Package leaflet: Information for the user

Finasteride Zentiva 5 mg film-coated tablets

Generic medicine
For use in men
Read this entire 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful to them.
If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Finasteride Zentiva is and what it is used for
What you need to know before taking Finasteride Zentiva
How to take Finasteride Zentiva
Possible side effects
How to store Finasteride Zentiva
Contents of the pack and other information

1. WHAT FINASTERIDE ZENTIVA IS AND WHAT IT IS USED FOR

Finasteride Zentiva is a 5-α-reductase inhibitor and reduces the size of the enlarged prostate gland.
Finasteride Zentiva is used:

To treat benign enlargement of the prostate (Benign Prostatic Hyperplasia - BPH)
To reduce the risk of acute urinary retention and surgical procedures related to BPH in patients with moderate to severe symptoms of BPH. Finasteride Zentiva should be used in patients with an enlarged prostate (volume of approximately 40 cm³ or more). BPH is a benign enlargement of the prostate gland, which commonly occurs in men over 50 years of age. The prostate is located at the point where the bladder meets the urethra, which surrounds it. Any enlargement of the prostate will therefore cause problems with urination. The following symptoms may occur in benign enlargement of the prostate gland (BPH):
Frequent urination, especially at night,
Sudden urgency to urinate,
Difficulty starting urination,
Weak or interrupted urinary stream,
Urinary retention, or the sensation that the bladder is unable to empty completely.

In some men, BPH can lead to serious conditions such as urinary tract infections, complete blockage of urine flow (acute urinary retention), and the need for surgery.

2. WHAT YOU SHOULD KNOW BEFORE TAKING FINASTERIDE ZENTIVA

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Do not take Finasteride Zentiva

If you are allergic to finasteride or to any of the ingredients of this medicine (listed in section 6).
If you are a pregnant woman or could be pregnant (see pregnancy and breastfeeding). Finasteride Zentiva is not indicated for use in women.

Warnings and precautions
Talk to your doctor or pharmacist before taking Finasteride Zentiva

Treatment with Finasteride Zentiva should only be initiated after consultation with a urologist.
Obstruction due to a certain growth pattern (trilobular) of the prostate must be ruled out before starting treatment.
Patients with a large residual urinary volume (amount of urine remaining in the bladder after urination) and/or severely reduced urinary flow should be kept under close medical supervision.
A test for early detection of prostate cancer should be performed as a control measure before starting and regularly during treatment with Finasteride Zentiva.
Since Finasteride Zentiva causes a decrease in prostate-specific antigen (PSA) levels in the blood, a reduction in PSA levels with Finasteride Zentiva does not exclude the presence of prostate cancer.
If you have impaired liver function, you should not be treated with Finasteride Zentiva, as there is insufficient information available.
If you notice any changes in your breast gland such as lumps, pain, breast enlargement, or nipple discharge, you must contact your doctor immediately. These signs may indicate a serious disease such as breast cancer.

Mood alterations and depression
Mood changes, such as depressed mood, depression, and, less frequently, suicidal thoughts,
have been reported in patients treated with Finasteride Zentiva. If you experience any of these
symptoms, contact your doctor as soon as possible for further advice.
Children
Children should not be treated with Finasteride Zentiva, as there is no available information.
Other medicines and Finasteride Zentiva
Talk to your doctor or pharmacist if you are taking, have recently taken, or might take
other medicines, including over-the-counter or herbal medicines. No clinically significant interactions
with Finasteride Zentiva are known.
Pregnancy and breastfeeding
Finasteride Zentiva is intended for use in men only.
Pregnancy
Women who are pregnant, could be pregnant, or who are breastfeeding must not take
Finasteride Zentiva. Finasteride Zentiva blocks the conversion of testosterone, the male sex hormone,
into dihydrotestosterone—the active form of the hormone produced in the prostate. If a
pregnant woman takes Finasteride Zentiva, this may cause malformations of the external genital organs
of male fetuses.
Do not handle crushed or broken Finasteride Zentiva tablets if you are a pregnant woman or planning
to become pregnant, due to the possibility of absorption (through the skin) of finasteride and the
potential risk to a male fetus. This particularly applies to healthcare personnel who may be at risk of
exposure.
Finasteride Zentiva tablets are film-coated, which prevents contact with the active substance during
normal handling, provided the tablets are not broken or crushed.
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If your partner is pregnant or could be pregnant, you must prevent contact between your partner and your semen, as it may contain small amounts of the medicine.
Breastfeeding
It is not known whether finasteride passes into breast milk.
Driving and operating machinery
Finasteride Zentiva is not expected to impair your ability to drive or operate machinery.
Finasteride Zentiva contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this
medicine. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e.,
essentially ‘sodium-free’.

