Gerocilan

Package leaflet: Information for the patient

Gerocilan, 5 mg, film-coated tablets
Tadalafil
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, 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 any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Gerocilan is and what it is used for
2. What you need to know 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 Gerocilan is and what it is used for

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

• with erectile dysfunction. This is a condition in which a man cannot achieve or maintain an erection sufficient for sexual intercourse. Tadalafil has been shown to significantly improve the ability to obtain an erection sufficient for sexual intercourse. After sexual stimulation, Gerocilan helps widen the blood vessels of the penis, allowing increased blood flow into the penis. As a result, erection improves. Gerocilan does not benefit patients who do not have erectile dysfunction. It is important to be aware that Gerocilan 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 medication for erectile dysfunction.
• with urinary symptoms caused by a common medical condition called benign prostatic hyperplasia. This is a condition in which the prostate gland enlarges with age. Symptoms include difficulty starting urination, sensation of incomplete bladder emptying, and the need to urinate more frequently, even at night. Tadalafil improves blood flow and causes relaxation of the muscles of the prostate and bladder, which may relieve symptoms of benign prostatic hyperplasia. It has been shown that tadalafil alleviates these urinary symptoms as early as 1–2 weeks after starting treatment.

2. Information before using Gerocilan

When not to use 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, e.g. 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 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 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.
• if the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), referred to as "eye damage".
• 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 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 Gerocilan, discuss this with your doctor.
Keep in mind that sexual activity involves some risk for patients with heart disease, as it places additional strain on the heart. If the patient has any heart problems, they should inform their doctor.
Benign prostatic hyperplasia and prostate cancer may have similar symptoms; therefore, the doctor will perform an examination to rule out prostate cancer before starting treatment with Gerocilan for symptoms of benign prostatic hyperplasia.
Gerocilan should not be used to treat prostate cancer.
Before taking Gerocilan, the patient should inform their doctor if any of the following conditions apply:

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

It is not known whether Gerocilan is effective in patients:

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

If during treatment with Gerocilan sudden worsening of vision or sudden vision loss occurs, or if images appear distorted or blurred, treatment with Gerocilan should be stopped immediately and the patient should contact their doctor without delay.
In some patients taking tadalafil, worsening or sudden hearing loss has been observed. Although it is not known whether this event is directly related to the use of tadalafil, if hearing deterioration or sudden hearing loss occurs, treatment with Gerocilan should be stopped and the patient should 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
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
Do not take Gerocilan if you are using nitrates.
Gerocilan may affect the action of certain medicines or other medicines may affect the action of Gerocilan. Inform your doctor or pharmacist if you are taking any of the following medicines:

• alpha-blockers (used to treat high blood pressure or urinary symptoms caused by 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 used in the treatment of AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Gerocilan, food, and alcohol
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Gerocilan, and therefore caution should be exercised when consuming it. For further information, consult your doctor.

Fertility
When Gerocilan was administered to dogs, a reduction in sperm production in the testes was observed. Reduced sperm concentration has been observed in some men. It is unlikely that this would lead to infertility.

Driving and operating machinery
In some men participating in clinical trials, dizziness was reported during treatment with tadalafil. Therefore, patients should be aware of their individual response to the tablets before deciding to drive a car or operate machinery.

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

3. How to take Gerocilan

This medicine should always be taken exactly as directed by the physician. If in doubt, consult
your doctor or pharmacist.
Gerocilan tablets are intended for oral administration only in men. Tablets should be swallowed
whole, with a small amount of water. Gerocilan tablets may be taken with or without food.
Alcohol consumption may cause a temporary drop in blood pressure. If a patient has taken or
plans to take Gerocilan, large amounts of alcohol (blood alcohol concentration of 0.08% or higher)
should not be consumed, as this may increase the risk of dizziness upon standing.

Treatment of erectile dysfunction
The recommended dose is one 5 mg tablet taken once daily, approximately at the same time
each day. The doctor may adjust the dose to 2.5 mg depending on the patient's response to
Gerocilan. In such case, the 2.5 mg tablet should be used.
Gerocilan should not be taken more frequently than once daily.
Taking Gerocilan once daily allows achieving an erection following sexual stimulation at any
time within 24 hours. Daily administration of Gerocilan may be beneficial for men who intend to
engage in sexual activity two or more times per week.
It is important to understand that Gerocilan does not work in the absence of sexual stimulation.
The patient and his partner should engage in foreplay, just as when the patient is not taking
medication for erectile dysfunction.
Alcohol consumption may affect the patient's ability to achieve an erection.

Treatment of symptoms of benign prostatic hyperplasia
The dose is one 5 mg tablet taken once daily, approximately at the same time each day. If a
patient has both benign prostatic hyperplasia and erectile dysfunction, the dose remains
unchanged at one 5 mg tablet once daily.
Gerocilan must not be taken more frequently than once daily.

Use of a higher than recommended dose of Gerocilan
Inform your doctor immediately. Adverse effects described in section 4 may occur.

Missed dose of Gerocilan
As soon as remembered, take the missed dose, but do not take a double dose to make up for a
missed tablet. Do not take Gerocilan more frequently than once daily.
If there are any further doubts concerning the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
These reactions are usually mild or moderate.
If any of the adverse reactions listed below occur, you should stop taking the medicine and seek immediate medical advice:

• 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 Gerocilan (rare). If such an erection occurs and lasts continuously for more than 4 hours, you should contact a doctor immediately.
• sudden loss of vision (rare), distorted, dimmed, blurred central vision, or sudden decrease in vision (frequency unknown).

Other reported adverse reactions:
Common (occur in no more than 1 in 10 patients)

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

Uncommon (occur in no more than 1 in 100 patients)

• 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 palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling of fatigue.

Rare (occur in no more than 1 in 1000 patients)

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

Heart attack and stroke have been rarely reported in men taking tadalafil. Most of these men had pre-existing heart problems before starting treatment with this medicine.
There have been reports of rare cases of partial, transient or permanent visual impairment or vision loss in one or both eyes.
In men taking tadalafil, a few additional rare adverse reactions 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 characterized by blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
• distorted, dimmed, blurred central vision or sudden decrease in vision (frequency unknown).

Adverse reaction: 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 adverse reactions
If any undesirable symptoms occur, including any adverse reactions not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse reactions can also 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 reactions can also be reported to the responsible entity.
By reporting adverse reactions, more information on the safety of the medicine can be collected.

5. How to store Gerocilan

Keep this 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 instructions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Gerocilan 5 mg contains

• The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
• Excipients:

Tablet core:
Lactose
Sodium croscarmellose
Sodium lauryl sulfate
Hydroxypropylcellulose
Polysorbate 80
Magnesium stearate

Coating:
Hypromellose 2910
Monohydrate lactose
Titanium dioxide (E 171)
Triacetin
Talc
Iron oxide yellow (E 172)

What Gerocilan 5 mg looks like and contents of the pack

Yellow, biconvex coated tablet in caplet shape, embossed with the code "T 5" on one side and smooth on the other.
Blister packs made of PVC/PVDC/Aluminum foil in cardboard boxes. The packaging 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 further information, contact the local representative of the Marketing Authorization 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
[email protected]