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

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the user

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

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

Dutasteride/Tamsulosin Krka 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.

Dutasteride/Tamsulosin Krka 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 can 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 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 necessary to reduce the size of the prostate or to remove it.

Dutasteride reduces the production of the hormone called 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 in the prostate, making urination easier and rapidly improving symptoms.

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

Do not take Dutasteride/Tamsulosin Krka

• if you are a woman (because this medicine is only for men).
• 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, to soya, peanut, or to any of the other components of this medicine (listed in section 6).
• if you have low blood pressure, which makes you feel dizzy, lightheaded, or causes 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 Dutasteride/Tamsulosin

• In some clinical studies, there were more 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 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 of time before the operation. Before the surgery, inform your ophthalmologist that you are taking dutasteride/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 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 may affect the normal development of a male baby. Dutasteride causes a reduction in sperm count, sperm motility, and semen volume. This may reduce your fertility.

• Dutasteride/Tamsulosin affects the serum PSA (prostate-specific antigen) test, 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 taking Dutasteride/Tamsulosin should have regular PSA monitoring.

• In a clinical study in men at increased risk of prostate cancer, men taking dutasteride were found to have a higher frequency of a more serious type of prostate cancer compared to those not taking dutasteride. The effect of dutasteride on this more serious type of prostate cancer is not clear.

• Dutasteride/Tamsulosin 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 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 group (oral 5-alpha-reductase inhibitor). If you experience any of these symptoms, contact your doctor for medical advice as soon as possible.

Talk to your doctor or pharmacist if you have any questions about taking Dutasteride/Tamsulosin.

Taking Dutasteride/Tamsulosin Krka 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 these medicines:

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

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

• ketoconazole (used to treat fungal infections).

Certain medicines may interact with Dutasteride/Tamsulosin, increasing the likelihood of experiencing adverse effects. Some of these medicines are:

• PDE5 enzyme inhibitors (used to help 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 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 Krka with food

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.

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, semen volume, and sperm motility. This may reduce your fertility.

Consult your doctor if a pregnant woman has been in contact with Dutasteride/Tamsulosin.

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.

Dutasteride/Tamsulosin Krka 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 peanut or soya.

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

This medicine contains 299 mg of propylene glycol in each capsule.

3. How to take Dutasteride/Tamsulosin Krka

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If you do not take it regularly, the control of your PSA levels may be affected. In case of 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 Krka 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 Krka

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

If you stop taking Dutasteride/Tamsulosin Krka

Do not stop treatment with Dutasteride/Tamsulosin Krka 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

Signs of an allergic reaction may include:

• 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 lying or sitting down, especially if you need to get up during the night, until you know how this medicine affects you. If you feel dizzy or faint during treatment, sit or lie down until these 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 have these symptoms and stop taking Dutasteride/Tamsulosin.

Common adverse effects

These may affect up to 1 in 10 men taking dutasteride/tamsulosin:

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

• decreased sex drive (libido)*

• difficulty with ejaculation, such as a decrease in the amount of semen released during sexual intercourse*

• enlarged breasts 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

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)
• reduction 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 body hair) 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 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 Krka

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

Do not use this medicine after the expiry date stated on the pack 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 should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Dutasteride/Tamsulosin Krka

The active substances are dutasteride and tamsulosin hydrochloride. Each hard capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride (equivalent to 0.367 mg of tamsulosin). 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 (dutasteride):

Propylene glycol monocaprylate, type II

Butylated hydroxytoluene (E321)

Soft capsule shell:

Gelatin

Glycerol

Titanium dioxide (E171)

Medium-chain triglycerides

Lecithin (may contain soybean oil)

Tamsulosin pellets:

Methacrylic acid copolymer and ethyl acrylate (1:1) dispersion 30% (containing sodium lauryl sulfate, polysorbate 80)

Microcrystalline cellulose

Dibutyl sebacate

Polysorbate 80

Hydrated colloidal silica

Calcium stearate

Black ink:

Shellac (E904)

Iron oxide black (E172)

Propylene glycol (E1520)

Concentrated ammonia solution (E527)

Potassium hydroxide (E525)

See section 2 “Dutasteride/Tamsulosin Krka contains soybean lecithin, propylene glycol and sodium”.

Nature of the product and contents of the container

This medicine is presented as hard, oblong 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 one 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:

KRKA, d.d., Novo mesto
Šmarješka cesta 6,
8501 Novo mesto, Slovenia

Manufacturer:

Laboratorios LEÓN FARMA, S.A.,
C/La Vallina, s/n, Polígono Industrial Navatejera,
24193 Villaquilambre, León, Spain

KRKA, d.d., Novo mesto
Šmarješka cesta 6,
8501 Novo mesto, Slovenia

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

KRKA Farmacéutica, S.L.,
Calle de Anabel Segura 10,
28108 Alcobendas, Madrid, Spain

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

Date of the last 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