PACKAGE LEAFLET: INFORMATION FOR THE USER

EQUIVALENT MEDICINE
Dutasteride Teva 0.5 mg soft capsules
dutasteride
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Dutasteride Teva is and what it is used for
What you need to know before taking Dutasteride Teva
How to take Dutasteride Teva
Possible side effects
How to store Dutasteride Teva
Contents of the pack and other information

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

Dutasteride Teva is used to treat men with an enlarged prostate gland called
"benign prostatic hyperplasia". This is a non-cancerous enlargement of the prostate gland caused by the overproduction of a hormone called dihydrotestosterone.
The active substance is dutasteride. Dutasteride Teva belongs to a group of medicines known as 5-alpha-reductase inhibitors.
An enlarged prostate can lead over time to urinary problems, such as difficulty urinating and the need to urinate frequently. It may also cause a weaker and slower urine stream. If left untreated, there is a risk of a complete blockage of urine flow ("acute urinary retention"), which requires immediate medical treatment. In some cases, surgery may be needed to remove the prostate gland or reduce its size. Dutasteride Teva reduces the production of dihydrotestosterone, helping to shrink the size of the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgical intervention.
Dutasteride Teva may also be used in combination with another medicine called tamsulosin (used to treat symptoms of an enlarged prostate).

2. What you should know before taking Dutasteride Teva

Do not take Dutasteride Teva

if you are allergic to dutasteride, to 5-alpha-reductase inhibitors, or to any of the other ingredients of this medicine (listed in section 6);
if you have severe liver disease.

Inform your doctor if you think you may have any of these conditions.
This medicine is intended for men only. It must not be used by women, children, or
adolescents.
Warnings and precautions.
Talk to your doctor or pharmacist before taking Dutasteride Teva.
Exercise particular caution with Dutasteride Teva

In some clinical studies, a higher number of patients treated with dutasteride and another medicine called an alpha-blocker, such as tamsulosin, developed heart failure compared to patients treated only with dutasteride or only with an alpha-blocker. Heart failure is a condition in which the heart is unable to pump blood properly.
Your doctor must be aware of any liver problems you may have before starting treatment with this medicine. If you have previously had liver disease, you may require periodic monitoring during treatment with Dutasteride Teva.
Women, children, and adolescents must avoid contact with damaged or leaking capsules of Dutasteride Teva because the active substance can be absorbed through the skin. The affected area must be washed immediately with soap and water in case of skin contact.
Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking this medicine. If your partner is or could be pregnant, you must avoid exposing her to your semen, as dutasteride could impair the normal development of a male fetus. It has been reported that dutasteride reduces sperm count, volume, and motility. This could reduce fertility.
Dutasteride Teva affects a blood test measuring PSA (prostate-specific antigen), which is sometimes used to detect prostate cancer. Your doctor should be aware of this effect and may still use this test to screen for prostate cancer. If you undergo a blood test to measure PSA, inform your doctor that you are taking Dutasteride Teva. Men taking Dutasteride Teva must undergo regular PSA monitoring.
Dutasteride Teva may cause breast enlargement and tenderness. If this effect causes discomfort, or if you notice the presence of breast nodules or nipple discharge, inform your doctor about these changes, as they could be signs of a serious condition, such as breast cancer.
In a clinical study conducted in men at increased risk of prostate cancer, patients treated with dutasteride developed a more severe form of prostate cancer more frequently than patients not treated with dutasteride. The effect of dutasteride on this severe form of prostate cancer is not fully understood.

Contact your doctor or pharmacist if you have any questions about taking Dutasteride Teva.
Other medicines and Dutasteride Teva Inform your doctor or pharmacist if you are taking, have recently
taken, or might take any other medicines.
Some medicines may interact with Dutasteride Teva and increase the risk of side effects.
A dose reduction of Dutasteride Teva may be necessary. 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 enlarged prostate or high blood pressure).

Dutasteride Teva with food and drink
Dutasteride Teva can be taken with or without food.
Pregnancy, breastfeeding and fertility
Pregnant women (or women who may become pregnant) must avoid any contact with damaged or leaking
capsules. Dutasteride can be absorbed through the skin and may impair the normal development of a
male fetus. This risk is particularly present during the first 16 weeks of pregnancy.
Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men
taking Dutasteride Teva. If your partner is or could be pregnant, you must avoid exposing her to your semen.
It has been reported that Dutasteride Teva reduces sperm count, volume, and motility. Therefore, it may reduce male fertility.
Contact your doctor immediately if a pregnant woman has been exposed to dutasteride.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
It is unlikely that Dutasteride Teva will affect your ability to drive or operate machinery.

