DUTASTERIDE RATIOPHARM 0.5 mg SOFT CAPSULES

Introduction

Patient Information: Summary of Product Characteristics

Dutasteride Ratiopharm 0.5 mg Soft Capsules EFG

Read this 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 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 leaflet. See section 4.

Contents of the pack:

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

Dutasteride is used in men to treat an enlarged prostate (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 a 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, which helps to reduce the size of the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgery.

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

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

Do not take Dutasteride Ratiopharm

• 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

Talk to your doctor or pharmacist before taking this medicine

Be particularly careful with Dutasteride Ratiopharm

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• 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 additional monitoring during treatment with dutasteride.
• Women, children, and adolescents should avoid contact with leaking dutasteride capsules, as the active ingredient 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 may be 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, motility, and semen volume, which may reduce fertility.
• Dutasteride may affect the results of blood tests for PSA (prostate-specific antigen) 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, inform your doctor that you are taking dutasteride. Men taking dutasteride should have regular PSA tests.

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• In a clinical trial with 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 unknown.
• Dutasteride Ratiopharm may cause breast tenderness or enlargement. If you experience any discomfort or notice lumps in your breasts or nipple discharge, consult your doctor, as these changes can be symptoms of a serious disease, such as breast cancer.

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

Using Dutasteride Ratiopharm 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 an enlarged prostate or high blood pressure)

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

Using 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) 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 be pregnant, she should avoid exposure to your semen.

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

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

Talk to 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 Ratiopharm

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

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. However, 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 Ratiopharm than you should

If you have taken too much of this medicine, talk to your doctor or pharmacist immediately or call the Poison Information Service on 91 562 04 20, quoting the medicine and the amount taken.

If you forget to take Dutasteride Ratiopharm

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 Ratiopharm

Do not stop taking this medicine without talking to 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 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

Symptoms of an allergic reaction can include:

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

You should immediately contact your doctorif you experience any of these symptoms and stop taking this medicine.

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

• inability to achieve or maintain an erection (impotence), which may continue after stopping Dutasteride Ratiopharm
• reduced sex drive (libido), which may continue after stopping Dutasteride Ratiopharm
• difficulty with ejaculation, such as a decrease in the amount of semen released during sex, which may continue after stopping Dutasteride Ratiopharm
• 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 to the Spanish Medicines Agency (AEMPS) via their website: www.notificaRAM.es. By reporting side 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 which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month shown.

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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Dutasteride Ratiopharm

• 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 Dutasteride Ratiopharm soft capsules are size 6, oblong, yellow, opaque, unmarked, and 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

Manufacturers:

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

This medicine is authorised in the Member States of the European Economic Area 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 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/