Dutasteride Tecnigen

Package leaflet: Information for the user

Dutasteride Tecnigen 0.5 mg soft capsules

Equivalent medicine
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 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, contact 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 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

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

The active substance 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 excessive production of a hormone called dihydrotestosterone.
An enlarged 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 urine flow (acute urinary retention), which requires immediate medical treatment. In some cases, surgery may be necessary to remove part of the prostate or reduce its size. Dutasteride Tecnigen reduces the production of dihydrotestosterone, helping to reduce the size of the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgical intervention.
Dutasteride Tecnigen may also be used in combination with another medicine called tamsulosin (used to treat 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 severe liver disease;
• if you are a child or adolescent.

Inform your doctor if you think any of the conditions listed above apply to you.
This medicine is intended for men only. It must 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 higher number of patients taking dutasteride together with 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 is unable to pump blood properly.
• Make sure your doctor is aware of any liver problems you may have before starting treatment with this medicine. If you have ever had any liver disease, you may require additional monitoring while taking Dutasteride Tecnigen.
• Women, children, and adolescents must not handle damaged or leaking capsules of Dutasteride Tecnigen, as the active substance can be absorbed through the skin. If contact with the skin occurs, wash the affected area immediately with soap and water.
• Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Dutasteride Tecnigen. If your partner is or could be pregnant, you must avoid exposing her to your semen, as Dutasteride Tecnigen could impair the normal development of a male fetus. It has been shown that dutasteride reduces 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 screen for prostate cancer. If you undergo a PSA test, inform your doctor that you are taking Dutasteride Tecnigen. Men taking Dutasteride Tecnigen should have regular PSA monitoring. In a clinical study conducted in men at increased risk of prostate cancer, patients taking Dutasteride Tecnigen developed a more serious form of prostate cancer more frequently than men not taking Dutasteride Tecnigen. The effect of Dutasteride Tecnigen on this serious form of prostate cancer is not fully understood.
• Dutasteride Tecnigen may cause breast enlargement and breast tenderness. If this causes you discomfort, or if you notice the development of breast lumps or nipple discharge, inform your doctor about these changes, as they could 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may interact with Dutasteride Tecnigen 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. It may be necessary to reduce the dose of Dutasteride Tecnigen.
Dutasteride Tecnigen with food and drink
Dutasteride Tecnigen can be taken on an empty stomach or with food.
Pregnancy, breastfeeding and fertility
Women must not take dutasteride.
Pregnant women (or women who may become pregnant) must not handle 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 relevant 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 could be pregnant, you must avoid exposing her to your semen.
It has been shown that Dutasteride Tecnigen reduces sperm count, semen volume, and sperm motility. Therefore, male fertility may be reduced.
Contact your doctor immediately if a pregnant woman has been exposed to Dutasteride Tecnigen.
Dutasteride Tecnigen contains soy lecithin
This medicine contains soy lecithin, which may contain soybean oil. If you are allergic to peanuts or 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 exactly as directed by your doctor or pharmacist. If you do not
take it regularly, monitoring of PSA levels may be affected. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is one capsule (0.5 mg) taken once daily. Swallow the capsules whole with
some water. Do not chew or open the capsule. Contact with the capsule contents may cause pain
in the mouth or throat.
Dutasteride Tecnigen is a long-term treatment. Some men may 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 taking Dutasteride Tecnigen for as long as your doctor
has instructed.
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 the missed capsule. Simply take the next dose at the usual time and continue with your regular 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 longer to achieve an effect.
If you have any questions about how to use 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 reactions
Signs of an allergic reaction may include:

• rash (with or without itching)
• hives
• swelling of the eyelids, face, lips, arms or legs. Stop taking Dutasteride Tecnigen and contact your doctor immediately if 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 persist even after stopping Dutasteride Tecnigen;
• decreased sexual desire (libido); this may persist after stopping Dutasteride Tecnigen;
• problems with ejaculation; this may persist after stopping Dutasteride Tecnigen;
• breast enlargement or tenderness (gynecomastia);
• dizziness when taken together with tamsulosine.

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

• the heart becomes less efficient at pumping blood around the body (heart failure). Symptoms may include shortness of breath, extreme fatigue, and swelling of the ankles and legs;
• hair loss (generally loss of body hair) or excessive hair growth.

Side effects with unknown frequency (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.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 the sight and reach of children.
Do not use this medicine after the expiry date 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 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 Tecnigen contains

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

Description of the appearance of Dutasteride Tecnigen and contents of the pack
Dutasteride Tecnigen are soft gelatin capsules, oblong-shaped, opaque and yellow in colour, containing a yellowish oily liquid.
Size of the soft capsule: 19 ± 0.8 mm x 6.9 ± 0.4 mm.
Dutasteride Sagaem is supplied in white opaque aluminum/PVC-PVDC blisters.
Pack size: 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
MILAN (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