3. HOW TO TAKE FINASTERIDE ZENTIVA

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Treatment as monotherapy
The recommended dose is 1 film-coated tablet of Finasteride Zentiva (5 mg of finasteride)
once daily.
Doses higher than the recommended dose have not shown a further increase in efficacy or have not
been studied. Therefore, the recommended dose is the maximum dose.
Although improvement may be observed within a short time, treatment for at least 6 months may be required
to objectively determine whether a satisfactory response to treatment has been achieved.
Treatment in combination with doxazosin
Your doctor will determine the dose of doxazosin, an alpha receptor blocker.
The following dosing regimen is recommended:
Finasteride Zentiva: 1 film-coated tablet (5 mg of finasteride) daily.
Doxazosin:
Week 1: 1 mg of doxazosin daily.
Week 2: 2 mg of doxazosin daily.
Week 3: 4 mg of doxazosin daily.
From week 4: 4 mg or 8 mg of doxazosin daily.
To reduce the risk of BPH progression, an increase to at least 4 mg of doxazosin daily is required.
Hepatic impairment
Currently, there is no available information on the use of finasteride in patients with impaired
liver function.
Renal impairment
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Significant evidence has shown that dose adjustment is not required when creatinine clearance is above 9 ml/min/1.73 m . There is no available information on the use of
finasteride in patients requiring dialysis.
Elderly
Elimination of finasteride is slightly reduced in patients over 70 years of age. However,
dose adjustment is not required.
How and when to take the film-coated tablets
Take one film-coated tablet once daily, swallowing it whole.
Taking film-coated tablets with food and drink
Finasteride Zentiva may be taken on an empty or full stomach with sufficient liquid.
If you take more Finasteride Zentiva than you should
No recommendations are provided for specific treatment of overdose with Finasteride Zentiva.
You must never take more film-coated tablets than prescribed by your doctor. However,
if you have taken too many film-coated tablets, consult your doctor immediately.
If you forget to take Finasteride Zentiva
Do not take a double dose to make up for the missed dose. Continue treatment with one tablet of Finasteride Zentiva daily.
If you stop taking Finasteride Zentiva
Benign enlargement of the prostate (BPH) develops over a long period of time. Some men
may experience early improvement in their symptoms as a result of treatment with Finasteride Zentiva, but treatment with Finasteride Zentiva for at least 6 months may also be required
before any concrete improvement occurs.
Regardless of whether you notice a change in your symptoms or not, treatment with
Finasteride Zentiva may reduce the risk of acute urinary retention and the need for
surgical intervention.
It is recommended that you consult your doctor regularly so that he or she can perform tests and evaluate the effectiveness of treatment.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Discontinue treatment with Finasteride Zentiva and consult a doctor immediately if you notice any of the following side effects: hypersensitivity reactions including swelling of the lips, tongue, neck, and face (angioedema); difficulty swallowing, urticaria (itchy and weeping skin rash), and breathing difficulties.

The following adverse effects have been reported in clinical studies and/or during post-marketing experience with finasteride 5 mg or lower doses of finasteride:

Common (may affect up to 1 in 10 people):
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Reduced volume of semen (reduced ejaculate volume), inability to achieve an erection (impotence), low sex drive (reduced libido).

Uncommon (may affect up to 1 in 100 people):
Ejaculation disorders, breast enlargement, breast tenderness, skin rash.

Frequency not known (frequency cannot be estimated from the available data):
Pruritus, increased liver enzymes, palpitations, testicular pain, blood in semen, persistent sexual dysfunction (erectile difficulties and ejaculation disorders) even after discontinuation of treatment, male infertility and/or poor semen quality; improvement in semen quality has been reported shortly after discontinuation of treatment; depression, low sex drive (reduced libido) that persists after discontinuation of treatment, anxiety.

In addition, cases of male breast cancer have been reported (see section 2, Warnings and precautions).

Treatment in combination with doxazosin
The following adverse effects have been reported more frequently when Finasteride Zentiva was used together with doxazosin, an alpha-blocker: fatigue 16.8% (placebo 7.1%), decrease in blood pressure upon standing 17.8% (placebo 8.0%), dizziness 23.2% (placebo 8.1%), and insufficient ejaculation 14.1% (placebo 2.3%).

Laboratory parameters
When measuring prostate-specific antigen (PSA) levels, it should be taken into account that PSA values are reduced by 50% in patients taking Finasteride Zentiva.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE FINASTERIDE ZENTIVA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Finasteride Zentiva contains
The active substance is finasteride. Each film-coated tablet contains 5 mg of finasteride.
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The other ingredients are monohydrate lactose, maize starch, povidone 30, sodium docusate, sodium
starch glycolate (type A), magnesium stearate, hypromellose 2910/5, macrogol 6000, talc, titanium dioxide
(E171), simeticone emulsion SE 4, iron oxide yellow (E172).
Description of the appearance of Finasteride Zentiva and pack sizes
Finasteride Zentiva is a yellow, round, biconvex film-coated tablet with a diameter of 7.1 mm.
Blister packs containing 7, 10, 14, 15, 28, 30, 49, 50, 98, 100 or 300 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milan, Italy
Manufacturer
Zentiva k.s.
U Kabelovny 130
102 37 Prague 10 – Czech Republic
Winthrop Arzneimittel GmbH,
Brüningstraße 50,
65926 Frankfurt am Main,
Germany
This medicinal product is authorised in the European Economic Area countries under the following
names:
Germany Finasterid Winthrop 5 mg Filmtabletten
Italy Finasteride Zentiva
This leaflet was last updated on:
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