Duplotrip 0.5 mg/0.4 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

DUPLOTRIP 0.5 mg/0.4 mg hard capsules EFG

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.

  1. If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Duplotrip is and what it is used for

2. What you need to know before taking Duplotrip

3. How to take Duplotrip

4. Possible side effects

5. Storage of Duplotrip

6. Contents of the pack and other information

1. What Duplotrip is and what it is used for

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

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

Dutasteride belongs to a group of medicines known as 5-alpha reductase enzyme inhibitors, and tamsulosina belongs to a group of medicines known as alpha-blockers.

As the prostate enlarges, it may cause urinary problems such as difficulty in the flow of 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). 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 shrink the size of the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgery. Tamsulosina works by relaxing the muscles in the prostate, making urination easier and rapidly improving symptoms.

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

Do not take Duplotrip

• if you are a woman (because this medicine is for men only).
• if you are a child or adolescent under 18 years of age.
• if you are allergic to dutasteride, to other 5-alpha reductase enzyme inhibitors, to tamsulosin, soy, peanut, or 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 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 Duplotrip:

• In some clinical studies, there was a higher number of patients taking dutasteride and another medicine called an alpha-blocker, such as tamsulosin, who developed 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 Duplotrip.

• 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 Duplotrip for a period before the operation. Before the surgery, inform your ophthalmologist that you are taking this medicine 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 Duplotrip 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 Duplotrip. If your partner is pregnant or 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.

• Duplotrip affects the serum PSA test (prostate-specific antigen), which is sometimes used to detect prostate cancer. Your doctor may still use this test to screen for 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 Duplotrip. Men taking this medicine should have regular PSA monitoring.

• In a clinical study conducted in men at increased risk of prostate cancer, men who took dutasteride had a higher frequency 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 fully understood.

• Duplotrip may cause breast enlargement and breast 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 oral medicine in the same therapeutic class (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 Duplotrip.

Taking Duplotrip 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 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 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 Duplotrip with food and drinks

Take this medicine 30 minutes after the same meal each day.

Pregnancy, breastfeeding, and fertility

Women must not take Duplotrip.

Pregnant women (or women who might 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.

?Consult your doctor if a pregnant woman has been exposed to 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 might be pregnant, you must avoid exposing her to your semen.

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

Driving and using machines

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

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

Duplotrip contains 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.

Lecithin derived from soybean oil

Duplotrip contains lecithin derived from soybean oil. Do not use this medicine if you are allergic to peanut or soy.

Sodium

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

3. How to take Duplotrip

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If you do not take Duplotrip regularly, the control 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 Duplotrip than you should

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

If you forget to take Duplotrip

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

Do not stop treatment with Duplotrip without advice

Do not interrupt treatment with this medicine 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 itch)
• 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 Duplotrip.

Dizziness, lightheadedness, and fainting

This medicine may cause dizziness, lightheadedness, and, rarely, fainting. You should be cautious when rising quickly from a sitting or lying position, especially if you need 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 passed.

Serious skin reactions

Signs of serious 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 Duplotrip.

Frequent adverse effects (may affect up to 1 in 10 people)

• Impotence (inability to achieve or maintain an erection)

• Decreased sexual desire (libido)

• Ejaculation disorders, such as reduced amount of semen released during sexual intercourse

• Breast enlargement and tenderness on palpation (gynecomastia)

• Dizziness

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

Uncommon adverse effects (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 shortness of breath, excessive tiredness, and swelling in the ankles and legs)
• Drop in blood pressure upon standing
• Faster than normal heartbeat (palpitations)
• Constipation, diarrhea, vomiting, nausea
• Weakness or loss of strength
• Headache
• Itching, nasal congestion or runny nose (rinitis)
• Skin rash, hives, itching
• Hair loss (usually body hair) or hair growth

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

• Swelling of the eyelids, face, lips, arms, or legs (angioedema)
• Fainting

Very rare adverse effects (may affect up to 1 in 10,000 people)

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

Other adverse effects

Other adverse effects have been reported in a small number of patients, but their 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
• Vision changes (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: www.notificaRAM.es. By reporting adverse 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 stated on the packaging, bottle, or blister after EXP. The expiry date refers to the last day of the month indicated.

For high-density polyethylene (HDPE) bottles, after first opening, do not use the 30-capsule bottles beyond 6 weeks, nor the 90-capsule bottles beyond 18 weeks.

Store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Duplotrip

• 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 (excipients) are:
• Capsule shell: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide (E171), iron oxide red (E172), orange yellow S (E110).
• Inside the hard capsule: glyceryl monocaprylocaprate and butylated hydroxytoluene (E321), gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), medium-chain triglycerides, lecithin (may contain soybean oil) (E322), microcrystalline cellulose, methylacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, methylacrylic acid-ethyl acrylate copolymer (1:1), magnesium stearate, sodium hydroxide, triacetin, talc, titanium dioxide (E171).

Nature of the product and pack sizes

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

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

Only certain pack 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 medicine is authorized in the European Economic Area member states under the following names:

ES: DUPLOTRIP 0.5 mg/0.4 mg Hard Capsules EFG

Date of the most recent review of this leaflet:

08/2025

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