DUTASTERIDE/TAMSULOSIN KRKA 0.5 mg/0.4 mg HARD CAPSULES EFG

Introduction

Package Leaflet: Information for the User

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

dutasteride/tamsulosin hydrochloride

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Dutasteride/Tamsulosin Krka and what is it 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 overproduction 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 called 5-alpha reductase inhibitors and tamsulosin belongs to a group of medicines called alpha blockers.

As the prostate grows, it can cause urinary problems such as difficulty in the flow of urine and a need to urinate more frequently. It can also cause the stream of urine to be weaker and less forceful. If left untreated, there is a risk that the flow of urine will be completely blocked (acute urinary retention). This 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, which helps to reduce 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 it easier to urinate and quickly improving symptoms.

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

Do not takeDutasteride/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, other 5-alpha reductase inhibitors, tamsulosin, soya, peanut or any of the other ingredients of this medicine (listed in section 6).
• if you have low blood pressure, which makes you feel dizzy, lightheaded or faint (orthostatic hypotension).
• if you have severe liver disease.

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

Warnings and precautions

Consult your doctor before starting to take 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 who took 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 disease that affects your liver, you may need some additional checks during your treatment with Dutasteride/Tamsulosin
• Make sure your doctor knows if you have severe kidney problems.

• Cataract surgery (cloudy lens). If you are going to have cataract surgery, your doctor may ask you to stop taking Dutasteride/Tamsulosin for a while before the operation. Before the operation, tell your ophthalmologist that you are taking dutasteride/tamsulosin or tamsulosin (or if you have taken them before). Your specialist will need to take the necessary precautions to avoid complications during the operation.

• Women, children, and adolescents must avoid contact with broken Dutasteride/Tamsulosin capsules since the active ingredient can be absorbed through the skin. If there is any contact with the skin, 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 thinks she may be pregnant, she should avoid exposure to your semen, as dutasteride may affect the normal development of a male baby. Dutasteride causes a decrease in sperm count, motility, and semen volume. This may reduce your fertility.
• Dutasteride/Tamsulosin affects the PSA blood test (prostate-specific antigen) used to detect prostate cancer. Your doctor may still use this test to detect prostate cancer, although they should be aware of this effect. If you have a blood test to determine your PSA, inform your doctor that you are taking Dutasteride/Tamsulosin. Men taking Dutasteride/Tamsulosin should have regular PSA checks.
• In a clinical study in men at increased risk of prostate cancer, men who took dutasteride had a higher incidence 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 you discomfort, or if you notice lumps in the breast or nipple discharge, consult your doctor, as these changes can be signs of a serious disease, such as breast cancer.

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

Taking Dutasteride/Tamsulosin Krka with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use 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, which may increase the risk of you experiencing side effects. Some of these medicines are:

• PDE5 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 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).

Tell 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 should not take Dutasteride/Tamsulosin

Pregnant women (or women who may be pregnant) should avoid contact with broken capsules. Dutasteride is absorbed through the skin and may affect the normal development of a male baby. This risk is especially 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 thinks she may be pregnant, she should avoid exposure 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 using machines

Some people may experience dizziness during treatment with Dutasteride/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 soya lecithin, propylene glycol, and sodium

This medicine contains soya lecithin, which may contain soya oil. It should not be used in case of peanut or soya allergy.

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 of administration of this medicine indicated by your doctor or pharmacist. If you do not take it regularly, the control 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 a day, 30 minutes after the same meal each day.

How to take it

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

If you take more Dutasteride/Tamsulosin Krka than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 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 taking Dutasteride/Tamsulosin Krka without consulting your doctor first.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reaction

Signs of an allergic reaction can include:

• skin rash (which can itch)
• hives (like 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, 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 lightheaded during treatment, sit or lie down until these symptoms have disappeared.

Severe skin reactions

Signs of severe skin reactions can 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 Dutasteride/Tamsulosin

Common side effects

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

• impotence (inability to achieve or maintain an erection)*
• decreased libido (sex drive)*
• difficulty with ejaculation, such as a decrease in the amount of semen released during sex*
• breast enlargement and breast tenderness (gynaecomastia)
• dizziness

• In a small number of people, some of these side effects may continue after stopping dutasteride/tamsulosin.

Uncommon side 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)
• reduced blood pressure when standing up
• fast or irregular heartbeat (palpitations)
• constipation, diarrhoea, vomiting, nausea
• weakness or loss of strength
• headache
• itching, blocked or runny nose (rhinitis)
• skin rash, hives, itching
• hair loss (usually from the body) or excessive 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 small number of men, but their exact frequency is unknown (the frequency cannot be estimated from the available data):

• abnormal or fast 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 problems)
• dry mouth

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side 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 which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container contents and additional information

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 shell:

Black iron oxide (E172)

Red iron oxide (E172)

Titanium dioxide (E171)

Yellow iron oxide (E172)

Gelatin

Contents of the soft dutasteride capsule:

Propylene glycol monocaprylate, type II

Butylhydroxytoluene (E321)

Soft capsule shell:

Gelatin

Glycerol

Titanium dioxide (E171)

Medium-chain triglycerides

Lecithin (may contain soybean oil)

Tamsulosin pellets:

Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30 percent (contains sodium lauryl sulfate, polysorbate 80)

Microcrystalline cellulose

Dibutyl sebacate

Polysorbate 80

Hydrated colloidal silica

Calcium stearate

Black ink:

Shellac (E904)

Black iron oxide (E172)

Propylene glycol (E1520)

Concentrated ammonia solution (E527)

Potassium hydroxide (E525)

See section 2 "Dutasterida/Tamsulosina Krka contains soybean lecithin, propylene glycol, and sodium".

Appearance of the product and container contents

This medicinal product is presented in hard, oblong capsules, approximately 24.2 mm x 7.7 mm in size, with a brown body and a 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 packs of 7, 30, and 90 capsules.

Only some pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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

You can request more information about this medicinal product by contacting the local representative of the marketing authorisation holder:

KRKA Farmacéutica, S.L.,

Calle de Anabel Segura 10,

28108 Alcobendas, Madrid, Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:February 2025

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es