Dutrozen

Package Leaflet: Information for the Patient

Dutrozen, 0.5 mg + 0.4 mg, hard capsules
Dutasteride + Tamsulosin hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

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

Contents of the Package Leaflet

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

1. What is Dutrozen and what is it used for

Dutrozen 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.
Dutrozen is a combination of two different active substances, dutasteride and tamsulosin.
Dutasteride belongs to a group of medicines called 5-alpha reductase inhibitors, and tamsulosin belongs to a group of alpha-blockers.
An enlarged prostate gland can lead to problems with urination, such as difficulty urinating and frequent urination. It can also cause a decrease in urine flow 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, surgery may be necessary to remove or reduce the size of the prostate gland.
Dutasteride reduces the production of dihydrotestosterone, which helps to reduce the size of the prostate and alleviate symptoms. It also reduces the risk of acute urinary retention and the need for surgery. Tamsulosin acts by relaxing the muscles in the prostate, making it easier to urinate and quickly alleviating symptoms.

2. Important information before taking Dutrozen

When not to take Dutrozen:

• if you are a woman(this medicine is for men only).
• if you are a child or adolescent under 18 years of age
• if you are allergic to dutasteride, other 5-alpha reductase inhibitors, tamsulosin, soy, peanuts (soy lecithin), or any of the other ingredients of this medicine (listed in section 6).
• if you have low blood pressurethat causes dizziness or fainting (orthostatic hypotension).
• if you have severe liver disease. If any of the above applies to you, do not take this medicine until you have consulted your doctor.

Warnings and precautions

Before taking Dutrozen, discuss it with your doctor.
In some clinical studies, more patients taking dutasteride and another alpha-blocker, such as tamsulosin, experienced heart failure than patients taking only dutasteride or another alpha-blocker.
Heart failure is a condition in which the heart does not pump blood as it should.

• Tell your doctor if you have liver disease.If you have had liver disease, you may need to have additional tests while taking Dutrozen.
• Tell your doctor if you have severe kidney disease.
• Cataract surgery (cloudy lens).If you are scheduled to have cataract surgery, your doctor may recommend stopping Dutrozen for a while. Before surgery, tell your eye doctor that you are taking Dutrozen or tamsulosin (or have taken them in the past). Your doctor will take appropriate precautions to prevent complications during surgery.
• Women, children, and adolescentsshould not touch damaged Dutrozen capsules, as the active substance may be absorbed through the skin. If skin contact occurs, wash the affected area immediately with soap and water.
• Use a condom during sexual intercourse.Dutasteride has been found in the semen of men taking Dutrozen. If your partner is pregnant or may become pregnant, avoid exposing her to contact with semen. Dutasteride may affect the development of a male fetus. It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility, which may lead to reduced fertility in men.
• Dutrozen affects the result of the prostate-specific antigen (PSA) test, which is sometimes performed to detect prostate cancer. Despite this, your doctor may still order this test to detect prostate cancer. If you are having a PSA test, tell your doctor that you are taking Dutrozen. PSA levels should be regularly checked in patients taking Dutrozen.
• In a clinical study of patients with an increased risk of prostate cancer, patients taking dutasteride were diagnosed with high-grade prostate cancer more oftenthan patients who did not take dutasteride. The effect of dutasteride on the risk of high-grade prostate cancer is not clear.
• Dutrozen may cause breast enlargement and tenderness.If these symptoms become troublesome or if you notice breast lumpsor discharge from the nipple, contact your doctor, as these may be signs of a serious condition, such as breast cancer. If you have any questions about taking Dutrozen, contact your doctor or pharmacist.

Dutrozen and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Do not take Dutrozen with:

• Other alpha-blockers (used for benign prostatic hyperplasia or high blood pressure).

Do not recommend taking Dutrozen with:

• Ketoconazole (used to treat fungal infections).

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

• PDE5 inhibitors (used to achieve or maintain an erection) such as vardenafil, sildenafil citrate, and tadalafil.
• 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).
• Cimetidine (used to treat stomach ulcers).
• Warfarin (used to treat excessive blood clotting).
• Erythromycin (an antibiotic used to treat bacterial infections).
• Paroxetine (used to treat depression).
• Terbinafine (used to treat fungal infections).
• Diclofenac (used to treat pain and inflammation).

Tell your doctor if you are taking any of these medicines.

Dutrozen with food and drink

Dutrozen should be taken 30 minutes after the same meal every day.

Pregnancy, breastfeeding, and fertility

Dutrozen must not be taken by women.

Women who are pregnant (or may become pregnant) must not touch damaged Dutrozen capsules.

Dutasteride is absorbed through the skin and may affect the normal development of a male fetus.
A special risk exists during the first 16 weeks of pregnancy.
Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Dutrozen. If your partner is pregnant or may become pregnant, avoid exposing her to contact with semen.
Dutrozen has been shown to reduce sperm count, semen volume, and sperm motility, which may lead to reduced fertility in men.
If a pregnant woman has come into contact with Dutrozen, she should contact her doctor.

Driving and using machines

Dutrozen can cause dizziness in some patients, which may affect their ability to drive or operate machines. If you experience these symptoms, do not drive or operate machines.

