DUTASTERIDE 0.5 mg Soft capsules

Зміст інструкції

1. Dutasteride Mylan 0,5 mg soft capsules
   1. What is Dutasteride Mylan and what it is used for
   2. What you need to know before taking Dutasteride Mylan
   3. How to take Dutasteride Mylan
   4. Possible side effects
   5. How to store Dutasteride Mylan
   6. Contents of the pack and other information

Dutasteride Mylan 0,5 mg soft capsules

dutasteride

Generic medicine

Read this leaflet carefully before taking this medicine, as 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 their symptoms are the same as yours, 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 Mylan is and what it is used for
• 2. What you need to know before you take Dutasteride Mylan
• 3. How to take Dutasteride Mylan
• 4. Possible side effects
• 5. How to store Dutasteride Mylan
• 6. Contents of the pack and other information

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

The active ingredient is dutasteride. It belongs to a group of medicines called 5-alpha reductase inhibitors.

Dutasteride Mylan is used to treat men with enlarged prostate(benign prostatic hyperplasia) - an increase in the volume of the prostate gland, of non-cancerous origin, caused by the production of excessive amounts of a hormone called dihydrotestosterone. Prostate enlargement can cause urinary problems over time, such as difficulty passing urine and the need to go to the bathroom frequently. It can also make the urine flow slower and weaker. If the enlargement is not treated, there is a risk of 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 Mylan reduces the production of dihydrotestosterone, helping to decrease the volume of the prostate and alleviate the symptoms. This will reduce the risk of acute urinary retention and the need for surgery.
Dutasteride Mylan can also be used together with another medicine called tamsulosin (used to treat the symptoms of enlarged prostate).

2. What you need to know before taking Dutasteride Mylan

Do not take Dutasteride Mylan

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

→ This medicine is intended for use by men only.It should not be used by women,
children or adolescents.
If you think any of these apply to you, tell your doctor.

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

• Make sure your doctor is aware of any liver problems you have. If you have suffered from a liver disease, you may need additional checks during treatment with Dutasteride Mylan.
• Women, children and adolescentsshould avoid contact with broken Dutasteride Mylan capsules because the active ingredient can be absorbed through the skin. The affected area should be 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 Dutasteride Mylan. If your partner is or may be 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 Mylan alters a blood test for measuring PSA(prostate-specific antigen) which is sometimes used to detect prostate cancer. Your doctor should be informed of this effect and may still use this test to detect prostate cancer. If you are having a blood test for measuring PSA, tell your doctor that you are taking Dutasteride Mylan. Men taking Dutasteride Mylan should have regular PSA checks. In a clinical study conducted on men at increased risk of prostate cancer, men treated with Dutasteride Mylan developed a more serious form of prostate cancer more oftenthan men not treated with Dutasteride Mylan. The effect of Dutasteride Mylan on this serious form of prostate cancer is unclear.
• Dutasteride Mylan 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 tell your doctor about these changes as they may be signs of a serious illness, such as breast cancer.

Changes in mood and depression
In patients treated with another medicine in the same therapeutic class (oral 5-alpha
reductase inhibitors), depressed mood, depression and, less frequently, suicidal thoughts have been reported.
If any of these symptoms occur, contact your doctor as soon as possible for further
advice.
The active ingredient of this medicine, dutasteride, is absorbed through the skin, therefore, it is
necessary to ensure that women, children and adolescents around you avoid handling
broken capsules. If their skin comes into contact with the contents of the capsules, they should wash
the affected area immediately with water and soap.
If you have any questions about taking Dutasteride Mylan, talk to your doctor or pharmacist.

Other medicines and Dutasteride Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Some medicines can interact with Dutasteride Mylan and increase 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 enlarged prostate or high blood pressure).

Tell your doctorif you are taking any of these medicines. It may be necessary to reduce your dose of
Dutasteride Mylan.

Dutasteride Mylan with food and drink
Dutasteride Mylan can be taken with or without food.

Pregnancy, breastfeeding and fertility
Women should not take dutasteride.

Pregnant women (or those 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.
→ If a pregnant woman has come into contact with this medicine contact your doctorfor
consultation.

Use a condom during sexual intercourse. The active ingredient of this
medicine, dutasteride, has been detected in the semen of men taking Dutasteride Mylan. If your
partner is or may be pregnant, you should avoid exposing her to your semen.
Dutasteride Mylan has been shown to reduce sperm count, volume and motility. Therefore,
it may reduce male fertility.

Driving and using machines
It is unlikely that Dutasteride Mylan will affect your ability to drive or operate machinery.

Dutasteride Mylan contains soy lecithin.
This medicine contains soy lecithin, may contain soybean oil. If you are allergic to peanuts or
soy, do not use this medicine.

3. How to take Dutasteride Mylan

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist. If you do not take it regularly, the monitoring of your PSA levels may be affected.

Recommended dose

• 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 Mylan is a long-term treatment. Some men notice a rapid improvement in symptoms, while others may need to take Dutasteride Mylan for 6 months or more before experiencing an effect. Continue to take Dutasteride Mylan for as long as indicated by your doctor.

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

If you forget to take Dutasteride Mylan
Do not take a double dose to make up for a missed dose. Take the next dose
at the usual time.

If you stop taking Dutasteride Mylan
Do not stop taking Dutasteride Mylan without first talking to your doctor. It may
take up to 6 months or more to notice an effect.
→ If you have further questions on 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
Signs of an allergic reaction may include:

• skin rash(which may be itchy);
• hives;
• swelling of eyelids, face, lips, arms or legs.

→ Contact your doctor immediatelyif you experience any of these symptoms and stop
treatment with Dutasteride Mylan.

Common side effects(may affect 1 in 10 men):

• inability to get or maintain an erection (impotence), this may continue after stopping Dutasteride Mylan;
• decreased sexual drive (libido), this may continue after stopping Dutasteride Mylan;
• difficulty ejaculating, for example, decreased amount of semen released during sexual intercourse this may continue after stopping Dutasteride Mylan;
• breast enlargement or tenderness (gynecomastia);
• dizziness when taken with tamsulosin.

Uncommon side effects(may affect 1 in 100 men):

• 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 (generally loss of body hair) or excessive hair growth.

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

• depression
• pain and swelling of the testicles

If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Dutasteride Mylan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the package leaflet
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 package to protect the medicine from moisture.
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 Mylan contains
The active ingredient is dutasteride.
Each soft capsule contains 0.5 mg of dutasteride.
The other ingredients are:

• inside the capsule: Glycerol monocaprylocaprate (Type I) and butylated hydroxytoluene (E321).
• capsule shell: gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), triglycerides (medium chain), lecithin (may contain soybean oil) (E322) and purified water.

Description of the appearance of Dutasteride Mylanand contents of the pack
Dutasteride Mylan soft capsules are size 6, oblong, yellow and opaque soft gelatin capsules
containing an oily and yellowish liquid. They are available in packs of 30 capsules.
The size of the soft capsules is: 19 ± 0.8 mm x 6.9 ± 0.4 mm.

Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Manufacturer:
Galenicum Health, S.L.U
Sant Gabriel, 50
Esplugues de LLobregat
08950 Barcelona
Spain
Cyndea Pharma, S.L
Polígono Industrial Emiliano Revilla Sanz,
Avenida de Ágreda, 31 Olvega, 42110
Soria, Spain
Pharmadox Healthcare, Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000, Malta
SAG MANUFACTURING, S.L.U.
Carretera Nacional 1 Km 36,
San Agustin del Guadalix, 28750
Madrid, Spain

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Malta: Dutasteride Mylan 0.5mg soft capsules
Italy: Dutasteride Mylan