Duodart 0.5 mg/0.4 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Duodart 0.5 mg/0.4 mg hard capsules

dutasteride/tamsulosin hydrochloride

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could be harmful to them.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet contents

1. What Duodart is and what it is used for
2. What you need to know 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 Duodart is and what it is used for

Duodart is used in men to treat an enlarged prostate (benign prostatic hyperplasia) – a non-cancerous growth of the prostate caused by overproduction of a hormone called dihydrotestosterone.

Duodart is a combination of two different medicines called dutasteride and tamsulosin. Dutasteride belongs to a group of medicines known as 5-alpha reductase inhibitors, and tamsulosin belongs to a group of medicines known as alpha-blockers.

As the prostate enlarges, it can cause urinary problems such as difficulty in passing urine and a need to urinate more frequently. It may also cause the urine stream to become weaker and less forceful. If benign prostatic hyperplasia is not treated, there is a risk that urine flow may become completely blocked (acute urinary retention), which requires immediate medical treatment. In some cases, surgery may be necessary to reduce the size of the prostate or to remove it.

Dutasteride reduces the production of dihydrotestosterone, helping to shrink the size of the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgery. Tamsulosin works by relaxing the muscles in the prostate, making it easier to urinate and rapidly improving symptoms.

2. What you need to know before starting Duodart

Do not take Duodart:

• if you are a woman (because this medicine is only for men)
• if you are a child or adolescent under 18 years of age
• if you are allergic to dutasteride, to other inhibitors of the enzyme 5-alpha reductase, to tamsulosin, to soya, to peanuts, or to any of the other components of this medicine (listed in section 6)
• if you have low blood pressure, which makes you feel dizzy, lightheaded, or causes fainting (orthostatic hypotension)
• if you have severe liver disease.

? If you think you have any of these conditions, do not take this medicine until you have consulted your doctor.

Warnings and precautions

Talk to your doctor before starting to take Duodart.

• In some clinical studies, there was a higher number of patients taking dutasteride and another medicine called an alpha blocker, such as tamsulosin, who experienced heart failure compared to patients taking only dutasteride or only an alpha blocker. Heart failure means that your heart does not pump blood as well as it should.

• Make sure your doctor knows if you have liver problems. If you have any condition affecting your liver, you may need additional monitoring during treatment with Duodart.

• Make sure your doctor knows if you have severe kidney problems.

• Cataract surgery (cloudy lens). If you are scheduled for cataract surgery, your doctor may ask you to stop taking Duodart for a period of time before the operation. Before the surgery, inform your ophthalmologist that you are taking Duodart or tamsulosin (or have taken them previously). Your specialist will need to take appropriate precautions to avoid complications during surgery.

• Women, children, and adolescents should avoid contact with broken Duodart capsules, as the active ingredient can be absorbed through the skin. If any contact with the skin occurs, the affected area must be washed immediately with soap and water.

• Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Duodart. If your partner is pregnant or suspects she might be pregnant, you must avoid exposing her to your semen, as dutasteride may affect the normal development of a male baby. Dutasteride causes a decrease in sperm count, sperm motility, and semen volume. This may reduce your fertility.

• Duodart affects the serum PSA test (prostate-specific antigen), which is sometimes used to detect prostate cancer. Your doctor may still use this test to detect prostate cancer, but must be aware of this effect. If you have a blood test to measure your PSA, inform your doctor that you are taking Duodart.

Men being treated with Duodart should have regular PSA monitoring.

• In a clinical study conducted in men at increased risk of developing prostate cancer, men who took dutasteride developed a more frequent occurrence of a more severe type of prostate cancer than those who did not take dutasteride. The effect of dutasteride on this severe type of prostate cancer is not clear.

• Duodart may cause breast enlargement and tenderness. If this causes discomfort, or if you notice lumps in the breast or nipple discharge, consult your doctor, as these changes may be signs of a serious condition, such as breast cancer.

Mood changes and depression

Depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with another medicine in the same therapeutic class (oral 5-alpha-reductase inhibitor). If you experience any of these symptoms, contact your doctor as soon as possible for further medical advice.

?Talk to your doctor or pharmacist if you have any questions about taking Duodart.

Taking Duodart with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take Duodart with these medicines:

• other alpha blockers (for enlarged prostate or high blood pressure).

Taking Duodart is not recommended with these medicines:

• ketoconazole (used to treat fungal infections).

Certain medicines may interact with Duodart, increasing the risk of adverse effects. Some of these medicines are:

• PDE5 enzyme inhibitors (used to achieve or maintain an erection), such as vardenafil, sildenafil citrate, and tadalafil
• verapamil or diltiazem (for high blood pressure)
• ritonavir or indinavir (for AIDS)
• itraconazole or ketoconazole (for fungal infections)
• nefazodone (an antidepressant)
• cimetidine (for stomach ulcers)
• warfarin (for blood clotting)
• erythromycin (an antibiotic used to treat infections)
• paroxetine (an antidepressant)
• terbinafine (used to treat fungal infections)
• diclofenac (used to treat pain and inflammation).