Dutrozen contains sodium, propylene glycol monocaprylate, and soy lecithin

The medicine contains less than 1 mmol of sodium (23 mg) per capsule, which means it is essentially "sodium-free".
Dutrozen contains 299.46 mg of propylene glycol monocaprylate (corresponding to 112.80 mg of propylene glycol) per capsule and trace amounts of propylene glycol in the black ink.
This medicine may contain trace amounts of soy lecithin. Do not take this medicine if you are hypersensitive to peanuts or soy (see section "When not to take Dutrozen").

3. How to take Dutrozen

Always take this medicine exactly as your doctor or pharmacist has told you. Irregular intake of the medicine may affect the monitoring of PSA levels. If you are unsure, ask your doctor or pharmacist.

Recommended dose

The recommended dose is one capsule taken once daily, 30 minutes after the same meal every day.

Method of administration

Swallow the capsule whole with water. Do not chew or open the capsules. Contact with the contents of the capsules may cause mouth or throat pain.

Overdose

If you take more Dutrozen than you should, contact your doctor or pharmacist.

Missed dose

Do not take a double dose to make up for a forgotten dose. Take the next capsule at the usual time.

Stopping treatment

Do not stop taking Dutrozen without first consulting your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Allergic reaction

Symptoms of an allergic reaction may include:

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

If you experience any of these symptoms, contact your doctor immediately and stop taking Dutrozen.

Dizziness, lightheadedness, and fainting

Dutrozen may cause dizziness, lightheadedness, and rarely fainting. Be careful when changing positions from lying down, sitting, or standing, especially when getting up at night, when you are not yet aware of how Dutrozen affects you. If you experience dizziness or lightheadedness, sit or lie down until the symptoms pass.

Severe skin reactions

Symptoms of severe skin reactions may include:

• widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome). If you experience any of these symptoms, contact your doctor immediately and stop taking Dutrozen.

Other side effects

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

• impotence (inability to achieve or maintain an erection)*,
• decreased libido (sex drive)*,
• difficulty with ejaculation, such as reduced semen volume*,
• breast enlargement or tenderness (gynaecomastia),
• dizziness.

* In some patients, the symptom may persist after stopping Dutrozen.
Uncommon (may affect up to 1 in 100 men):

• heart failure (less efficient heart function). Possible symptoms include shortness of breath, extreme tiredness, and swelling in the ankles and legs),
• low blood pressure when standing up,
• rapid heartbeat (palpitations),
• constipation, diarrhea, vomiting, nausea,
• weakness or loss of strength,
• headache,
• itchy, stuffy nose, rhinitis,
• skin rash, hives, itching,
• hair loss (usually body hair) or excessive hair growth.

Rare (may affect up to 1 in 1,000 men):

• swelling of the eyelids, face, lips, arms, or legs (angioedema),
• itching.

Very rare (may affect up to 1 in 10,000 men):

• prolonged painful erection (priapism),
• severe skin reactions (Stevens-Johnson syndrome).

Other side effects with unknown frequency (frequency cannot be estimated from available data):

• abnormal or rapid heartbeat (arrhythmia or tachycardia or atrial fibrillation),
• difficulty breathing (dyspnea),
• depression,
• testicular pain and swelling,
• nosebleeds,
• severe skin rashes,
• changes in vision (blurred vision or problems with vision)
• dry mouth.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
Jerozolimskie Avenue 181 C

• 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309

e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Dutrozen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton after "Expiry date (EXP)". The expiry date refers to the last day of the month.
Store in a temperature below 30°C.
Shelf life after first opening the bottle: 90 days.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Dutrozen contains

• The active substances are dutasteride (0.5 mg) and tamsulosin hydrochloride (0.4 mg, equivalent to 0.367 mg tamsulosin).
• The other ingredients are: Soft capsules with dutasteride: propylene glycol monocaprylate, Type II; butylhydroxytoluene (E 321), gelatin; glycerol; titanium dioxide (E 171); triglycerides of saturated fatty acids with a medium chain length*; soy lecithin (may contain soybean oil)*. * potential, residual traces from the manufacturing process. Tamsulosin hydrochloride pellets: microcrystalline cellulose; methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion (contains sodium lauryl sulfate and Polysorbate 80); dibutyl sebacate; colloidal silicon dioxide; Polysorbate 80; calcium stearate. Hard capsule: gelatin; titanium dioxide (E 171); iron oxide red (E 172); iron oxide yellow (E 172); iron oxide black (E 172). Black ink: propylene glycol; potassium hydroxide; concentrated ammonia solution, iron oxide black (E 172); shellac.

What Dutrozen looks like and contents of the pack

Dutrozen is a hard, gelatin capsule, 24.2 x 7.7 mm in size, with a brown body and a beige cap, with the black inscription C001. Each capsule contains:

• one soft, gelatin capsule with dutasteride (approximately 16.5 x 6.5 mm) of light yellow color, filled with a clear liquid,
• approximately 183.8 mg of tamsulosin in pellets with modified release, white to off-white in color. Dutrozen is packaged in white HDPE bottles with a desiccant in the form of silica gel, placed under a white PP cap. Dutrozen is available in packs of 7, 30, or 90 capsules. Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, k. s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer

Laboratorios León Farma, SA
c/La Vallina s/n, Polígono Industrial Navatejera,
24193 Villaquilambre, León
Spain
Date of last revision of the leaflet:July 2024