Package leaflet: Information for the patient

Genaprost 5 mg film-coated tablets

Finasteride
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 could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Genaprost is and what it is used for

Genaprost contains the active substance finasteride and belongs to a group of medicines known as 5α-reductase inhibitors. These medicines work by reducing the size of the prostate gland in men.
Genaprost is indicated for the treatment and management of benign enlargement of the prostate (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 for use in male patients only.

2. What you need to know before taking Genaprost

Do not take Genaprost if:

you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
you are a woman;
you are a child;
you are a pregnant woman or could potentially 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 tumour, nor can it become one, both conditions may coexist. Before starting treatment with Genaprost and periodically during treatment, your doctor will likely perform some simple tests to rule out the possibility of prostate cancer. These tests include digital rectal examination and a blood test to determine the level of prostate-specific antigen (PSA).
Exercise particular caution with Genaprost if:

you have difficulty completely emptying your bladder or have a markedly reduced urinary flow. In such cases, your doctor must carefully examine you before starting treatment with Genaprost;
you need to undergo a blood test called “PSA”. Make sure to inform your doctor before having the test, as Genaprost may alter the test results;
you experience nodules, pain, swelling of the breast or nipple discharge. Promptly report any changes in breast tissue to your doctor, as these may be signs of a serious condition, such as breast cancer;
your sexual partner is or could be pregnant, you must avoid exposing her to finasteride. Avoid exposing her to your seminal fluid, as it may contain small amounts of finasteride (see section “Pregn游戏副本

3. How to take Genaprost

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is one 5 mg film-coated tablet daily. It can be taken with or
without food.
Although improvement is often observed within a short time, treatment may need to be continued for at least 6 months.
Your doctor may prescribe Genaprost together with another medicine containing doxazosin to improve control of benign prostatic hyperplasia.
Use in the elderly
Although 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 prescribed, contact your doctor immediately or go to the nearest hospital.
There are no specific recommended treatments in case of finasteride overdose.
If you forget to take Genaprost
Do not take a double dose to make up for a forgotten dose.
If you stop taking Genaprost
If you have any questions about using 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 (inability to achieve an erection) and reduced sexual desire. These side effects occur at the beginning of treatment and resolve during treatment in most patients.
The following side effects have been reported with the use of finasteride:
Common (may affect up to 1 in 10 people)

decrease in the amount of semen released during sexual intercourse (reduced ejaculate volume);
impotence (inability to achieve an erection);
reduced 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 the available data)

palpitations (fast and/or irregular heartbeat);
itching, urticaria;
allergic reactions, such as swelling of the lips and face;
increased liver enzymes;
testicular pain, persistent impotence even after discontinuation of treatment, male infertility and/or poor semen quality (which may normalize or improve after discontinuation of treatment), male breast cancer (see section “Warnings and precautions”);
depression;
reduced sexual desire, inability to achieve an erection, ejaculation problems, persisting even after discontinuation of treatment.

Diagnostic tests: the use of finasteride may alter blood test results used to determine PSA levels.
When finasteride and doxazosin are used concomitantly, an increased frequency of ejaculation disorders has been observed compared to either medicine taken alone.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via 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 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 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 pack and other information

What Genaprost contains

The active substance is finasteride. One film-coated tablet contains 5 mg of finasteride.
The other components are: monohydrate lactose, pregelatinized starch, sodium carboxymethyl starch, yellow iron oxide, sodium dioctyl sulfosuccinate, microcrystalline cellulose, magnesium stearate, hypromellose, hydroxypropylcellulose, titanium dioxide, talc, E132 indigotine on aluminium hydrate.

Description of the appearance of Genaprost and pack sizes
Film-coated tablets of Genaprost are contained in opaque PVC/PE/PVDC and aluminum blisters.
Available pack sizes are 15 and 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Neopharmed Gentili S.r.l.
Via San Giuseppe Cottolengo 15,
20143 Milan, Italy

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