DUTASTERIDE TEVA 0.5 mg SOFT CAPSULES

Introduction

Patient Information Leaflet

Dutasteride Teva 0.5 mg soft capsules EFG

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

• Keep this leaflet, 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

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

Dutasteride is used in men to treat prostate enlargement (benign prostatic hyperplasia), a non-cancerous growth of the prostate caused by producing too much of a hormone called dihydrotestosterone.

As the prostate grows, it can cause urinary problems such as difficulty urinating and a need to urinate more often. It can also cause the flow of urine to be slower and less forceful. If left untreated, benign prostatic hyperplasia can lead to complete blockage of urine flow (acute urinary retention), which requires immediate medical treatment. In some cases, surgery may be necessary to reduce the size of the prostate or remove it. Dutasteride reduces the production of dihydrotestosterone, 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 with another medicine called tamsulosin (used to treat symptoms of prostate enlargement).

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

Do not take Dutasteride Teva

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

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

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

Be careful with Dutasteride Teva

• Make sure your doctor knows you have liver problems before taking this medicine. If you have any disease that affects your liver, you may need extra checks during your treatment with dutasteride.
• Women, children, and adolescents should avoid contact with leaking capsules of dutasteride, as the active ingredient can be absorbed through the skin. If skin contact occurs, the affected area should be washed immediately with soap and water.
• Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking dutasteride. If your partner is pregnant or may become pregnant, she should avoid exposure to your semen, as dutasteride may affect the normal development of a male fetus. Dutasteride has been shown to decrease sperm count, sperm motility, and semen volume, which may reduce male fertility.
• Dutasteride may affect the results of a blood test for prostate-specific antigen (PSA), which is sometimes used to detect prostate cancer. Your doctor may still use this test to detect prostate cancer, but should be aware of this effect. If you have a blood test for PSA, tell your doctor you are taking dutasteride. Men taking dutasteride should have regular PSA tests.

• In a clinical trial of men at higher risk of prostate cancer, men taking dutasteride were more likely to develop a serious form of prostate cancer than men not taking dutasteride. The effect of dutasteride on this serious form of prostate cancer is not known.
• Dutasteride Teva may cause breast tenderness or enlargement. If you notice any changes or lumps in your breasts, or nipple discharge, consult your doctor, as these changes may be signs of a serious condition, such as breast cancer.

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

Using Dutasteride Teva with other medicines

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

Some medicines may interact with dutasteride, increasing 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 prostate enlargement or high blood pressure)

• Tell your doctorif you are taking any of these medicines. Your dose of Dutasteride Teva may need to be reduced.

Using Dutasteride Teva with food and drink

This medicine can be taken with or without food.

Pregnancy, breast-feeding, and fertility

Pregnant women (or women who may become pregnant) should avoid contact with leaking capsules.Dutasteride is absorbed through the skin and may affect the normal development of a male fetus. This risk is especially 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 may become pregnant, she should avoid exposure to your semen.

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

• Consult your doctor immediatelyif a pregnant woman has come into contact with dutasteride.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Dutasteride is unlikely to affect your ability to drive or use machines.

3. How to take Dutasteride Teva

Take this medicine exactly as your doctor or pharmacist has told you. Monitoring of PSA levels may be affected if you do not follow your treatment regularly. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is one capsule (0.5 mg) once a day. The capsules should be swallowed whole with water. Do not chew or open the capsules. Contact with the contents of the capsules can irritate your mouth or throat.

Treatment with dutasteride is long-term. Some men may notice rapid improvement in symptoms, while others may need to continue treatment for 6 months or more before an effect is seen. Continue taking dutasteride for as long as your doctor has told you.

If you take more Dutasteride Teva than you should

If you have taken too much of this medicine, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Dutasteride Teva

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

Do not stop taking Dutasteride Teva

Do not stop taking this medicine without consulting your doctor first. It may take up to 6 months or more to see an effect.

If you have any further questions about 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 reaction

Symptoms of an allergic reaction can include:

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

You should contactyour doctor immediately if you experience any of these symptoms and stop taking Dutasteride Teva.

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

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

• reduced sex drive (libido), which may continue after stopping Dutasteride Teva
• difficulty with ejaculation, such as a decrease in the amount of semen released during sex, which may continue after stopping Dutasteride Teva
• breast tenderness or enlargement (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 to the rest of the body. You may have symptoms such as shortness of breath, extreme tiredness, swelling of the ankles and legs).
• hair loss (usually from the body) or increased hair growth.

Rare(cannot be estimated from the available data):

• depression
• testicular pain or 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 leaflet. You can also report side effects directly via the Spanish Medicines Agency website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

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5. Storage of Dutasteride Teva

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

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

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

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

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 other information

Composition of Dutasteride Teva

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

Appearance and packaging of the product

The 0.5 mg soft capsules of Dutasteride Teva are size 6, oblong, yellow, opaque, and have no markings. They are filled with a clear or slightly yellowish solution.

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

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

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

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

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

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

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

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

Not all 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 1ª planta

28108 Alcobendas – Madrid

Spain

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, 1ª planta (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 medicine is authorised 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

Date of last revision of this leaflet:October 2021.

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