DUODART 0.5 mg/0.4 mg HARD CAPSULES

Introduction

Patient Information Leaflet

Duodart 0.5 mg/0.4 mg hard capsules

dutasteride/hydrochloride tamsulosin

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Duodart and what is it used for
2. What you need to know before you take Duodart
3. How to take Duodart
4. Possible side effects
5. Storage of Duodart
6. Contents of the pack and other information

1. What is Duodart and what is it 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 called 5-alpha reductase inhibitorsand tamsulosin belongs to a group of medicines called alpha-blockers.

As the prostate grows, it can cause urinary problems such as difficulty in the flow of urine and a need to urinate more often. It can also cause the urine stream to be weaker. If left untreated, benign prostatic hyperplasia can lead to a risk of the urine flow being completely blocked (acute urinary retention). This 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, which helps to shrink 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 quickly improving symptoms.

2. What you need to know before you take 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, other 5-alpha reductase inhibitors, tamsulosin, soy, peanut, or any of the other ingredients of this medicine (listed in section 6)
• if you have low blood pressure, which makes you feel dizzy, lightheaded, or faint (orthostatic hypotension)
• if you have severe liver disease.

If you think you may have any of these conditions, do not take this medicine until you have spoken to your doctor.

Warnings and precautions

Consult 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 who took only dutasteride or only an alpha-blocker. Heart failure means that your heart does not pump blood as it should.

• Make sure your doctor knows if you have liver problems. If you have any disease that affects your liver, you may need some additional checks during your treatment with Duodart.

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

• Cataract surgery (cloudy lens). If you are going to have cataract surgery, your doctor may ask you to stop taking Duodart for a while before the operation. Before the operation, tell your eye specialist that you are taking Duodart or tamsulosin (or if you have taken them before). Your specialist will need to take the necessary precautions to avoid complications during the operation.

• Women, children, and adolescentsshould avoid contact with broken Duodart capsules, as the active ingredient can be absorbed through the skin. If there is any contact with the skin, the affected area should be washed immediatelywith water and soap.

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

• Duodart affects the PSA blood test(prostate-specific antigen) that is sometimes used to detect prostate cancer. Your doctor may still use this test to detect prostate cancer, although they should be aware of this effect. If you have a blood test to check your PSA, tell your doctor that you are taking Duodart.

Men taking Duodart should have regular PSA checks.

• In a clinical study in men at high risk of prostate cancer, men who took dutasteride had a higher incidence of high-grade prostate cancerthan those who did not take dutasteride. The effect of dutasteride on this type of high-grade prostate cancer is not clear.

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

Consult your doctor or pharmacistif you have any questions about taking Duodart.

Using Duodart with other medicines

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

Do not take Duodart with these medicines:

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

It is not recommended to take Duodart with these medicines:

• ketoconazole (used to treat fungal infections).

Certain medicines may interact with Duodart, which may increase the risk of you experiencing side effects. Some of these medicines are:

• PDE5 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 doctorif 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 takeDuodart.

Pregnant women (or women who may be pregnant) should avoid contact with broken Duodart capsules. Dutasteride is absorbed through the skin and may affect the normal development of a male baby. This risk is especially 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 thinks she may be pregnant, she should avoid exposure to your semen.

Duodart has been shown to decrease sperm count, motility, and semen volume. This may reduce your fertility.

Consult your doctorif a pregnant woman has come into contact with Duodart.

Driving and using machines

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

Do not drive or operate machineryif you are affected in this way.

Duodart contains orange yellow S (E110) and soy lecithin

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

Duodart contains soy lecithin. It must not be used in case of peanut or soy allergy.

3. How to take Duodart

Follow exactly the instructions of administration of this medicine given to you by your doctor or pharmacist. If you do not take Duodart regularly, the control of your PSA levels may be affected. In case of doubt, consult your doctor or pharmacist again.

What dose should you take

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

How to take it

The capsules should be swallowed whole, with water. Do not chew or open the capsules. Contact with the contents of the capsules can 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, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Duodart

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

Do not stop taking Duodart without advice

Do not stop taking Duodart without consulting your doctor first.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reaction

The symptoms of an allergic reaction can include:

• skin rash(which may itch)
• hives(like nettle rash)
• swelling of the eyelids, face, lips, arms, or legs

Contact your doctor immediatelyif you experience any of these symptoms and stop taking Duodart.

Dizziness, lightheadedness, and fainting

Duodart may cause dizziness, lightheadedness, and, in rare cases, fainting. You should be careful when getting up quickly after sitting or lying down, especially if you have to get up during the night, until you know how this medicine affects you. If you feel dizzy or lightheaded during treatment, sit or lie down until these symptoms have disappeared.

Severe skin reactions

The signs of severe skin reactions can include:

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

Contact your doctor immediatelyif you have these symptoms and stop using Duodart.

Common side effects

These may affect up to 1 in 10 people:

• impotence (inability to achieve or maintain an erection)*
• decreased sex drive (libido)*
• difficulty with ejaculation, such as a decrease in the amount of semen released during sexual intercourse*
• breast enlargement and breast tenderness (gynaecomastia)
• dizziness

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

Uncommon side effects

These may affect up to 1 in 100 people:

• heart failure (the heart becomes less efficient at pumping blood around the body. This could lead to symptoms such as difficulty breathing, excessive tiredness, and swelling in the ankles and legs)
• reduced blood pressure when standing up
• fast heart rate (palpitations)
• constipation, diarrhea, vomiting, nausea
• weakness or loss of strength
• headache
• itching, stuffy or runny nose (rhinitis)
• skin rash, hives, itching
• hair loss (usually from the body) or hair growth

Rare side effects

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

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

Very rare side 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 side effects

Other side effects have been reported in a small number of patients, but their frequency is not known (the frequency cannot be estimated from the available data):

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: https://www.notificaRAM.es. By reporting side 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 which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 ingredients are:

• capsule shell: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide (E171), red iron oxide (E172), orange yellow S (E110), carnauba wax, corn starch
• inside the capsule shell: mono- and diglycerides of capric/caprylic acid, butylhydroxytoluene (E321), gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), medium-chain triglycerides, soy lecithin (may contain soybean oil), microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer (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 and packaging

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

es-ci@gsk.com

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 authorised in the Member States of the European Economic Area under the following names:

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

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

Date of last revision of this leaflet:August 2023

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