Gerocilan

Patient Information Leaflet

Gerocilan, 2.5 mg, coated tablets
Tadalafil
Please read this leaflet carefully before taking this medicine, because it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Gerocilan is and what it is 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 Gerocilan is and what it is used for

Gerocilan is a medicine intended for adult men with erectile dysfunction. This is a condition in which a man is unable to achieve or maintain an erection sufficient for sexual intercourse. Tadalafil has been shown to significantly improve the ability to achieve an erection adequate for sexual intercourse.
Gerocilan contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation, Gerocilan helps widen the blood vessels of the penis, allowing increased blood flow into the penis. This results in improved erection. 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.

2. Information before using 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 in the treatment of 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 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 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.
Before taking the medicine, the patient should inform their doctor if any of the following apply:

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

It is not known whether Gerocilan is effective in patients:

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

If during treatment with Gerocilan sudden worsening of vision or sudden vision loss occurs, or if vision becomes distorted, blurred, or impaired, 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 loss or worsening of hearing 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 with 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.
Gerocilan must not be taken if the patient is 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-adrenergic receptor 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 to treat 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 the medicine was administered to dogs, a reduction in sperm production in the testes occurred.
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 taking tadalafil during clinical trials, dizziness was reported. Therefore, the patient should be aware of their individual response to the tablets before deciding to drive 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 prescribed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Gerocilan tablets are intended for oral administration only in men. The tablets should be swallowed whole, with a small amount of water. Gerocilan tablets may be taken with or without food.
The recommended dose is one 5 mg tablet taken once daily at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg depending on your response to Gerocilan. In such case, the 2.5 mg tablet should be used.
Do not take Gerocilan more often than once daily.
Taking Gerocilan once daily may be beneficial for men who plan to engage in sexual activity two or more times per week.
Taking Gerocilan once daily allows achieving an erection following sexual stimulation at any time within 24 hours.
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.
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 Gerocilan, he should not consume large amounts of alcohol (blood alcohol concentration of 0.08% or higher), as this may increase the risk of experiencing dizziness upon standing.
Use of a higher than recommended dose of Gerocilan
Inform your doctor immediately. Adverse reactions described in section 4 may occur.
Missed dose of Gerocilan
As soon as you remember, take the missed dose, but do not take a double dose to make up for the missed tablet. Do not take Gerocilan more often than once daily.
If you have any further questions regarding 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, stop taking the medicine
and seek immediate medical advice:

• allergic reactions, including rashes (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, seek immediate medical advice.
• sudden loss of vision (rare), distorted, blurred, or reduced central vision, or sudden decrease in vision (frequency unknown).

Other reported adverse reactions:
Common (occur in not 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 not more than 1 in 100 patients)

• dizziness, abdominal pain, nausea, vomiting, regurgitation of stomach contents into the oesophagus, blurred vision, eye pain, breathing difficulties, presence of blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling tired.

Rare (occur in not 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 facial and throat swelling, severe skin rashes, disorders manifesting as blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
• distorted, blurred, reduced central vision or sudden worsening of vision (frequency unknown).

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

5. How to store Gerocilan

Keep this medicine out of the 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 apply 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 pack and other information

What Gerocilan 2.5 mg contains

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

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

Coating:
Hypromellose 2910
Monohydrate lactose
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 coated tablet in caplet shape, embossed with the code "T 2" on one side and smooth on the other.

Packs of PVC/PVDC/Aluminium blisters in cardboard boxes. 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 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 18th 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 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
[email protected]