Dutasteride ratiopharm 0.5 mg soft capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dutasteride ratiopharm 0.5 mg soft capsules EFG

Read the entire leaflet carefully before you start 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What is Dutasteride ratiopharm and what is it used for?

Dutasteride ratiopharm contains the active substance dutasteride. Dutasteride belongs to a group of medicines called 5-alpha-reductase enzyme inhibitors.

Dutasteride is used in men to treat an enlarged prostate (benign prostatic hyperplasia), a non-cancerous growth of the prostate caused by overproduction of a hormone called dihydrotestosterone.

As the prostate enlarges, urinary problems may occur, such as difficulty urinating and a more frequent need to urinate. It may also cause the urine stream to become weaker and less forceful. If benign prostatic hyperplasia is left untreated, there is a risk that urine flow may become completely blocked (acute urinary retention), which requires immediate medical treatment. In some cases, surgery may be necessary to reduce the size of the prostate or to remove it. Dutasteride reduces the production of dihydrotestosterone, thereby helping to reduce the size of the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgery.

Dutasteride may also be used in combination with another medicine called tamsulosin (used to treat symptoms of prostate enlargement).

2. What you need to know before taking Dutasteride ratiopharm

Do not take Dutasteride ratiopharm

• if you are allergic to dutasteride, to other 5-alpha reductase enzyme inhibitors, 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 situations apply to you, do not take this medicine until you have consulted your doctor.

This medicine is for men only. Women, children, and adolescents must not take it.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

Take special care with Dutasteride ratiopharm

• Make sure your doctor knows if you have liver problems before taking this medicine. If you have a disease affecting your liver, you may need additional monitoring during treatment with dutasteride.
• Women, children, and adolescents must avoid contact with crushed or opened dutasteride capsules, as the active substance can be absorbed through the skin. If skin contact occurs, the affected area should be washed immediately with water and soap.
• Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking dutasteride. If your partner is pregnant or suspects she may be pregnant, you must avoid exposing her to your semen, because dutasteride may affect the normal development of a male fetus. Dutasteride has been shown to reduce sperm count, sperm motility, and semen volume. This may reduce your fertility.
• Dutasteride may affect the results of blood tests for PSA (prostate-specific antigen), which are sometimes used to detect prostate cancer. Your doctor may still use this test to screen for prostate cancer, but must be aware of this effect. If you have a blood test for PSA, inform your doctor that you are taking dutasteride. Men being treated with dutasteride should have the PSA test performed regularly.

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• In a clinical trial involving men at higher risk of prostate cancer, men treated with dutasteride developed a more aggressive form of prostate cancer more frequently than men not taking dutasteride. The effect of dutasteride on this aggressive form of prostate cancer is unknown.

• Dutasteride ratiopharm may cause an increase in breast size and tenderness. If you experience discomfort, notice lumps in the breasts, or nipple discharge, consult your doctor, as these changes may be symptoms of a serious condition, such as breast cancer.

• Talk to your doctor or pharmacist if you have any questions about taking this medicine.

Mood changes and depression

Depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with another medicine in the same therapeutic class (oral 5-alpha-reductase inhibitor). If you experience any of these symptoms, contact your doctor as soon as possible for further medical advice.

Taking Dutasteride ratiopharm with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Some medicines may interact with dutasteride, increasing the risk of adverse 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)

• Inform your doctor if you are taking any of these medicines. A dose reduction of Dutasteride ratiopharm may be necessary.

Taking Dutasteride ratiopharm with food and drink

This medicine can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnant women (or women who may be pregnant) must avoid contact with crushed capsules. Dutasteride can be absorbed through the skin and may affect the normal development of a male baby. This risk is particularly important during the first 16 weeks of pregnancy.

Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking dutasteride. If your partner is pregnant or suspects she may be pregnant, you must avoid exposing her to your semen.

Dutasteride has been shown to reduce sperm count, sperm motility, and semen volume. This may reduce male fertility.

• Contact your doctor immediately if a pregnant woman has been exposed to dutasteride.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

It is unlikely that dutasteride will affect your ability to drive or operate machinery.

