DUTASTERIDE 0.5 MG Soft capsule

Зміст інструкції

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

Dutasteride Tecnigen 0,5 mg soft capsules

Generic medicine

Read this leaflet carefully before you start 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 they have the same symptoms as you, as it may 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 Tecnigen is and what it is used for
• 2. What you need to know before you take Dutasteride Tecnigen
• 3. How to take Dutasteride Tecnigen
• 4. Possible side effects
• 5. How to store Dutasteride Tecnigen
• 6. Contents of the pack and other information

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

The active ingredient of this medicine is dutasteride, which belongs to a group of medicines called
5-alpha-reductase inhibitors.

Dutasteride Tecnigen is used for the treatment of enlarged prostate(benign prostatic hyperplasia). This is a non-cancerous growth of the prostate gland caused by the excessive
production of a hormone called dihydrotestosterone.
Enlargement of the prostate can cause urinary problems, such as difficulty urinating and the need to urinate
frequently. It can also make the urine flow slower and weaker. If left untreated, there is a
risk of complete blockage of the urine flow (acute urinary retention) which requires immediate
medical treatment. In some situations, surgery is necessary to remove the prostate or reduce its
size. Dutasteride Tecnigen reduces the production of dihydrotestosterone helping to reduce the
size of the prostate and to relieve the symptoms. This reduces the risk of acute urinary retention and the
need for surgery.
Dutasteride Tecnigen can also be used with another medicine called tamsulosin (used for the
treatment of symptoms of enlarged prostate).

2. What you need to know before taking Dutasteride Tecnigen

Do not take Dutasteride Tecnigen

• if you are allergic to dutasteride, to other 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 a severe liver disease;
• if you are a child or an adolescent.

Inform your doctor if you think that any of the above conditions apply to you.

This medicine is only indicated for men. It should not be taken by women, children or adolescents.

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

• In some clinical studies, a greater number of patients taking dutasteride and another medicine called an alpha-blocker (such as tamsulosin) developed heart failure compared to patients taking only dutasteride or only an alpha-blocker. Heart failure is a condition in which the heart cannot pump blood as it should.
• Make sure your doctor is aware of any liver problems you have before startingtreatment with this medicine.If you have had any liver disease, you may need further checks while taking Dutasteride Tecnigen.
• Women, children and adolescentsshould not handle broken or opened Dutasteride Tecnigen capsules, as the active ingredient can be absorbed through the skin. If contact with the skin occurs, wash the affected area immediatelywith water and soap.
• Use a condom during sexual intercourse.Dutasteride has been found in the semen of men taking Dutasteride Tecnigen. If your partner is or may be pregnant, she should avoid exposure to your semen as Dutasteride Tecnigen may impair the normal development of a male fetus. Dutasteride has been shown to decrease sperm count, semen volume and sperm motility. This may reduce fertility.
• Dutasteride Tecnigen affects the blood test for PSA(prostate-specific antigen), which is sometimes used to detect prostate cancer. Your doctor should be aware of this effect and may still use the test to detect prostate cancer. If you are having a PSA test, tell your doctor that you are taking Dutasteride Tecnigen. Men takingDutasteride Tecnigen should have regular PSA checks.In a clinical study conducted on men at higher risk of prostate cancer, patients taking Dutasteride Tecnigen developed a more serious form of prostate cancer moreoftenthan men who were not taking Dutasteride Tecnigen. The effect of Dutasteride Tecnigen on this serious form of prostate cancer is unclear.
• Dutasteride Tecnigen may cause breast enlargement and breast tenderness.If this effect causes you discomfort or if you notice the appearance of lumps in the breastor nipple discharge, you should inform your doctor of these changes as they may be signs of a serious condition, such as breast cancer.

Contact your doctor or pharmacist if you have any doubts about taking Dutasteride Tecnigen.

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

Tell your doctor if you are taking any of these medicines. It may be necessary to reduce the dose of
Dutasteride Tecnigen.

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

Pregnancy, breastfeeding and fertility
Women should not take dutasteride.

