DUTASTERIDE FAIRMED 0.5 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Dutasteride Fairmed0.5 mg soft capsules EFG

Read this package leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Dutasteride Fairmed and what is it used for
2. What you need to know before you take Dutasteride Fairmed
3. How to take Dutasteride Fairmed
4. Possible side effects
5. Storage of Dutasteride Fairmed
6. Contents of the pack and further information

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

Dutasteride Fairmed contains the active substance dutasteride, which belongs to a group of medicines called '5-alpha-reductase inhibitors'.

Dutasteride Fairmedis used to treat enlarged prostate in men(benign prostatic hyperplasia) — a non-cancerous enlargement of the prostate — caused by excessive production of a hormone called 'dihydrotestosterone'.

As the prostate grows, it can cause urinary problems such as difficulty in urinating and the need to urinate more frequently. It can also cause a decrease in urine flow and make it harder to start urinating. If left untreated, there is a risk that the urine flow may be completely blocked (acute urinary retention), which requires immediate medical treatment. In some cases, surgery may be necessary to remove or reduce the size of the prostate. Dutasteride Fairmed reduces the production of dihydrotestosterone, which helps to decrease the size of the prostate and relieve symptoms. This reduces the risk of developing acute urinary retention and the need for surgical intervention.

Dutasteride Fairmed can also be used with another medicine called 'tamsulosin' (used to treat symptoms of enlarged prostate).

2. What you need to know before you take Dutasteride Fairmed

Do not takeDutasteride Fairmed:

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

If you think you may have any of these conditions, consult your doctor.

The use of this medicine is indicated only in males.This medicine should not be taken by women, children, or adolescents.

Warnings and precautions

Consult your doctor or pharmacist before you start taking Dutasteride Fairmed.

• In some clinical trials, the number of patients who took dutasteride with another medicine called 'alpha-blocker' (such as tamsulosin) and developed heart failure was higher than in patients who took only an alpha-blocker. Heart failure means that the heart does not pump blood as it should.
• Make sure to inform your doctor about any liver problems you may have.If you have had any liver disease, you should have additional check-ups while being treated with Dutasteride Fairmed.
• Women, children, and adolescentsshould not handle broken Dutasteride Fairmed capsules, as the active substance can be absorbed through the skin. If skin contact occurs, wash the affected area immediatelywith water and soap.
• Use a condom during sexual intercourse.Dutasteride has been detected in the semen of men taking this medicine. If your partner is pregnant or may become pregnant, you should avoid exposing your partner to semen, as dutasteride may affect the normal development of a male fetus. Dutasteride decreases sperm count, semen volume, and sperm motility, which may reduce fertility.
• Dutasteride Fairmedaffects blood tests for PSA (prostate-specific antigen). This test is sometimes used to detect prostate cancer. Your doctor should be aware of this effect and may continue to use this test to detect prostate cancer. If you have this test, inform your doctor that you are taking Dutasteride Fairmed. Men takingDutasteride Fairmedshould have regular PSA tests.
• In a clinical trial in men at high risk of developing prostate cancer, men who took dutasteride developed a more serious type of prostate cancer than men who did not take dutasteride. The effect of dutasteride on this serious type of prostate cancer is not fully understood.
• Dutasteride Fairmedmay cause breast enlargement and breast tenderness.If you experience any discomfort or notice breast lumpsor nipple discharge, you should inform your doctor, as these could be signs of a serious disease such as breast cancer.

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

TakingDutasteride Fairmedwith other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes any medicines you have bought without a prescription.

Some medicines may interact with Dutasteride Fairmed and increase the risk of side effects. These medicines include:

• verapamil or diltiazem(for high blood pressure)
• ritonavir or indinavir(for HIV)
• itraconazole or ketoconazole(for fungal infections)
• nefazodone(an antidepressant)
• alpha-blockers(for enlarged prostate or high blood pressure)

Tell your doctor if you are taking any of these medicines, as it may be necessary to reduce the dose of Dutasteride Fairmed.