3. How to take Dutasterida ratiopharm

Follow exactly the instructions for use of this medicine as given by your doctor. Monitoring of PSA levels may be affected if you do not follow the treatment regularly. If in doubt, please consult your doctor or pharmacist again.

The recommended dose is one capsule (0.5 mg) once daily. The capsules must be swallowed whole with water. Do not chew or open the capsules. Contact with the capsule contents may irritate your mouth or throat.

Treatment with dutasteride is long-term. Some men may notice a rapid improvement in symptoms. However, others may need to continue treatment for 6 months or longer before an effect begins. Continue taking dutasteride for as long as your doctor has instructed.

If you take more Dutasterida ratiopharm than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Dutasterida ratiopharm

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

Do not stop treatment with Dutasterida ratiopharm

Do not stop treatment with this medicine without first consulting your doctor. It may take up to 6 months or longer before you notice an effect.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Allergic reaction

Symptoms of an allergic reaction may include:

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

You must contact your doctor immediately if you experience any of these symptoms and stop taking this medicine.

Frequent: (may affect up to 1 in 10 men):

• inability to achieve or maintain an erection (impotence), which may continue after stopping Dutasterida ratiopharm
• decreased sex drive (libido), which may continue after stopping Dutasterida ratiopharm
• problems with ejaculation, such as a decrease in the amount of semen released during sexual intercourse, which could continue after stopping Dutasterida ratiopharm
• swelling or tenderness of the breast (gynecomastia)
• dizziness, when taken with tamsulosin

Uncommon: (may affect up to 1 in 100 men):

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

Not known: (frequency cannot be estimated from available data)

• depression
• pain or swelling of the testicles

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dutasteride ratiopharm

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C. Store in the original packaging to protect from light.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Pack contents and other information

Composition of Dutasterida ratiopharm

• The active substance is dutasteride.
• Each soft capsule contains 0.5 mg of dutasteride.
• The other ingredients are butylated hydroxytoluene (E321), caprylic/capric mono-glycerides, medium-chain triglycerides and purified water.
• The capsule shell contains gelatin (160 Bloom), glycerol (E422), titanium dioxide (E171) and yellow iron oxide (E172).

Appearance of the product and pack contents

The 0.5 mg Dutasterida ratiopharm soft capsules are size 6, oblong, yellow, opaque, unmarked, and filled with a transparent or slightly yellow oily liquid or soft mass.

They are available in packs containing 10, 28, 30, 50, 60, 90 and 100 capsules.

10 (blister packs of: 2 x 5 capsules, 1 x 10 capsules) / box

28 (blister packs of: 2 x 14 capsules, 4 x 7 capsules, 7 x 4 capsules) / box

30 (blister packs of: 3 x 10 capsules, 6 x 5 capsules) / box

50 (blister packs of: 5 x 10 capsules, 10 x 5 capsules) / box

60 (blister packs of: 6 x 10 capsules, 12 x 5 capsules) / box

90 (blister packs of: 9 x 10 capsules, 18 x 5 capsules) / box

100 (blister packs of: 10 x 10 capsules, 5 x 20 capsules) / box

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B 1st floor

28108 Alcobendas – Madrid

Spain

Manufacturers:

Pharmachemie B.V.

Swensweg, 5. P.O. Box 552 (Haarlem) - NL-2003 RN

The Netherlands

Merckle GmbH

Ludwig-Merckle-Strasse, 3 (Blaubeuren) - D-89143

Germany

Teva Pharmaceutical Works Private Limited Company

Pallagi ut 13 (Debrecen) - H-4042

Hungary

Teva Czech Industries S.R.O.

Ostravska 29, c.p. 305, Building No 80 Small OSD and building No 881- NOSD (Opava-Komarov) - 747 70 –

Czech Republic

This medicinal product is authorised in the European Economic Area member states under the following names:

Estonia: Dutasteride Ratiopharm, 0.5 mg soft capsules

Portugal: Dutasterida ratiopharm

Spain: Dutasterida ratiopharm 0.5 mg soft capsules EFG

Date of most recent review of this leaflet: October 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/