Prospecto: information for the patient

Dutasterida Teva 0.5 mg soft capsules EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor, even if they are not listed in this prospect. See section 4.

1.What is Dutasterida Teva and what it is used for

2.What you need to know before starting to take Dutasterida Teva

3.How to take Dutasterida Teva

4.Possible adverse effects

5.Storage of Dutasterida Teva

6.Contents of the package and additional information

Dutasterida Teva 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 excessive production of a hormone called dihydrotestosterone.

As the prostate grows in size, urinary problems may occur, such as difficulty urinating and a need to urinate more frequently. It may also cause the urine flow to be slower and less intense. If benign prostatic hyperplasia is not treated, there is a risk of complete urine flow blockage (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 dihydrotestosterone production, thus helping to reduce prostate size and alleviate symptoms. This would reduce the risk of acute urinary retention and the need for surgery.

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

Do not take Dutasterida Teva

-if you are allergic to dutasteride, other 5-alpha reductase inhibitors, or any of the other ingredients in this medication (listed in section 6).

-if you have a serious liver disease.

If you think you are in any of these situations, do not take this medication until you have consulted with your doctor.

This medication is only for men.Women, children, and adolescents should not take it.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

Be especially careful with Dutasterida Teva

-Make sure your doctor knows that you have liver problems before taking this medication.If you have any liver disease, you may need additional monitoring during your treatment with dutasteride.

-Women, children, and adolescentsshould avoid contact with broken dutasteride capsules, as the active ingredient can be absorbed through the skin. If skin contact occurs,the affected area should be washed immediatelywith water and soap.

-Use a condom during sex.Dutasteride has been detected in the semen of men taking dutasteride. If your partner is pregnant or may be pregnant, you should avoid exposing her to your semen because dutasteride may affect the normal development of the male fetus. Dutasteride has been shown to decrease sperm count, motility, and semen volume. This may reduce male fertility.

-Dutasteride may affect the results of blood tests for PSA (prostate-specific antigen) that are sometimes used to detect prostate cancer. Your doctor may still use this test to detect prostate cancer, but you should know about this effect. If you have a blood test for PSA, inform your doctor that you are taking dutasteride.Men taking dutasteride should have frequent PSA tests.

-In a clinical trial of men at higher risk of prostate cancer, men taking dutasteride developed amore severe form of prostate cancer more frequentlythan men not taking dutasteride. The effect of dutasteride on this severe form of prostate cancer is unknown.

• Dutasterida Teva may causean increase in breast size and tenderness. If you experience any discomfort or noticelumps in the breastsordischarge from the nipple, consult your doctor, as these changes may be symptoms of a serious disease, such as breast cancer.

• Consult your doctor or pharmacist if you have any questions about taking this medication.

Use of Dutasterida Teva with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Some medications may interact with dutasteride, increasing the risk of adverse effects. These medications are:

-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 doctorif you are taking any of these medications. You may need to reduce the dose of Dutasterida Teva.

Use of Dutasterida Teva with food and drinks

This medication can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnant women (or those who may be pregnant) should avoid contact with broken capsules.Dutasteride is absorbed through the skin and may affect the normal development of the male fetus. This risk is especially important in the first 16 weeks of pregnancy.

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

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

• Consult your doctor immediatelyif a pregnant woman has been in contact with dutasteride.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Follow exactly the administration instructions for this medication as indicated 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 a day. Capsules should be swallowed whole with water. Do not chew or break the capsules. Contact with the contents of the capsules may irritate your mouth or throat.

Dutasterida treatment is long-term. Some men may notice a quick improvement in symptoms. However, others may need to continue treatment for 6 months or more before an effect begins. Continue taking dutasterida for the time your doctor has indicated.

If you take more Dutasterida Teva than you should

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

If you forgot to take Dutasterida Teva

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

Do not interrupt treatment with Dutasterida Teva

Do not interrupt treatment with this medication without consulting your doctor first. It may take up to 6 months or more to notice an effect.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Allergic reaction

The symptoms of an allergic reaction may include:

-skin rash(which may itch)

-hives

-swelling of eyelids, face, lips, arms, or legs

You shouldimmediately contact your doctor if you experience any of these symptoms andstop taking Dutasterida Teva.

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

inability to achieve or maintain an erection (impotence), which may continue after stopping Dutasterida Teva

-decreased libido, which may continue after stopping Dutasterida Teva

-difficulty with ejaculation, such as a decrease in the amount of semen released during sexual intercourse, which may continue after stopping Dutasterida Teva

-breast tenderness or sensitivity (gynecomastia)

-dizziness, when taken with tamsulosina

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. You may have symptoms such as shorter breathing, extreme fatigue, swelling of the ankles and legs).

-hair loss (usually of the body) or excessive hair growth.

Unknown:(the frequency cannot be estimated based on available data)

• depression
• testicular pain or swelling

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use website:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store above30 °C. Store in the original packaging to protect it from light.

Do not use this medication if you observe visible signs of deterioration.

Medications should not be disposed of through drains or in the trash.Deposit containers and medications you no longer need at the SIGRE point of your pharmacy.If in doubt, please ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Dutasterida Teva

-The active ingredient is dutasteride

-Each soft capsule contains 0.5 mg of dutasteride

-The other ingredients are butylhydroxytoluene (E321), monoglycerides of capric/caprylic acids, medium-chain triglycerides, and purified water

-The capsule coating contains gelatin (160 Bloom), glycerol (E422), titanium dioxide (E171), and yellow iron oxide (E172).

Appearance of the product and contents of the package

The 0.5 mg soft capsules of Dutasterida Teva are size 6, oblong, yellow, opaque, unprinted, and filled with a transparent or slightly yellowish solution.

They are available in packages of 10, 28, 30, 50, 60, 90, and 100 capsules.

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

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

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

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

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

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

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

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma S.L.U.

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

28108 Alcobendas – Madrid

Spain

Responsible manufacturer:

Pharmachemie B.V.

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

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 Member States of the European Economic Area under the following names:

Bulgaria: Dutasteride Teva 0.5mg 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 0.5mg 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 0.5 mg cápsulas blandas EFG

Last date of revision of this leaflet:October 2021.

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