Dutasteride/tamsulosin Aristo 0.5 mg/0.4 mg hard capsules EFG

Package Leaflet: Information for the Patient

Introduction

Package Leaflet: Information for the Patient

Dutasteride/Tamsulosin Aristo 0.5 mg/0.4 mg Hard Capsules EFG

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, and you should not give it to others, 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 they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

This medicine 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 Aristo 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 not treated, there is a risk that urine flow may become completely blocked (acute urinary retention). This 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 Aristo

Do not take dutasteride/tamsulosin:

• if you are a woman (because this medicine is for men only)
• if you are a child or adolescent under 18 years of age
• if you are allergic to dutasteride, to other 5-alpha reductase enzyme inhibitors, to tamsulosin, soy, peanut, or to 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 dutasteride/tamsulosin.

• In some clinical studies, a higher number of patients taking dutasteride and another medicine called an alpha-blocker, such as tamsulosin, 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 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 dutasteride/tamsulosin.

• 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 dutasteride/tamsulosin for a period before the operation. Before surgery, inform your ophthalmologist that you are taking dutasteride/tamsulosin or tamsulosin (or have taken them previously). Your specialist will need to take appropriate precautions to avoid complications during surgery.

• Women, children, and adolescents should avoid contact with broken capsules of dutasteride/tamsulosin, as the active ingredient can be absorbed through the skin. If any contact with the skin 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 can affect the normal development of a male baby. Dutasteride causes a decrease in sperm count, sperm motility, and semen volume. This may reduce your fertility.

• Dutasteride/tamsulosin affects the serum 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 dutasteride/tamsulosin.

Men being treated with dutasteride/tamsulosin should have regular PSA monitoring.

• In a clinical study conducted in men at increased 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 serious type of prostate cancer is not clear.

• Dutasteride/tamsulosin may cause breast enlargement and breast 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 breast cancer.

• Mood changes and depression: Depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with another oral medicine in the same therapeutic class (5-alpha-reductase inhibitor). If you experience any of these symptoms, contact your doctor for medical advice as soon as possible.

? Consult your doctor or pharmacist if you have any questions about taking dutasteride/tamsulosin.

Taking dutasteride/tamsulosin with other medicines

Inform 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 (for enlarged prostate or high blood pressure).

The use of dutasteride/tamsulosin with the following medicines is not recommended:

• 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 ulcer)
• 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 with food and drinks

You should take dutasteride/tamsulosin 30 minutes after the same meal each day.

Pregnancy, breastfeeding, and fertility

Women must not take dutasteride/tamsulosin.

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 baby. This risk is particularly important during the first 16 weeks of pregnancy.

??Consult your doctor if a pregnant woman has been in contact with dutasteride/tamsulosin.

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.

Dutasteride/tamsulosin has been shown to reduce sperm count, sperm motility, and semen volume. This may reduce your fertility.

Driving and using machines

Some people may experience dizziness during treatment with dutasteride/tamsulosin, 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 sunset yellow FCF (E110), soy lecithin, and sodium.

It may cause allergic reactions because it contains sunset yellow FCF (E110). It may provoke asthma, especially in patients allergic to acetylsalicylic acid.

Dutasteride/Tamsulosin Aristo contains soy lecithin. It must not be used if you are allergic to peanut or soy.

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

3. How to take Dutasteride/Tamsulosin Aristo

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you do not take dutasteride/tamsulosin regularly, the monitoring of 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 contents of the capsules 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: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take dutasteride/tamsulosin

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

Do not stop dutasteride/tamsulosin treatment without advice

Do not discontinue treatment with dutasteride/tamsulosin 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 experiences them.

Allergic reaction

Symptoms of an allergic reaction may include:

• skin rash (which may be itchy)
• hives (like a 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 dutasteride/tamsulosin.

Dizziness, lightheadedness, and fainting

Dutasteride/tamsulosin 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 pass.

Serious skin reactions

Signs of serious skin reactions may include:

• widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)

??Contact your doctor immediately if you experience any of these symptoms and stop taking dutasteride/tamsulosin.

Frequent adverse effects (may affect up to 1 in 10 patients):

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

• decreased sex drive (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 dutasteride/tamsulosin.

Uncommon adverse effects (may affect up to 1 in 100 patients):

• 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 unwell (nausea)
• weakness or loss of strength
• headache
• itching, blocked or runny nose (rhinitis)
• skin rash, hives, itching
• hair loss (usually of the body) or hair growth

Rare adverse effects (may affect up to 1 in 1,000 patients):

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

Very rare adverse effects (may affect up to 1 in 10,000 patients):

• prolonged and painful erection of the penis (priapism)
• serious skin reactions (Stevens-Johnson syndrome)

Other adverse effects

Other adverse effects have occurred in a small number of patients, but their exact frequency is unknown (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
• 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 Aristo

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 blister after EXP. The expiry date is the last day of the month indicated.

Do not store above 30 °C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Dutasteride/Tamsulosin Aristo

• 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: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide (E171), iron oxide red (E172), orange-yellow S (E110).

• inside the hard capsule: glycerol monocaprylocaprate (Type I), butylhydroxytoluene (E321), gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), medium-chain triglycerides, soybean lecithin (may contain soybean oil) (E322), microcrystalline cellulose, methylacrylic acid-ethyl acrylate copolymer (1:1) 30% dispersion, methylmethacrylate-ethyl acrylate copolymer (1:1), magnesium stearate, sodium hydroxide, triacetin, talc, titanium dioxide (E171).

Appearance of the medicine and contents of the pack

This medicine is presented as hard, oblong capsules approximately 24 mm in length, with a brown body and an orange cap.

It is available in packs of 9, 30 and 90 capsules in aluminum/aluminum blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

Manufacturer:

SAG MANUFACTURING, S.L.U.
Ctra. N-I, km 36
San Agustín de Guadalix
28750, Madrid, Spain

or

Galenicum Health S.L.U.
Calle Sant Gabriel, 50
Esplugues de Llobregat
08950, Barcelona, Spain

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Aristo Pharma Iberia, S.L.
C/ Solana, 26
28850, Torrejón de Ardoz
Madrid, Spain

This medicine is authorized in the European Economic Area member states under the following names:

Malta: Dutasteride/Tamsulosin Aristo 0.5 mg/0.4 mg hard capsules
Czech Republic: Marumax 0.5 mg/0.4 mg tvrdé tobolky
Germany: Dutalosin 0.5 mg/0.4 mg Hartkapseln
Italy: Dutasteride e Tamsulosina Aristo 0.5 mg/0.4 mg capsule rigide
Portugal: Dutasterida/Tansulosina Aristo 0.5 mg/0.4 mg cápsula
Poland: Marumax 0.5 mg + 0.4 mg kapsulki twarde
Spain: Dutasterida/Tamsulosina Aristo 0.5 mg/0.4 mg cápsulas duras
United Kingdom: Dutasteride/Tamsulosin hydrochloride 0.5 mg/0.4 mg hard capsules

Date of the most recent revision of this Patient Information Leaflet: September 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