DUPLOTRIP 0.5 mg/0.4 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

DUPLOTRIP0.5 mg/0.4 mg hard capsules EFG

dutasteride/tamsulosin hydrochloride

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.
• 1. 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 Duplotrip is and what it is used for
2. What you need to know before you take Duplotrip
3. How to take Duplotrip
4. Possible side effects

5 Storage of Duplotrip

1. Contents of the pack and other information

1. What Duplotrip is and what it is used for

Duplotrip 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.

Duplotrip is a combination of two different medicines called dutasteride and tamsulosin.

Dutasteride belongs to a group of medicines called 5-alpha reductase enzyme 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 frequently. It can also cause the stream of urine to be weaker. If benign prostatic hyperplasia is not treated, there is a risk that the flow of urine will be 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 relieve symptoms. This reduces the risk of acute urinary retention and the need for surgery. Tamsulosin works by relaxing the muscles of the prostate, making it easier to urinate and quickly improving symptoms.

2. What you need to know before you take Duplotrip

Do not takeDuplotrip

• 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 allergicto dutasteride, to other 5-alpha reductase enzyme inhibitors, to tamsulosin, to soy, peanutor to 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 takethis medicine until you have consulted your doctor.

Warnings and precautions

Consult your doctor before starting to take Duplotrip:

• In some clinical studies, there were more 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 Duplotrip.

• 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 Duplotrip for a while before the operation. Before the operation, tell your ophthalmologist that you are taking this medicine 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 Duplotrip 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 Duplotrip. If your partner is pregnant or thinks she may be pregnant, you should avoid exposing her to your semen.

• Duplotripaffects the PSA blood test(prostate-specific antigen) that is sometimes used to detect prostate cancer. Your doctor can 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 Duplotrip. Men taking this medicineshould 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.

• Duplotripmay cause breast enlargement and breast tenderness. If this causes you discomfort, or if you notice breast lumpsor 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 Duplotrip.

TakingDuplotrip withother medicines

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

Do not take Duplotrip with these medicines:

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

It is not recommended to take Duplotrip with these medicines:

• ketoconazole (used to treat fungal infections)

Certain medicines may interact with Duplotrip or increase the risk of side effects. Some of these medicines are:

• PDE5 inhibitors(used to achieve or maintain an erection) such as vardenafil, sildenafil citrate, and tadalafil
• verapamilor diltiazem(for high blood pressure)
• ritonaviror indinavir(for AIDS)
• itraconazoleor 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.

TakingDuplotrip withfood and drinks

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

Pregnancy, breast-feeding, and fertility

Women must not takeDuplotrip

Pregnant women (or women who may be pregnant) must avoid contact with broken 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.

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

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

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

Driving and using machines

Some people may experience dizziness during treatment with Duplotrip, 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

Orange Yellow S

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

Soybean lecithin

Duplotrip contains soybean lecithin. Do not use this medicine if you are allergic to peanuts or soy.

Sodium

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

3. How to take Duplotrip

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you do not take Duplotrip 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 moreDuplotrip than you should

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

If you forget to takeDuplotrip

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

Do not stop takingDuplotrip without advice

Do not stop taking this medicine without consulting your doctor first.

If you have any further questions on the use of this medicine, 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 can itch)
• hives(like nettle rash)
• swelling of the eyelids, face, lips, arms, or legs

?Contactyour doctor immediatelyif you experience any of these symptoms and stop takingDuplotrip.

Dizziness, lightheadedness, and fainting

This medicine can 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 usingDuplotrip.

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

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

• In a small number of people, some of these side effects may continue after stopping Duplotrip.

Uncommon side effects(may affect up to 1 in 100 people)

• heart failure (the heart becomes less efficient at pumping blood through the body. This could cause symptoms such as difficulty breathing, excessive tiredness, and swelling in the ankles and legs)
• reduced blood pressure when standing up
• rapid heartbeat (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(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 small number of patients, but their frequency is not known (the frequency cannot be estimated from the available data):

• abnormal or rapid heartbeat (arrhythmia or 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 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 through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Duplotrip

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 packaging or blister after EXP. The expiry date is the last day of the month shown.

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 via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Composition ofDuplotrip

• The active ingredients are dutasteride and tamsulosin hydrochloride. Each capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride.
• The other components (excipients) are:
• Hard capsule shell: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide (E171), red iron oxide (E172), orange yellow S (E110).
• Inside the hard capsule: glycerol monocaprylate, butylhydroxytoluene (E321), gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), medium-chain triglycerides, lecithin (may contain soybean oil) (E322), microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, methacrylic acid and ethyl acrylate copolymer (1:1), magnesium stearate, sodium hydroxide, triacetin, talc, titanium dioxide (E171).

Appearance of the Product and Container Content

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing authorization holder:

GP-Pharm, S.A.

Polígono Industrial Els Vinyets-Els Fogars

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

08777 Sant Quintí de Mediona,

Barcelona – Spain

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.

Polígono Industrial Emiliano Revilla Sanz,

Avenida de Ágreda, 31,

42110 Olvega, Soria - Spain

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

MT: Duplotrip 0.5 mg/0.4 mg Hard Capsules

ES: DUPLOTRIP 0.5 mg/0.4 mg Hard Capsules EFG

Date of the Last Revision of this Leaflet:

10/2022

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