Avodart 0.5 mg soft capsules – dutasteride for the symptoms of benign prostatic hyperplasia (enlarged prostate)

Avodart is a medicine containing the active substance dutasteride, a 5-alpha reductase inhibitor. It reduces the production of the hormone dihydrotestosterone, which is responsible for the non-cancerous enlargement of the prostate, so the prostate gradually shrinks and urinary symptoms ease.

In Serbia it is authorised as 0.5 mg soft capsules (30 capsules) and is a prescription-only medicine. It is intended for men only, with benign prostatic hyperplasia (BPH); it can be taken alone or together with tamsulosin.

What is Avodart (dutasteride) used for and how should it be taken?

Key facts about the medicine

What is Avodart used for?

According to the Summary of Product Characteristics, Avodart is indicated for:

• treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH)
• reduction in the risk of acute urinary retention (inability to pass urine) and surgery in men with moderate to severe BPH symptoms

An enlarged prostate can make urination difficult and slow and cause a frequent need to pass urine; if untreated, there is a risk of complete urinary blockage, which needs urgent medical treatment.

How is it taken and dosed?

• Usual dose: one soft capsule (0.5 mg) once daily, alone or together with tamsulosin (0.4 mg).
• Swallow the capsule whole with water, with or without food. Do not chew or open it – the contents may irritate the mouth and throat.
• Avodart is a long-term treatment: some men improve quickly, while others need 6 months or longer.
• Irregular use may affect PSA monitoring.

This is general dosing from the leaflet and SmPC – your doctor decides your treatment.

Special patient groups

• Older men: no dose adjustment needed.
• Kidney impairment: no dose adjustment needed.
• Liver impairment: caution in mild to moderate impairment; contraindicated in severe impairment.
• Women, children and adolescents: must not be used.

Contraindications – when the medicine must not be used

• women, children and adolescents
• hypersensitivity to dutasteride, other 5-alpha reductase inhibitors, soya, peanut or any of the excipients
• severe liver impairment

Precautions and warnings

• Tell your doctor if you have liver problems – additional tests may be needed.
• Dutasteride reduces sperm count, sperm motility and semen volume, which may reduce fertility.
• The medicine affects PSA levels; the doctor takes this into account when interpreting results, and PSA should be checked regularly.
• In clinical studies in men at increased risk of prostate cancer, those taking Avodart more often had a more serious form of prostate cancer; the effect of the medicine has not been clarified.
• Report breast tenderness or enlargement, lumps or nipple discharge to your doctor.
• The capsules contain soya lecithin – people allergic to soya or peanut must not take them.

Interactions with other medicines and food

• The risk of side effects may be increased by: verapamil, diltiazem, ritonavir, indinavir, itraconazole, ketoconazole, nefazodone and alpha-blockers – the doctor may reduce the Avodart dose.
• Food does not affect use – the capsule can be taken with or without a meal.

Pregnancy, breast-feeding and fertility

The medicine is for men only. Pregnant women (and women who may be pregnant) must not come into contact with a leaking capsule, especially during the first 16 weeks of pregnancy, as dutasteride may affect the normal development of a male baby. If your partner is or may be pregnant, use a condom. If a pregnant woman has come into contact with dutasteride, seek medical advice.

Driving and using machines

Avodart is unlikely to affect the ability to drive and use machines.

Possible side effects

• Common: impotence, reduced libido and ejaculation problems (reduced semen volume) – these may persist after stopping the medicine; breast enlargement or tenderness (gynaecomastia); dizziness when taken with tamsulosin.
• Uncommon: heart failure (breathlessness, extreme tiredness, swelling of ankles and legs); loss of body hair or increased hair growth.
• Frequency not known: depression, testicular pain and swelling.
• Allergic reactions: rash, itching, hives, swelling of the eyelids, face, lips, arms or legs – stop the medicine and contact your doctor.

Report suspected side effects to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• If you take more capsules than you should, ask your doctor or pharmacist for advice.
• Missed dose: take the next dose at the usual time; do not take a double dose.
• Do not stop treatment without talking to your doctor – the effects may only become noticeable after 6 months or more.

Related information

For additional care and support with enlarged prostate symptoms, see also the Preparations for an enlarged prostate and urination problems category – products in this category do not replace the medicine you have been prescribed.

Composition, packaging and manufacturer

• Active substance: dutasteride 0.5 mg per soft capsule.
• Capsule contents: caprylic/capric acid mono- and diglycerides, butylated hydroxytoluene (E321).
• Capsule shell: gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), medium-chain triglycerides, lecithin (may contain soya oil).
• Pack: PVC/PVDC-Al blister of 10 capsules; carton with 3 blisters (30 soft capsules).
• Marketing authorisation holder: EVROPA LEK PHARMA D.O.O. BEOGRAD, Bore Stankovića 2, Belgrade. Manufacturer: Delpharm Poznan S.A., Poznań, Poland.

Storage

• Store below 30 °C.
• Shelf life: 4 years. Keep out of the sight and reach of children.
• Return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

How quickly does Avodart start working?

Some men improve quickly, but many need 6 months or longer before the effect is noticeable. Treatment should therefore not be stopped without talking to the doctor.

Does Avodart affect PSA?

Yes. The medicine changes PSA levels in the blood, so tell your doctor you take Avodart before every test; PSA should be checked regularly.

Can women touch the capsules?

Women, children and adolescents must not come into contact with leaking capsules, because dutasteride is absorbed through the skin. If contact occurs, wash the skin immediately.

Can Avodart be taken with tamsulosin?

Yes, according to the SmPC Avodart can be used alone or in combination with tamsulosin (0.4 mg); dizziness is then a more common side effect.

Sources

• ALIMS – Summary of Product Characteristics Avodart® 0.5 mg soft capsule (Serbian)
• ALIMS – Patient leaflet Avodart® 0.5 mg soft capsule, November 2024 (Serbian)

Sources checked on: 23 October 2026.