Dutasteride/tamsulosin Mabo 0.5 mg/0.4 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dutasteride/Tamsulosin Mabo 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.
• 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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Dutasteride/Tamsulosin Mabo is and what it is used for

2. What you need to know before taking Dutasteride/Tamsulosin Mabo

3. How to take Dutasteride/Tamsulosin Mabo

4. Possible side effects

5. How to store Dutasteride/Tamsulosin Mabo

6. Contents of the pack and other information

1. What Dutasteride/Tamsulosin Mabo 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.

This medicine is a combination of two different medicines called dutasteride and tamsulosin. 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 may 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 needed 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 in the prostate, making urination easier and rapidly improving symptoms.

2. What you need to know before taking Dutasteride/Tamsulosin Mabo

Do not take Dutasteride/Tamsulosin Mabo:

• if you are a woman (because this medicine is intended for men only)
• 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, peanut, or any of the other ingredients of this medicine (listed in section 6)
• if you have low blood pressure, causing dizziness, lightheadedness, or 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 this medicine.

• In some clinical studies, there was a higher number of patients taking dutasteride and another medicine called an alpha-blocker, such as tamsulosin, who experienced heart failure compared to patients taking dutasteride alone or an alpha-blocker alone.

Heart failure means your heart does not pump blood as well as it should.

• Make sure your doctor knows if you have liver problems. If you have a 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 before the operation. Before surgery, inform your ophthalmologist that you are taking dutasteride/tamsulosin (or have previously taken them). 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 skin contact occurs, the affected area should be washed immediately with soap and water.
• 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, 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.
• Dutasteride/tamsulosin affects the serum PSA (prostate-specific antigen) test, 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 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 had a higher incidence of a more aggressive type of prostate cancer compared to those not taking dutasteride. The effect of dutasteride on this type of aggressive prostate cancer is not fully understood.
• Dutasteride/tamsulosin may cause breast enlargement and tenderness. If this is bothersome, 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 (5-alpha-reductase inhibitor) taken orally. 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 dutasteride/tamsulosin.

Taking Dutasteride/Tamsulosin Mabo with other medicines

Inform 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 (used for enlarged prostate or high blood pressure).

It is not recommended to take dutasteride/tamsulosin 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 HIV)
• 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 doctor if you are taking any of these medicines.

Taking Dutasteride/Tamsulosin Mabo with food and drinks

Take dutasteride/tamsulosin 30 minutes after the same meal each day.

Pregnancy, breastfeeding, and fertility

Women must not take dutasteride/tamsulosin.

Pregnant women (or women who may 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 dutasteride/tamsulosin.

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, you must avoid exposing her to your semen.

It has been shown that dutasteride/tamsulosin reduces sperm count, sperm motility, and semen volume. This may reduce your fertility.

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.

Dutasteride/Tamsulosin Mabo contains lecithin which may contain soybean oil and propylene glycol.

It should not be used if you are allergic to peanut or soy.

This medicine contains 299.46 mg of propylene glycol in each capsule.

3. How to take Dutasteride/Tamsulosin Mabo

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If you do not take dutasteride/tamsulosin regularly, monitoring 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 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 Dutasteride/Tamsulosin Mabo 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 Dutasteride/Tamsulosin Mabo

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

If you stop taking Dutasteride/Tamsulosin Mabo

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 can cause adverse effects, although not everyone experiences them.

Allergic reaction

Symptoms of an allergic reaction may include:

• 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 dutasteride/tamsulosin.

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 the symptoms pass.

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 using dutasteride/tamsulosin.

Common adverse effects

These may affect up to 1 in 10 patients taking dutasteride/tamsulosin:

• impotence (inability to achieve or maintain an erection)*

• decreased sexual desire (libido)*

• difficulty with ejaculation, with a reduction in the amount of semen released during sexual activity*

• enlargement of the breast and tenderness on palpation (gynecomastia)

• dizziness.

• In a small number of people, one or more of these adverse events may continue after stopping dutasteride/tamsulosin.

Uncommon adverse effects

These may affect up to 1 in 100 patients:

• 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, diarrhea, vomiting, discomfort (nausea)
• weakness or loss of strength
• headache
• itching, nasal congestion, or runny nose (rhinitis)
• skin rash, hives, itching
• hair loss (usually of the body) or hair growth.

Rare adverse effects

These may affect up to 1 in 1,000 patients:

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

Very rare adverse effects

These may affect up to 1 in 10,000 patients:

• 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 or tachycardia or atrial fibrillation)
• difficulty breathing (dyspnea)
• 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 through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dutasteride/Tamsulosin MABO

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 container or bottle after EXP. The expiry date refers to the last day of the month indicated.

Period of validity after first opening of the container: 90 days.

Store below 25 °C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and additional information

Composition of Dutasteride/Tamsulosin MABO

• The active substances are dutasteride and tamsulosin hydrochloride. Each capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride (equivalent to 0.367 mg of tamsulosin).

• The other components are:

• capsule shell: black iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172), gelatin

• dutasteride soft capsule contents: propylene glycol monocaprylate (type II), butylated hydroxytoluene (E321)

• soft capsule components: gelatin, glycerol, titanium dioxide (E171), medium-chain triglycerides, soy lecithin (may contain soybean oil)

• tamsulosin pellets: copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion, microcrystalline cellulose, dibutyl sebacate, polysorbate 80, anhydrous colloidal silica, calcium stearate

• printing inks: shellac (E904), propylene glycol, black iron oxide (E172), strong ammonia solution, potassium hydroxide.

Appearance of the medicine and contents of the container

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

It is available in packs of 30 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Vía de los Poblados, 3,

Building 6, 28033 Madrid,

Spain.

Manufacturer

Laboratorios LEÓN FARMA, S.A.

Navatejera Industrial Estate

C/La Vallina, s/n - 24193 Navatejera - León

Spain

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

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