Dutasteride Mylan

Package leaflet: Information for the user

Dutasteride Mylan 0.5 mg soft capsules

dutasteride
Generic medicine
Please read all of 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 give it to other people, even if their symptoms are the same as yours, as 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.

What this leaflet contains:

1. What Dutasteride Mylan is 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

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

The active substance is dutasteride. It belongs to a group of medicines called 5-alpha-reductase inhibitors.
Dutasteride Mylan is used to treat men with an enlarged prostate
(benign prostatic hyperplasia) – a non-cancerous increase in the size of the prostate gland caused by excessive production of a hormone called dihydrotestosterone.
An enlarged prostate can over time lead to urinary problems, such as difficulty passing urine and frequent need to urinate. It may also cause a slow and weak urinary stream. If left untreated, there is a risk of complete blockage of urine flow ( acute urinary retention ), which requires immediate medical treatment. In some cases, surgery may be needed to remove part of the prostate gland or reduce its size. Dutasteride Mylan reduces the production of dihydrotestosterone, helping to shrink the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgical intervention.
Dutasteride Mylan may also be used in combination with another medicine called tamsulosin (used to treat symptoms of an 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 peanuts, or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver disease

→ This medicine is intended for men only. It must not be used by women,
children or adolescents.
If you think any of these situations apply to you, inform 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 may have. If you have previously suffered from liver disease, you may require additional monitoring during treatment with Dutasteride Mylan.
• Women, children and adolescents must avoid contact with damaged or leaking capsules of Dutasteride Mylan, because the active ingredient can be absorbed through the skin. The affected area must be washed immediately with soap and water if skin contact occurs.
• Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking Dutasteride Mylan. If your partner is or could be pregnant, you must 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, semen volume and sperm motility. This may reduce fertility.
• Dutasteride Mylan affects a blood test used to measure 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 screen for prostate cancer. If you undergo a blood test to measure PSA, inform your doctor that you are taking Dutasteride Mylan. Men taking Dutasteride Mylan should have regular PSA checks. In a clinical study conducted in men at increased risk of prostate cancer, men treated with Dutasteride Mylan developed a more serious form of prostate cancer more frequently than men not treated with Dutasteride Mylan. The effect of Dutasteride Mylan on this serious form of prostate cancer is not fully understood.
• Dutasteride Mylan may cause breast enlargement and tenderness. If this effect causes you discomfort, or if you notice breast lumps or nipple discharge, inform your doctor about these changes, as they could be signs of a serious condition, such as breast cancer.

Mood changes and depression
Depressed mood, depression, and less frequently suicidal thoughts have been reported in patients treated with another medicine in the same therapeutic class (oral 5-alpha reductase inhibitors).
If any of these symptoms occur, contact your doctor as soon as possible for further advice.
Dutasteride, the active substance of this medicine, is absorbed through the skin; therefore, it is important to ensure that women, children and adolescents around you avoid handling damaged capsules. If their skin comes into contact with the capsule contents, they must wash the affected area immediately with soap and water.
If you have any doubts about taking Dutasteride Mylan, contact your doctor or pharmacist.
Other medicines and Dutasteride Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may interact with Dutasteride Mylan and increase the risk of side effects. These 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).

Inform your doctor if you are taking any of these medicines. Your dose of Dutasteride Mylan may need to be reduced.
Dutasteride Mylan with food and drink
Dutasteride Mylan can be taken with or without food.
Pregnancy, breastfeeding and fertility
Women must not take dutasteride.
Pregnant women (or those who may become pregnant) must avoid any contact with damaged or leaking capsules.
Dutasteride is absorbed through the skin and may 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 a doctor for advice.
Use a condom during sexual intercourse. Dutasteride, the active ingredient of this medicine, has been detected in the semen of men taking Dutasteride Mylan. If your partner is or could be pregnant, you must avoid exposing her to your semen.
It has been shown that Dutasteride Mylan reduces sperm count, semen volume and sperm 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 and 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 exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. If you do not take it regularly, monitoring of your PSA levels may be affected.
Recommended dose

• 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 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 longer before experiencing an effect. Continue taking Dutasteride Mylan for as long as your doctor has instructed.

If you take more Dutasteride Mylan than 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 the forgotten dose. Take the next dose at your 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 longer before an effect is noticed.
→ 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
Signs of allergic reactions may include:

• skin rash (which may cause itching);
• hives;
• swelling of the eyelids, face, lips, arms or legs.

→ Contact your doctor immediately if you experience any of these symptoms and stop treatment with
Dutasteride Mylan.
Common side effects (may affect up to 1 in 10 men):

• inability to achieve or maintain an erection (impotence); this may continue after stopping treatment with Dutasteride Mylan;
• decreased sexual desire (libido); this may continue after stopping treatment with Dutasteride Mylan;
• problems with ejaculation, for example, reduced volume of semen released during sexual intercourse; this may continue after stopping treatment with Dutasteride Mylan;
• enlarged or tender breasts (gynaecomastia);
• dizziness when taken together with tamsulosin.

Uncommon side effects (may affect up to 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 the ankles and legs);
• hair loss (generally loss of body hair) or excessive hair growth.

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

• depression
• pain and swelling of the testicles

If any side effect becomes serious, or if you notice any side effects not listed in this leaflet, contact your
doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following address: 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 the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack.
EXPIRY. 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 moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Dutasteride Mylan contains
The active substance is dutasteride.
Each soft capsule contains 0.5 mg of dutasteride.
The other components are:

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

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

Marketing Authorization 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
SAG MANUFACTURING, S.L.U.
Carretera Nacional 1 Km 36,
San Agustin del Guadalix, 28750
Madrid, Spain

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