Dutasteride/tamsulosin Qualigen 0.5 mg/0.4 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dutasteride/Tamsulosina Qualigen 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 such effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Dutasteride/tamsulosin 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 administered together.

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 enzyme 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 passing 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 needed to reduce the size of the prostate or to remove it.

Dutasteride reduces the production of dihydrotestosterone, helping to reduce 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 Dutasteride / Tamsulosin Qualigen

Do not take dutasteride/tamsulosin:

• if you are allergic (hypersensitive) to dutasteride, to other 5-alpha reductase enzyme inhibitors, to tamsulosin, or to any of the other ingredients of this medicine (listed in section 6).
• this medicine contains soybean lecithin, which may contain soybean oil. It should not be used if you are allergic to peanuts or soy.
• if you suffer from fainting due to low blood pressure when changing posture (sitting and 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 situations.

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, compared to patients taking 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.

• if you have kidney problems.

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

• women, children, and adolescents must avoid contact with crushed dutasteride/tamsulosin capsules, as the active ingredient can be absorbed through the skin. If skin contact occurs, wash the affected area 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 reduces sperm count, sperm motility, and semen volume. This may reduce your fertility.

• this medicine affects the blood PSA test (prostate-specific antigen), which is sometimes used to detect prostate cancer. Your doctor may still use this test to detect 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 high-grade prostate cancer compared to those who did not take dutasteride. The effect of dutasteride on this type of high-grade prostate cancer is not clear.

• this medicine may cause breast enlargement and 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 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 dutasteride/tamsulosin with other medicines

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

Do not take dutasteride/tamsulosin with these medicines:

• other alpha-blockers (used 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, 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).

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

Taking dutasteride/tamsulosin with food and drinks

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

Do not take this medicine with alcohol. Alcohol may worsen the adverse effects of this medicine.

Pregnancy, breastfeeding, and fertility

Pregnant women (or women who may be pregnant) must avoid contact with crushed 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.

It has been shown that dutasteride/tamsulosin reduces 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 during treatment with 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.

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

3. How to take Dutasteride / Tamsulosin Qualigen

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

If you do not take this medicine regularly, monitoring of your PSA levels may be affected.

What dose should be taken

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 than you should

In case of overdose or accidental ingestion, consult 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 this medicine

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

Do not interrupt treatment with this medicine

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 will experience them.

Allergic reaction

Symptoms of an allergic reaction may include:

• rash (which may be itchy)
• hives (such as 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 rising 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 subside.

Severe skin reactions

Signs of severe skin reactions may include:

• widespread rash with blistering 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*
• breast enlargement and tenderness (gynecomastia)
• dizziness

*In a small number of people, one or more 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)
• drop in blood pressure upon standing
• faster than normal heartbeat (palpitations)
• constipation, diarrhoea, vomiting, feeling sick (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)
• severe 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 adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Dutasteride / Tamsulosin Qualigen

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. The expiry date refers to the last day of the month indicated.

Store below 25°C.

After first opening of the container: 90 days.

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

6. Contents of the pack and other information

Composition of Dutasteride/Tamsulosin Qualigen

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

Soft capsule containing dutasteride:

Contents of the soft capsule: propylene glycol monocaprylate, butylated hydroxytoluene (E321).

Soft capsule shell: gelatin, glycerol (E422), 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 (E460), dibutyl sebacate, polysorbate 80 (E433), colloidal hydrated silica, calcium stearate.

Black ink: shellac (E904), black iron oxide (E172), propylene glycol (E1520), concentrated ammonia solution (E527), potassium hydroxide (E525).

Appearance of the medicine and contents of the pack

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

Dutasteride/Tamsulosin Qualigen is available in high-density polyethylene (HDPE) bottles containing 30 capsules.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí – (Barcelona), Spain

Manufacturer:

Laboratorios LEÓN FARMA, S.A.

Navatejera Industrial Estate

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

Spain

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 Medical Devices (AEMPS) http://www.aemps.gob.es