Geroladut

Leaflet included in the packaging: patient information

Geroladut, 0.5 mg, soft capsules
Dutasteride
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 you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to you for a specific person. 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 tell their doctor, pharmacist, or nurse.See section 4.

Table of contents of the leaflet

• 1. What is Geroladut and what is it used for
• 2. Important information before taking Geroladut
• 3. How to take Geroladut
• 4. Possible side effects
• 5. How to store Geroladut
• 6. Contents of the packaging and other information

1. What is Geroladut and what is it used for

Geroladut is used in men with an enlarged prostate gland (benign prostatic hyperplasia) - a non-cancerous enlargement of the prostate gland caused by excessive production of a hormone called dihydrotestosterone.
The active substance of the medicine is dutasteride, which belongs to a group of medicines called 5-alpha-reductase inhibitors.
Enlargement of the prostate gland can lead to problems with urination, such as difficulty urinating and frequent urination. It can also cause a slow flow of urine and a weak urine stream. If left untreated, it can lead to complete blockage of urine flow (acute urinary retention). This situation requires immediate treatment. In some cases, surgical intervention may be necessary to remove or reduce the size of the prostate gland. Geroladut reduces the production of dihydrotestosterone, which leads to a reduction in the size of the prostate gland and alleviation of symptoms. It therefore reduces the likelihood of acute urinary retention and the need for surgical intervention.
Geroladut can also be used in combination with another medicine called tamsulosin (used to treat symptoms of enlarged prostate gland).

2. Important information before taking Geroladut

When not to take Geroladut

• If any of the above applies to the patient, they should not take the medicine before consulting a doctor.

The medicine is intended only for men. It should not be used in women, children, and adolescents.

Warnings and precautions

Before taking Geroladut, the patient should consult a doctor.

• The patient should inform their doctor if they have liver disease.If the patient has had liver disease, additional tests may be necessary during treatment with Geroladut.
• Women, children, and adolescentsshould not touch damaged Geroladut capsules, as the active substance can be absorbed through the skin. In case of skin contact, the contaminated area should be washed immediately with soap and water.
• A condom should be used during sexual intercourse.Dutasteride has been found in the semen of men taking Geroladut. If the partner is pregnant or may become pregnant, they should avoid exposure to semen. Dutasteride may interfere with the development of a male fetus. It has been shown that Geroladut can reduce sperm count, semen volume, and sperm motility, which can lead to reduced fertility.
• Geroladut affects the measurement of prostate-specific antigen (PSA) levels,which is sometimes performed to detect prostate cancer. Despite this, the doctor may still order this test to detect prostate cancer. If the patient is undergoing a PSA test, they should inform their doctor that they are taking Geroladut. Patients taking Geroladut should have their PSA levels checked regularly.
• In a clinical study involving patients with a high risk of prostate cancer, high-grade prostate cancer was diagnosed more frequentlyin patients taking Geroladut than in those not taking the medicine. The effect of Geroladut on the risk of developing high-grade prostate cancer is not clear.
• Geroladut may cause breast enlargement and tenderness.If these symptoms become troublesome or if lumps or discharge from the nipple occur, the patient should consult a doctor, as these may be symptoms of a serious condition such as breast cancer.
• If the patient has any questions about taking Geroladut, they should consult a doctor or pharmacist.

Geroladut 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.
Some medicines taken with Geroladut may increase the risk of side effects. These include:

• verapamil or diltiazem (used to treat high blood pressure)
• ritonavir or indinavir (used to treat HIV infection)
• itraconazole or ketoconazole (used to treat fungal infections)
• nefazodone (used to treat depression)
• alpha-blockers (used to treat enlarged prostate gland or high blood pressure)
• The patient should inform their doctor if they are taking any of these medicines.It may be necessary to reduce the dose of Geroladut.

Taking Geroladut with food and drink

The medicine can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnant women (or women who may become pregnant) should not touch damaged capsules.

