Package leaflet: Information for the patient

Warning! Keep the package leaflet! The information on the immediate packaging is in a foreign language.
Duodart
0.5 mg + 0.4 mg (0.5 mg/0.4 mg), hard capsules
Dutasteridum + Tamsulosini hydrochloridum
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific person. Do not pass it on to others. This medicine may harm another person, 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 of the leaflet:

What Duodart is and what it is used for
Important information before taking Duodart
How to take Duodart
Possible side effects
How to store Duodart
Contents of the pack and other information

1. What Duodart is and what it is used for

Duodart 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.
Duodart capsules contain a combination of two medicines: dutasteride and tamsulosin.
Dutasteride belongs to a group of medicines called 5-alpha-reductase inhibitors, and tamsulosin belongs to a group of medicines called alpha-adrenergic receptor antagonists.
An enlarged prostate gland may lead to problems with urination, such as difficulty passing urine and increased frequency of urination. There may also be reduced urine flow and a weak urine stream. If left untreated, complete blockage of urine flow (acute urinary retention) may occur. This condition requires immediate treatment. In some cases, surgery may be needed to remove the prostate gland or reduce its size.
Dutasteride reduces the production of a hormone called dihydrotestosterone, which leads to a reduction in the size of the prostate gland and relief of symptoms. By this action, dutasteride reduces the risk of acute urinary retention and the need for surgical intervention. Tamsulosin works by relaxing the muscles in the prostate gland, which improves urine flow and provides rapid symptom relief.

2. Important information before taking Duodart

When not to take Duodart

if the patient is allergic to dutasteride, other drugs in the 5-alpha-reductase inhibitor class, tamsulosin, soya, peanuts or any of the other ingredients of this medicine

(listed in section 6),

if the patient is a woman, since this medicine is intended only for men,
if the patient is a child or under 18 years of age,
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, do not take this medicine until you have consulted your doctor.

Warnings and precautions
Before starting Duodart, discuss this with your doctor.

In some clinical studies, heart failure was observed in a higher number of patients taking dutasteride together with a medicine belonging to a group called alpha-adrenergic receptor antagonists (such as tamsulosin), compared to patients taking dutasteride alone or an alpha-adrenergic receptor antagonist alone. Heart failure means the heart does not pump blood properly.
Inform your doctor if the patient has liver disease. If the patient has liver disease, additional tests may be required during treatment with Duodart.
Inform your doctor if the patient has kidney disease.
Cataract surgery (cloudy lens). If the patient is scheduled for surgical cataract removal, the doctor may advise temporarily stopping Duodart before the procedure. Inform the ophthalmologist before surgery if the patient is currently taking or has previously taken Duodart or tamsulosin. The doctor will take appropriate precautions to prevent complications during surgery.
Women, children and adolescents must not touch damaged Duodart capsules, 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 Duodart. 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.
Duodart affects the measurement of prostate-specific antigen (prostate specific antigen – PSA), which is sometimes tested to diagnose prostate cancer. Despite this, your doctor may deliberately order this test. If the patient is being tested for PSA levels, inform the doctor about taking Duodart. Patients taking Duodart should have their PSA levels monitored regularly.
In a clinical study involving patients with an 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 high-grade prostate cancer is not clear.
Duodart may cause breast enlargement and breast pain. 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.

If you have any questions about using Duodart, contact your doctor
or pharmacist.
Duodart with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking,
has recently taken, or plans to take.
Do not take Duodart with the following medicines:

other medicines in the class of alpha-adrenergic receptor antagonists (used to treat benign prostatic hyperplasia or high blood pressure)

It is not recommended to take Duodart with the following medicines:

ketoconazole (used to treat fungal infections) Some medicines may interact with Duodart and increase the risk of side effects. These include:
PDE5 inhibitors (used to induce or maintain 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 (an antidepressant)
cimetidine (used to treat peptic ulcer disease)
warfarin (used to treat blood clots)
erythromycin (an antibiotic used to treat infections)
paroxetine (an antidepressant)
terbinafine (used to treat fungal infections)
diclofenac (used to treat inflammatory conditions and pain)

Inform your doctor if the patient is taking any of these medicines.
Duodart with food and drink
Take Duodart 30 minutes after the same meal each day.
Pregnancy, breastfeeding and effects on fertility
Taking Duodart is contraindicated in women.
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.
Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking Duodart. If the partner is pregnant or may be pregnant, avoid exposing her to semen.
It has been shown that Duodart reduces sperm count, semen volume and sperm motility. This may lead to reduced fertility in men.
If a pregnant woman has been exposed to Duodart, contact a doctor immediately.
Driving and using machines
Duodart may cause dizziness in some patients, which may affect the ability to drive or operate machinery.
If such symptoms occur, do not drive or operate machinery.
Important information about some ingredients of Duodart
Duodart contains a colouring agent – sunset yellow (E 110), which may cause allergic reactions.
Duodart contains soya-derived lecithin. Do not use if hypersensitivity to peanuts or soya has been diagnosed.

