Package leaflet: Information for the patient

Dutamsol Mono, 0.5 mg, soft capsules
Dutasteride
Please read the entire leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same as yours.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What Dutamsol Mono is and what it is used for
Important information before taking Dutamsol Mono
How to take Dutamsol Mono
Possible side effects
How to store Dutamsol Mono
Contents of the package and other information

1. What Dutamsol Mono is and what it is used for

The active substance is dutasteride. This substance belongs to a group of medicines called 5-alpha reductase inhibitors.
Dutamsol Mono is used to treat men with an enlarged prostate gland (benign prostatic hyperplasia) – a non-cancerous enlargement of the prostate gland caused by excessive production of a hormone called dihydrotestosterone.
Enlargement of the prostate gland may lead to urinary problems such as difficulty in urinating, increased frequency of urination, reduced urine flow, and weak urine stream. In some cases, complete blockage of urine flow may occur (acute urinary retention). This condition requires immediate treatment. In some cases, surgery may be necessary to remove or reduce the size of the prostate gland. Dutamsol Mono reduces the production of dihydrotestosterone, thereby shrinking the prostate gland and relieving symptoms. As a result, the risk of developing acute urinary retention and the need for surgery is reduced.
Dutamsol Mono may also be used in combination with another medicine called tamsulosin (used to treat symptoms of an enlarged prostate gland).

2. Important information before taking Dutamsol Mono
Do not take Dutamsol Mono:

if you are allergic to dutasteride, other 5-alpha reductase inhibitors, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6).
if you have severe liver disease.

If any of the above apply to you, do not take this medicine until you have consulted your doctor.
This medicine is intended for men only. It must not be taken by women, children, or adolescents.

Warnings and precautions
Before starting treatment with Dutamsol Mono, discuss this with your doctor.

Inform your doctor if you have liver disease. If you have liver disease, you may require additional monitoring during treatment with Dutamsol Mono.
Women, children, and adolescents must not touch damaged capsules of Dutamsol Mono, as the active substance may be absorbed through the skin. In case of skin contact, the contaminated area should be washed immediately with soap and water.
Use a condom during sexual intercourse. It has been shown that dutasteride is present in the semen of men taking Dutamsol Mono. If your partner is or may be pregnant, exposure to her semen should be avoided, as dutasteride may impair the development of a male fetus. It has been demonstrated that dutasteride reduces sperm count, semen volume, and sperm motility. This may reduce your fertility.
Dutamsol Mono affects the measurement of prostate-specific antigen (PSA), a test sometimes used to diagnose prostate cancer. Nevertheless, your doctor may intentionally order this test. If you are undergoing PSA testing, inform your doctor that you are taking Dutamsol Mono. Patients taking Dutamsol Mono should have their PSA levels monitored regularly.
In a clinical study involving men at risk of developing prostate cancer, men taking Dutamsol Mono were diagnosed with high-grade prostate cancer more frequently than men not taking Dutamsol Mono. The effect of dutasteride on high-grade prostate cancer is not fully understood.
Dutamsol Mono may cause breast enlargement and tenderness (pain). If these symptoms are bothersome, or if you develop lumps in the breasts or nipple discharge, contact your doctor, as these may be signs of a serious condition such as breast cancer.

If you have any questions about taking Dutamsol Mono, please contact your doctor or pharmacist.
Dutamsol Mono and other medicines
Inform your doctor about all medicines you are currently taking, have recently taken, or plan to take.
Some medicines may interact with Dutamsol Mono, increasing the likelihood of adverse effects. These include:

verapamil or diltiazem (used to treat high blood pressure)
ritonavir or indinavir (used to treat HIV infection)
itraconazole or ketoconazole (used to treat fungal infections)
nefazodone (an antidepressant)
alpha-blocking agents (used to treat enlarged prostate and high blood pressure)

Inform your doctor if you are taking any of these medicines. A dose adjustment of Dutamsol Mono may be necessary.
Dutamsol Mono with food and drink
Dutamsol Mono can be taken with or without food.
Pregnancy, breastfeeding, and effects on fertility
Pregnant women (or women who may be pregnant) must not handle damaged capsules. Dutasteride is absorbed through the skin and may impair the development of a male fetus. The risk is particularly high during the first 16 weeks of pregnancy.
Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking Dutamsol Mono. If your partner is or may be pregnant, avoid exposing her to your semen.
It has been shown that Dutamsol Mono reduces sperm count, semen volume, and sperm motility. This may lead to reduced fertility in men.
Contact your doctor if a pregnant woman has been exposed to dutasteride.
Driving and operating machinery
It is unlikely that Dutamsol Mono will affect your ability to drive or operate machinery.
Dutamsol Mono contains lecithin derived from soy
The medicine contains soy lecithin, which may contain soy oil. Do not use if you are known to be hypersensitive to peanuts or soy.

