DUTASTERIDE/TAMSULOSIN MANA PHARMA 0.5 mg/0.4 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Dutasteride/Tamsulosin MANA PHARMA 0.5 mg/0.4 mg hard capsules

Dutasteride/Tamsulosin Hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Dutasteride/Tamsulosin MANA PHARMA and what is it used for
2. What you need to know before taking Dutasteride/Tamsulosin MANA PHARMA
3. How to take Dutasteride/Tamsulosin MANA PHARMA
4. Possible side effects
5. Storage of Dutasteride/Tamsulosin MANA PHARMA
6. Package contents and additional information

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

Dutasteride/Tamsulosin is used in men to treat an enlarged prostate (benign prostatic hyperplasia) - a non-cancerous growth of the prostate caused by excessive production of a hormone called dihydrotestosterone, in patients already controlled with dutasteride and tamsulosin administered at the same time.

This medication is a combination of two different medications called dutasteride and tamsulosin. Dutasteride belongs to a group of medications called 5-alpha reductase enzyme inhibitors, and tamsulosin belongs to a group of medications called alpha blockers.

As the prostate grows in size, 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 urine stream to be weaker and less forceful. If left untreated, benign prostatic hyperplasia can lead to a risk of the urine flow being 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 remove it.

Dutasteride reduces the production of dihydrotestosterone, which helps to reduce the size of the prostate and alleviate 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 taking Dutasteride/Tamsulosin MANA PHARMA

Do not take Dutasteride/Tamsulosin:

• if you are allergic to dutasteride, other 5-alpha reductase enzyme inhibitors, tamsulosin, soy, peanuts, or any of the other components of this medication (listed in section 6).
• if you experience fainting due to a decrease in blood pressure when changing posture (sitting and standing) (orthostatic hypotension).
• if you have severe liver disease.
• if you are a woman, child, or adolescent.

Consult your doctorif you think you are in any of these situations.

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

Warnings and precautions

Consult your doctor before starting to take this medication:

• in some clinical studies, the number of patients who experienced heart failure was higher in those taking dutasteride and another medication 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 as it should.
• if you have liver problems. If you have any disease that affects your liver, you may need additional checks during your treatment with this medication.
• if you have kidney problems.
• if you are going to have cataract surgery, inform your ophthalmologist that you are taking or have previously taken this medication. Your ophthalmologist will need to take the necessary precautions to avoid complications during the operation.
• women, children, and adolescents should 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 should be washed immediately with 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, she should avoid exposure to your semen, as dutasteride can affect the normal development of a male fetus. Dutasteride causes a decrease in sperm count, motility, and semen volume. This can reduce male fertility.
• this medication affects the PSA blood test (prostate-specific antigen) 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, inform your doctor that you are taking this medication. Men taking this medication should have regular PSA checks.
• this medication can 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 can be signs of a serious disease, 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 medication 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.

Other medications andDutasteride/Tamsulosin MANA PHARMA

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Do not take Dutasteride/Tamsulosin with these medications:

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

It is not recommended to take Dutasteride/Tamsulosin with these medications:

• ketoconazole(used to treat fungal infections).

Certain medications can interact with Dutasteride/Tamsulosin, which can increase the risk of you experiencing side effects. Some of these medications 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 coagulation)
• 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 doctorif you are taking any of these medications.

Taking Dutasteride/Tamsulosin with food and drinks

You should take this medication 30 minutes after the same meal each day.

Do not take this medication with alcohol. Alcohol can worsen the side effects of this medication.

Pregnancy, breastfeeding, and fertility

Pregnant women (or those who may be pregnant) should avoid contact with broken Dutasteride/Tamsulosin capsules. Dutasteride is absorbed through the skin and can affect the normal development of a 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, she should avoid exposure to your semen.

Dutasteride/Tamsulosin has been shown to decrease sperm count, motility, and semen volume. This can reduce male fertility.

Consult your doctorif a pregnant woman has come into contact with Dutasteride/Tamsulosin.

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

Driving and using machines

Some people may experience dizziness during treatment with this medication, which can affect their ability to drive or operate machinery safely.

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

Dutasteride/Tamsulosin MANA PHARMA contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Dutasteride/Tamsulosin MANA PHARMA

Follow the instructions for taking this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

If you do not take this medication regularly, your PSA levels may be affected.

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 Dutasteride/Tamsulosin 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 medication and the amount taken.

If you forget to take this medication

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

Do not stop taking this medication

Do not stop taking this medication without consulting your doctor first.

If you have any other questions about taking this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience 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 immediately if you experience any of these symptoms and stop taking this medication.

Dizziness, lightheadedness, and fainting

This medication 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 need to get up during the night, until you know how this medication affects you. If you feel dizzy or lightheaded during treatment, sit or lie down until these symptoms have passed.

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 immediately if you have these symptoms and stop using this medication.

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

• impotence (inability to achieve or maintain an erection)*
• decreased sex drive (libido)*
• difficulty ejaculating*
• breast enlargement and tenderness (gynecomastia)
• dizziness

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

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
• 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)

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

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Dutasteride/Tamsulosin MANA PHARMA

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the packaging and carton. The expiration date is the last day of the month indicated.

Store below 25°C.

After the first opening of the package: 90 days.

Medications should not be disposed of through wastewater or household waste. Return the packaging and any unused medication to the pharmacy's SIGRE point. If you are unsure, ask your pharmacist how to dispose of the packaging and medication you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition ofDutasteride/Tamsulosin MANA PHARMA

• The active ingredients are dutasteride and tamsulosin hydrochloride. Each capsule contains 0.5 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.

Soft dutasteride capsule:

Soft capsule contents:propylene glycol monocaprylate, butylhydroxytoluene (E321).

Soft capsule shell:gelatin, 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 (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 product and package contents

This medication is presented in hard capsules, oblong, size 0, with a brown body and orange cap, printed with C001 in black ink.

Dutasteride/Tamsulosin MANA PHARMA is available in high-density polyethylene (HDPE) bottles of 30 capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder:

MANA PHARMA, S.L.

Carretera de Fuencarral, 22,

Alcobendas, 28108 Madrid,

Spain

Manufacturer:

Laboratorios LEÓN FARMA, SA

Polígono Industrial Navatejera

C/La Vallina, s/n - 24008 Navatejera - León

Spain

You can request more information about this medication from the local representative of the marketing authorization holder.

MANA PHARMA, S.L.

Carretera de Fuencarral, 22,

Alcobendas, 28108 Madrid,

Spain

Date of the last revision of this package leaflet:September 2025

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