Duodart

Package Leaflet: Information for the User

Duodart, 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.

• This leaflet should be kept, so it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. 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 pack 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 contain 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.
Enlargement of the 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, surgical intervention may be necessary to remove the prostate gland or reduce its size.
Dutasteride reduces the production of the hormone dihydrotestosterone, which reduces the size of the prostate gland and alleviates 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 quickly relieving 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.),
• , as this medicine is only intended for men,
• ,
• , causing dizziness or fainting (orthostatic hypotension),
• . If any of the above apply to the patient, they should not take this medicineuntil they have consulted their doctor.

Warnings and precautions

Before starting treatment with Duodart, the doctor should be consulted.

• 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 patients taking dutasteride alone or an alpha-adrenergic receptor antagonist alone. Heart failure means the heart is not pumping blood properly.
• The doctor should be informed if the patient has liver disease. If the patient has had liver disease, additional tests may be necessary while taking Duodart.
• The doctor should be informed if the patient has kidney disease.
• Cataract surgery (cloudy lens). If the patient is scheduled for cataract surgery, the doctor may recommend stopping Duodart for a period before the surgery. The ophthalmologist should be informed if the patient is taking or has taken Duodart or tamsulosin in the past. The doctor will take appropriate precautions to prevent complications during surgery.
• Women, children, and adolescentsshould 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 immediatelywith soap and water.
• A condom should be used during sexual intercourse. Dutasteride has been found in the semen of men taking Duodart. If the partner is pregnant or may become pregnant, they should avoid exposure to semen, as 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.
• 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 aggressive prostate cancer more oftenthan patients not taking dutasteride. The effect of dutasteride on aggressive prostate cancer is unclear.
• Duodart may cause breast enlargement and tenderness. If these symptoms become bothersome or if breast lumpsor discharge from the nippleoccur, the patient should contact 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 contact
their doctor or pharmacist.

Duodart and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
Duodart should not be taken 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 doctor should be informedif the patient is taking any of these medicines.

Duodart with food and drink

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

Pregnancy, breastfeeding, and fertility

Taking Duodart is contraindicated in women.

Women who are pregnant (or may become pregnant) should not touch 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.
A condom should be used during sexual intercourse. Dutasteride has been found in the semen of men taking Duodart. If the partner is pregnant or may become pregnant, they should avoid exposure 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 come into contact with Duodart, she should contact her doctor.

Driving and using machines

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

Important information about some ingredients of Duodart

Duodart contains a colorant – orange yellow (E110), which may cause allergic reactions.
Duodart contains soy 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 doctor or pharmacist should be consulted.

How much 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. 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 prescribed

In case of taking more Duodart capsules than prescribed, the doctor or pharmacist should be consulted.

Missing a dose of Duodart

A double dose should not be taken to make up for a missed dose.
The next capsule should be taken at the usual time.

Stopping treatment with Duodart

Treatment with Duodart should not be stopped unless the doctor recommends it.
In case of any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

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 doctor should be contacted immediately and Duodart treatment should be stopped.

Dizziness, feeling dizzy, and fainting

Duodart may cause dizziness or, in rare cases, fainting. Until it is known how the medicine affects the patient, they should be cautious when changing body position from lying 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.

Severe skin reactions

Symptoms of a severe 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 doctor should be contacted immediately and Duodart treatment should be stopped.

Common side effects

May occur in up to 1 in 10 men taking Duodart:

• impotence (inability to achieve or maintain an erection )*
• decreased libido (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

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

May occur in up to 1 in 1,000 men taking Duodart :

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

Very rare side effects

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

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

Other side effects

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

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

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Duodart

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiration date stated on the carton and bottle after: EXP. The expiration date refers to the last day of the month.
The batch number is stated on the packaging after the abbreviation "Lot".
Duodart should not be stored above 30 ° C.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked 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 of Duodart are dutasteride and tamsulosin hydrochloride. Each capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride.
The other ingredients are:

• hard capsule: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide (E171), iron oxide red (E172), orange yellow (E110), carnauba wax, cornstarch,
• inside the hard capsule: mono-di-glycerides of caprylic/capric acid and butylhydroxytoluene (E321), gelatin, glycerol, titanium dioxide (E171), iron oxide yellow (E172), medium-chain triglycerides, lecithin (may contain soybean oil), microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer (containing polysorbate 80 and sodium lauryl sulfate), talc, triethyl citrate,
• black ink (SW-9010 or SW-9008): shellac, propylene glycol, iron oxide black (E172), potassium hydroxide (only in black ink SW-9008).

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 or 90 capsules. Not all pack sizes may be available in every country.

Marketing authorization holder and manufacturer

Marketing authorization holder:

GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland

Manufacturer:

Catalent Germany Schorndorf GmbH
Steinbeisstrasse 1 i 2
73614 Schorndorf
Germany

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

Duodart -Austria, Bulgaria, Cyprus, Finland, Greece, Spain, Iceland, Germany, Norway, Poland,
Romania, Czech Republic, Slovakia, Hungary,
Combodart-Belgium, Denmark, Estonia, France, Netherlands, Ireland, Lithuania, Luxembourg, Latvia, Malta,
Portugal, Slovenia, Italy
To obtain more detailed information on this medicine, the representative of the marketing authorization holder should be contacted.
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
Phone: + 48 22 576 9000

Date of last revision of the leaflet: January 2025