Dutasteride/tamsulosin Almus Pharma 0.5 mg/0.4 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dutasteride/Tamsulosin Almus Pharma 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; 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 others, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Dutasteride / Tamsulosin Almus Pharma 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 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 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 of the prostate, making urination easier and rapidly improving symptoms.

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

Do not take dutasteride/tamsulosin:

• if you are allergic (hypersensitive) to dutasteride, to other 5-alpha reductase enzyme inhibitors, to tamsulosin, to soya, to peanuts, or to any of the other ingredients of this medicine (listed in section 6).
• if you suffer from fainting due to a drop in blood pressure when changing position (sitting and standing) (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 to take 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 taking 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 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 (cloudy lens), 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 or broken dutasteride/tamsulosin capsules, as the active ingredient can be absorbed through the skin. If any 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 pregnant, you must avoid exposing her to your semen, as dutasteride may affect the normal development of a male fetus. Dutasteride causes a decrease 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 incidence of a more aggressive type of prostate cancer than those who did not take dutasteride. The effect of dutasteride on this aggressive 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 may be signs of a serious condition, such as male breast cancer.

Changes in mood 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.

Other medicines and dutasteride/tamsulosin

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 (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)

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

Taking dutasteride/tamsulosin with food and drink

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 might 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 might 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 might 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 soya lecithin, propylene glycol, and sodium.

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

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

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

3. How to take Dutasteride / Tamsulosin Almus Pharma

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

If you do not take this medicine regularly, 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 dutasteride/tamsulosin 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 this medicine

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

Do not stop 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 (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 these symptoms have passed.

Severe skin reactions

Signs of severe 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.

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

• impotence (inability to achieve or maintain an erection)*
• decreased sexual desire (libido)*
• difficulty with ejaculation*
• increase in breast size and tenderness (gynaecomastia)
• 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 may 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, stuffy 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)
• collapse

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 kind of adverse effect, consult 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 Almus Pharma

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.

After first opening the container: 90 days.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dutasteride/Tamsulosin Almus Pharma

• 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 of dutasteride:

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

Soft capsule shell: gelatin, glycerol (E422), titanium dioxide (E171).

Tamsulosin pellets: methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (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 of size 0el, with a brown body and beige cap, printed with "C001" in black ink.

It is available in high-density polyethylene (HDPE) bottles containing 30 capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer:

Laboratorios León Farma, S.A.

Polígono Industrial Navatejera

C/La Vallina, s/n

24193 Villaquilambre (León), Spain

Date of the most recent revision of this leaflet: October 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