DUODART 0.5 mg/0.4 mg Capsules

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
3. Duodart
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Duodart and what is it used for
5. Important information before taking Duodart
   1. When not to take Duodart
   2. Warnings and precautions
   3. Duodart and other medicines
   4. Duodart with food and drink
   5. Pregnancy, breastfeeding, and fertility
   6. Women who are pregnant (or may become pregnant) should not handle damaged capsules.
   7. Driving and using machines
   8. Important information about some ingredients of Duodart
6. How to take Duodart
   1. How much to take
   2. The recommended dose is one capsule taken once a day, 30 minutes after the same meal every day.
   3. How to take it
   4. Taking more Duodart than recommended
   5. Missing a dose of Duodart
   6. Stopping treatment with Duodart
7. Possible side effects
   1. Like all medicines, Duodart can cause side effects, although not everybody gets them.
   2. Allergic reactions
   3. Dizziness, feeling faint, and fainting
   4. Serious skin reactions
   5. Common side effects
   6. Uncommon side effects
   7. Rare side effects
   8. Very rare side effects
   9. Other side effects
   10. Reporting side effects
8. How to store Duodart
9. Contents of the packaging and other information
   1. What Duodart contains
   2. Other ingredients are:
   3. What Duodart looks like and contents of the pack
   4. Marketing authorization holder in Spain, the country of export:
   5. Manufacturer:
   6. Parallel importer:
   7. Repackaged by:
   8. Parallel import authorization number: 225/22
   9. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Duodart

0.5 mg + 0.4 mg (0.5 mg/0.4 mg), hard capsules
Dutasteride + Tamsulosin hydrochloride

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 necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 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 Duodart and what is it used for
• 2. Important information before taking Duodart
• 3. How to take Duodart
• 4. Possible side effects
• 5. How to store Duodart
• 6. Contents of the packaging and other information

1. What is Duodart and what is it 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.
The Duodart capsules are a combination of two other 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 can lead to problems with urination, such as difficulty urinating and frequent urination. There may also be 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 the prostate gland or reduce its size.
Dutasteride reduces the production of the hormone dihydrotestosterone, which leads to a reduction in the size of the prostate gland and alleviation of symptoms. By doing so, dutasteride reduces the risk of acute urinary retention and the need for surgical intervention. The action of tamsulosin involves relaxing the muscles in the prostate gland, making it easier to urinate and providing quick relief from symptoms.

2. Important information before taking Duodart

When not to take Duodart

• or any of the other ingredients of this medicine (listed in section 6.),

(see section 6.),

• , as this medicine is only intended for men,
• ,
• , causing dizziness or fainting ( orthostatic hypotension),
• . If any of the above applies to the patient, they should not take this medicineuntil they have consulted a doctor.

Warnings and precautions

Before starting treatment with Duodart, the patient should discuss it with their doctor.

• In some clinical trials, it was found that more patients taking dutasteride with an alpha-adrenergic receptor antagonist (such as tamsulosin) experienced heart failure than those taking dutasteride alone or an alpha-adrenergic receptor antagonist alone. Heart failure means that the heart does not pump blood properly.
• The patient should inform their doctor if they have liver disease. If the patient has had liver disease, they may need to have additional tests while taking Duodart.
• The patient should inform their doctor if they have kidney disease.
• Cataract surgery (cloudy lens). If the patient is scheduled to have cataract surgery, their doctor may recommend stopping Duodart for a while before the surgery. The patient should inform their ophthalmologist if they are taking or have taken Duodart or tamsulosin in the past. The doctor will take appropriate precautions to prevent complications during surgery.
• Women, children, and adolescentsshould not handle damaged Duodart capsules, as the active substance may be absorbed through the skin. In case of skin contact, the affected area should be washed immediately with soap and water.
• The patient should use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Duodart. If the partner is pregnant or may become pregnant, the patient should avoid exposing them to semen. It has been shown that dutasteride can disrupt the development of a male fetus.
• Duodart affects the measurement of prostate-specific antigen (PSA), which is sometimes performed to diagnose prostate cancer. However, the doctor may still order this test. If the patient's PSA level is being measured, they should inform their doctor that they are taking Duodart. Patients taking Duodart should have their PSA level checked regularly.
• In a clinical trial involving patients with an increased risk of prostate cancer, patients taking dutasteride were diagnosed with high-grade prostate cancer more frequentlythan those not taking dutasteride. The effect of dutasteride on high-grade prostate cancer is not clear.
• Duodart may cause breast enlargement and tenderness. If these symptoms become troublesome or if the patient experiences breast lumps or nipple discharge, they should consult their doctor, as these may be symptoms of a serious condition, such as breast cancer.

In case of questions about taking Duodart, the patient should consult their doctor or pharmacist.

Duodart and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should not take Duodart with the following medicines:

• other alpha-adrenergic receptor antagonists(used to treat enlarged prostate or high blood pressure)

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

• ketokonazole(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 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 ketokonazole(used to treat fungal infections)
• nefazodone(an antidepressant)
• cimetidine(used to treat stomach ulcers)
• 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)

The patient should inform their doctorif they are taking any of these medicines.

