Package leaflet: Information for the user

FINASTERIDE DOC

5 mg film-coated tablets
Generic medicine
Read this entire 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 they have the same symptoms as you, because it could 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:

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

1. What FINASTERIDE DOC is and what it is used for

FINASTERIDE DOC contains the active substance finasteride, which belongs to a group of medicines called
5α-reductase inhibitors.
FINASTERIDE DOC is used to treat and control benign enlargement of the prostate gland ( benign prostatic
hyperplasia-BPH ). This medicine works by reducing the size of the enlarged prostate gland in men, improving urinary flow and symptoms caused by BPH.

2. What you need to know before taking FINASTERIDE DOC

FINASTERIDE DOC is intended for male patients only.
Do not take FINASTERIDE DOC

If you are allergic to finasteride or any of the other ingredients of this medicine (listed in section 6);
If you are a woman (see also section “Pregnancy and breastfeeding”);
If you are a child.

Warnings and precautions
Talk to your doctor or pharmacist before taking FINASTERIDE DOC.
If you have a significant amount of residual urine in your bladder after urinating and/or severely reduced urinary flow, you should be carefully monitored for possible narrowing of the urinary tract. In such cases, your doctor may consider the possibility of surgical intervention.
Benign prostatic hyperplasia (BPH) is not cancer and does not lead to cancer, but both conditions can be present simultaneously. Before starting treatment with finasteride 5 mg, and periodically during treatment, your doctor will likely perform some simple tests to check whether you have prostate cancer. These tests include a digital rectal examination and a blood test to measure the level of prostate-specific antigen (PSA). Your doctor will evaluate your symptoms and their possible causes. If in doubt, ask your doctor for further information.
Mood changes and depression: Mood changes such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with finasteride 5 mg. If you experience any of these symptoms, contact your doctor as soon as possible for further advice.
FINASTERIDE DOC may affect PSA levels in the blood (a test used to detect prostate cancer). If you need to undergo this test, inform your doctor or nurse that you are taking finasteride.
If your sexual partner is pregnant or could be pregnant, you must avoid exposing her to finasteride. Avoid exposing her to your semen, as it may contain small amounts of the drug (see section “Pregnancy and breastfeeding”).
Promptly report to your doctor any changes in breast tissue, such as lumps, pain, breast enlargement, or nipple discharge, as these may be signs of a serious condition such as breast cancer.
Other medicines and FINASTERIDE DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
FINASTERIDE DOC generally does not interfere with other medicines.
Pregnancy and breastfeeding
FINASTERIDE DOC is for use in males only and must not be taken by women (see also section 2 “Do not take FINASTERIDE DOC”).
Pregnant women or women who suspect they might be pregnant should not come into contact with FINASTERIDE DOC tablets, especially if they are crushed or broken. If finasteride, the active ingredient in FINASTERIDE DOC, is taken orally or absorbed through the skin by a woman carrying a male fetus, it may interfere with the normal development of the baby's genital organs.
If your partner is pregnant or suspects she might be pregnant, avoid exposing her to your semen, as it may contain a small amount of the medicine.
FINASTERIDE DOC tablets are coated, which prevents contact with the active ingredient during normal handling, provided the tablets have not been broken or crushed.
Driving and using machines
There are no data suggesting that finasteride affects the ability to drive vehicles or operate machinery.
FINASTERIDE DOC contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
FINASTERIDE DOC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to take FINASTERIDE DOC

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet containing 5 mg of finasteride, taken orally once daily. The tablets may be taken with or without food. The tablet must be swallowed whole and must not be split or crushed (see section Pregnancy and breastfeeding).
Although improvement may be observed within a short time, treatment for at least six months may be necessary to determine whether a beneficial response has been achieved.
Your doctor may prescribe FINASTERIDE DOC together with another medicine called doxazosin, to improve the management of benign prostatic hyperplasia.

Use in patients with renal impairment
No dose adjustment is required.

Use in the elderly
No dose adjustment is required.

If you take more FINASTERIDE DOC than you should
If you have taken more tablets than prescribed, contact your doctor immediately or go to the nearest hospital.
No specific treatment is recommended in case of finasteride overdose.

If you forget to take FINASTERIDE DOC
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose; in this case, continue as prescribed. Do not take a double dose to make up for the forgotten tablet.

If you stop taking FINASTERIDE DOC
Do not change the dose or stop treatment without informing your doctor.
If you have any questions about the use of this medicine, consult 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 frequent side effects are impotence (inability to achieve an erection) and decreased libido.
These side effects occur during the initial phase of treatment and resolve in most patients during the course of therapy.
With FINASTERIDE DOC, the following side effects may occur:

Common side effects (may affect up to 1 in 10 people)

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

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

rash;
ejaculation disorders;
breast enlargement;
breast tenderness.

Side effects with unknown frequency (frequency cannot be estimated from the available data)

allergic reactions, such as swelling of the lips and face;
depression;
decreased libido, which persists even after discontinuation of treatment;
palpitations (rapid and/or irregular heartbeat);
increased liver enzymes;
itching, hives;
testicular pain;
impotence, which persists even after discontinuation of treatment;
male infertility and/or poor semen quality;
anxiety.

In clinical studies and post-marketing experience, the following adverse events have been reported: breast cancer in males (see "Warnings and precautions").
The safety and tolerability profiles of finasteride and doxazosin, either alone or in combination, are comparable; however, the frequency of ejaculation disorders is additive when both drugs are used together, corresponding to the sum of the frequencies observed with finasteride alone and doxazosin alone.
The side effects occurring more frequently when finasteride is administered concomitantly with doxazosin are: fatigue, low 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").
Following the instructions provided in this leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://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 FINASTERIDE DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. 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 any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What FINASTERIDE DOC contains

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

Description of the appearance of FINASTERIDE DOC and contents of the pack
Film-coated tablets available in blisters containing 15 tablets.
Film-coated tablets available in blisters containing 30 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
DOC Generici s.r.l.
Via Turati, 40
20121 Milan - Italy

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