DUTAMSOL 0.5 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
   1. Read all of this leaflet carefully before taking this medicine because it contains important information for you.
   2. Contents of the pack
2. What is Dutamsol Mono and what is it used for
3. Before you take Dutamsol Mono
   1. When not to take Dutamsol Mono:
   2. Warnings and precautions
   3. 1 4
   4. In men taking Dutamsol Mono, high-grade prostate cancer has been detected more oftenthan in men not taking Dutamsol Mono. The impact of dutasteride on high-grade prostate cancer is not clear.Dutamsol Mono may cause breast enlargement and tenderness. If these symptoms are a problem, or if you notice any lumps or discharge from your nipples, you should see your doctor, as these may be signs of a serious condition, such as breast cancer.If you have any questions about taking Dutamsol Mono, you should consult your doctor or pharmacist.Dutamsol Mono and other medicines
   5. Dutamsol Mono with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Dutamsol Mono contains soy lecithin
4. How to take Dutamsol Mono
   1. How much to take
   2. 2 4
   3. If you take more Dutamsol Mono than you should
   4. If you forget to take Dutamsol Mono
   5. Do not stop taking Dutamsol Mono without talking to your doctor
   6. If you have any further questions on the use of this product, ask your doctor or pharmacist
5. Possible side effects
   1. Like all medicines, this medicine can cause side effects, although not everybody gets them.
   2. Allergic reactions
   3. Common side effects
   4. Uncommon side effects
   5. Rare side effects
   6. Reporting of side effects
   7. 3 4
6. How to store Dutamsol Mono
7. Contents of the pack and other information
   1. What Dutamsol Mono contains
   2. What Dutamsol Mono looks like and contents of the pack
   3. Marketing Authorisation Holder
   4. Manufacturer
   5. Date of last revision of the leaflet:
   6. 4 4

Package Leaflet: Information for the Patient

Dutamsol Mono, 0.5 mg, Soft Capsules
Dutasteride

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• You should keep this leaflet, 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What is Dutamsol Mono and what is it used for
• 2. Before you take Dutamsol Mono
• 3. How to take Dutamsol Mono
• 4. Possible side effects
• 5. How to store Dutamsol Mono
• 6. Contents of the pack and other information

1. What is Dutamsol Mono and what is it 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 an excessive production of a hormone called dihydrotestosterone.
The enlargement of the prostate gland can lead to problems with the urinary system, such as difficulty urinating and frequent urination. It can also cause a decrease in urine flow and a weak urine stream. If left untreated, it can lead to a complete blockage of urine flow ( acute urinary retention). This condition requires immediate treatment. In some cases, surgical intervention may be necessary to remove or reduce the size of the prostate gland. Dutamsol Mono reduces the production of dihydrotestosterone, which leads to a reduction in the size of the prostate gland and alleviation of symptoms. This reduces the risk of developing acute urinary retention and the need for surgical intervention.
Dutamsol Mono can also be used in combination with another medicine called tamsulosin (used to treat symptoms of an enlarged prostate gland).

2. Before you take Dutamsol Mono

When not to take Dutamsol Mono:

• If you are allergic to dutasteride, other 5-alpha reductase inhibitors, soy, or peanutsor any of the other ingredients of this medicine (listed in section 6).
• If you have severe liver disease.If any of the above applies to you, do not take this medicine until you have talked to your doctor.

This medicine is for use in men only.It must not be taken by women, children, or adolescents.

Warnings and precautions

You should discuss this with your doctor before taking Dutamsol Mono.

• Tell your doctor if you have liver disease. If you have had liver disease, you may need to have additional tests while taking Dutamsol Mono.
• Women, children, and adolescentsmust not handle damaged Dutamsol Mono capsules because the active substance can be absorbed through the skin. If contact occurs with the skin, wash the affected area 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, you must avoid exposing her to your semen.

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It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility. This may reduce fertility in men.
Dutamsol Mono affects the measurement of prostate-specific antigen (PSA), which is sometimes carried out to diagnose prostate cancer. However, your doctor may still decide to perform this test. If you are having a PSA test, you should tell your doctor that you are taking Dutamsol Mono.

