Dutasteride Krka

Patient Information Leaflet

Dutasteride Krka 0.5 mg soft capsules

Generic medicine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Dutasteride Krka is used for the treatment of men with enlarged prostate (benign prostatic hyperplasia) – a non-cancerous increase in the size of the prostate gland caused by excessive production of a hormone called dihydrotestosterone.
The active substance in this medicine is dutasteride. It belongs to a class of medicines known as 5-alpha reductase inhibitors.
Enlargement of the prostate can cause urinary problems such as difficulty urinating and the need to urinate frequently. It may also cause the urine stream to become slower and weaker. 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 needed to remove or reduce the size of the prostate. Dutasteride Krka 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 surgical intervention.
Dutasteride Krka may also be used in combination with another medicine called tamsulosin (used to treat symptoms of enlarged prostate).

2. What you need to know before taking Dutasteride Krka

Do not take Dutasteride Krka:

• if you are allergic to dutasteride, to other 5-alpha-reductase inhibitors, to soya, to peanuts, or to any of the other ingredients of this medicine (listed in section 6)
• if you have severe liver disease.

Inform your doctor if you think any of the above conditions apply to you.
This medicine is intended only for men. It must not be taken by women, children, or adolescents.
Warnings and precautions

Talk to your doctor or pharmacist before taking Dutasteride Krka.

• In some clinical studies, a higher number of patients treated with dutasteride and another medicine called an alpha-blocker, such as tamsulosin, developed heart failure compared to patients treated only with dutasteride or only with an alpha-blocker. Heart failure is a condition in which the heart is unable to pump blood properly.
• Make sure your doctor is aware of any liver problems you may have. If you have had any liver disease, you may need additional monitoring during treatment with Dutasteride Krka.
• Women, children, and adolescents must not handle damaged or leaking capsules of Dutasteride Krka, as the active substance can be absorbed through the skin. In case of skin contact, wash the affected area immediately with water and soap.
• Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Dutasteride Krka. If your partner is or may be pregnant, you must avoid exposing her to your semen, as dutasteride may affect the normal development of a male fetus. It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility. This may reduce your fertility.
• Dutasteride Krka affects the blood test measuring PSA (prostate-specific antigen), which is sometimes used to detect prostate cancer. Your doctor should be aware of this effect and may still use the test to screen for prostate cancer. If you are due to have a PSA test, inform your doctor that you are taking Dutasteride Krka. Men taking Dutasteride Krka should have regular PSA checks.
• In a clinical study conducted in men at higher risk of prostate cancer, men treated with Dutasteride Krka developed prostate cancer more frequently than men not taking Dutasteride Krka. The effect of Dutasteride Krka on this more serious form of prostate cancer is unclear.
• Dutasteride Krka may cause breast enlargement and tenderness. If this becomes bothersome, or if you notice lumps in the breast or nipple discharge, inform your doctor about these changes, as they could be signs of a serious condition, such as breast cancer.

If you have any doubts about using Dutasteride Krka, consult your doctor or pharmacist.
Children and adolescents

This medicine is intended only for men. Women, children, and adolescents must not handle damaged or leaking capsules.
Other medicines and Dutasteride Krka

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines may interact with Dutasteride Krka and increase the likelihood of side effects. These medicines include:

• verapamil or diltiazem (for high blood pressure)
• ritonavir or indinavir (for HIV)
• itraconazole or ketoconazole (for fungal infections)
• nefazodone (an antidepressant)
• alpha-blockers (for enlarged prostate or high blood pressure).

Inform your doctor if you are taking any of these medicines. It may be necessary to reduce the dose of Dutasteride Krka.
Dutasteride Krka with food and drink

Dutasteride Krka can be taken with or without food.
Pregnancy, breastfeeding and fertility

Women who are pregnant (or who may become pregnant) must not handle opened 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 Krka. If your partner is pregnant or may be pregnant, you must avoid exposing her to your semen.
It has been shown that Dutasteride Krka reduces sperm count, semen volume, and sperm motility.
Therefore, male fertility may be reduced.
Ask your doctor for advice if a pregnant woman has been exposed to dutasteride.
Driving and using machines

Dutasteride Krka does not appear to affect the ability to drive or operate machinery.

3. How to take Dutasteride Krka

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
If you do not take this medicine regularly, monitoring of your PSA levels may be affected.

Recommended dose
The recommended dose is one capsule (0.5 mg) taken once daily. Swallow the capsules whole with water. Do not chew or open the capsules. Contact with the contents of the capsules may cause irritation or pain in the mouth or throat.
The capsules may be taken with or without food.

Dutasteride Krka is for long-term treatment. Some men may notice an early improvement in their symptoms. However, others may need to take Dutasteride Krka for 6 months or longer before it starts to work. Continue taking Dutasteride Krka for as long as your doctor tells you to.

Hepatic impairment
If you have liver problems (mild to moderate), consult your doctor or pharmacist. The use of Dutasteride Krka is not recommended in patients with severe hepatic impairment (see section "Do not take Dutasteride Krka").

If you take more Dutasteride Krka than you should
Contact your doctor or pharmacist if you take too many Dutasteride Krka capsules.

If you forget to take Dutasteride Krka
Do not take a double dose to make up for the forgotten dose. Take the next dose at your usual time.

If you stop taking Dutasteride Krka
Do not stop taking Dutasteride Krka without first talking to your doctor. It may take 6 months or longer to notice an effect.

If you have any doubts about how to use 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 may include:

• rash (which may be itchy)
• hives (redness with itching)
• swelling of the eyelids, face, lips, arms or legs.

Stop taking Dutasteride Krka and contact your doctor immediately if you notice any of these symptoms.
Common (may affect up to 1 in 10 people):

• inability to achieve or maintain an erection (impotence), which may continue even after stopping Dutasteride Krka
• decreased sexual desire (libido), which may continue even after stopping Dutasteride Krka
• problems with ejaculation, which may continue even after stopping Dutasteride Krka
• breast enlargement or breast tenderness (gynecomastia)
• dizziness when also taking tamsulosin.

Uncommon (may affect up to 1 in 100 people):

• heart failure (the heart becomes less efficient at pumping blood around the body. Symptoms may include shortness of breath, extreme tiredness, and swelling of the ankles and legs)
• hair loss (usually from the body) or hair growth

Not known (frequency cannot be estimated from the available data):

• depressed mood
• pain and swelling in the testicles

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dutasteride Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp. The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep the blister in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Dutasteride Krka contains

• The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.
• The other excipients are: propylene glycol monocaprylate type II and butylated hydroxytoluene (E321) in the capsule core, and gelatin, glycerol and titanium dioxide (E171) in the capsule shell.

Description of the appearance of Dutasteride Krka and contents of the pack
Dutasteride Krka soft capsules (capsules) are yellow, opaque, elongated soft gelatin capsules (approximately 16.5 x 6.5 mm) filled with a clear solution.
Dutasteride Krka is available in boxes containing 10, 30, 50, 60 or 90 soft capsules, in triple-layer transparent blisters (PVC-PE-PVDC)/Al.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Local representative for Italy
Krka Farmaceutici Milano S.r.l. – Italy
Manufacturer
Laboratorios León Farma, SA - Polígono Industrial Navatejera - C/La Vallina s/n, Villaquilambre
León - 24008 Navatejera (León) - Spain
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
This medicinal product is authorised in the European Economic Area countries with the following names: