Gerocilan

Package leaflet: Information for the patient

Gerocilan, 10 mg, coated tablets
Tadalafil
Please read this leaflet carefully before using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Contents of the 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 suitable for sexual activity.

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 in the penis, allowing increased blood flow into the penis and resulting in improved erection. Gerocilan does not benefit patients who do not have erectile dysfunction.

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 they would if the patient were not taking medication for erectile dysfunction.

2. Important 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, e.g. amyl nitrite. This is a group of medicines ("nitrates") used in the treatment of angina (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 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 problems".
• 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, 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 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 bone marrow cancer).
• 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 pelvic surgery.
• after total or partial removal of the prostate gland with nerve-sparing (radical prostatectomy with nerve preservation).

If during treatment with Gerocilan sudden worsening of vision or sudden vision loss occurs, or if vision is distorted, blurred, or dim, 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 and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not take Gerocilan if you are taking 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, alcohol, and grapefruit juice
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 occurred.
Reduced sperm concentration has been observed in some men. It is unlikely that this would lead to infertility.

Driving and operating machinery
In clinical trials, some men taking tadalafil reported dizziness. 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 your doctor. If you have any doubts, you should consult your 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. Gerocilan tablets may be taken with or without food.

The recommended starting dose is one 10 mg tablet taken prior to planned sexual activity. If this dose is not effective, your doctor may increase the dose to 20 mg. Gerocilan tablets are intended for oral administration.

Gerocilan may be taken at least 30 minutes before planned sexual activity. The effect of Gerocilan may last up to 36 hours after taking the tablet.

Gerocilan should not be taken more than once a day. Gerocilan 10 mg and 20 mg are intended to be used as needed, prior to planned sexual activity. Regular, daily use of this medicine is not recommended.

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 dizziness upon standing.

Use of a higher than recommended dose of Gerocilan
You should inform your doctor. Adverse effects described in section 4 may occur.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may 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 rashes (uncommon).
• Chest pain – do not take nitrates, but seek immediate medical help (uncommon).
• Priapism, 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, blurred, or impaired central vision, or sudden worsening of 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, 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 no more than 1 in 1000 patients)

• Fainting, seizures, transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, urticaria (itchy red raised areas on the skin), 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 conditions 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 increased blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
• Distorted, blurred, or impaired 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 effects not listed in this leaflet, you should 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 may 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 the medicine Gerocilan

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

6. Contents of the pack and other information

What Gerocilan 10 mg contains

• The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.
• Excipients:

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

Tablet coating:
Hypromellose 2910
Monohydrate lactose
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 coated tablet in capsule shape, embossed with the code "T 10" on one side and plain on the other.
Blister packs made of PVC/PVDC/Aluminum in cardboard boxes. 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 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, please 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]