Stecur

Patient Information Leaflet

STECUR 5 mg film-coated tablets

Finasteride
Generic 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What STECUR is and what it is used for

STECUR contains the active substance finasteride, which belongs to a group of medicines called
5α-reductase inhibitors (an enzyme that metabolizes testosterone and produces
dihydrotestosterone, a hormone that promotes prostate growth).
STECUR is used to treat and control benign enlargement of the prostate ( benign prostatic
hyperplasia - BPH ). This medicine works by reducing the size of the enlarged prostate gland
in men, improving urinary flow and symptoms associated with BPH.

2. What you should know before taking STECUR

Do not take STECUR

• If you are allergic to finasteride or to any of the other ingredients of this medicine (listed in section 6).
• If you are a woman
• If you are a child
• If you are pregnant, suspect you may be pregnant, or are planning to become pregnant: see section "Pregnancy and breastfeeding".

Warnings and precautions
Talk to your doctor or pharmacist before taking STECUR.
If you have a significant amount of residual urine in your bladder after urination and/or severely reduced urinary flow, your doctor will carefully monitor you to avoid possible obstruction of the urinary tract. In such cases, your doctor may consider the possibility of surgical intervention.
Although BPH is not a malignant tumour and cannot become one, both conditions may be present simultaneously. Only your doctor can evaluate symptoms and possible causes. Before starting treatment with STECUR and periodically during treatment, your doctor will perform certain tests to check whether you have prostate cancer. These tests include digital rectal examination and a blood test to determine the level of PSA (prostate-specific antigen).
Effects on PSA and detection of prostate cancer
STECUR reduces blood levels of PSA even in the presence of prostate cancer (a test used to detect prostate cancer). If you need to undergo this test, inform your doctor that you are taking finasteride. Your doctor will take this into account when interpreting the test results.
This reduction, although it may vary among individual patients, applies across the entire range of PSA values.
Breast cancer in men
Promptly inform your doctor of any changes in your breast tissue, such as lumps, pain, breast enlargement (gynecomastia), or nipple discharge, as these could be signs of a serious condition such as breast cancer.
Children
STECUR is not indicated for use in children.
The safety and efficacy in children have not been established.
Other medicines and STECUR
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
STECUR generally does not interfere with other medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
STECUR is contraindicated in women who are or may potentially be pregnant (see section "Do not take STECUR").
If your sexual partner is or could be pregnant, you must avoid exposing her to your semen, which may contain trace amounts of the medicine.
Pregnant women or women of childbearing age must not come into contact with crushed or broken STECUR tablets, as finasteride may be absorbed through the skin and cause abnormalities in the external genitalia of a male fetus.
STECUR tablets have a coating that prevents contact with the active ingredient during normal handling, provided the tablets have not been crushed or broken.
Breastfeeding
The use of STECUR is not indicated in women.
It is not known whether finasteride is excreted in human milk.
Driving and using machines
There are no data suggesting that STECUR affects the ability to drive or operate machinery.
STECUR contains lactose.
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take STECUR

Take this medicine exactly as your doctor has told you. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose is one 5 mg tablet daily. The tablets can be
taken during or apart from meals.
Your doctor may prescribe STECUR together with another medicine called doxazosin, to
improve the control of benign prostatic hyperplasia.
Although early improvement may be observed, a therapeutic effect of at least six
months may be necessary to determine whether a favourable response has been achieved.
Use in patients with renal impairment
No dose adjustment is required.
Use in the elderly
No dose adjustment is required.
If you take more STECUR than you should
In case of accidental ingestion or overdose of STECUR, contact your doctor immediately or go to the nearest hospital.
No adverse effects have been reported in patients who have taken high doses of Stecur for periods up to three months.
No specific treatment is recommended in case of finasteride overdose.
If you forget to take STECUR
Do not take a double dose to make up for the forgotten dose.
If you have any doubts 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 experiences them.
The most common side effects are impotence and decreased sexual desire. These side effects usually occur during the initial phase of treatment and generally resolve during the course of therapy.

The following side effects may occur with STECUR, listed in order of frequency:
Common (may affect up to 1 in 10 people)

• decreased sexual desire (reduced libido);
• impotence (inability to achieve an erection);
• reduced ejaculate volume (decrease in the amount of semen released during sexual intercourse).

Uncommon (may affect up to 1 in 100 people)

• skin rash;
• ejaculation disorders;
• breast enlargement;
• breast tenderness.

Not known (frequency cannot be estimated from the available data)

• hypersensitivity reactions, including swelling of the lips and face;
• palpitations;
• increased blood levels of liver function enzymes;
• itching, hives;
• testicular pain.

Additionally, cases of male breast cancer have been reported in clinical studies and after marketing (see section “Warnings and precautions”).
A study on the combination treatment of finasteride and doxazosin showed that the combination of finasteride and doxazosin leads to an increased frequency of ejaculation disorders equal to the sum of those observed with each individual treatment.
The side effects that occurred more frequently when finasteride was administered concomitantly with doxazosin were: asthenia, drop in blood pressure upon standing, dizziness, and ejaculation disorders.
When measuring prostate-specific antigen (PSA) levels, it should be noted that PSA values are reduced by approximately half during treatment with finasteride (see section "Warnings and precautions").

Reporting of side effects
If you experience any side effects, 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 STECUR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month. The expiry date applies to the product in its original unopened packaging, stored correctly.
Do not store above 25°C.
Do not dispose of medicines 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 STECUR contains

• The active substance is finasteride. One film-coated tablet contains 5 mg of finasteride.
• The other components are: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate, sodium lauryl sulfate, yellow iron oxide (E172). Coating: hypromellose, hydroxypropylcellulose, titanium dioxide, polyethylene glycol, indigo carmine lake (E132), talc.

Description of the appearance of STECUR and contents of the pack
Film-coated tablets – 15 tablets in blisters.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Genetic S.p.A. Via G. Della Monica 26 - 84083 Castel San Giorgio (SA)
Manufacturer
Genetic S.p.A. Contrada Canfora - 84084 Fisciano (SA)

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