DUPROST 0.5 mg/0.4 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Duprost 0.5 mg/0.4 mg Hard Capsules EFG

Dutasteride/Hydrochloride Tamsulosin

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

1. What is Duprost and what is it 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 producing too much of a hormone called dihydrotestosterone.

Duprost 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 acts 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 Duprost

Do not takeDuprost

• 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, other 5-alpha reductase enzyme inhibitors, tamsulosin, soy, peanuts, or any of the other components 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.
• this medicine contains soy lecithin, which may contain soybean oil. It must not be used in case of peanut or soy allergy.

If you think you may have any of these conditions, do not take this medicine until you have consulted your doctor.

Warnings and precautions

Consult 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 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 dutasteride/tamsulosin.

• 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 dutasteride/tamsulosin for a while before the operation. Before the operation, tell your ophthalmologist that you are taking dutasteride/tamsulosin 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 adolescents must avoid contact with broken dutasteride/tamsulosin capsules, 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 sexual intercourse. Dutasteride has been found in the semen of men taking dutasteride/tamsulosin. If your partner is pregnant or thinks she 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.

• Dutasteride/tamsulosin affects the PSA serum 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 determine your PSA, tell your doctor that you are taking dutasteride/tamsulosin.

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

• In a clinical study in men at high risk of prostate cancer, men who took dutasteride had more frequent serious prostate cancerthan those who did not take dutasteride. The effect of dutasteride on this serious type of prostate cancer is not clear.

• Dutasteride/tamsulosin may cause breast enlargement and pain on palpation.If this causes you discomfort, or if you notice lumps in the breast or nipple discharge, consult your doctor, as these changes can be signs of a serious disease, 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 group (oral 5-alpha-reductase inhibitor). If you experience any of these symptoms, contact your doctor for additional medical advice as soon as possible.

If you have any doubts about taking this medicine, ask your doctor or pharmacist.

Using Dutasteride/Tamsulosin with other medicines

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

Do not take dutasteride/tamsulosin with these medicines:

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

It is not recommended to take dutasteride/tamsulosin with these medicines:

• ketoconazole (used to treat fungal infections).

Certain medicines may interact with dutasteride/tamsulosin, which can cause you to experience 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.

Pregnancy, breastfeeding, and fertility

Women must not takethis medicine.

Pregnant women (or those who may be pregnant) must 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 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 thinks she 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.

If a pregnant woman has been in contact with dutasteride/tamsulosin, consult your doctor.

Driving and using machines

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

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

Duprost contains soy lecithin

This medicine contains soy lecithin. It must not be used in case of peanut or soy allergy.

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

3. How to take Duprost

Follow the instructions for taking this medicine exactly as indicated by your doctor or pharmacist. If you do not take this medicine regularly, 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 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 more Duprost 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 take Duprost

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

Do not stop taking Duprost without advice

Do not stop treatment with dutasteride/tamsulosin without consulting your doctor first.

If you have any other doubts about taking 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

Contact your doctor immediatelyif you experience any of these symptoms and stop taking this medicine.

Dizziness, lightheadedness, and fainting

Dutasteride/tamsulosin 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 taking this medicine.

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

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

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

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 (feeling sick)
• 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 occurred 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 side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use https://www.notificaram.es. By reporting side 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 is the last day of the month indicated.

Store below 25°C. Use within 90 days of opening the packaging.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Duprost

Each capsule contains0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride. The other ingredients are:

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

Appearance of the product and packaging contents

This medicine is presented in hard, oblong capsules with a brown body and a 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 last revision of this leaflet: August 2025

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