3. How to use Dutamsol Mono

This medicine should always be taken exactly as directed by a doctor or pharmacist. Irregular
use of this medicine may affect PSA test results. If in doubt, consult a
doctor or pharmacist.
How much medicine to take
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The recommended dose is one capsule (0.5 mg) taken orally once daily. The capsule should be swallowed whole with water. Do not chew or crush the capsule. Contact of the capsule contents with the mucous membranes of the mouth or throat may cause irritation.
Dutamsol Mono is a medicine intended for long-term use. In some men, symptoms may improve quickly. However, other patients may need to take Dutamsol Mono for 6 months or longer before it starts to work. Dutamsol Mono should be taken for as long as directed by the doctor.

Taking more Dutamsol Mono than recommended
If more capsules of Dutamsol Mono than recommended have been taken, consult a
doctor or pharmacist.
If you miss a dose of Dutamsol Mono
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
Do not stop taking Dutamsol Mono unless advised by your doctor.
Do not discontinue treatment with Dutamsol Mono without first discussing it with your doctor. Noticeable
improvement may occur only after 6 months or longer of treatment.
If you have any further doubts regarding the use of this medicine,
consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Allergic reactions
Symptoms of an allergic reaction may include:

skin rash (which may be itchy)
urticaria
swelling of the eyelids, face, lips, hands or feet.

You should contact your doctor immediately and stop taking Dutamsol Mono if any of the symptoms listed above occur.
Common side effects
May occur in up to 1 in 10 men taking Dutamsol Mono:

inability to achieve or maintain an erection (impotence), which may persist after stopping Dutamsol Mono
reduced sexual desire (libido), which may persist after stopping Dutamsol Mono
problems with ejaculation, including reduced semen volume during ejaculation, which may persist after stopping Dutamsol Mono
enlargement or tenderness of the breast glands (gynaecomastia)
dizziness when taking tamsulosin concomitantly.

Uncommon side effects
May occur in up to 1 in 100 men taking Dutamsol Mono:

heart failure (the heart's ability to pump blood becomes less efficient. Symptoms may include shortness of breath, severe fatigue, and swelling in the ankles and legs)
hair loss (usually body hair) or hair growth

Unknown frequency side effects
Based on available data, the frequency cannot be estimated:

Mood changes (depression)
Pain and swelling of the testicles

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
By reporting side effects, additional information on the safety of this medicine can be collected.
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5. How to store Dutamsol Mono

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister, following the word: EXP. The expiry date refers to the last day of the specified month.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Dutamsol Mono contains
The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.
Other ingredients are:

capsule filling: glycerol monocaprylocaprate (type I), butylated hydroxytoluene (E 321).
capsule shell: gelatin, glycerol, titanium dioxide (E 171), yellow iron oxide (E 172), medium-chain triglycerides, soybean lecithin (E 322), and purified water.

What Dutamsol Mono looks like and contents of the pack
Dutamsol Mono is available as soft capsules of size 6 – elongated, opaque, yellow capsules containing a yellowish oily liquid.
They are available in packs containing 10, 30, 50, 60 and 90 soft capsules.
Not all pack sizes may be marketed.
Dimensions of soft capsules: 19 ± 0.8 mm x 6.9 ± 0.4 mm

Marketing Authorisation Holder
Solinea Sp. z o.o. Sp. K.
Elizówka 65
21-003 Ciecierzyn
Poland

Manufacturer
Cyndea Pharma S.L.
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda, 31
Olvega, 42110 Soria
Spain

Galenicum Health S.L.
Avda. Cornellá 144, 7º-1ª, Edificio LEKLA
Esplugues de Llobregat
08950 Barcelona
Spain

SAG MANUFACTURING, S.L.U
Crta. N-I, Km 36, San Agustín de Guadalix
28750 Madrid
Spain

Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park
Paola PLA 3000
Malta

12-08-2021
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