Package Insert: Information for the Patient

Duodart 0.5 mg/0.4 mg Hard Capsules

dutasteride/hydrochloride of tamsulosin

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

Duodart is a combination of two different medications called dutasteride and tamsulosin. Dutasteride belongs to a group of medications called5-alpha reductase inhibitorsand tamsulosin belongs to a group of medications calledalpha-blockers.

As the prostate grows in size, it can produce urinary problems such as difficulty in urinating and a need to urinate more frequently. It can also cause the urine stream to be smaller and less forceful. If benign prostatic hyperplasia is not treated, there is 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 reduce the size of the prostate and alleviate symptoms. This reduces the risk of acute urinary retention and the need for surgery. Tamsulosin acts by relaxing the muscles of the prostate, making urination easier and rapidly improving symptoms.

Do not takeDuodart:

-if you are awoman(because this medication is only for men)

-if you are achild or adolescent under 18 years of age

-if you are allergicto dutasteride,to other5-alpha reductase inhibitors, to tamsulosin, to soy, peanutsorto any of the other components of this medication(listed in section 6)

-if you havelow blood pressure, which makes you feel dizzy, lightheaded, or faint (orthostatic hypotension)

-if you have anyserious liver disease.

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

Warnings and precautions

Consult your doctor before starting to take Duodart.

• In some clinical studies, there were more patients taking dutasteride and another medication 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 is not pumping blood as it should.

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

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

• Cataract surgery (opaque crystalline lens).If you are going to have cataract surgery, your doctor may ask you to stop taking Duodart for a while before the surgery. Before the surgery, inform your ophthalmologist 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 surgery.

• 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, you should avoid exposing her to your semen, as dutasteride may affect the normal development of the male fetus. Dutasteride causes a decrease in sperm count, motility, and semen volume.This may reduce your fertility.

• Duodart affects PSA blood tests(prostate-specific antigen) used sometimes to detect prostate cancer.Your doctor may still use this test to detect prostate cancer, but they should know about this effect. If you have a blood test to determine your PSA, inform your doctor that you are taking Duodart.

Men taking Duodart should have regular PSA checks.

• In a clinical study conducted in men at increased risk of developing prostate cancer, men taking dutasteride hadmore frequently a type of severe prostate cancerthan those not taking dutasteride. The effect of dutasteride on this type of severe prostate cancer is unclear.

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

?Consult your doctor or pharmacistif you have any questions related to taking Duodart.

Use of Duodart with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Do not take Duodart with these medications:

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

Do not take Duodart with these medications:

• ketoconazole (used to treat fungal infections).

Certain medications may interact with Duodart, which may cause you to experience adverse effects. Some of these medications 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 HIV/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).

?Inform your doctorif you are taking any of these medications.

Taking Duodart with food and drinks

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

Pregnancy, breastfeeding, and fertility

Women should not takeDuodart.

Pregnant women (or those who may be pregnant) should avoid contact with broken capsules. Dutasteride is absorbed through the skin and may affect the normal development of the male fetus. This risk is especially important in the first 16 weeks of pregnancy.

Use a condom during sexual intercourse.Dutasteride has been found in the semen of men takingDuodart.If your partner is pregnant or thinks she may be pregnant, you should avoid exposing her 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 been in contact with Duodart.

Driving and operating machinery

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 yellow orange S (E110) and soy lecithin

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

Duodart contains soy lecithin. It should not be used in cases of allergy to peanuts or soy.

Follow exactly the administration instructions for this medication as indicated 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 break the capsules. Contact with the contents of the capsules 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Duodart

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

Do not interrupt Duodart treatment without advice

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

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

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

Allergic reaction

The symptoms of an allergic reaction may include:

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

?Contact your doctor immediatelyif you experience any of these symptoms andstop takingDuodart.

Dizziness, lightheadedness, and fainting

Duodart may cause dizziness, lightheadedness, and, in rare cases, fainting. You should be careful whengetting 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 experience lightheadedness during treatment,sit or lie down until these symptoms have disappeared.

Severe skin reactions

The signs of severe skin reactions may include:

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

?Contact your doctor immediatelyif you have these symptoms andstop using Duodart.

Common side effects

These may affectup to 1 in 10 people:

• impotence(inability to achieve or maintain an erection)*
• decreased libido*
• difficulty with ejaculation, such as a decrease in the amount of semen released during sexual intercourse*
• enlargement of the breasts and pain on palpation (gynecomastia)
• dizziness

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

These may affectup to 1 in 100 people:

• heart failure (the heart becomes less efficient at pumping blood throughout the body. This could cause symptoms such as difficulty breathing, excessive fatigue, and inflammation in the ankles and legs)
• reduction in blood pressure when standing up
• abnormal heart rhythm (arrhythmia or tachycardia or atrial fibrillation)
• constipation, diarrhea, vomiting, discomfort (nausea)
• weakness or loss of strength
• headache
• itching, nasal congestion or discharge (rhinitis)
• skin rash, hives, itching
• hair loss (usually on the body) or hair growth

Rare side effects

These may affectup to 1 in 1,000 people:

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

Very rare side effects

These may affectup 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 reduced number of patients, but their exact frequency is unknown (the frequency cannot be estimated from the available data):

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and in the bottle. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need.By doing so, you will help protect the environment.

Composition of Duodart

The active principles are dutasteride and hydrochloride of tamsulosin.Each capsule contains0.5 mg of dutasteride and 0.4 mg of hydrochloride of tamsulosin.

The other components are:

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

Appearance of the product and contents of the package

This medicine is presented inhard, oblong capsules, with brown body and orange cap printed with GS 7CZ in black ink. It is available in packages of 7, 30 and 90 capsules.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

GlaxoSmithKline, S.A.

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

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Responsible for manufacturing:

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 member states of the European Economic Area with 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 last review of this leaflet:August 2023

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