Duodart with food and drink

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

Pregnancy, breastfeeding, and fertility

Taking Duodart during pregnancy is contraindicated.

Women who are pregnant (or may become pregnant) should not handle damaged capsules.

Dutasteride is absorbed through the skin and may disrupt the development of a male fetus. There is a particular risk during the first 16 weeks of pregnancy.
The patient should use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Duodart. If the partner is pregnant or may become pregnant, the patient should avoid exposing them to semen.
It has been shown that Duodart can reduce sperm count, semen volume, and sperm motility. This may lead to reduced fertility in men.
If a pregnant woman has come into contact with Duodart, she should consult her doctor.

Driving and using machines

In some patients, Duodart may cause dizziness, which may negatively affect the ability to drive or operate machinery.
If such symptoms occur, the patient should not drive or operate machinery.

Important information about some ingredients of Duodart

Duodart contains a coloring agent – orange yellow S (E 110), which may cause allergic reactions.
Duodart contains soybean lecithin. It should not be taken in case of known hypersensitivity to peanuts or soy.

3. How to take Duodart

This medicine should always be taken as directed by the doctor or pharmacist. Irregular intake of the medicine may affect the results of PSA level tests. In case of doubts, the patient should consult their doctor or pharmacist.

How much to take

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

How to take it

The capsule should be swallowed whole with water. The capsules should not be chewed or opened.
Contact with the contents of the capsules may cause mouth or throat pain.

Taking more Duodart than recommended

If more Duodart capsules than recommended are taken, the patient should consult their doctor or pharmacist.

Missing a dose of Duodart

The patient should not take a double dose to make up for a missed dose. They should take the next capsule at the usual time.

Stopping treatment with Duodart

The patient should not stop taking Duodart unless their doctor recommends it.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Duodart 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 their doctor immediately and stop taking Duodart.

Dizziness, feeling faint, and fainting

Duodart may cause dizziness or, in rare cases, fainting. Until it is known how the medicine affects the patient, they should be careful when changing positions from lying down or sitting to sitting or standing, especially when getting up at night. If dizziness occurs at any time during treatment, the patient should sit or lie down and wait for the symptoms to pass.

Serious skin reactions

Symptoms of a serious skin reaction may include:

• widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals(Stevens-Johnson syndrome) If any of these symptoms occur, the patient should contact their doctor immediately and stop taking Duodart.

Common side effects

These may occur in up to 1 in 10 men taking Duodart:

• impotence (inability to achieve or maintain an erection)*
• decreased sex drive (libido)*
• difficulty with ejaculation, including reduced semen volume during ejaculation*
• breast enlargement or tenderness (gynecomastia)
• dizziness. * In a small number of men, these side effects may persist even after stopping Duodart.

Uncommon side effects

These may occur in up to 1 in 100 men taking Duodart:

• heart failure (less efficient heart function, which may cause symptoms such as shortness of breath, extreme fatigue, 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
• itching or blocked nose, runny nose ( rhinitis)
• skin rash, hives, itching
• hair loss (usually body hair) or excessive hair growth.

Rare side effects

These may occur in up to 1 in 1000 men taking Duodart:

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

Very rare side effects

These may occur in up to 1 in 10,000 men taking Duodart:

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

Other side effects

Other side effects have occurred in a small number of men, but their exact frequency is unknown (based on available data, the frequency cannot be estimated):

• abnormal or rapid heart rhythm (arrhythmia, tachycardia, or atrial fibrillation)
• difficulty breathing (dyspnea)
• depression
• testicular pain and swelling
• nosebleeds
• severe skin rash
• vision changes (blurred vision or eye problems)
• dry mouth.

Reporting side effects

If the patient experiences any side effects, including any 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, Ministry of Health, via phone: +48 22 49 21 301, fax: +48 22 49 21 309, or website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Duodart

The medicine should be stored out of sight and reach of children.
The patient should not take this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The medicine should not be stored above 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the packaging and other information

What Duodart contains

The active substances of Duodart 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), yellow iron oxide (E 172), medium-chain triglycerides, lecithin (may contain soybean oil).
Pellets with tamsulosin hydrochloride: microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (contains polysorbate 80 and sodium lauryl sulfate), talc, triethyl citrate.
Hard capsule shell:carrageenan (E 407), potassium chloride, red iron oxide (E 172), titanium dioxide (E 171), hypromellose, carnauba wax, cornstarch, orange yellow S (E 110)
black ink SW-9010:shellac, propylene glycol, black iron oxide (E 172)
or black ink SW-9008: shellac, propylene glycol, black iron oxide (E 172), potassium hydroxide.

What Duodart looks like and contents of the pack

Duodart is a hard capsule with a brown body and an orange cap, with a black ink print. Duodart is available in packs of 30 capsules.
For more detailed information, the patient should consult the marketing authorization holder or parallel importer.

Marketing authorization 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 by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Spain, the country of export:700698.5

Parallel import authorization number: 225/22

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Duodart -Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Iceland, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain
Combodart -Belgium, Estonia, France, Ireland, Lithuania, Luxembourg, Malta, Slovenia, United Kingdom
Date of leaflet approval: 20.05.2022
[Information about the trademark]