Package leaflet: Information for the patient

Dutasteride Accord 0.5 mg soft capsules

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Dutasteride Accord is and what it is used for
What you need to know before taking Dutasteride Accord
How to take Dutasteride Accord
Possible side effects
How to store Dutasteride Accord
Contents of the pack and other information

1. What Dutasteride Accord is and what it is used for

The active substance is dutasteride. It belongs to a class of medicines called 5-alpha reductase inhibitors.
Dutasteride Accord is used to treat men with an enlarged prostate
(benign prostatic hyperplasia) – a non-malignant increase in the size of the prostate caused by excessive production of a hormone called dihydrotestosterone.
When the prostate enlarges, it can cause urinary problems such as difficulty in passing urine and the need to urinate frequently. This may also result in a weaker and slower urine flow. If 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 remove or reduce the size of the prostate.
Dutasteride Accord reduces the production of dihydrotestosterone, thereby helping to decrease prostate size and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgical intervention.
Dutasteride Accord may be used together with another medicine called tamsulosin (used in the treatment of symptoms of prostate enlargement).

2. What you need to know before taking Dutasteride Accord

Do not take Dutasteride Accord

if you are allergic to dutasteride, to other 5-alpha reductase inhibitors, to soy, 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 any of these conditions apply to you, do not take this medicine until you have consulted your doctor.
This medicine is intended for use in men only. It must not be taken by women, children, or adolescents.

Warnings and precautions
Talk to your doctor before taking Dutasteride Accord.

Make sure your doctor knows about any liver problems you may have. If you have had any liver disease, you may require additional monitoring while taking Dutasteride Accord.
Women, children, and adolescents must avoid contact with damaged or leaking capsules of Dutasteride Accord, as the active substance can be absorbed through the skin. In case of skin contact, wash the affected area immediately with soap and water.
Use a condom during sexual intercourse. Dutasteride has been found in the semen of men being treated with Dutasteride Accord. If your partner is or could be pregnant, you must avoid exposing her to your semen, as dutasteride may interfere with the normal development of a male fetus. It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility. This may reduce your fertility.
Dutasteride Accord affects a blood test for PSA (prostate-specific antigen), which is sometimes used to detect prostate cancer. Your doctor should be aware of this effect and may still recommend the test to check for prostate cancer. If you are due to have a PSA test, inform your doctor that you are taking Dutasteride Accord. Men taking Dutasteride Accord must have the PSA test regularly.
In a clinical study conducted in men at increased risk of prostate cancer, men taking Dutasteride Accord were found to have a higher incidence of high-grade prostate cancer compared to men not taking Dutasteride Accord. The effect of Dutasteride Accord on this type of high-grade prostate cancer is not fully understood.
Dutasteride Accord may cause breast enlargement and tenderness. If this becomes bothersome, or if you notice breast lumps or nipple discharge, you should speak to your doctor about these changes, as they may be signs of a serious condition, such as breast cancer.

Mood changes and depression
In patients treated with another medicine of the same therapeutic class (oral 5-alpha reductase inhibitors), depressive mood, depression, and, less frequently, suicidal thoughts have been reported.
If you experience any of these symptoms, contact your doctor as soon as possible for further advice.
Ask your doctor or pharmacist if you have any questions about taking Dutasteride Accord.

Other medicines and Dutasteride Accord
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Some medicines may interact with Dutasteride Accord and increase the risk of side effects. These include:

verapamil or diltiazem (for hypertension)
ritonavir or indinavir (for HIV)
itraconazole or ketoconazole (for fungal infections)
nefazodone (an antidepressant)
alpha-blockers (for enlarged prostate or hypertension).

Inform your doctor if you are taking any of these medicines. It may be necessary to reduce the dose of Dutasteride Accord you are taking.

Dutasteride Accord with food and drink
Dutasteride Accord can be taken with or without food.

