Dutacap 0.5 mg soft capsules EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Dutacap 0.5 mg soft capsules EFG
Dutasteride
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 others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the package leaflet
- What Dutacap is and what it is used for
- What you need to know before taking Dutacap
- How to take Dutacap
- Possible side effects
- How to store Dutacap
- Contents of the pack and other information
1. What Dutacap is and what it is used for
The active substance is dutasteride, which belongs to a group of medicines called 5-alpha reductase enzyme inhibitors.
Dutacap is used in men to treat enlargement of the prostate gland (benign prostatic hyperplasia), a non-cancerous growth of the prostate caused by overproduction of a hormone called dihydrotestosterone.
As the prostate enlarges, it may cause urinary problems such as difficulty in the flow of urine and a need to urinate more frequently. It may also cause the urine stream to become weaker and less forceful. If benign prostatic hyperplasia is left untreated, there is a risk that urine flow may become 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. Dutacap 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 surgery.
Dutacap may also be used in combination with another medicine called tamsulosin (used to treat symptoms of an enlarged prostate).
2. What you need to know before taking Dutacap
Do not take Dutacap
-
if you are allergic to dutasteride, to other inhibitors of the enzyme 5-alpha reductase, to soya, to peanuts, or to any of the other ingredients of this medicine (listed in section 6).
-
if you have severe liver disease.
If you think you fall into any of these situations, do not take this medicine until you have consulted your doctor.
This medicine is for men only. Women, children, and adolescents must not take it.
Warnings and precautions
Talk to your doctor before starting to take Dutacap.
- In some clinical studies, there was a higher number of 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. You may need additional monitoring during treatment with Dutacap if you have any condition affecting your liver.
- Women, children, and adolescents must avoid contact with broken Dutacap capsules because the active substance 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. If your partner is pregnant or suspects she may be pregnant, you must avoid exposing her to your semen, as dutasteride may affect the normal development of a male baby.
Dutasteride has been shown to reduce sperm count, sperm motility, and semen volume. This may reduce your fertility.
- Dutasteride affects the serum PSA (prostate-specific antigen) test, which is sometimes used to detect prostate cancer. Your doctor may still use this test to screen for prostate cancer, but must be aware of this effect. If you have a blood test for PSA, inform your doctor that you are taking Dutacap. Men taking Dutacap should have regular PSA monitoring.
- In a clinical study conducted in men at increased risk of developing prostate cancer, men taking dutasteride were found to have a higher incidence of a more aggressive type of prostate cancer compared to those not taking dutasteride. The effect of dutasteride on these more aggressive types of prostate cancer is not clear.
- Dutacap may cause breast enlargement and breast 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.
Talk to 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 need to take any other medicines.
Certain medicines may interact with Dutacap, increasing the risk of adverse 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 doctor if you are taking any of these medicines. A dose adjustment of Dutacap may be necessary.
Taking Dutacap with food and drink
Dutacap can be taken with or without food.
Pregnancy, breastfeeding, and fertility
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. If your partner is pregnant or suspects she may be pregnant, you must avoid exposing her to your semen.
Dutasteride has been shown to reduce sperm count, sperm motility, and semen volume. This may reduce your fertility.
Consult your doctor if a pregnant woman has been exposed to dutasteride.
Driving and using machines
It is unlikely that dutasteride will affect your ability to drive or operate machinery.
Dutacap contains soya lecithin
This medicine contains soya lecithin, which may contain soya oil. It must not be used if you are allergic to peanuts or soya.
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 class (oral 5-alpha-reductase inhibitor). If you experience any of these symptoms, contact your doctor for further medical advice as soon as possible.
3. How to take Dutacap
Follow exactly the administration instructions for this medicine as 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 daily. 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.
- Treatment with Dutacap is long-term. Some men may experience a rapid improvement in symptoms. However, others may need to take this medicine for up to 6 months or longer before an effect begins. Continue taking Dutacap for as long as your doctor has instructed.
If you take more Dutacap than you should
In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 915620420, stating the medicine and the amount ingested. It is recommended to take the medicine package and leaflet to the healthcare professional.
If you forget to take Dutacap
Do not take a double dose to make up for missed doses. Take the next dose at the usual time.
Do not stop treatment with Dutacap
Do not stop treatment with Dutacap without first consulting your doctor. It may take up to 6 months or longer before an effect is noticed.
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 may cause adverse effects, although not everyone will experience them.
Allergic reaction
Symptoms of an allergic reaction may include:
- rash (which may be itchy)
- skin lumps
- swelling of the eyelids, face, lips, arms and legs.
If you experience any of these symptoms, inform your doctor immediately and stop taking Dutacap.
Frequent adverse effects, may affect up to 1 in every 10 men:
- inability to achieve or maintain an erection (impotence), which could continue after stopping Dutacap
- decreased sex drive (libido), which could continue after stopping Dutacap
- problems with ejaculation, such as a decrease in the amount of semen released during sexual intercourse, which could continue after stopping Dutacap
- swelling or tenderness of the breast (gynaecomastia)
- dizziness, when taken with tamsulosin
Uncommon adverse effects, may affect up to 1 in every 100 men:
- heart failure (the heart becomes less efficient at pumping blood around the body. This may cause symptoms such as difficulty breathing, excessive tiredness, and swelling in the ankles and legs).
- loss of body hair or hair growth.
Adverse effects of unknown frequency, frequency cannot be estimated from the available data:
- depression.
- pain and inflammation of the testicles.
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: www.notificaRAM.es. By reporting adverse 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 stated on the carton, blister pack, or bottle after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 30°C.
Keep in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. 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 components are:
- capsule contents: glycerol monocaprylocaprate (type I), butylated hydroxytoluene (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 of the product and contents of the pack
Soft capsules. Opaque, oblong, yellow soft gelatin capsules filled with a yellowish oily liquid, size 14.7 ± 0.5 mm x 5.9 ± 0.2 mm, unmarked.
Available in: white opaque PVC/PVDC-Aluminum blister packs containing 30 or 90 capsules.
Only some 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.U.
Sant Gabriel, 5008950 Esplugues de Llobregat
Barcelona - Spain
Date of the most recent review of this leaflet: September 2025
Other sources of information
Detailed and up-to-date 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/).