Prospect: information for the patient

DUPLOTRIP0.5 mg/0.4 mg hard EFG capsules

dutasteride/tamsulosin hydrochloride

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

• Keep this prospect, as you may need to read it again.
• 1. If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribed only to you, and you should not give it to other people 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 prospect. See section 4.

1.What is Duplotrip and what is it used for

2.What you need to know before starting to take Duplotrip

3.How to take Duplotrip

4.Possible adverse effects

5Storage of Duplotrip

6.Contents of the package and additional information

Duplotripis 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.

Duplotripis 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 a smaller and weaker urine stream. If benign prostatic hyperplasia is not treated, there is a risk of complete blockage of the urine flow(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 takeDuplotrip

-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 havesevere liver disease.

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

Warnings and precautions

Consult your doctor before starting to takeDuplotrip:

• 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 disease that affects your liver, you may need additional checks during your treatment withDuplotrip.

• 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 takingDuplotripfor a while before the surgery. Before the surgery, inform your ophthalmologist that you are takingthis medicationor 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 adolescentsmust avoid contact with brokenDuplotripcapsules, as the active ingredient can be absorbed through the skin.If there is any contact with the skin,the affected area must be washed immediatelywith water and soap.

• Use a condom during sex.Dutasteride has been found in the semen of men takingDuplotrip.If your partner is pregnant or may be pregnant, you must 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.

• Duplotripaffects PSA blood tests(prostate-specific antigen) used sometimes to detect prostate cancer.Sometimes your doctor may still use this test to detect prostate cancer, but they must know about this effect. If you have a blood test to determine your PSA, inform your doctor that you are takingDuplotrip.Men taking this medicationmust have regular PSA checks.

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

• Duplotripmay cause breast enlargement and tenderness.If this causes you discomfort, or if you noticelumps in the breastordischarge from the nipple, 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 doubts related to takingDuplotrip.

TakingDuplotripwith other medications

Inform your doctor or pharmacist if you aretaking, have takenrecentlyor may need to take any other medication.

Do not takeDuplotripwith these medications:

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

Do not takeDuplotripwith these medications:

-ketoconazole(used to treat fungal infections)

Certain medications may interactDuplotripor may cause you to experience side effects. Some of these medications are:

• phosphodiesterase type 5 inhibitors(used to achieve or maintain an erection) such as vardenafil, sildenafil citrate, and tadalafil
• verapamilor 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.

TakingDuplotripwith food and drinks

You must takethis medication30 minutes after the same meal every day.

Pregnancy,breastfeedingand fertility

Women should not takeDuplotrip

Women who are pregnant (or may be pregnant) must avoid contact with brokencapsules. 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.

?Consult your doctorif a pregnant woman has been in contact withDuplotrip.

Use a condom during sex.Dutasteride has been found in the semen of men takingthis medication.If your partner is pregnant or may be pregnant, you must avoid exposing her to your semen.

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

Driving and operating machinery

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

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

Duplotripcontains the following excipients

Yellow orange S

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

Soy lecithin

Duplotripcontains soy lecithin.Do not use this medication in case of allergy to peanuts or soy.

Sodium

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.If you do not takeDuplotripregularly, 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 every 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 moreDuplotripthan 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 takeDuplotrip

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

Do not interrupt the treatment ofDuplotripwithout advice

Do not interrupt the treatment withthis medicationwithout consulting your doctor first.

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

This medication, like all others, may 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(such as urticaria)
• swelling of the eyelids, face, lips, arms, or legs

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

Dizziness, lightheadedness, and fainting

This medicationmay 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 medication 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).

?Contact your doctor immediatelyif you have these symptoms andstop usingDuplotrip.

Common side effects(may affect up to 1 in 10 people)

• impotence(inability to achieve or maintain an erection)*
• decreased libido(sex drive)decreased*
• 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 stoppingDuplotrip.

(may affect up 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)
• reduced blood pressure when standing up
• abnormally fast heart rate (palpitations)
• constipation, diarrhea, vomiting, discomfort (nausea)
• weakness or loss of strength
• headache
• itching, congestion, or dripping nose (rhinitis)
• skin rash, hives, itching
• hair loss (usually on the body) or hair growth.

Rare side effects(may affect up to 1 in 1,000 people)

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

Very rare side effects(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 reduced number of patients, but their exact frequency is unknown (the frequency cannot be estimated from the available data):

• abnormal or accelerated 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:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging or bottle or blister pack after CAD.The expiration date is the last day of the month indicated.

For high-density polyethylene (HDPE) bottles, after the first opening, do not use for more than 6 weeks for 30-capsule bottles, and more than 18 weeks for 90-capsule bottles.

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications.By doing so, you will help protect the environment.

Composition ofDuplotrip

• The active principles aredutasteride and hydrochloride of tamsulosin.Each capsule contains0.5 mg of dutasteride and 0.4 mg of hydrochloride of tamsulosin.
• The other components(excipients)are:
• Capsule hard shell:hypromellose, carrageenan(E407),potassium chloride,titanium dioxide(E171),red iron oxide(E172),yellow orange S(E110).
• Inside the hard capsule:monocaprilocapratoofglyceryl andbutilhydroxytoluene(E321),gelatin, glycerol, titanium dioxide(E171),yellow iron oxide(E172),triglycerides (medium chain),lecithin (may contain soy oil)(E322),microcrystalline cellulose,copolymer of methacrylic acid and ethyl acrylate(1:1) dispersion 30%,copolymer of methacrylic acid and ethyl acrylate(1:1), magnesium stearate, sodium hydroxide, triacetin, talc, titanium dioxide (E171).

Appearance of the product and contents of the package

This medication is presented as hard, oblong capsules, approximately 24 mm in length, with a brown body and orange cap.

They are available in packages of 7, 30, and 90 capsules in high-density polyethylene (HDPE) bottles or in aluminum/aluminum blisters.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

GP-Pharm, S.A.

Industrial Estate Els Vinyets-Els Fogars

Sector 2, Ctra. C-244, km. 22

08777 Sant Quintí de Mediona,

Barcelona – Spain

Responsible manufacturer:

SAG MANUFACTURING, S.L.U.

Ctra. N-I, km 36

28750 San Agustín de Guadalix

Madrid – Spain

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

Spain

CYNDEA PHARMA, S.L.

Industrial Estate Emiliano Revilla Sanz,

Avenida de Ágreda, 31,

42110 Olvega, Soria - Spain

This medication is authorized in the member states of the European Economic Area with the following names:

MT: Duplotrip 0.5 mg/0.4 mg Hard Capsules

ES:DUPLOTRIP 0,5 mg/0,4 mg Hard Capsules EFG

Last review date of this leaflet:

10/2022

Further information on this medication is available on the website of theSpanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es