Dutasteride/tamsulosin Combix Pharma 0.5 mg/0.4 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dutasteride/Tamsulosin Combix Pharma 0.5 mg/0.4 mg hard capsules EFG

dutasteride/tamsulosin hydrochloride

Read the entire leaflet carefully before you start using 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 others, 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.

Contents of the leaflet

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

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

Dutasteride/Tamsulosin Combix Pharma 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.

Dutasteride/Tamsulosin Combix Pharma 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 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 left untreated, 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 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 of the prostate, making urination easier and rapidly improving symptoms.

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

Do not take Dutasteride/Tamsulosin Combix Pharma:

• if you are a woman (because this medicine is intended 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 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 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 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 only dutasteride or only an alpha blocker. Heart failure means that your heart does not pump blood as well as it should.

• 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 this medicine.

• 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 this medicine for a period of time before the procedure. Before the surgery, inform your ophthalmologist that you are taking this medicine or tamsulosin (or have taken them previously). Your specialist 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 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 this medicine. 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 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 this medicine. Men taking this medicine should have regular PSA monitoring.

• In a clinical study conducted in men at increased risk of prostate cancer, men who took dutasteride were more likely to develop a more serious type of prostate cancer than those who did not take dutasteride. The effect of dutasteride on this more serious type of prostate cancer is not fully understood.

• 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 could 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.

• Consult your doctor or pharmacist if you have any questions about taking this medicine.

Taking Dutasteride/Tamsulosin Combix Pharma 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 (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 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).

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

Taking Dutasteride/Tamsulosin Combix Pharma with food and drinks

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

Pregnancy, breastfeeding, and fertility

Women must not take this medicine.

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 this medicine. If your partner is pregnant or suspects she may be pregnant, you must avoid exposing her to your semen.

This medicine 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 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.

Dutasteride/Tamsulosin Combix Pharma contains soy lecithin, propylene glycol, and sodium

This medicine contains soy lecithin and may therefore contain soybean oil. Do not use this medicine 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 Dutasteride/Tamsulosin Combix Pharma

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you do not take dutasteride/tamsulosin 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 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 Combix Pharma 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 Combix Pharma

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

If you stop taking Dutasteride/Tamsulosin Combix Pharma 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 may 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 lightheaded during treatment, sit or lie down until the 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

These may affect up to 1 in 10 men taking this medicine:

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

• decreased sexual desire (libido)*

• problems 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, one or more of these adverse events may continue after stopping this medicine.

Uncommon adverse effects

These may affect up to 1 in 100 men:

• 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 of the body) or hair growth

Rare adverse effects

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

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

Very rare adverse effects

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

• 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 men, but their frequency is unknown (frequency cannot be estimated from the available data):

• abnormal or rapid heartbeat (arrhythmia, tachycardia or atrial fibrillation)
• difficulty breathing (dyspnoea)
• depression
• pain and swelling in the testicles
• nosebleeds
• 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 Dutasteride/Tamsulosin Combix Pharma

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 packaging and on the bottle after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Dutasteride/Tamsulosin Combix Pharma

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 tamsulosine). 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 content of dutasteride:

Propylene glycol monocaprylate type II
Butylhydroxytoluene (E321)

Soft capsule shell:

Gelatin
Glycerol
Titanium dioxide (E171)
Medium-chain triglycerides
Soybean lecithin (may contain soybean oil) (see section 2)

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 hydrated silica
Calcium stearate

Black printing inks:

Shellac (E904)
Iron oxide black (E172)
Propylene glycol (E1520)
Concentrated ammonia solution (E527)
Potassium hydroxide (E525)

Section 2: “Dutasteride/Tamsulosin Combix Pharma contains soybean lecithin and propylene glycol”

Appearance of the product and contents of the pack

This medicine consists of oblong hard gelatin capsules, approximately 24.2 mm x 7.7 mm, with a brown body and beige cap, printed with C001 in black ink.

Each hard capsule contains modified-release pellets of tamsulosin hydrochloride and a soft gelatin capsule containing dutasteride.

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

Laboratorios Combix, S.L.U.
C/ Badajoz 2, Edificio 2
28223 Pozuelo de Alarcón (Madrid)
Spain

Manufacturer

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

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

Greece: ZYTODUR 0.5 mg/0.4 mg, σκληρ? καψ?κια
Poland: Dutasteride + Tamsulosin hydrochloride León Farma, 0.5 mg + 0.4 mg, hard capsules
Portugal: Dutasteride + Tamsulosin Bluepharma
Croatia: Atekago 0.5 mg/0.4 mg hard capsules

Date of the most recent revision of this package leaflet: October 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.es/