Duprost 0.5 mg/0.4 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Duprost 0.5 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, as you may need to read it again.
• 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 other people even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Duprost is and what it is used for

This medicine 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.

Duprost is a combination of two different medicines called dutasteride and tamsulosine. Dutasteride belongs to a group of medicines known as 5-alpha reductase inhibitors, and tamsulosin belongs to a group of medicines known as alpha-blockers.

As the prostate enlarges, it can cause urinary problems such as difficulty in urine flow 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), which 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, helping 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 of the prostate, making urination easier and rapidly improving symptoms.

2. What you need to know before taking Duprost

Do not take Duprost

• 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, to other 5-alpha reductase enzyme inhibitors, to tamsulosin, to soy, peanuts, 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.
• this medicine contains soya lecithin, which may contain soya oil. It must not be used if you are allergic to peanuts or soya.

? If you think you are in any of these situations, do not take this medicine until you have consulted your doctor.

Warnings and precautions

Talk to your doctor before starting to take this medicine.

• 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 taking only dutasteride or only an alpha-blocker. Heart failure means that your heart does not pump blood properly.

• 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 dutasteride/tamsulosin.

• 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 dutasteride/tamsulosin for a period of time before the procedure. Before the surgery, inform your ophthalmologist that you are taking dutasteride/tamsulosin 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 capsules of dutasteride/tamsulosin, 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 water and soap.

• Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking dutasteride/tamsulosin. If your partner is pregnant or suspects she might be pregnant, you must avoid exposing her to your semen, as dutasteride may affect the normal development of a male fetus. Dutasteride causes a reduction in sperm count, sperm motility, and semen volume. This may reduce your fertility.

• Dutasteride/tamsulosin affects serum PSA (prostate-specific antigen) tests, which are 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 dutasteride/tamsulosin.

Men being treated with dutasteride/tamsulosin should have regular PSA monitoring.

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

• Dutasteride/tamsulosin 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 medicine in the same therapeutic class (oral 5-alpha-reductase inhibitor). If you experience any of these symptoms, contact your doctor for medical advice as soon as possible.

?Talk to your doctor or pharmacist if you have any questions about taking this medicine.

Taking dutasteride/tamsulosin 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 dutasteride/tamsulosin with the following medicines:

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

Taking dutasteride/tamsulosin is not recommended with the following medicines:

• ketoconazole (used to treat fungal infections).

Certain medicines may interact with dutasteride/tamsulosin, increasing the risk of adverse 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.

Pregnancy, breastfeeding, and fertility

Women must not take this medicine.

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 a male fetus. This risk is particularly important during the first 16 weeks of pregnancy.

Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking dutasteride/tamsulosin. If your partner is pregnant or suspects she 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.

?Consult your doctor if a pregnant woman has been exposed to dutasteride/tamsulosin.

Driving and using machines

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

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

Duprost contains soybean lecithin

This medicine contains soybean lecithin. It should not be used if you are allergic to peanuts or soy.

This medicine contains 299.46 mg of propylene glycol monocaprylate (E1520) in each capsule, equivalent to 4.27 mg/kg.

3. How to take Duprost

Follow exactly the instructions for taking this medicine as given by your doctor or pharmacist. If you do not take this medicine 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 Duprost 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, indicating the medicine and the amount ingested.

If you forget to take Duprost

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

Do not stop Duprost treatment without advice

Do not stop treatment with dutasteride/tamsulosin 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 may cause adverse effects, although not everyone experiences them.

Allergic reaction

Symptoms of an allergic reaction may include:

• skin rash (which may be itchy)
• 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 this medicine.

Dizziness, lightheadedness and fainting

Dutasteride/tamsulosin may cause dizziness, lightheadedness and, rarely, fainting. You should be cautious when standing up quickly after sitting or lying down, 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 of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)

? Contact your doctor immediately if you have these symptoms and stop taking this medicine.

Frequent adverse effects (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*

• enlargement of the breast and tenderness (gynecomastia)

• dizziness

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

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 difficulty breathing, excessive tiredness and swelling in the ankles and legs)
• reduction in blood pressure upon standing
• faster than normal heartbeat (palpitations)
• constipation, diarrhoea, vomiting, feeling unwell (nausea)
• weakness or loss of strength
• headache
• itching, stuffiness or runny nose (rhinitis)
• skin rash, hives, itching
• hair loss (usually of the body) 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)
• collapse

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 exact frequency is unknown (frequency cannot be estimated from the available data):

• abnormal or rapid heartbeat (arrhythmia or tachycardia or atrial fibrillation)
• difficulty breathing (dyspnoea)
• depression
• pain and swelling in the testicles
• nosebleed
• severe skin rash
• changes in vision (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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Duprost

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

Do not use this medicine after the expiry date stated on the packaging and on the bottle after EXP. The expiry date refers to the last day of the month indicated.

Store below 25°C. Use within 90 days after first opening of the container.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Duprost

Each capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride. The other components are:

• hard capsule shell: iron oxide black (E172), iron oxide red (E172), titanium dioxide (E171), iron oxide yellow (E172), gelatin (E441).
• soft capsule of dutasteride: propylene glycol monocaprylate type II (E1520), butylated hydroxytoluene (E321).
• soft capsule coating: gelatin (E441), glycerol (E422), titanium dioxide (E171).
• tamsulosin pellets: copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion (also contains polysorbate 80 and sodium lauryl sulfate), microcrystalline cellulose, dibutyl sebacate, polysorbate 80, colloidal hydrated silica, calcium stearate.
• black inks: shellac, iron oxide black (E172), propylene glycol (E1520), concentrated ammonia solution (E527), potassium hydroxide (E525).

Nature of the product and pack contents

This medicine is presented as hard, oblong capsules with a brown body and beige cap, printed with "C001" in black ink.

Available in packs of 30 capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

Laboratorios León Farma, S.A.

Polígono Industrial Navatejera

C/ La Vallina s/n

24193 Villaquilambre, León

Spain

Date of the most recent review of this leaflet: August 2025

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