GENAPROST 5 mg Фильм-Coated Таблетки

Содержание инструкции

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

Genaprost 5 mg film-coated tablets

Finasteride

Read this leaflet carefully before you start taking this medicinebecause 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 could 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 Genaprost is and what it is used for
• 2. What you need to know before you take Genaprost
• 3. How to take Genaprost
• 4. Possible side effects
• 5. How to store Genaprost
• 6. Contents of the pack and other information

1. What is Genaprost and what is it used for

Genaprost contains the active ingredient finasteride and belongs to a group of medicines called
5α-reductase enzyme inhibitors. These medicines work by reducing the size of the
prostate gland in men.
Genaprost is indicated for the treatment and control of benign prostatic hyperplasia
(benign prostatic hyperplasia), it works by reducing the size of the enlarged prostate
gland in men, improving urinary flow and symptoms caused by benign prostatic hyperplasia.
Genaprost is intended exclusively for male patients.

2. What you need to know before taking Genaprost

Do not take Genaprost if:

• you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6);
• you are a woman;
• you are a child;
• you are pregnant or potentially could be pregnant (see section “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Genaprost.
Although benign prostatic hyperplasia is not a malignant tumor, nor can it become one, the two
conditions can coexist. Before starting therapy with Genaprost and periodically during the
treatment, your doctor will likely perform some simple tests to rule out the
possibility of prostate cancer. These tests include a digital rectal exam and a blood test to determine the level of prostate-specific antigen (PSA).
Take particular care with Genaprost:
if you have difficulty completely emptying your bladder or have a severely
reduced urinary flow. In this case, your doctor will need to examine you carefully before starting treatment with
Genaprost;
if you need to have a blood test called “PSA”. Make sure to inform your
doctor before having the test, as Genaprost may alter the test results;
if you experience lumps, pain, breast swelling or nipple discharge. Promptly inform your
doctor of any changes in breast tissue as they may
be signs of a serious condition, such as breast cancer;
if your sexual partner is or may be pregnant, they should not come into contact
with finasteride. Avoid exposing them to contact with your semen, as it may contain
small amounts of finasteride (see section “Pregnancy, breastfeeding and fertility”).
Mood changes, such as depressed mood, depression, and, less frequently, suicidal thoughts
have been reported in patients treated with Genaprost. If you experience any of these symptoms, contact
your doctor as soon as possible for further information.

Children and adolescents
Genaprost is not indicated for use in children.

Other medicines and Genaprost
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
No significant interactions with other medicines have been observed.

Pregnancy, breastfeeding and fertility
Genaprost is indicated exclusively in men and should not be taken by women (see
section “Do not take Genaprost if”).
Pregnant women or those who suspect they may be pregnant should not come into contact with
crushed or broken Genaprost tablets, as the possible absorption of finasteride by a
woman carrying a male fetus may interfere with the normal development of the
child's sexual organs.
Intact Genaprost tablets have a coating that prevents contact with the active
ingredient during normal handling, provided the tablets have not been crushed or broken.
If your sexual partner is or may be pregnant, avoid exposing them to your semen,
as it may contain a modest amount of medicine.

Driving and using machines
There is no data to suggest that Genaprost may interfere with the ability to drive or operate
machinery.

Genaprost contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this
medicine.

3. How to take Genaprost

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
The recommended dose is one film-coated tablet of 5 mg per day. It can be taken with or
without food.
Although improvement is often observed within a short time, it may be necessary to continue the
treatment for at least 6 months.
The doctor may prescribe Genaprost together with another medicine containing doxazosin, to
improve the control of prostatic hypertrophy.

Use in the elderly
Although the elimination of finasteride from the body may slightly decrease in elderly patients
over 70 years of age, no dose adjustment is required.

Use in children and adolescents
Genaprost is not indicated for use in children.

If you take more Genaprost than you should
If you have taken more Genaprost tablets than you should, contact your doctor immediately or
go to the nearest hospital.
There are no specific treatments recommended in case of finasteride overdose.

If you forget to take Genaprost
Do not take a double dose to make up for a missed dose.

If you stop taking Genaprost
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 everyone will experience them.
The most common side effects are impotence (inability to achieve an erection) and decreased
sexual desire. These side effects occur at the beginning of treatment and, in most
patients, resolve during the course of treatment.
With the use of finasteride, the following side effects have been reported:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

Not known (frequency cannot be estimated from available data)

• palpitations (fast and/or irregular heartbeats);
• itching, urticaria;
• allergic reactions, such as swelling of the lips and face;
• increased liver enzymes;
• testicular pain, impotence, which continues even after discontinuation of treatment, male infertility and/or poor semen quality (which may normalise or improve after discontinuation of treatment), breast cancer in men (see section “Warnings

and precautions”);

• depression;
• decreased sexual desire, inability to achieve an erection, ejaculation problems, which continue even after discontinuation of treatment.

Diagnostic tests: the use of finasteride may alter the results of blood tests to determine the
PSA levels
With the concomitant use of finasteride and doxazosin, an increase in the frequency of ejaculation disorders has been observed compared to the two medicines taken individually.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at http:// www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Genaprost

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging 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 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 Genaprost contains

• The active ingredient is finasteride. One film-coated tablet contains 5 mg of finasteride.
• The other ingredients are: lactose monohydrate, pregelatinized starch, sodium carboxymethylamide, yellow iron oxide, sodium dioctylsulfosuccinate, microcrystalline cellulose, magnesium stearate, hypromellose, hydroxypropylcellulose, titanium dioxide, talc, E132 indigotine on hydrated aluminum.

Description of the appearance of Genaprost and contents of the pack
The film-coated tablets of Genaprost are contained in opaque PVC/PE/PVDC and
aluminum blisters. They are available in packs of 15 and 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Neopharmed Gentili S.r.l.
Via San Giuseppe Cottolengo 15,
20143 Milano

Manufacturer
Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore (Piacenza)