DUTASTERIDE 0.5 MG Soft capsules

Зміст інструкції

1. Dutasteride Teva 0.5 mg soft capsules
   1. What is Dutasteride Teva and what is it used for
   2. What you need to know before taking Dutasteride Teva
   3. Possible side effects
   4. How to store Dutasteride Teva
   5. Contents of the pack and other information

EQUIVALENT MEDICINE

Dutasteride Teva 0.5 mg soft capsules

dutasteride

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Dutasteride Teva is used to treat men who suffer from an enlargement of the prostate gland called
“benign prostatic hyperplasia”. This is an increase in the volume of the prostate gland, not of cancerous origin, caused by the production of excessive amounts of a hormone called dihydrotestosterone.
The active ingredient is dutasteride. Dutasteride Teva belongs to a category of medicines called
5-alpha reductase inhibitors.
Prostate enlargement can cause urinary problems over time, such as difficulty urinating
and the need to urinate frequently. Furthermore, it can make the urine flow slower and weaker. If
the enlargement is not treated, there is a risk of a complete blockage of urine flow (“acute urinary retention”) which requires immediate medical treatment. In some situations, surgery is necessary to remove the prostate gland or reduce its size. Dutasteride Teva reduces the
production of dihydrotestosterone, helping to decrease the volume of the prostate and alleviate the symptoms. This
reduces the risk of acute urinary retention and the need for surgery.
Dutasteride Teva can also be used together with another medicine called tamsulosin (used to treat the
symptoms of prostate enlargement).

2. What you need to 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 a severe liver disease

Inform your doctor if you think you may have any of these conditions.

This medicine is intended for use by men only.It should not be used by women, children or
adolescents.

Warnings and precautions.
Talk to your doctor or pharmacist before taking Dutasteride Teva.

Pay particular attention with Dutasteride Teva

• In some clinical studies, a higher number of patients treated with dutasteride and another medicine called alpha-blocker, such as tamsulosin, developed heart failure compared to patients treated only with dutasteride or with an alpha-blocker. Heart failure is a condition in which the heart cannot pump blood as it should.
• Your doctor must be aware of any liver problems you have before treatment withthis medicine.If you have suffered from a liver disease, you may need to be monitored periodically during treatment with Dutasteride Teva.
• Women, children and adolescentsshould avoid contact with broken Dutasteride Teva capsules because the active ingredient can be absorbed through the skin. The affected area shouldbe washed immediatelywith water and soap if contact with the skin occurs.
• Use a condom during sexual intercourse.Dutasteride has been detected in the semen of men taking this medicine. If your partner is or may become pregnant, you should avoid exposing her to your semen as dutasteride may impair the normal development of a male fetus. Dutasteride has been shown to reduce sperm count, volume and motility. This may reduce fertility.
• Dutasteride Teva alters a blood test for measuring PSA (prostate-specific antigen) which is sometimes used to detect prostate cancer. Your doctor must be informed of this effect and may still use this test to detect prostate cancer. If you are having a blood test for PSA, tell your doctor that you are taking Dutasteride Teva. Men who are taking Dutasteride Teva should haveperiodic PSA checks.
• Dutasteride Teva may cause enlargement and tenderness of the breasts. If this effect causes you discomfort or if you notice the presence of breast lumpsor nipple discharge, you should inform your doctor about these changes as they may be signs of a serious illness, such as breast cancer.
• In a clinical study conducted on men at increased risk of prostate cancer, patients treated with dutasteride developed a severe form of prostate cancer moreoftenthan patients not treated with dutasteride. The effect of dutasteride on this severe form of prostate cancer is unclear.

Contact your doctor or pharmacist if you have any questions about taking Dutasteride Teva.

Other medicines and Dutasteride TevaTell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Some medicines can interact with Dutasteride Teva and increase the risk of side effects.
It may be necessary to reduce the dose of Dutasteride Teva. 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
Women who are pregnant (or who may become pregnant) should avoid any contact with broken
capsules.Dutasteride is absorbed through the skin and can impair the normal development of a
male fetus. This risk is especially present during the first 16 weeks of pregnancy.

Use a condom during sexual intercourse.Dutasteride has been detected in the semen of men
who are taking Dutasteride Teva. If your partner is or may become pregnant, you should avoid
exposing her to your semen.
Dutasteride Teva has been shown to reduce sperm count, volume and motility. Therefore, it may reduce
male fertility.

Contact your doctor immediatelyif a pregnant woman has come into contact with dutasteride.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
It is unlikely that Dutasteride Teva will affect your ability to drive or operate machinery.

• 3. How to take Dutasteride TevaAlways take this medicine exactly as your doctor or pharmacist has told you. If you do not take the medicine regularly, monitoring of your PSA levels may be altered. If you have any doubts, ask your doctor or pharmacist.

The recommended dose is one capsule (0.5 mg) once a day. 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 more before obtaining
an effect. Continue to take Dutasteride Teva for as long as your doctor has told you.

If you take more Dutasteride Teva than you should
Contact your doctor or pharmacist for advice if you take too many Dutasteride Teva capsules.

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 schedule.

If you stop taking Dutasteride Teva
Do not stop taking Dutasteride Teva before talking to your doctor. It may take
up to 6 months to see an effect.
If you have any further questions, 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
The signs of an allergic reaction may include:

• skin rash(which may be itchy);
• hives;
• swelling of eyelids, face, lips, arms or legs. Stop taking Dutasteride Teva and contact your doctor immediatelyif you notice any of these symptoms.

Common(may affect up to 1 in 10 people)

• impotence (inability to get 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;
• difficulty with ejaculation, this symptom may continue even after stopping Dutasteride Teva;
• breast enlargement or tenderness (gynecomastia);
• dizziness when taken with tamsulosin. Uncommon(may affect up to 1 in 100 people)
• heart failure (the heart pumps blood around the body less efficiently. You may develop symptoms such as shortness of breath, extreme tiredness and swelling of ankles and legs);
• hair loss (usually loss of body hair) or excessive hair growth.

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

• depressed mood
• pain and swelling in the testicles

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 package and on the blister after EXP. The
expiry date refers to the last day of that month.
Do not store at a temperature above 30°C. Store in the original packaging to protect the
medicine from light.
Do not use this medicine if you notice visible signs of deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Dutasteride Teva contains

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

Description of Dutasteride Teva and contents of the pack
Dutasteride Teva 0.5 mg soft capsules measure 6, oblong, yellow, opaque soft capsules filled with a
solution from clear to yellowish, without inscriptions.
They are available in packs of 10, 28, 30, 50, 60, 90 and 100.
10 (blisters of: 2 x 5 capsules, 1 x 10 capsules) /carton
28 (blisters of: 2 x 14 capsules, 4 x 7 capsules, 7 x 4 capsules) /carton
30 (blisters of: 3 x 10 capsules, 6 x 5 capsules) /carton
50 (blisters of: 5 x 10 capsules, 10 x 5 capsules) /carton
60 (blisters of: 6 x 10 capsules, 12 x 5 capsules) /carton
90 (blisters of: 9 x 10 capsules, 18 x 5 capsules) /carton
100 (blisters of: 10 x 10 capsules 5 x 20 capsules) /carton
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Teva Italia S.r.l. – Via Messina, 38 – 20154 Milano

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 UIm
Germany
Merckle GmbH
Ludwig-Merckle-Straße 3, 89143 Blaubeuren
Germany
HBM Pharma s.r.o
Sklabinská 30, 036 80 Martin
Slovak Republic