3. How to use Duodart

This medicine should always be taken exactly as recommended by your doctor or pharmacist.
Irregular use of this medicine may affect PSA level test results. If in doubt, consult your doctor or pharmacist.
How much medicine to take
The recommended dose is one capsule taken once daily, 30 minutes after the same meal each day.
How to take the medicine
The capsule should be swallowed whole with water. Do not chew or open the capsule.
Contact with the capsule contents may cause mouth or throat irritation and pain.
Taking more Duodart than recommended
If you take more capsules than recommended, consult your doctor or pharmacist immediately.
If you forget to take Duodart
Do not take a double dose to make up for a forgotten dose. Take the next capsule at your usual time.
Stopping Duodart
Do not stop taking Duodart unless your doctor advises you to do so.
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 can cause adverse reactions, although they do not occur in everyone.

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 a doctor immediately and discontinue use of Duodart.

Dizziness, feeling faint and fainting
Duodart may cause dizziness or, in rare cases, fainting. Until you know how the medicine affects you, take care when changing position from lying or sitting to standing, especially when getting up during the night. If dizziness occurs at any time during treatment, sit or lie down and wait for symptoms to subside.

Serious skin reactions
Symptoms of a serious skin reaction 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 Duodart.

Common adverse reactions
May affect up to 1 in 10 men taking Duodart:

impotence (inability to achieve or maintain an erection)*
reduced sexual desire (libido)*
problems with ejaculation, including reduced volume of semen during ejaculation*
enlargement or tenderness of the breasts (gynaecomastia)
dizziness. * In a small number of individuals, these adverse reactions may persist even after stopping treatment with Duodart.

Uncommon adverse reactions
May affect up to 1 in 100 men taking Duodart:

heart failure (less efficient heart function. Symptoms may include shortness of breath, extreme fatigue, and swelling in the ankles and lower limbs)
low blood pressure when standing (orthostatic hypotension)
rapid heartbeat (palpitations)
constipation, diarrhoea, vomiting, nausea
weakness or loss of strength
headache
itching or stuffy nose, runny nose (nasopharyngitis)
skin rash, urticaria, itching
hair loss (usually body hair) or excessive hair growth.

Rare adverse reactions
May affect up to 1 in 1,000 men taking Duodart:

swelling of the eyelids, face, lips, hands or feet (angioedema)
fainting.

Very rare adverse reactions
May affect up to 1 in 10,000 men taking Duodart:

prolonged, painful erection of the penis (priapism)
serious skin reactions (Stevens-Johnson syndrome).

Other adverse reactions
Other adverse reactions have been reported in a small number of men, but their exact frequency is unknown (based on available data, frequency cannot be estimated):

irregular or rapid heartbeat (arrhythmia, tachycardia or atrial fibrillation)
difficulty breathing (dyspnoea)
depression
pain and swelling of the testicles
nosebleeds
severe skin rash
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, tell 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.

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

5. How to store Duodart

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines must 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 Duodart contains
The active substances are dutasteride and tamsulosin hydrochloride. Each capsule
contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride.
Other ingredients are:
Soft capsule with dutasteride: mono-di-glycerides of caprylic/capric acid,
butylhydroxytoluene (E 321); soft capsule shell: gelatin, glycerol, titanium dioxide (E 171), iron oxide yellow (E 172), medium-chain triglycerides, lecithin (may contain soybean oil).
Tamsulosin hydrochloride pellets: microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30% (containing polysorbate 80 and sodium lauryl sulfate), talc, triethyl citrate.
Hard capsule shell: carrageenan (E 407), potassium chloride, iron oxide red (E 172), titanium dioxide (E 171), hypromellose, carnauba wax, corn starch, sunset yellow FCF (E 110)
black ink SW-9010: shellac, propylene glycol, iron oxide black (E 172)
or black ink SW-9008: shellac, propylene glycol, iron oxide black (E 172), potassium hydroxide.
What Duodart looks like and contents of the pack
Duodart is a hard, elongated capsule with a brown body and an orange cap, printed in black ink with the code "GS 7CZ". The medicine is available in packs containing 30 capsules.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Spain, the country of export:
GlaxoSmithKline, S.A.
P.T.M. C/Severo Ochoa, 2
28760 Tres Cantos (Madrid)
Spain
Manufacturer:
Catalent Germany Schorndorf GmbH
Steinbeisstrasse 2
73614 Schorndorf
Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Spain, the country of export: 700698.5
Parallel import licence number: 225/22
This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Duodart - Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Iceland, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Slovak Republic, Spain
Combodart - Belgium, Estonia, France, Ireland, Lithuania, Luxembourg, Malta, Slovenia, United Kingdom