Dutasteride Teva-Ratiopharm 0.5 mg soft capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dutasteride Teva-ratiopharm 0.5 mg soft capsules EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Dutasteride Teva-ratiopharm is and what it is used for

Dutasteride Teva-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 need to urinate more frequently. It may also cause the urine flow to become slower and weaker. If benign prostatic hyperplasia is left untreated, there is a risk that the flow of urine may become completely blocked (acute urinary retention), which requires immediate medical treatment. In some cases, surgery may be needed to reduce the size of the prostate or to remove it. Dutasteride reduces the production of dihydrotestosterone, thereby helping to shrink 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 Teva-ratiopharm

Do not take Dutasteride Teva-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 you fall into any of these categories, 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 Teva-ratiopharm

• Make sure your doctor knows if you have liver problems before taking this medicine. If you have a condition affecting your liver, you may need additional monitoring during treatment with dutasteride.

• Women, children, and adolescents must avoid contact with crushed or broken dutasteride capsules, as the active substance can be absorbed through the skin. If skin contact occurs, wash the affected area immediately with 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 suspects she may be pregnant, you must avoid exposing her to your semen, because dutasteride may affect the normal development of a male fetus. It has been shown that dutasteride reduces 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 taking dutasteride should have the PSA test performed regularly.

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

  • Dutasteride Teva-ratiopharm may cause breast enlargement and tenderness on palpation. If you experience discomfort or 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.

• Consult 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 for medical advice as soon as possible.

Taking Dutasteride Teva-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 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. It may be necessary to reduce the dose of Dutasteride Teva-ratiopharm.

Taking Dutasteride Teva-ratiopharm with food and drinks

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 broken 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 this medicine. If your partner is pregnant or suspects she may be pregnant, you must avoid exposing her to your semen.

It has been shown that dutasteride reduces sperm count, sperm motility, and semen volume. Therefore, male fertility may be reduced.

• 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 Dutasteride Teva-ratiopharm

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

The recommended dose is one capsule (0.5 mg) once daily. The capsules should 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 Dutasteride Teva-ratiopharm than you should

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

If you forget to take Dutasteride Teva-ratiopharm

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

Do not stop treatment with Dutasteride Teva-ratiopharm

Do not discontinue treatment with this medicine without consulting your doctor first. 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 product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 Dutasteride Teva-ratiopharm.

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

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

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

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

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

• depression
• pain or swelling of the testicles

Reporting of adverse effects

If you experience any type of 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 Teva-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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Dutasteride Teva-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 contents of the container

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

Available pack sizes: 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 Authorization Holder and Manufacturer

Marketing Authorization 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

Teva Pharma, S.L.U.
C/ Anabel Segura, 11, Edificio Albatros B, 1st floor (Alcobendas (Madrid)) - 28108
Spain

Teva Operations Poland SP.Z.O.O.
Ul. Mogilska 80 (Krakow) - 31-546
Poland

Teva Operations Poland, S.P. Z.O.O.
ul Sienkiewicza 25 (Kutno) - 99-300
Poland

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

Bulgaria: Dutasteride Teva 0.5 mg soft gel capsules
Denmark: Dutasteride Teva
Estonia: Dutasteride Teva
Finland: Dutasteride ratiopharm 0.5 mg pehmeä kapseli
France: Dutasteride Teva 0.5 mg capsule molle
Germany: Dutasterid AbZ 0.5 mg Weichkapseln
Italy: Dutasteride Teva 0.5 mg capsule molli
Ireland: Dutasteride Teva 0.5 mg Soft Capsules
Latvia: Dutasteride Teva 0.5 mg mikstas kapsulas
Lithuania: Dutasteride Teva 0.5 mg minkštos kapsules
Malta: Dutasteride Teva 0.5 mg soft gel capsules
Netherlands: Dutasteride Teva 0.5 mg, zachte capsules
Poland: Dutasteride Teva, 0.5 mg, kapsulki miekkie
Portugal: Dutasterida Teva
Romania: Dutasterida Teva 0.5 mg capsule moi
Spain: Dutasterida Teva-ratiopharm 0.5 mg cápsulas blandas EFG

Date of the 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 Health Products (AEMPS) at http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77634/P_77634.html