Dutrozen

Package leaflet: Information for the patient

Dutrozen, 0.5 mg + 0.4 mg, hard capsules
Dutasteride + Tamsulosin hydrochloride
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

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

Table of contents

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

Dutrozen is used in men with an enlarged prostate gland (benign prostatic hyperplasia) – a non-cancerous enlargement of the prostate 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 the group of alpha-blockers.
Enlargement of the prostate may lead to problems with urination, such as difficulty 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.
Dutasteride reduces the production of the hormone dihydrotestosterone, helping to shrink the prostate and relieve symptoms. It reduces the risk of acute urinary retention and the need for surgery. Tamsulosin relaxes the muscles of the prostate, thus facilitating urine flow and rapidly relieving symptoms.

2. Important information before using Dutrozen

When not to use Dutrozen:

• if the patient is a woman (this medicine is intended for men only).
• if the patient is a child or adolescent under 18 years of age.
• if the patient is 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 the patient has low blood pressure causing dizziness or fainting (orthostatic hypotension).
• if the patient has severe liver disease.
  If any of the above apply to the patient, this medicine should not be taken until discussed with a doctor.

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

• Inform your doctor if you have liver disease. If you have liver disease, additional tests may be required while taking Dutrozen.
• Inform your doctor if you have severe kidney disease.
• Cataract surgery (cloudy lens). If you are scheduled for cataract surgery, your doctor may advise you to stop taking Dutrozen for a period of time. Before surgery, inform your ophthalmologist that you are taking or have previously taken Dutrozen or tamsulosin. Your doctor will take appropriate precautions to prevent complications during surgery.
• Women, children and adolescents must not handle damaged capsules of Dutrozen, as the active substance may be absorbed through the skin. In case of skin contact, the contaminated area should be washed immediately with soap and water.
• Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking Dutrozen. If your partner is pregnant or may be pregnant, avoid exposing her to contact with semen, because dutasteride may disrupt 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.
• Dutrozen affects the results of prostate-specific antigen (PSA) blood tests, which are sometimes performed to detect prostate cancer. Despite this, your doctor may intentionally order this test to screen for prostate cancer. If you are having a PSA test, you should inform your doctor that you are taking Dutrozen. Patients taking Dutrozen should have their PSA levels monitored regularly.
• In a clinical study involving patients at increased risk of prostate cancer, high-grade prostate cancer was diagnosed more frequently in patients taking dutasteride than in those not taking dutasteride. The effect of dutasteride on the risk of developing high-grade prostate cancer is not fully understood.
• Dutrozen may cause breast enlargement and tenderness. If these symptoms become bothersome or if lumps in the breast or nipple discharge occur, contact your doctor, as these may be signs of a serious condition such as breast cancer.

Mood changes and depression
In patients taking another medicine from the same therapeutic class (5-alpha reductase inhibitor) orally, depressive mood, depression, and rarely suicidal thoughts have been reported. If any of these symptoms occur, seek immediate medical advice from your doctor.
If you have any questions about the use of Dutrozen, contact your doctor or pharmacist.

Dutrozen and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Do not take Dutrozen with:

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

Concomitant use of Dutrozen is not recommended with:

• Ketoconazole (used to treat fungal infections).

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

• PDE5 inhibitors (used to achieve or maintain erection), e.g. 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 inflammatory conditions).

Inform 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 each day.

Pregnancy, breastfeeding and fertility
Dutrozen must not be taken by women.
Women who are pregnant (or who may become pregnant) must not handle damaged capsules.
Dutasteride is absorbed through the skin and may interfere with the normal development of a male fetus.
The risk is particularly high during the first 16 weeks of pregnancy.
Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking Dutrozen. If your partner is pregnant or may be pregnant, avoid exposing her to contact with semen.
It has been shown that Dutrozen reduces sperm count, semen volume, and sperm motility. This may lead to reduced fertility in men.
If a pregnant woman has had contact with Dutrozen, contact a doctor immediately.

Driving and operating machinery
Dutrozen may cause dizziness in some patients, which may affect the ability to drive or operate machinery. If you experience these symptoms, do not drive or operate machinery.

Dutrozen contains sodium, propylene glycol monocaprylate, and soy lecithin
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, meaning this medicine is considered "sodium-free".
Dutrozen contains 299.46 mg of propylene glycol monocaprylate (equivalent 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 use this medicine if you have been diagnosed with hypersensitivity to peanuts or soy (see section "When not to use Dutrozen").

