Dutamsin 0.5 mg/0.4 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dutamsin 0.5 mg/0.4 mg hard capsules

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

Leaflet contents

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

1. What Dutamsin is and what it is used for

Dutamsin is used in men to treat enlarged prostate (benign prostatic hyperplasia) – a non-cancerous growth of the prostate caused by overproduction of a hormone called dihydrotestosterone, in patients already being controlled with dutasteride and tamsulosin taken together.

Dutamsin 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 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), 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 and helps shrink 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 in the prostate, making urination easier and rapidly improving symptoms.

2. What you need to know before taking Dutamsin

Do not take Dutamsin:

• if you are allergic (hypersensitive) 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 suffer from fainting due to low blood pressure when changing position (sitting or standing up) (orthostatic hypotension);
• if you have severe liver disease;
• if you are a woman, child, or adolescent.

Consult your doctor if you think you fall into any of these categories.

This medicine is for men only. It must not be taken by women, children, or adolescents.

Warnings and precautions

Talk to your doctor before starting this medicine.

• In some clinical studies, the number of patients who experienced heart failure was higher in those taking dutasteride and another medicine called an alpha-blocker, such as tamsulosin, than in patients who took only dutasteride or only an alpha-blocker. Heart failure means that your heart does not pump blood properly.

• if you have liver problems. If you have any condition affecting your liver, you may need additional monitoring during treatment with this medicine.

• Inform your doctor if you have kidney problems.

• If you are scheduled for cataract surgery, inform your ophthalmologist that you are currently taking or have previously taken Dutamsin or tamsulosin. Your ophthalmologist will need to take appropriate precautions to avoid complications during surgery.

• Women, children, and adolescents must avoid contact with broken capsules of this medicine, as the active ingredient can be absorbed through the skin. If 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 may 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.

• This medicine affects the blood test for PSA (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 this medicine. Men taking this medicine should have regular PSA monitoring.

• In a clinical study conducted in men at high risk of developing prostate cancer, men who took dutasteride had a higher frequency of a more aggressive type of prostate cancer compared to those who did not take dutasteride. The effect of dutasteride on this more aggressive form of prostate cancer is not fully understood.

• This medicine may cause breast enlargement and tenderness. If this causes discomfort, or if you notice lumps or nipple discharge, consult your doctor, as these changes may be signs of a serious condition, such as male 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.

Taking Dutamsin with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes any medicines purchased without a prescription.

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) in combination with paroxetine (an antidepressant) or in combination with terbinafine (used to treat fungal infections);
• terbinafine (for fungal infections);
• diclofenac (used to treat pain and inflammation).

Inform your doctor if you are taking any of these medicines.

Taking Dutamsin with food and drink

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

Pregnancy, breastfeeding, and fertility

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 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 may 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 male fertility.

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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Driving and using machines

Some people may experience dizziness while taking this medicine, which could affect their ability to drive or operate machinery safely.

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

Dutamsin contains soybean lecithin and propylene glycol.

This medicine contains soybean lecithin, which may contain soybean oil. It should not be used if you are allergic to peanuts or soy.

This medicine contains less than 23 mg of sodium (1 mmol) per capsule, which is essentially “sodium-free.”

This medicine contains 299 mg of propylene glycol in each capsule.

3. How to take Dutamsin

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

If you do not take Dutamsin regularly, the control of your PSA levels may be affected.

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 Dutamsin than you should

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

If you forget to take Dutamsin

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

Do not stop Dutamsin treatment

Do not stop 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 gets 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 this medicine.

Dizziness, lightheadedness, and fainting

This medicine 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 experience lightheadedness 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 using this medicine.

Common adverse effects (may affect more than 1 in 10 people)

• impotence (inability to achieve or maintain an erection)*
• decreased sex drive (libido)*
• difficulty with ejaculation*
• increase in breast size and tenderness to touch (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 could 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, blocked or runny nose (rhinitis)
• rash, hives, itching
• hair loss (usually body hair) or hair growth

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

• sudden localized swelling of soft tissues of the body (e.g., throat or tongue), difficulty breathing and/or itching and rash, often as an allergic reaction (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

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

Reporting of adverse effects

If you experience any type of 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 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 Dutamsin

Keep this medicine out of sight and reach of children.

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

Store below 25°C.

The product must be used within 90 days after opening.

Medicines must not be disposed of via wastewater or household waste. Instead, return unused medicines and their packaging to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Dutamsin

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 are:

Hard capsule shell:

Iron oxide black (E172)
Iron oxide red (E172)
Titanium dioxide (E171)
Iron oxide yellow (E172)
Gelatin

Soft capsule of dutasteride:

Contents of the soft capsule:

Propylene glycol monocaprylate, type II
Butylhydroxytoluene (E321)

Soft capsule shell:

Gelatin
Glycerol
Titanium dioxide (E171)

Tamsulosin pellets:

Methylacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 percent (also contains polysorbate 80 and sodium lauryl sulfate)
Microcrystalline cellulose
Dibutyl sebacate
Polysorbate 80
Colloidal anhydrous silica
Calcium stearate

Black printing ink:

Shellac
Iron oxide black (E172)
Propylene glycol
Concentrated ammonia solution
Potassium hydroxide

Appearance of the medicine and contents of the container

This medicine is presented as hard, oblong capsules, size 0EL, with a brown body and beige cap, printed with "C001" in black ink.

It is available in packs of 7, 30 and 90 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Exeltis Healthcare, S.L.
Avenida Miralcampo 7,
19200 Azuqueca de Henares
Guadalajara
Spain

Manufacturer:

Laboratorios LEÓN FARMA, S.A.
Polígono Industrial Navatejera
C/La Vallina, s/n
24193 Villaquilambre - León
Spain

or

GENERICON PHARMA GMBH
Hafnerstrasse, 211 - Graz-Austria - A-8054 - Austria

This medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands: Dutasteride/Tamsulosine HCl 0.5 mg/0.4 mg Focus, hard capsules
Portugal: Sarix 0.5 mg + 0.4 mg capsules
Austria: Du Tamsul 0.5/0.4 mg Hartkapseln

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

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