How to take Dutasteride Teva Always take this medicine exactly as your doctor or pharmacist has instructed you. If you do not take the medicine regularly, monitoring of your PSA levels may be affected. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is one capsule (0.5 mg) once daily. Swallow the capsule whole with water. Do not chew or open the capsule. Contact with the capsule contents may cause pain in the mouth or throat.
Dutasteride Teva is a long-term treatment. Some men notice a rapid improvement in symptoms, while others may need to take Dutasteride Teva for 6 months or longer before an effect is achieved. Continue taking Dutasteride Teva for as long as your doctor has instructed.
If you take more Dutasteride Teva than you should
Contact your doctor or pharmacist for advice if you take too many capsules of Dutasteride Teva.
If you forget to take Dutasteride Teva
Do not take a double dose to make up for a missed capsule. Simply take the next dose at the usual time and continue with your regular dosing schedule.
If you stop taking Dutasteride Teva
Do not stop taking Dutasteride Teva without first discussing it with your doctor. It may take up to 6 months to achieve an effect.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Allergic reaction
Signs of allergic reactions may include:

rash (which may cause itching);
hives;
swelling of the eyelids, face, lips, arms or legs.
Stop taking Dutasteride Teva and contact your doctor immediately if you notice any of these symptoms.

Common (may affect up to 1 in 10 people)

impotence (inability to achieve or maintain an erection); this symptom may continue even after stopping Dutasteride Teva;
decreased sex drive (libido); this symptom may continue even after stopping Dutasteride Teva;
problems with ejaculation; this symptom may continue even after stopping Dutasteride Teva;
breast enlargement or tenderness (gynecomastia);
dizziness when taken together with tamsulosin.

Uncommon (may affect up to 1 in 100 people)

heart failure (the heart pumps blood around the body less effectively; you may develop symptoms such as breathlessness, extreme tiredness, and swelling of the ankles and legs);
hair loss (generally body hair loss) or excessive hair growth.

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

depressed mood
pain and swelling of the testicles

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 refers to the last day of that month.
Do not store above 30°C. Keep in the original packaging to protect the medicine from light.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Dutasteride Teva Contains

The active substance is dutasteride.
Each soft capsule contains 0.5 mg of dutasteride.
The other components are butylated hydroxytoluene (E321), glycerol monocaprylocaprate, medium-chain triglycerides, liquid paraffin, and purified water.
The capsule shell contains gelatin (160 Bloom), glycerol (E422), titanium dioxide (E171), and yellow iron oxide (E172).

Description of the Appearance of Dutasteride Teva and Contents of the Pack
Dutasteride Teva 0.5 mg soft capsules are size 6, oblong, opaque yellow soft capsules filled with a clear to slightly yellowish solution, without any printing.
Available in packs containing 10, 28, 30, 50, 60, 90, and 100 capsules:
10 (blister packs of: 2 x 5 capsules, 1 x 10 capsules) / carton
28 (blister packs of: 2 x 14 capsules, 4 x 7 capsules, 7 x 4 capsules) / carton
30 (blister packs of: 3 x 10 capsules, 6 x 5 capsules) / carton
50 (blister packs of: 5 x 10 capsules, 10 x 5 capsules) / carton
60 (blister packs of: 6 x 10 capsules, 12 x 5 capsules) / carton
90 (blister packs of: 9 x 10 capsules, 18 x 5 capsules) / carton
100 (blister packs of: 10 x 10 capsules, 5 x 20 capsules) / carton
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Teva Italia S.r.l. – Via Messina, 38 – 20154 Milan, Italy

Manufacturer Responsible for Batch Release:
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen, Hungary
TEVA UK Ltd
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem, The Netherlands
TEVA Santé
Rue Bellocier, 89100 Sens, France
Teva Czech Industries s.r.o.
Ostravska 29, c.p. 305, 74770 Opava-Komarov, Czech Republic
CT Arzneimittel GmbH
Graf-Arco-Straße 3, 89079 Ulm, Germany
Merckle GmbH
Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany
HBM Pharma s.r.o.
Sklabinská 30, 036 80 Martin, Slovak Republic