• Men taking Dutamsol Mono should have their PSA levels regularly checked.

In men taking Dutamsol Mono, high-grade prostate cancer has been detected more oftenthan in men not taking Dutamsol Mono. The impact of dutasteride on high-grade prostate cancer is not clear.

Dutamsol Mono may cause breast enlargement and tenderness. If these symptoms are a problem, or if you notice any lumps or discharge from your nipples, you should see your doctor, as these may be signs of a serious condition, such as breast cancer.

If you have any questions about taking Dutamsol Mono, you should consult your doctor or pharmacist.

Dutamsol Mono and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, and about any medicines you plan to take.
Some medicines can interact with Dutamsol Mono, increasing the risk of side effects. These medicines 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-blockers(used to treat enlarged prostate and high blood pressure)

Tell your doctorif you are taking any of these medicines. It may be necessary to reduce the dose of Dutamsol Mono.

Dutamsol Mono with food and drink

Dutamsol Mono can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Women who are or may be pregnant must not handle damaged capsules. Dutasteride is absorbed through the skin and can affect the development of a male fetus. There is a special risk in the first 16 weeks of pregnancy.
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, you must avoid exposing her to your semen.
Dutamsol Mono has been shown to reduce sperm count, semen volume, and sperm motility. This may reduce fertility in men.
Consult your doctorif a pregnant woman has been exposed to dutasteride.

Driving and using machines

The likelihood of Dutamsol Mono affecting your ability to drive or use machines is low.

Dutamsol Mono contains soy lecithin

The medicine contains soy lecithin, which may contain soybean oil. Do not take if you are allergic to peanuts or soy.

3. How to take Dutamsol Mono

This medicine should always be taken exactly as your doctor or pharmacist has told you. Irregular use of the medicine may affect the results of PSA tests. If you are in doubt, consult your doctor or pharmacist.

How much to take

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• The recommended dose is one capsule (0.5 mg) taken orally once a day. 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 long-term treatment. Some men may experience rapid relief from symptoms. However, others may need to take Dutamsol Mono for 6 months or longer before it starts to work. You should take Dutamsol Mono for as long as your doctor recommends.

If you take more Dutamsol Mono than you should

If you have taken more capsules than you should, talk to your doctor or pharmacist.

If you forget to take Dutamsol Mono

Do not take a double dose to make up for a forgotten dose. Take your next dose at the usual time.

Do not stop taking Dutamsol Mono without talking to your doctor

Do not stop taking Dutamsol Mono without talking to your doctor first. Noticeable improvement may only be seen after 6 months or more of treatment.

If you have any further questions on the use of this product, 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 an allergic reaction may include:

• skin rash(which may be itchy)
• hives
• swelling of the face, lips, tongue, or throat.

Stop taking Dutamsol Mono and see your doctor immediatelyif you get any of these symptoms.

Common side effects

These may affect up to 1 in 10 men taking Dutamsol Mono:

• erectile dysfunction (impotence), which may persist after stopping Dutamsol Mono
• decreased libido, which may persist after stopping Dutamsol Mono
• ejaculation disorders, including reduced semen volume, which may persist after stopping Dutamsol Mono
• breast tenderness or enlargement (gynecomastia)
• dizziness when taken with tamsulosin.

Uncommon side effects

These may affect up to 1 in 100 men taking Dutamsol Mono:

• heart failure (the heart does not pump blood as well as it should. You may feel short of breath, very tired, or have swollen ankles and feet)
• hair loss (usually body hair) or increased hair growth

Rare side effects

Frequency cannot be estimated from the available data:

• Depression
• Painful or swollen testicles

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the website. By reporting side effects, you can help provide more information on the safety of this medicine.

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5. How to store Dutamsol Mono

Keep this medicine out of the sight and reach of children.
Do not take Dutamsol Mono 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.
Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Dutamsol Mono contains

The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.
The other ingredients are:

• capsule filling: glycerol monocaprylocaprate (type I), butylhydroxytoluene (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 a soft capsule, size 6 - elongated, opaque, and yellow, containing a yellowish oily liquid. They are available in packs of 10, 30, 50, 60, and 90 soft 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

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

Date of last revision of the leaflet:

12-08-2021

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