DUTACAP 0.5 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the User

Dutacap 0.5 mg Soft Capsules EFG

Dutasteride

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

1. What is Dutacap and what is it used for

The active substance is dutasteride, which belongs to a group of medicines called 5-alpha reductase inhibitors.

Dutacap is used in men to treat enlarged prostate (benign prostatic hyperplasia), a non-cancerous growth of the prostate caused by overproduction of a hormone called dihydrotestosterone.

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, benign prostatic hyperplasia can lead to a risk of the urine flow being 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 remove it. Dutacap reduces the production of 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.

Dutacap can also be used with another medicine called tamsulosin (used to treat symptoms of enlarged prostate).

2. What you need to know before you take Dutacap

Do not take Dutacap

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

-if you have severe liver disease.

If you think you may be in one of these situations, do not takethis medicine until you have consulted your doctor.

This medicine is only for men.Women, children, and adolescents must not take it.

Warnings and precautions

Consult your doctor before starting to take Dutacap.

• In some clinical studies, there were more patients taking dutasteride and another medicine called 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 it should.
• Make sure your doctor knows if you have liver problems. You may need some additional checks during your treatment with Dutacap if you have any liver disease.
• Women, children, and adolescents should avoid contact with broken Dutacap capsules because the active substance 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. If your partner is pregnant or thinks she may be pregnant, she should avoid exposure to your semen because dutasteride may affect the normal development of a male baby.

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

• Dutasteride affects the PSA test, which is sometimes used to detect prostate cancer. Your doctor may still use this test to detect prostate cancer, but should be aware of this effect. If you have a blood test for PSA, tell your doctor that you are taking Dutacap. Men taking Dutacap should have regular PSA checks.
• In a clinical study in men at high risk of prostate cancer, men taking dutasteride were more likely to have a serious type of prostate cancer than those not taking dutasteride. The effect of dutasteride on these serious types of prostate cancer is not clear.
• Dutacap may cause breast enlargement and breast tenderness. If this causes you discomfort, or if you notice lumps in your 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 about taking Dutacap.

Other medicines and Dutacap

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

Certain medicines may interact with Dutacap, which may increase the risk of you experiencing side effects. Some of these medicines are:

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

Tell your doctorif you are taking any of these medicines. It may be necessary to reduce the dose of Dutacap.

Taking Dutacap with food and drinks

Dutacap can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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. If your partner is pregnant or thinks she may be pregnant, she should avoid exposure to your semen.

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

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

Driving and using machines

It is unlikely that dutasteride will affect your ability to drive or use machines.

Dutacap contains soy lecithin

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

3. How to take Dutacap

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you do not take Dutacap regularly, the control of your PSA levels may be affected. If in doubt, ask your doctor or pharmacist.

What dose should you take

• The recommended dose is one capsule (0.5 mg) once a day. 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.
• Treatment with Dutacap is long-term. Some men may experience rapid improvement in symptoms. However, others may need to take this medicine for 6 months or more before an effect is seen. Continue taking Dutacap for as long as your doctor has told you.

If you take more Dutacap than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 915620420, indicating the medicine and the amount taken. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Dutacap

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

Do not stop taking Dutacap

Do not stop taking Dutacap without consulting your doctor first. It may be necessary to take this medicine for 6 months or more to see an effect.

If you have any further 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

The symptoms of an allergic reaction can include:

• skin rash (which may itch)
• hives
• swelling of the eyelids, face, lips, arms, and legs.

If you experience any of these symptoms, tell your doctor immediately and stop taking Dutacap.

Common side effects, may affect up to 1 in 10 men:

• inability to get or maintain an erection (impotence), which may continue after stopping Dutacap
• decreased sex drive (libido), which may continue after stopping Dutacap
• difficulty with ejaculation, such as a decrease in the amount of semen released during sex, which may continue after stopping Dutacap
• breast tenderness or enlargement (gynecomastia)
• dizziness, when taken with tamsulosin

Uncommon side effects, may affect up to 1 in 100 men:

• heart failure (the heart becomes less efficient at pumping blood around the body. This can cause symptoms such as difficulty breathing, excessive tiredness, and swelling in the ankles and legs).
• hair loss (usually from the body) or increased hair growth.

Rare side effects, frequency cannot be estimated from the available data:

• depression.
• testicular pain and swelling.

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 (AEMPS) at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dutacap

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, blister, or bottle after EXP. The expiry date is the last day of the month stated.

Do not store above 30°C.

Store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dutacap

The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.

The other ingredients are:

• capsule content: glycerol monocaprylocaprate (type I), butylhydroxytoluene (E321).
• capsule shell: gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), medium-chain triglycerides, lecithin (may contain soybean oil) (E322), and purified water.

Appearance and packaging

Soft capsules. Yellow, opaque, oblong gelatin capsules filled with a yellowish oily liquid, size 14.7 ± 0.5 mm x 5.9 ± 0.2 mm, without markings.

Available in: white opaque PVC/PVDC-Aluminum blister packs containing 30 or 90 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Galenicum Derma, S.L.U.

Ctra. N-1, Km 36

28750 - San Agustín del Guadalix

Madrid - Spain

Manufacturer

Cyndea Pharma, S.L

Polígono Industrial Emiliano Revilla Sanz,

Avenida de Ágreda, 31 Olvega, 42110,

Soria, Spain

or

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid 82

28802 Alcalá de Henares

Madrid – Spain

or

Galenicum Health S.L.

Avda. Cornellá 144, 7º-1ª, Edificio Lekla

Esplugues de Llobregat

08950 Barcelona - Spain

Date of last revision of this leaflet: September 2019

Other sources of information

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).