Dutasteride is absorbed through the skin and may interfere with the development of a male fetus.There is a special risk during the first 16 weeks of pregnancy.
A condom should be used during sexual intercourse.Dutasteride has been found in the semen of men taking Geroladut. If the partner is pregnant or may become pregnant, they should avoid exposure to semen.
Geroladut has been shown to reduce sperm count, semen volume, and sperm motility, which can lead to reduced fertility in men.

• If a pregnant woman has come into contact with dutasteride, she should consult a doctor.

Driving and using machines

It is unlikely that taking dutasteride will affect the patient's ability to drive or use machines.

Geroladut contains soy lecithin

This medicine contains soy lecithin, which may contain soybean oil.It should not be taken if the patient has a known allergy to peanuts or soy.

3. How to take Geroladut

This medicine should always be taken as directed by the doctor.
Irregular intake of the medicine may affect monitored PSA levels.
If the patient has any doubts, they should consult a doctor or pharmacist.

Recommended dose

The usual dose is one capsule (0.5 mg) taken once a day.The capsule should be swallowed whole, with a glass of water. The capsule should not be chewed or opened. Contact with the contents of the capsule can cause mouth or throat pain. The medicine can be taken with or without food.
Geroladut is intended for long-term use.Some men may experience relief from symptoms at the beginning of treatment. However, others may need to take Geroladut for 6 months or longer to see an improvement. The patient should take Geroladut for as long as the doctor recommends.

Taking more than the recommended dose of Geroladut

If the patient takes more than the recommended dose of Geroladut, they should consult a doctor or pharmacist.

Missing a dose of Geroladut

The patient should not take a double dose to make up for a missed dose.
The patient should take the next dose at the usual time and continue with the previous dosing schedule.

Stopping treatment with Geroladut

The patient should not stop taking Geroladut without consulting a doctor.To see an improvement, it may be necessary to continue treatment for 6 months or longer.

• If the patient has any doubts about taking the medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Geroladut can cause side effects, although not everybody gets them.

Allergic reactions

Symptoms of an allergic reaction may include:

• skin rash (which may be itchy)
• hives
• swelling of the eyelids, face, lips, hands, or feet.
• If any of these symptoms occur, the patient should contact a doctor immediately and stop taking Geroladut.

Common (may affect up to 1 in 10 men):

• impotence (difficulty getting or keeping an erection), which may persist after stopping treatment with Geroladut
• decreased libido (sex drive), which may persist after stopping treatment with Geroladut
• difficulty with ejaculation, including reduced semen volume, which may persist after stopping treatment with Geroladut
• breast tenderness or enlargement (gynecomastia)
• dizziness when taken with tamsulosin.

Uncommon (may affect up to 1 in 100 men):

• heart failure (less efficient heart function, which may cause symptoms such as shortness of breath, extreme tiredness, and swelling of the feet and ankles)
• hair loss (usually body hair) or increased hair growth.

Frequency not known (cannot be estimated from the available data):

• depression
• testicular pain and swelling.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse.Side effects can be reported directly to the Department of Drug Safety 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Geroladut

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
The medicine should be stored at a temperature below 30°C.
The medicine should be stored in its original packaging to protect it from light.
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 Geroladut contains

• The active substance is dutasteride.Each soft capsule contains 0.5 mg of dutasteride.
• The other ingredients are:
• capsule fill: propylene glycol monocaprylate, type II, butylhydroxytoluene (E 321);
• capsule shell: gelatin, glycerol, titanium dioxide (E 171), medium-chain triglycerides, soy lecithin (may contain soybean oil) (E 322).

What Geroladut looks like and contents of the pack

Geroladut soft capsules are yellow, transparent, and filled with a clear liquid.They are approximately 16.5 x 6.5 mm in size and have a gelatin shell.
The capsules are packaged in a transparent, triple-layer blister pack (PVC/PE/PVDC/Aluminum) in a cardboard box.
Available pack sizes: 10, 30, 50, 60, and 90 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer

Laboratorios Leon Farma, S.A.
C/ La Vallina, s/n,
Polígono Industrial Navatejera,
24193 Villaquilambre (León), Spain

For more information and to find out about the names of the medicinal product in other EU countries, please contact the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o.
ul. Sienna 75; 00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]

Date of last revision of the leaflet: 05.01.2025