Avidart 0.5 mg soft capsules
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Avidart 0.5 mg soft capsules
dutasteride
Read the entire package 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; do not pass it on to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these are effects not listed in this leaflet. See section 4.
Contents of the package leaflet
- What Avidart is and what it is used for
- What you need to know before taking Avidart
- How to take Avidart
- Possible adverse effects
- How to store Avidart
Contents of the pack and other information
1. What Avidart is and what it is used for
Avidart 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. Avidart belongs to a group of medicines known as 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 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. Avidart 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.
Avidart 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 Avidart
Do not take Avidart:
- if you are allergic to dutasteride, to other 5-alpha reductase enzyme inhibitors, to soy, to peanuts, or to any of the other components of this medicine (listed in section 6)
- 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 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 Avidart.
- Make sure your doctor knows if you have liver problems. You may need additional monitoring during treatment with Avidart if you have a condition affecting your liver.
- Women, children, and adolescents should avoid contact with broken Avidart capsules because the active ingredient can be absorbed through the skin. If any contact with the skin occurs, the affected area must be washed immediately with water and soap.
- Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Avidart. If your partner is pregnant or suspects she might be pregnant, you must avoid exposing her to your semen because 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.
- Avidart 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 Avidart. Men taking Avidart should have regular PSA monitoring.
- In a clinical study conducted in men at increased risk of prostate cancer, men who took Avidart developed a higher frequency of high-grade prostate cancer than those who did not take Avidart. The effect of Avidart on these high-grade types of prostate cancer is not clear.
- Avidart may cause breast enlargement and 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.
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.
??Consult your doctor or pharmacist if you have any doubts regarding the use of Avidart.
Taking Avidart with other medicines
Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.
Certain medicines may interact with Avidart, increasing the likelihood of experiencing 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)
- alpha-blockers (for enlarged prostate or high blood pressure).
??Inform your doctor if you are taking any of these medicines. A dose reduction of Avidart may be necessary.
Taking Avidart with food and drinks
Avidart 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 Avidart. If your partner is pregnant or suspects she might be pregnant, you must avoid exposing her to your semen.
Avidart 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 Avidart will affect your ability to drive or operate machinery.
Avidart contains soy lecithin
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 Avidart
Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If you do not take Avidart regularly, 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 (0.5 mg) once daily. Avidart 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 Avidart is long-term. Some men may experience rapid improvement in symptoms. However, others may need to continue treatment for up to 6 months or longer before an effect begins. Continue taking Avidart for as long as your doctor has instructed.
If you take more Avidart than you should
In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 915620420, stating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.
If you forget to take Avidart
Do not take a double dose to make up for missed doses. Take the next dose at the usual time.
Do not stop Avidart treatment
Do not stop treatment with Avidart without first consulting your doctor. It may take up to 6 months or longer before you notice an effect.
- 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:
- skin rash (which may be itchy)
- hives (like urticaria)
- swelling of the eyelids, face, lips, arms, or legs.
??Contact your doctor immediately if you experience any of these symptoms and stop taking Avidart.
Frequent adverse effects
These may affect up to 1 in every 10 patients taking Avidart:
- inability to achieve or maintain an erection (impotence), which may continue after stopping Avidart
- reduced sex drive (libido), which may continue after stopping Avidart
- difficulty with ejaculation, such as a decrease in the amount of semen released during sexual intercourse, which may continue after stopping Avidart
- enlargement of the breast and tenderness to touch (gynecomastia)
- dizziness, when taken with tamsulosin.
Uncommon adverse effects
These may affect up to 1 in every 100 patients taking Avidart:
- 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)
- hair loss (usually 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Avidart
Keep this medicine out of the sight and reach of children.
Do not store above 30 °C.
Do not use this medicine after the expiry date stated on the container. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Avidart
The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.
The other components are:
- capsule contents: mono- and diglycerides of caprylic/capric acid and butylated hydroxytoluene (E321)
- capsule shell: gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), medium-chain triglycerides and lecithin (may contain soybean oil).
Appearance of the product and contents of the pack
Avidart soft capsules are oblong, opaque, yellow, soft gelatin capsules, marked with GX CE2. They are available in packs of 10, 30, 50, 60 and 90 capsules. Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
GlaxoSmithKline, S.A.
P.T.M. C/ Severo Ochoa, 2
28760 Tres Cantos (Madrid)
Spain
Manufacturer:
Delpharm Poznan Spólka Akcyjna
ul. Grunwaldzka 189
60-322 Poznan
Poland
or
Aspen Bad Oldesloe GmbH
Industriestrasse 32-36
23843 Bad Oldesloe
Germany
Local representative:
Casen Recordati, S.L.
Autovía de Logroño, Km 13,300
50180 Utebo (Zaragoza)
Spain
This medicinal product is authorized in the European Economic Area member states under the following names:
Avodart – Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Sweden, Netherlands, United Kingdom
Avidart – Spain
Date of the most recent revision of this leaflet: October 2025.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es