3. How to take Dutrozen

This medicine should always be taken as directed by a doctor or pharmacist. Irregular
use of the medicine may affect PSA level monitoring. If in doubt, consult a doctor or
pharmacist.
Recommended dose
The recommended dose is 1 capsule taken once daily, 30 minutes after the same meal each
day.
Method of administration
The capsule should be swallowed whole with water. Do not chew or open the capsule.
Contact with the capsule contents may cause oral cavity pain or throat pain.
Taking more Dutrozen than recommended
If more Dutrozen has been taken than recommended, consult a doctor or pharmacist.
Missed dose of Dutrozen
Do not take a double dose to make up for a missed dose. Take the next capsule at the usual time.
Stopping treatment with Dutrozen
Do not stop taking Dutrozen without first consulting a doctor. If you have any further
doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone will experience them.

Allergic reaction
Symptoms of an allergic reaction may include:

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

If any of these symptoms occur, contact a doctor immediately and stop using Dutrozen.

Dizziness, feeling of emptiness in the head and fainting
Dutrozen may cause dizziness, a feeling of emptiness in the head and, rarely, fainting. Caution should be taken when changing position from lying, sitting or standing, especially when getting up at night, when the patient does not yet know how Dutrozen affects them. If dizziness or a feeling of emptiness in the head occurs during treatment, the patient should sit or lie down until symptoms subside.

Serious skin reactions
Symptoms of serious skin reactions may include:

• widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome). If any of these symptoms occur, contact a doctor immediately and discontinue use of Dutrozen.

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

• inability to achieve or maintain an erection (impotence)*,
• reduced sexual desire (libido)*,
• problems with ejaculation, such as reduced volume of semen released during intercourse*,
• enlargement or tenderness of the breasts (gynaecomastia),
• dizziness.

* In some patients, the symptom may persist after stopping treatment with Dutrozen.

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

• heart failure (less efficient heart function). Possible symptoms include shortness of breath, extreme fatigue and swelling around the ankles and lower limbs,
• low blood pressure upon standing,
• rapid heartbeat (palpitations),
• constipation, diarrhoea, vomiting, nausea,
• weakness or loss of strength,
• headache,
• itchy, stuffy nose, nasal inflammation,
• skin rash, urticaria, itching,
• hair loss (usually body hair) or excessive hair growth.

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

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

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

• persistent painful erection (priapism),
• serious skin reactions (Stevens-Johnson syndrome).

Other adverse reactions occurring with unknown frequency (frequency cannot be estimated from available data):

• irregular or rapid heartbeat (arrhythmia or tachycardia or atrial fibrillation),
• difficulty breathing (dyspnoea),
• depression,
• pain and swelling of the testicles,
• nosebleeds,
• severe skin rashes,
• changes in vision (blurred vision or visual disturbances),
• dry mouth.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. 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 181 C
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 or its representative in Poland.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Dutrozen

Keep this medicine out of 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 stated month.
Store below 30°C.
Period of usability after first opening the bottle: 90 days.
Medicines must not be disposed of via the sewage system 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 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: glycol mono-caprylate of propylene glycol, Type II; butylhydroxytoluene (E 321); gelatin; glycerol; titanium dioxide (E 171); medium-chain triglycerides*; soybean lecithin (may contain soybean oil)*. * Potential trace residues from the manufacturing process.
  Pellets with tamsulosin hydrochloride: microcrystalline cellulose; copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion (containing sodium lauryl sulfate and Polysorbate 80); dibutyl sebacate; hydrated colloidal silica; Polysorbate 80; calcium stearate.
  Hard capsule shell: gelatin; titanium dioxide (E 171); red iron oxide (E 172); yellow iron oxide (E 172); black iron oxide (E 172).
  Black ink: propylene glycol; potassium hydroxide; concentrated ammonium hydroxide; black iron oxide (E 172); shellac.

What Dutrozen looks like and contents of the pack
Dutrozen is an elongated, hard gelatin capsule measuring 24.2 x 7.7 mm, with a brown body and a beige cap, printed with the black code "C001". Each capsule contains:

• one elongated, soft, light yellow gelatin capsule containing dutasteride (approximately 16.5 x 6.5 mm), filled with a clear liquid,
• approximately 183.8 mg of tamsulosin in white to off-white modified-release pellets.

Dutrozen is packed in white HDPE bottles with a desiccant (silica gel) placed under a white PP cap. Dutrozen is available in pack sizes of 7, 30 or 90 capsules. Not all pack sizes may be marketed.

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

Manufacturer
Laboratorios León Farma, S.A.
c/La Vallina s/n, Polígono Industrial Navatejera,
24193 Villaquilambre, León
Spain

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00

This medicinal product is authorised in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:
Bulgaria, Czech Republic, Estonia, Latvia, Lithuania, Poland, and the United Kingdom: Dutrozen
Germany: Dutasterid-Tamsulosin Zentiva
Portugal: Dutasterida + Tansulosina Zentiva
Romania: Dutazen 0.5 mg/0.4 mg capsule
Spain: Dutasterida/Tamsulosina Zentiva
France: Dutasteride/Tamsulosine Zentiva 0.5 mg/0.4 mg gélules