Package Leaflet: Information for the User

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

dutasteride/hydrochloride of tamsulosin

Read this leaflet carefully before you start to take 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 others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Dutasterida/Tamsulosina 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.

Dutasterida/Tamsulosina Krkais a combination of two different medications called dutasteride and tamsulosin. Dutasteride belongs to a group of medications called5-alpha reductase inhibitorsand tamsulosin belongs to a group of medications calledalpha blockers.

As the prostate grows in size, it may produce urinary problems such as difficulty in urinating and a need to urinate more frequently. It may also cause the urine stream to be smaller and weaker. If left untreated, there is a risk of complete blockage of the urine flow(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 the hormone called 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 urination easier and rapidly improving symptoms.

Do not takeDutasteride/Tamsulosin Krka

-if you are a woman (because this medication 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 soy, peanuts, orto any of the other components of this medication(listed in section 6).

-if you have low blood pressure, which makes you feel dizzy, lightheaded, or faint (orthostatic hypotension).

-if you have a severe liver disease.

If you think you have any of these conditions, do not take this medication until you have consulted with your doctor.

Warnings and precautions

Consult your doctor before starting to take Dutasteride/Tamsulosin

• In some clinical studies, there was a higher number of patients taking dutasteride and another medication 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 is not pumping blood as it should.

• Make sure your doctor knows if you have liver problems. If you have any disease that affects your liver, you may need some additional review during your treatment with Dutasteride/Tamsulosin
• Make sure your doctor knows if you have severe kidney problems.

• Cataract surgery (opaque crystalline lens).If you are going to have cataract surgery, your doctor may ask you to stop takingDutasteride/Tamsulosinfor a while before the surgery. Before the surgery, inform your ophthalmologist that you are takingdutasteride/tamsulosinor have taken it before. Your specialist will need to take the necessary precautions to avoid complications during the surgery.

• 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 skin contact, 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 may be pregnant, you should avoid exposing her to your semen, as dutasteride may affect the normal development of the male fetus. Dutasteride causes a decrease in sperm count, motility, and semen volume.This may reduce your fertility.
• Dutasteride/Tamsulosin affects the PSA (prostate-specific antigen) blood test that is sometimes used to detect prostate cancer.Your doctor may still use this test to detect prostate cancer, but they should be aware of this effect. If you have a blood test to determine your PSA, inform your doctor that you are takingDutasteride/Tamsulosin. Men taking Dutasteride/Tamsulosin should have regular PSA checks.
• In a clinical study conducted in men at increased risk of developing prostate cancer, men taking dutasteride presented with more frequent severe prostate cancer than those not taking dutasteride. The effect of dutasteride on this type of severe prostate cancer is unclear.
• Dutasteride/Tamsulosin may cause breast enlargement and tenderness. If this causes you discomfort, or if you notice lumps in your breast or nipple discharge, consult your doctor, as these changes may be signs of a serious disease, such as breast cancer.

Consult your doctor or pharmacist if you have any doubts related to taking Dutasteride/Tamsulosin

Taking Dutasteride/Tamsulosin Krka with other medications

Inform your doctor or pharmacist if you are using, have used recently, 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).

Do not take Dutasteride/Tamsulosin with these medications:

• ketoconazole (used to treat fungal infections).

Certain medications may interact with Dutasteride/Tamsulosin, which may cause you to experience adverse effects. Some of these medications are:

• inhibitors of the PDE5 enzyme (used to help achieve or maintain an erection) such as vardenafil, sildenafil citrate, and tadalafil
• verapamilor 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)
• 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 medications.

Taking Dutasteride/Tamsulosin Krka with food

You should takeDutasteride/Tamsulosin30 minutes after the same meal every day.

Pregnancy, breastfeeding, and fertility

Women should not takeDutasteride/Tamsulosin

Pregnant women (or those who may be pregnant) should avoid contact with broken capsules. Dutasteride is absorbed through the skin and may affect the normal development of the male fetus. This risk is especially important in 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 may be pregnant, you should avoid exposing her to your semen.

Dutasteride/Tamsulosin has been shown to decrease 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 operating machinery

Some people may experience dizziness during treatment withDutasteride/Tamsulosin, which may 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 lecithin from soy, propylene glycol, and sodium

This medication contains lecithin from soy, which may contain soy oil. It should not be used in cases of allergy to peanuts or soy.

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

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

Follow exactly the administration instructions for this medication as indicated 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 a day, 30 minutes after the same meal every day.

