Ilmago 0.5 mg/0.4 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ilmago 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Ilmago 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 called alpha-blockers.

As the prostate enlarges, it may cause urinary problems such as difficulty in urine flow 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, 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 in the prostate, making urination easier and rapidly improving symptoms.

2. What you need to know before taking Ilmago

Do not take Ilmago:

• if you are allergic (hypersensitive) to dutasteride, to other 5-alpha reductase enzyme inhibitors, to tamsulosin, to soya, 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 posture (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 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 who took only dutasteride or only an alpha-blocker. Heart failure means that your heart does not pump blood as well as it should.

• if you have liver problems. If you have any condition affecting your liver, you may require 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 dutasteride/tamsulosin capsules, as the active ingredient can be absorbed through the skin. If skin 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 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 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 as soon as possible for further medical advice.

Taking Ilmago 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 Ilmago with the following medicines:

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

Ilmago is not recommended with the following medicines:

• ketoconazole (used to treat fungal infections).

Certain medicines may interact with dutasteride/tamsulosin, increasing the risk of side 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 Ilmago 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 side effects of this medicine.

Pregnancy, breastfeeding, and fertility

Pregnant women (or those 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.

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 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.

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

3. How to take Ilmago

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

If you do not take this medicine regularly, 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 Ilmago than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 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 may 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 experience lightheadedness during treatment, sit or lie down until these symptoms have passed.

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.

Frequent 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 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, 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)
• 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 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 Ilmago

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the outer packaging and on the bottle after EXP. 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 must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, please consult your pharmacist on how to properly dispose of unused containers and medicines. This helps protect the environment.

6. Contents of the pack and other information

Composition of Ilmago

• 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).

Tamsulosine pellets: polymethacrylic acid-ethyl acrylate copolymer (1:1) 30% dispersion (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 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.

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Laboratorios Salvat, S.A.

C/ Gall, 30-36 - 08950

Esplugues de Llobregat

Barcelona - Spain

Manufacturer:

Laboratorios LEÓN FARMA, S.A.

Polígono Industrial Navatejera

C/La Vallina, s/n - 24193 Navatejera - 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 for Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es