vision loss or sudden loss of vision, or distorted vision, they should stop taking Gerocilan and seek medical attention immediately.
Some patients taking tadalafil have reported a decrease in hearing or sudden hearing loss. Although it is not known whether this event is directly related to the use of tadalafil, if the patient experiences a decrease in hearing or sudden hearing loss, they should stop taking Gerocilan and seek medical attention 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.
Gerocilan should not be taken if the patient is 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 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 in tablets (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (antiepileptic medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Gerocilan with food and alcohol

Information on the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Gerocilan, and therefore, caution should be exercised when consuming it. For more information, the patient should consult their 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 operating machinery

Some men taking tadalafil during clinical trials reported dizziness, so the patient 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 consult their doctor before taking the medicine.

3. How to take Gerocilan

This medicine should always be taken exactly as prescribed by the doctor. If the patient is unsure, they should consult their doctor or pharmacist.
Gerocilan tablets are intended 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 this dose is not sufficient, the doctor may increase the dose to 20 mg. Gerocilan tablets are intended for oral use.
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.
The patient 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 be aware that Gerocilan does not work without sexual stimulation.
The patient and their partner should engage in foreplay, just as they would if the patient were 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 0.08% or higher), as this may increase the risk of dizziness when standing up.

Taking more than the recommended dose of Gerocilan

The patient should inform their doctor. Undesirable effects may occur, as described in section 4.
If the patient has any further doubts about the use of the medicine, they should consult their doctor or pharmacist.

4. Possible undesirable effects

Like all medicines, this medicine can cause undesirable effects, although not everybody gets them.
These effects are usually mild or moderate.
If the patient experiences any of the following undesirable effects, they should stop taking the medicine and consult their doctor immediately:

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

Other reported undesirable effects:

• Common(occurring in less than 1 in 10 patients)
• headache, back pain, muscle pain, pain in arms and legs, flushing, nasal congestion, and nausea.

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 erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of the face, hands, or feet, and feeling tired.

Rare(occurring in less than 1 in 1000 patients)

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

Myocardial infarction 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 loss of vision or blindness in one or both eyes.
Men taking tadalafil have reported several additional rare undesirable effects, which 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, blurred, or unclear vision, or sudden worsening of vision (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 undesirable effects

If the patient experiences any undesirable effects, including any undesirable effects not mentioned in the leaflet, they should inform their doctor, pharmacist, or nurse. Undesirable effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Undesirable effects can also be reported to the marketing authorization holder.
Reporting undesirable effects helps 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.
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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Gerocilan 10 mg contains

• The active substance of the medicine is tadalafil. Each tablet contains 10 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)
Black iron oxide (E 172)

What Gerocilan 10 mg looks like and contents of the pack

Yellow, biconvex, film-coated tablet in the shape of an oval, with the inscription "T 10" 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, or 40 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