Pregnant women (or those who might become pregnant) should not handle broken or opened capsules.
Dutasteride is absorbed through the skin and can 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 found in the semen of men
taking this medicine. If your partner is or may be pregnant, she should avoid
exposure to your semen.
Dutasteride Tecnigen has been shown to reduce sperm count, semen volume and
sperm motility. Therefore, male fertility may be reduced.

Contact your doctor immediatelyif a pregnant woman has come into contact with
Dutasteride Tecnigen.

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

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

3. How to take Dutasteride Tecnigen

Take this medicine following exactly the instructions of your doctor or pharmacist. If you do not take it
regularly, the control of your PSA levels may be affected. If you have doubts, consult your
doctor or pharmacist.
The recommended dose is one capsule (0.5 mg) taken once a day. Swallow the capsules whole with a
little water. Do not chew or open the capsule. Contact with the capsule contents may cause you pain
in the mouth or throat.
Dutasteride Tecnigen is a long-term treatment. Some men notice an early improvement in their
symptoms. However, others may need to take Dutasteride Tecnigen for 6 months or longer
before it starts to have an effect. Continue to take Dutasteride Tecnigen for as long as
indicated by your doctor.

If you take more Dutasteride Tecnigen than you should
Contact your doctor or pharmacist if you take more Dutasteride Tecnigen capsules than prescribed.

If you forget to take Dutasteride Tecnigen
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 usual dosing schedule.

If you stop taking Dutasteride Tecnigen
Do not stop taking Dutasteride Tecnigen without first talking to your doctor. It may
take 6 months or more to see an effect.
If you have any 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.
manifest.

Allergic reactions
The signs of an allergic reaction may include:

• skin rash(with or without itching)
• hives
• swelling of the eyelids, face, lips, arms or legs.Stop taking Dutasteride Tecnigen and contact your doctor immediatelyif you experience any of these symptoms. Common side effects(may affect up to 1 in 10 people)
• inability to achieve or maintain an erection (impotence); this symptom may continue to occur even after stopping Dutasteride Tecnigen;
• decreased sexual desire (libido); this may continue to occur after stopping Dutasteride Tecnigen;
• difficulty with ejaculation; this may continue to occur after stopping Dutasteride Tecnigen
• enlargement or tenderness of the breasts (gynecomastia)
• dizziness when taken with tamsulosin.

Uncommon side effects(may affect up to 1 in 100 people)

• the heart becomes less efficient at pumping blood around the body (heart failure). This can have symptoms such as shortness of breath, extreme fatigue and swelling of the ankles and legs.
• hair loss (usually loss of body hair) or excessive hair growth Unknown side effects(frequency cannot be estimated based on available data)
• depressed mood
• pain and swelling of the testicles

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 Tecnigen

Keep this medicine out of 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 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 Tecnigen contains

• The active ingredient is dutasteride. Each capsule contains 0.5 mg of dutasteride.
• The other ingredients are:
• Capsule content:glycerol monocaprylocaprate type I, butylhydroxytoluene (E321)
• Capsule shell:gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), medium chain triglycerides, soybean lecithin (E322) and purified water.

Description of Dutasteride Tecnigen and contents of the pack
Dutasteride Tecnigen are oblong, opaque, yellow soft gelatin capsules containing an
oily and yellowish liquid.
Soft capsule dimensions: 19 ± 0.8 mm x 6.9 ± 0.4 mm.
Dutasteride Sagaem is supplied in white opaque Aluminium/PVC-PVDC blisters.
Pack of 30 soft capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TECNIGEN S.R.L.
VIA GALILEO GALILEI 40, 20092
CINISELLO BALSAMO
MILANO (MI)

Manufacturers responsible for batch release
Cyndea Pharma S.L.
Polígono Industrial Emiliano Revilla Sanz, Avenida de Ágreda, 31
Olvega 42110, Soria, Spain
Galenicum Health S.L.
Avda. Cornellá 144, 7º-1a, Edificio Lekla, Esplugues de Llobregat
08950 Barcelona, Spain
Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park, Paola
PLA 3000 Malta