Evidutix 0.5 mg soft capsules EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Evidutix 0.5 mg soft capsules EFG
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, pharmacist, or nurse.
- 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 may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Evidutix is and what it is used for
- What you need to know before taking Evidutix
- How to take Evidutix
- Possible adverse effects
- How to store Evidutix
- Contents of the pack and other information
1. What Evidutix is and what it is used for
Evidutix 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.
The active substance is dutasteride, which belongs to a group of medicines called 5 alpha-reductase enzyme inhibitors.
As the prostate enlarges, it may cause urinary problems such as difficulty in urine flow 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 not treated, 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. Evidutix reduces the production of dihydrotestosterone, helping to shrink the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgery.
Dutasteride may also be used together with another medicine called tamsulosin (used to treat symptoms of an enlarged prostate).
2. What you need to know before taking Evidutix
Do not take Evidutix
-
if you are allergic to dutasteride, soy, peanuts, other inhibitors of the enzyme 5-alpha reductase, or to any of the other components of this medicine (listed in section 6).
-
if you are allergic
- if you have severe liver disease.
If you think you are in any of these situations, do not take this medicine until you have consulted with your doctor.
This medicine is for men only. Women, children, and adolescents must not take it.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take this medicine.
- In some clinical studies, a higher number of patients taking dutasteride and another medicine called an alpha blocker, such as tamsulosin, 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 dutasteride if you have a condition affecting your liver.
- Women, children, and adolescents must avoid contact with broken capsules of dutasteride because the active ingredient can be absorbed through the skin. If contact occurs, 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 suspects she may be pregnant, you must avoid exposing her to your semen because dutasteride can affect the normal development of a male fetus. Dutasteride has been shown to reduce sperm count, sperm motility, and semen volume. This may reduce your fertility.
- Dutasteride affects the serum PSA test (prostate-specific antigen), which is sometimes used to detect prostate cancer. Your doctor may still use this test to detect prostate cancer, but must be aware of this effect. If you have a blood test for PSA, inform your doctor that you are taking dutasteride. Men taking dutasteride should have regular PSA monitoring.
- In a clinical study conducted in men with an increased risk of developing prostate cancer, men who took dutasteride were more likely to develop a more severe type of prostate cancer than those who did not take dutasteride. The effect of dutasteride on these more severe types of prostate cancer is not clear.
- Dutasteride may cause breast enlargement and tenderness upon palpation. 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.
- 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 as soon as possible for further medical advice.
Talk to your doctor or pharmacist if you have any questions about taking this medicine.
Taking Evidutix with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take other medicines.
Do not take dutasteride with these medicines:
- Other alpha blockers (for enlarged prostate or high blood pressure).
Certain medicines may interact with dutasteride, 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)
Inform your doctor if you are taking any of these medicines. It may be necessary to reduce the dose of Evidutix.
Taking Evidutix with food, drinks, and alcohol
Evidutix 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 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 this medicine. 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 use machinery.
Important information about some of the ingredients of Evidutix. This medicine contains soy lecithin and may therefore contain soybean oil. Do not use this medicine if you are allergic to peanuts or soy.
3. How to take Evidutix
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.
Always take this medicine regularly. If you do not take this medicine regularly, control of your PSA levels may be affected (see section 2, "Warnings and precautions").
What dose should you take
The usual dose is one capsule (0.5 mg) once daily. Dutasteride 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 dutasteride is long-term. Some men may experience rapid symptom improvement. However, others may need to continue treatment for up to 6 months or longer before an effect begins. Continue taking this medicine for as long as your doctor has instructed.
If you take more Evidutix 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, indicating the medicine and the amount ingested.
If you forget to take Evidutix
Do not take a double dose to make up for missed doses. Take the next dose at the usual time.
If you stop taking Evidutix
Do not stop treatment with Evidutix 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 can 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.
You should contact your doctor immediately if you experience any of these symptoms and stop taking dutasteride.
Frequent adverse effects (may affect up to 1 in 10 men)
- inability to achieve or maintain an erection (impotence), which may continue after stopping dutasteride
- decreased sex drive (libido), which may continue after stopping dutasteride
- difficulty in ejaculation, which may continue after stopping dutasteride
- swelling or tenderness of the breast (gynaecomastia)
- dizziness, when taken with tamsulosin.
Uncommon adverse effects (may affect up to 1 in 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 hair (usually body hair) or hair growth.
Adverse effects of unknown frequency
Frequency cannot be estimated from the available data:
- depressed mood
- pain and swelling of the testicles.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor, pharmacist or nurse, 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. Website: www.notificaRAM.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Evidutix
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging or on the 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 containers at the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.
6. Package contents and additional information
Composition of Evidutix
The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride. The other components are:
Contents of the capsule: Glyceryl monocaprylocaprate (type I) and butylated hydroxytoluene (E-321)
Capsule shell: gelatin, glycerol, titanium dioxide (E-171), yellow iron oxide (E-172), medium-chain triglycerides, lecithin (may contain soybean oil), and purified water.
Appearance of Evidutix and pack contents
Evidutix consists of yellow, opaque, oblong soft gelatin capsules without imprint, containing a yellowish oily liquid. It is available in packs of 30 capsules.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Tecnimede España Industria Farmacéutica, S.A.
Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,
28108 Alcobendas (Madrid), Spain
Manufacturer
Cyndea Pharma S.L.
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda, 31
Olvega, 42110 Soria
Spain
or
Galenicum Health S.L.U.
Sant Gabriel, 50
Esplugues de Llobregat
08950 Barcelona
Spain
or
Pharmadox Healthcare, Ltd.
KW20A Kordin Industrial Park,
Paola, PLA 3000, Malta
or
SAG Manufacturing S.L.U.
Ctra. N-I, Km 36
28750 San Agustín de Guadalix
Madrid, Spain
Date of the most recent revision of this leaflet: September 2025
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