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

Taking Duodart with food and drink

You should take Duodart 30 minutes after the same meal each day.

Pregnancy, breastfeeding, and fertility

Women must not take Duodart.

Pregnant women (or those who may be pregnant) must avoid contact with broken capsules. Dutasteride can be absorbed through the skin and may affect the normal development of a male baby. This risk is particularly important during the first 16 weeks of pregnancy.

Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Duodart. If your partner is pregnant or suspects she might be pregnant, you must avoid exposing her to your semen.

It has been shown that Duodart reduces sperm count, sperm motility, and semen volume. This may reduce your fertility.

?Consult your doctor if a pregnant woman has been exposed to Duodart.

Driving and using machines

Some people may experience dizziness during treatment with Duodart, which could affect their ability to drive or operate machinery safely.

?Do not drive or operate machinery if you are affected in this way.

Duodart contains sunset yellow FCF (E110) and soya lecithin

This medicine may cause allergic reactions because it contains sunset yellow FCF (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Duodart contains soya lecithin. It must not be used if you are allergic to peanuts or soya.

3. How to take Duodart

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If you do not take Duodart regularly, monitoring of your PSA levels may be affected. If in doubt, consult your doctor or pharmacist again.

What dose should you take

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

How to take it

The capsules must be swallowed whole, with water. Do not chew or open the capsules. Contact with the capsule contents may irritate your mouth or throat.

If you take more Duodart than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Duodart

Do not take a double dose to make up for missed doses. Take the next dose at your usual time.

Do not stop Duodart treatment without advice

Do not stop treatment with Duodart without first consulting your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Allergic reaction

Symptoms of an allergic reaction may include:

• skin rash (which may be itchy)
• hives (like urticaria)
• swelling of the eyelids, face, lips, arms, or legs

? Contact your doctor immediately if you experience any of these symptoms and stop taking Duodart.

Dizziness, lightheadedness, and fainting

Duodart may cause dizziness, lightheadedness, and, rarely, fainting. You should be cautious when standing up quickly after sitting or lying down, especially if you need to get up during the night, until you know how this medicine affects you. If you feel dizzy or experience lightheadedness during treatment, sit or lie down until these symptoms have passed.

Severe skin reactions

Signs of severe skin reactions may include:

• widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)

? Contact your doctor immediately if you have these symptoms and stop using Duodart.

Frequent adverse effects

These may affect up to 1 in 10 people:

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

• decreased sex drive (libido)*

• problems with ejaculation, such as reduced amount of semen released during sexual intercourse*

• enlargement of the breast and tenderness to touch (gynecomastia)

• dizziness

• In a small number of people, some of these adverse events may continue after stopping Duodart.

Uncommon adverse effects

These may affect up to 1 in 100 people:

• heart failure (the heart becomes less efficient at pumping blood around the body. This may cause symptoms such as difficulty breathing, excessive tiredness, and swelling in the ankles and legs)
• reduction in blood pressure upon standing
• faster than normal heartbeat (palpitations)
• constipation, diarrhoea, vomiting, feeling sick (nausea)
• weakness or loss of strength
• headache
• itching, stuffy or runny nose (rhinitis)
• skin rash, hives, itching
• hair loss (usually body hair) or hair growth

Rare adverse effects

These may affect up to 1 in 1,000 people:

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

Very rare adverse effects

These may affect up to 1 in 10,000 people:

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

Other adverse effects

Other adverse effects have occurred in a small number of patients, but their exact frequency is unknown (frequency cannot be estimated from the available data):

• abnormal or rapid heartbeat (arrhythmia, tachycardia, or atrial fibrillation)
• difficulty breathing (dyspnea)
• depression
• pain and swelling in the testicles
• nosebleeds
• severe skin rash
• changes in vision (blurred vision or visual disturbances)
• dry mouth

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Duodart

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the bottle. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE Point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Duodart

The active substances are dutasteride and tamsulosin hydrochloride. Each capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride.

The other components are:

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

Appearance of the product and contents of the pack

This medicine is presented as oblong, hard capsules with a brown body and orange cap, printed with "GS 7CZ" in black ink. It is available in packs of 7, 30 and 90 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

GlaxoSmithKline, S.A.
P.T.M. C/ Severo Ochoa, 2
28760 Tres Cantos (Madrid)
Tel: +34 900 202 700
[email protected]

Manufacturer:

Catalent Germany Schorndorf GmbH
Steinbeisstrasse 1 and 2
73614 Schorndorf
Germany

Local representative:

Casen Recordati, S.L.
Autovía de Logroño, Km 13,300
50180 Utebo (Zaragoza)
Spain

This medicine is authorized in the European Economic Area (EEA) member states under the following names:

Duodart – Austria, Bulgaria, Cyprus, Czech Republic, Finland, Germany, Greece, Hungary, Iceland, Norway, Poland, Romania, Slovak Republic, Spain.

Combodart – Belgium, Denmark, Estonia, Italy, Latvia, Netherlands, France, Ireland, Lithuania, Luxembourg, Malta, Portugal, Slovenia.

Date of the most recent review of this leaflet: September 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es