Pregnancy, breastfeeding and fertility
Pregnant women (or women who could be pregnant) must not handle damaged or leaking capsules. Dutasteride is absorbed through the skin and may interfere with the normal development of a male fetus. This is particularly risky during the first 16 weeks of pregnancy.
Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Dutasteride Accord. If your partner is pregnant or could be pregnant, you must avoid exposing her to your semen.
Dutasteride Accord has been shown to reduce sperm count, semen volume, and sperm motility. Therefore, male fertility may be reduced.
Consult your doctor if a pregnant woman has been exposed to dutasteride.

Driving and using machines
It is unlikely that Dutasteride Accord will affect your ability to drive or operate machinery.

Dutasteride Accord contains soy lecithin
This medicine contains soy lecithin, which may contain soybean oil. If you are allergic to peanuts or soy, do not use this medicine.

3. How to take Dutasteride Accord

Take this medicine exactly as your doctor or pharmacist has told you. If you do not take it regularly, PSA level monitoring may be affected. If you are unsure, consult your doctor or pharmacist.
How much Dutasteride Accord to take

The recommended dose is one capsule (0.5 mg) taken once daily. Swallow the capsules whole with water. Do not chew or open the capsules. Contact with the capsule contents may irritate the mouth or throat.
Treatment with Dutasteride Accord is long-term. Some individuals may notice an early improvement in symptoms. However, others may need to take Dutasteride Accord for 6 months or longer before it starts to work. Continue taking Dutasteride Accord for as long as your doctor tells you to.

If you take more Dutasteride Accord than you should
If you take more capsules than prescribed, contact your doctor or pharmacist for advice.
If you forget to take Dutasteride Accord
Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.
Do not stop treatment with Dutasteride Accord without consulting your doctor
Do not stop taking Dutasteride Accord without first consulting your doctor. It may take 6 months or longer before you notice an improvement.
If you have 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 reactions
Signs of allergic reactions may include:

skin rash (which may be itchy)
hives
swelling of the eyelids, face, lips, arms or legs.

Contact your doctor immediately if you experience any of these symptoms and stop taking
Dutasteride Accord.
Common side effects
These may affect up to 1 in 10 people treated with Dutasteride Accord:

inability to achieve or maintain an erection (impotence) *this may continue after you have stopped taking Dutasteride Accord
decreased sexual desire (libido), this may continue after you have stopped taking Dutasteride Accord
ejaculation difficulties, such as a decrease in the amount of semen released during sexual intercourse, this may continue after you have stopped taking Dutasteride Accord
breast enlargement or tenderness (gynaecomastia)
dizziness when taking tamsulosin.

Uncommon side effects
These may affect up to 1 in 100 people treated with Dutasteride Accord:

heart failure (the heart becomes less efficient at pumping blood around the body. Symptoms may include shortness of breath, extreme tiredness, and swelling of the ankles and legs)
hair loss (usually from the body) or hair growth.

Side effects not known
Frequency cannot be estimated from the available data:

depression
pain and swelling of the testicles.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dutasteride Accord

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 and blister after
"Exp.". The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep in the original container to protect from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Dutasteride Accord contains
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 coating: gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), medium-chain triglycerides, soybean lecithin (E-322), purified water.

Description of the appearance of Dutasteride Accord and package contents
Dutasteride Accord soft capsules are opaque, yellow, oblong, size 6 gelatin capsules containing a yellowish oily liquid. They are available in packs of 10, 30, 50, 60, 90 capsules and in perforated blister packs of 10x1, 30x1, 50x1, 60x1 and 90x1 capsules. Not all pack sizes may be marketed.
The dimensions of the soft capsules are: 19 ± 0.8 mm x 6.9 ± 0.4 mm.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturers:
Cyndea Pharma S.L.
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda, 31
Olvega, 42110 Soria
Spain
Galenicum Health S.L.U.
Sant Gabriel, 50,
Esplugues de Llobregat
08950, Barcelona
Spain
Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park
Paola PLA 3000
Malta
SAG Manufacturing, S.L.U.
Crta. N-I, Km 36 San Agustin de Guadalix 28750 Madrid,
Spain