TakingDutasteride Fairmedwith food and drinks

Dutasteride Fairmed can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnant women (or women who may become pregnant) should not handle broken capsules.Dutasteride is absorbed through the skin and may affect the normal development of male fetuses, especially during the first 16 weeks of pregnancy.

Use a condom during sexual intercourse.Dutasteride has been detected in the semen of men taking Dutasteride Fairmed. If your partner is pregnant or may become pregnant, you should avoid exposing your partner to semen.

Dutasteride Fairmed decreases sperm count, semen volume, and sperm motility, which may reduce male fertility.

If a pregnant woman has been in contact with dutasteride, she should contact her doctorfor advice.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Dutasteride Fairmed is not expected to affect your ability to drive or use machines.

3. How to take Dutasteride Fairmed

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist.Not taking this medicine regularly may affect your PSA levels. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one capsule (0.5 mg) once a day.Swallow the capsules whole with water. Do not chew or open the capsule. Contact with the contents of the capsules can cause ulcers in the mouth or throat.

Treatment with Dutasteride Fairmed is long-term. Some men may notice an early improvement in their symptoms, but others may need to take this medicine for 6 months or more before they start to feel an effect. Continue taking Dutasteride Fairmed for as long as your doctor tells you.

If you take moreDutasteride Fairmedthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 620 420, stating the medicine and the amount taken.

If you forget to takeDutasteride Fairmed

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

If you stop takingDutasteride Fairmed

Do not stop taking Dutasteride Fairmed without consulting your doctor first. It may take more than 6 months before you notice an effect.

If you have any further questions on 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 reaction

Signs of an allergic reaction can include:

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

If you experience any of these symptoms, consult your doctor immediately and stop taking Dutasteride Fairmed.

Common side effects(may affect up to 1 in 10 people):

• impotence (inability to achieve or maintain an erection); may continue after you stop taking Dutasteride Fairmed.
• decreased sex drive (libido); may continue after you stop taking Dutasteride Fairmed.
• difficulty ejaculating; may continue after you stop taking Dutasteride Fairmed.
• breast enlargement or breast tenderness (gynecomastia).
• dizziness when taking the medicine with tamsulosin.

Uncommon side effects(may affect up to 1 in 100 people):

• heart failure (reduced heart function, which can cause symptoms such as shortness of breath, extreme tiredness, and swelling of the ankles and legs).
• hair loss (usually from the body) or increased hair growth.

Rare side effects

Frequency cannot be estimated from the available data:

• depression
• testicular pain and swelling

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dutasteride Fairmed

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister, label, and carton after EXP. The expiry date is the last day of the month stated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition ofDutasteride Fairmed

The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.

The other ingredients are:

• Inside the capsule: glycerol monocaprylocaprate, butylhydroxytoluene.
• Capsule shell: gelatin, glycerol, glycine, anhydrous citric acid, titanium dioxide, yellow iron oxide.
• Printing ink: propylene glycol, red iron oxide, polyvinyl acetate phthalate, macrogol 400, ammonium hydroxide.

Appearance and packaging of the product

Dutasteride Fairmed capsules are oblong, light yellow, soft gelatin capsules, containing a clear oily liquid, and are marked with a 0.5. Dimensions: 18.6 mm x 6.7 mm.

Dutasteride Fairmed is available in blisters of 10, 30, 50, 60, and 90 soft gelatin capsules and in HDPE bottles with a polypropylene cap of 30 and 90 soft gelatin capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Fairmed Healthcare GmbH

Dorotheenstraße 48

22301 Hamburg

Germany

pv@fair-med.com

Manufacturer

Fairmed Healthcare GmbH

Maria-Goeppert-Straße 3

23562 Lübeck

Germany

LABORATORIOS BOHM, S.A.

C/ Molinaseca, 23 Polígono Industrial Cobo Calleja.

28947 Fuenlabrada. (Madrid)

91 642 18 18

Date of last revision of this package leaflet: August 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/