Prospect: information for the patient

Dutasteride ratiopharm 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 to 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 Dutasteride ratiopharm is and for what it is used

2.What you need to know before starting to take Dutasteride ratiopharm

3.How to take Dutasteride ratiopharm

4.Possible adverse effects

5.Storage of Dutasteride ratiopharm

6.Contents of the package and additional information

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

Do not take Dutasterida ratiopharm

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

-if you have a severe 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 ratiopharm

-

-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 must 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 inform your doctor that you are taking dutasteride.Men taking dutasteride should have frequent PSA tests.

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-In a clinical trial of men at higher risk of prostate cancer, men taking dutasteride experienced 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 ratiopharm may causean increase in breast size and pain on palpation. 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 ratiopharm 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 ratiopharm.

Use of Dutasterida ratiopharm 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. Monitoring of PSA levels may be affected if you do not follow the treatment regularly. In case of 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 ratiopharm 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 ratiopharm

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 ratiopharm

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 medication, 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 must contact your doctor immediatelyif you experience any of these symptoms andstop taking this medicine.

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

-inability to achieve or maintain an erection (impotence), this may continue after stopping Dutasterida ratiopharm

-decreased libido, this may continue after stopping Dutasterida ratiopharm

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

-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.

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 above 86°F (30°C). Store in the original packaging to protect it from light.

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

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

Composition of Dutasterida ratiopharm

-The active ingredient is dutasteride

-Each soft capsule contains 0.5 mg of dutasteride

-The other ingredients are butylhydroxytoluene (E321), monoglycerides of caprylic/capric 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 ratiopharm 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.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Teva Pharma, S.L.U.

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

28108 Alcobendas – Madrid

Spain

Responsible 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 authorized in the member states of the European Economic Area with 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 the last review of this leaflet:October 2021

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