How to take it

The capsules should be swallowed whole, with water. Do not chew or break the capsules. Contact with the contents of the capsules may irritate your mouth or throat.

If you take more Dutasterida/Tamsulosina Krka than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Dutasterida/Tamsulosina Krka

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

If you interrupt the treatment with Dutasterida/Tamsulosina Krka

Do not interrupt the treatment with Dutasterida/Tamsulosina Krka without consulting your doctor first.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Allergic reaction

The signs of an allergic reaction may include:

• skin rash (which may itch)
• 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 Dutasteride/Tamsulosin.

Dizziness, lightheadedness, and fainting

Dutasteride/tamsulosin may cause dizziness, lightheadedness, and, in rare cases, fainting. You should be careful when getting up quickly after lying down or sitting, especially if you have 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 disappeared.

Severe skin reactions

The signs of severe skin reactions may include:

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

Contact your doctor immediately if you have these symptoms and stop using Dutasteride/Tamsulosin.

Common side effects

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

• impotence(inability to achieve or maintain an erection)*
• decreased libido*
• difficulty with ejaculation, such as a decrease in the amount of semen released during sexual intercourse*
• enlargement of the breasts and tenderness to the touch(gynecomastia)
• dizziness

*In a small number of people, some of these adverse events may continue after stopping dutasteride/tamsulosin.

These may affect up to 1 in 100 men:

• heart failure (the heart becomes less efficient at pumping blood throughout the body. This could cause symptoms such as difficulty breathing, excessive fatigue, and inflammation in the ankles and legs)
• reduced blood pressure when standing
• abnormal heart rhythm (arrhythmia or tachycardia or atrial fibrillation)
• constipation, diarrhea, vomiting, discomfort (nausea)
• weakness or loss of strength
• headache
• itching, congestion, or dripping nose (rhinitis)
• skin rash, hives, itching
• hair loss (usually on the body) or hair growth

Rare side effects

These may affect up to 1 in 1,000 men:

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

Very rare side effects

These may affect up to 1 in 10,000 men:

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

Other side effects

Other side effects have been reported in a reduced number ofmen,but their exact frequency is unknown (the frequency cannot be estimated from the available data):

• abnormal or accelerated heart rhythm (arrhythmia or tachycardia or atrial fibrillation)
• difficulty breathing (shortness of breath)
• depression
• pain and swelling in the testicles
• nosebleed
• severe skin rash
• changes in vision (blurred vision or visual problems)
• dry mouth

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and on the bottle after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need.By doing so, you will help protect the environment.

Composition of Dutasterida/Tamsulosina Krka

The active ingredients 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 coating:

Iron oxide black (E172)

Iron oxide red (E172)

Titanium dioxide (E171)

Iron oxide yellow (E172)

Gelatin

Content of the soft gelatin capsule of dutasteride:

Propylene glycol monocaprylate, type II

Butylhydroxytoluene (E321)

Coating of the soft gelatin capsule:

Gelatin

Glycerol

Titanium dioxide (E171)

Medium-chain triglycerides

Lecithin (may contain soy oil)

Tamsulosin pellets:

Copolymer of methyl acrylate and ethyl acrylate (1:1) dispersion 30 percent (contains sodium lauryl sulfate, polysorbate 80)

Microcrystalline cellulose

Dibutyl sebacate

Polysorbate 80

Colloidal hydrated silica

Calcium stearate

Black ink:

Shellac (E904)

Iron oxide black (E172)

Propylene glycol (E1520)

Concentrated ammonia solution (E527)

Potassium hydroxide (E525)

See section 2 “Dutasterida/Tamsulosina Krka contains soy lecithin, propylene glycol, and sodium”.

Appearance of the product and contents of the package

This medicine is presented inhard, 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 a soft gelatin capsule of dutasteride.

It is available in packages of 7, 30, and 90 capsules.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

KRKA, d.d., Novo mesto

Šmarješka cesta 6,

8501 Novo mesto, Slovenia

Manufacturer responsible:

LEÓN FARMA, S.A.,

C/La Vallina, s/n, Industrial Estate Navatejera,

24193 Villaquilambre, León, Spain

KRKA, d.d., Novo mesto

Šmarješkacesta 6,

8501 Novo mesto, Slovenia

You can request more information about this medicine by contacting 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 with the following names:

Last review date of this leaflet:February 2025

For detailed and updated information about this medicine, visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es