Geroladut

Patient Information Leaflet included in the packaging: Information for the Patient

Geroladut, 0.5 mg, soft capsules
Dutasteridum
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• 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. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

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 pack 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 in this medicine is dutasteride, which belongs to a group of medicines known as 5-alpha-reductase inhibitors.
Enlargement of the prostate gland may lead to problems with urination, such as difficulty in passing urine and increased frequency of urination. There may also be a slowing of urine flow and a weak urine stream. If left untreated, complete blockage of urine flow may occur (acute urinary retention). This condition requires immediate treatment. In some cases, surgery may be needed to remove or reduce the size of the prostate gland. Geroladut reduces the production of dihydrotestosterone, thereby reducing the size of the prostate gland and relieving symptoms. As a result, it reduces the likelihood of acute urinary retention and the need for surgical intervention.
Geroladut may also be used in combination with another medicine called tamsulosin (used to treat symptoms of an enlarged prostate gland).

2. Important information before using Geroladut

When not to use Geroladut

• if the patient is allergic to dutasteride, other 5-alpha-reductase inhibitors, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe liver disease.

If any of the above apply to the patient, do not take the medicine before consulting a doctor.

Geroladut is intended exclusively for men. It must not be used in women, children, or adolescents.

Warnings and precautions

Before taking Geroladut, consult a doctor.

• Inform the doctor if the patient has liver disease. If the patient has liver disease, additional monitoring may be required during treatment with Geroladut.
• Women, children, and adolescents must not touch damaged capsules of Geroladut, as the active substance may be absorbed through the skin. In case of skin contact, the affected area must be washed immediately with soap and water.
• Condoms must be used during sexual intercourse. Dutasteride has been detected in the semen of men taking Geroladut. If the partner is pregnant or may be pregnant, exposure to semen should be avoided, as dutasteride may impair the development of a male fetus. It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility. This may 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 intentionally order this test to screen for prostate cancer. If PSA testing is performed in the patient, the patient should inform the doctor about taking Geroladut. Patients taking Geroladut should have their PSA levels monitored regularly.
• In a clinical trial involving patients at increased risk of prostate cancer, high-grade prostate cancer was diagnosed more frequently in patients taking Geroladut than in those not taking the medicine. The effect of Geroladut on the potential development of high-grade prostate cancer is not fully understood.
• Geroladut may cause breast enlargement and breast pain. If these symptoms become bothersome or if lumps in the breast or nipple discharge occur, contact a doctor, as these may be signs of a serious condition such as breast cancer.
• If you have any questions about the use of Geroladut, contact your doctor or pharmacist.

Geroladut and other medicines

Tell your doctor about all medicines currently used, recently used, or planned for use.

Some medicines taken concurrently with Geroladut may increase the risk of adverse 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-blocking medicines (used to treat benign prostatic hyperplasia or high blood pressure)

Inform the doctor if any of these medicines are being used. It may be necessary to reduce the dose of Geroladut.

Taking Geroladut with food and drink

Geroladut may be taken with or without food.

Pregnancy, breastfeeding, and effects on fertility

Pregnant women (or women who may be pregnant) must not touch damaged capsules.
Dutasteride is absorbed through the skin and may impair the development of a male fetus. The risk is particularly high during the first 16 weeks of pregnancy.

Condoms must be used during sexual intercourse. Dutasteride has been detected in the semen of men taking Geroladut. If the partner is pregnant or may be pregnant, exposure to semen should be avoided.

It has been shown that Geroladut reduces sperm count, semen volume, and sperm motility. This may lead to reduced fertility in men.

• If a pregnant woman has been exposed to dutasteride, consult a doctor.

Driving and operating machinery

It is unlikely that dutasteride will affect the ability to drive or operate machinery.

Geroladut contains lecithin (soya)

This medicine contains soya-derived lecithin, which may contain soya oil. Do not use if hypersensitivity to peanuts or soya has been diagnosed.

3. How to take Geroladut

This medicine should always be taken as directed by your doctor.
Irregular use of the medicine may affect monitored PSA levels.
If you have any doubts, consult your doctor or pharmacist.

Recommended dose
The usual dose is one capsule (0.5 mg) taken once daily. The capsule should be swallowed whole with water. Do not chew or open the capsule. Contact with the capsule contents may cause pain in the mouth or throat. Geroladut can be taken with or without food.

Geroladut is intended for long-term use. Some men may notice symptom improvement early in treatment. However, others may require 6 months or longer of treatment with Geroladut before improvement occurs. Continue taking Geroladut for as long as your doctor recommends.

Taking more than the recommended dose of Geroladut
If you take more Geroladut capsules than recommended, contact your doctor or pharmacist immediately.

Missed dose of Geroladut
Do not take a double dose to make up for a missed dose.
Take the next dose at your usual time and continue with your regular dosing schedule.

Stopping treatment with Geroladut
Do not stop taking Geroladut unless your doctor tells you to. Improvement may require continuing treatment for 6 months or longer.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Allergic reactions
Symptoms of an allergic reaction may include:

• skin rash (which may be itchy)
• urticaria
• swelling of the eyelids, face, lips, hands or feet.

If any of these symptoms occur, contact your doctor immediately and discontinue use of Geroladut.

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

• difficulty achieving or maintaining an erection (impotence), which may persist after stopping treatment with Geroladut
• decreased sexual desire (libido), which may persist after stopping treatment with Geroladut
• problems with ejaculation, including reduced semen volume during ejaculation, which may persist after stopping treatment with Geroladut
• enlargement or pain in the breast glands (gynaecomastia)
• dizziness when used with tamsulosin

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

• heart failure (reduced heart function. Possible symptoms include shortness of breath, extreme fatigue, and swelling in the ankles and lower limbs)
• hair loss (usually body hair) or excessive hair growth

Frequency unknown (cannot be estimated from available data):

• depression
• pain and swelling of the testicles

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.

Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Geroladut

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.
Store below 30°C.
Keep in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the package and other information

What Geroladut contains

• The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.
• Other ingredients are:
  • Inside the capsule: 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 elongated, soft gelatin capsules (approximately 16.5 x 6.5 mm) of light yellow colour, filled with a clear liquid.
The capsules are packed in transparent triple-layer blisters (PVC/PE/PVDC/Aluminium) in cardboard boxes.
Pack sizes: 10, 30, 50, 60 and 90 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation 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 further information and details of the product names in other EEA countries,
please contact the representative of the Marketing Authorisation 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]