Package leaflet: Information for the user

FINASTERIDE ABC 5 mg film-coated tablets

Finasteride
Generic medicine
Please read all of 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 side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

FINASTERIDE ABC contains the active substance finasteride, which belongs to a group of medicines
called 5α-reductase inhibitors, which work by reducing the size of the prostate gland in men.
FINASTERIDE ABC is indicated for the treatment and management of benign prostatic hyperplasia (BPH ),
also known as prostate enlargement, characterized by a benign enlargement of the prostate.
FINASTERIDE ABC improves urinary flow and symptoms associated with BPH.

2. What you need to know before taking FINASTERIDE ABC

Do not take FINASTERIDE ABC

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 or a child;
If you are a pregnant woman or suspect you may be pregnant (see section “Pregnancy and breastfeeding”)

Warnings and precautions
Talk to your doctor or pharmacist before taking FINASTERIDE ABC.
Although benign prostatic hyperplasia (BPH) is not a malignant tumour and cannot become one, both conditions may coexist.
Only your doctor can evaluate your symptoms, possible causes, and the appropriate treatment for you.
Inform your doctor:

if you have or have had any medical conditions, diseases, or allergies;
if you have difficulty completely emptying your bladder or a significantly reduced urine flow.

Inform your doctor if you have been taking finasteride for 6 months or longer and if you need to have blood tests to determine your PSA levels (a marker for possible prostate cancer), as finasteride may affect the results of this test.
Mood changes and depression
Mood changes such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with Finasteride ABC. If you experience any of these symptoms, contact your doctor as soon as possible for further advice.
Use in children
FINASTERIDE ABC is not indicated for pediatric use, as safety and efficacy in children have not been established.
Other medicines and Finasteride ABC
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
No clinically significant interactions have been identified between FINASTERIDE ABC and other medicines. In particular, NO significant interactions have been observed with the following medicines:

propranolol (used to treat high blood pressure and angina pectoris);
digoxin (used to treat heart rhythm problems);
glibenclamide (used to lower blood sugar levels);
warfarin (used to prevent blood clots);
theophylline (used to treat asthma);
phenazone (used to treat inflammation).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If your sexual partner is pregnant or suspects she may be pregnant, you must avoid exposing her to your semen, as it may contain a small amount of the medicine.
If a woman is pregnant or suspects she may be pregnant, she must not take FINASTERIDE ABC (see section “Do not take FINASTERIDE ABC”). Furthermore, she must not handle crushed or broken FINASTERIDE ABC tablets, as the active ingredient in the tablets may be absorbed through the skin and could interfere with the normal development of a male fetus.
Intact FINASTERIDE ABC tablets have a coating that prevents contact with the active ingredient during normal handling, provided the tablets have not been crushed or broken.
Breastfeeding
It is not known whether finasteride is excreted in human milk; however, if you are a woman, you must not take FINASTERIDE ABC.
Driving and using machines
No effects on the ability to drive or operate machinery are known.
FINASTERIDE ABC contains lactose.
FINASTERIDE ABC contains lactose, a milk sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
FINASTERIDE ABC 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 ABC

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 5 mg tablet daily, which can be taken regardless of
meals.
Your doctor may prescribe FINASTERIDE ABC together with another medicine, doxazosin, used to
improve the management of benign prostatic hyperplasia.
Although improvement is often observed after a short period, treatment should be continued for
at least six months to achieve benefit. Your doctor will advise you on how long to take FINASTERIDE ABC.
Use in patients with renal impairment
If you have reduced kidney function (renal insufficiency), no dose adjustment of
FINASTERIDE ABC is necessary.
Use in elderly patients
If you are elderly, no dose adjustment of FINASTERIDE ABC is necessary, although in patients over
70 years of age, finasteride is eliminated to a lesser extent.
If you take more FINASTERIDE ABC than you should
In case of accidental overdose of FINASTERIDE ABC, contact your doctor immediately or go to the nearest hospital.
No adverse effects have been reported in patients who have taken high doses of FINASTERIDE ABC for periods up to three months.
If you forget to take FINASTERIDE ABC
Do not take a double dose to make up for the missed dose.
If you stop taking FINASTERIDE ABC
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 gets them.
Impotence and decreased sexual desire are the most common adverse reactions. These adverse reactions occur during the initial phase of treatment and resolve during the course of therapy in most patients.

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

Decreased semen volume
Impotence
Decreased sexual desire

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

Rash
Ejaculation disorders
Breast tenderness
Breast enlargement

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

Irregular heartbeat
Hypersensitivity reactions such as itching, urticaria, and swelling (angioedema) of various parts of the body including lips, tongue, throat, and face
Increased liver enzymes
Testicular pain
Blood in semen
Erectile dysfunction, which may continue after discontinuation of finasteride
Male infertility and/or poor semen quality, which normalizes or improves after discontinuation of finasteride
Breast cancer in men
Depression
Persistent reduction in sexual desire after stopping treatment
Persistent ejaculation problems after stopping treatment
Anxiety
Suicidal thoughts

Diagnostic tests:
If you need to have blood tests to determine PSA levels (an indicator of possible prostate cancer), bear in mind that finasteride may alter the results of this test.
Immediately inform your doctor of any changes in breast tissue (mammary gland), such as lumps, pain, enlargement of breast tissue in males, or nipple discharge, as these may be signs of a serious condition such as male breast cancer.
Stop treatment with FINASTERIDE ABC and contact your doctor immediately if you experience any of the following symptoms of angioedema:

Swelling of the face, tongue, or throat
Difficulty swallowing
Urticaria
Difficulty breathing

Reporting of side effects
If you experience any side effect, 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 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 ABC

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. The expiry date applies to the product in its original intact packaging, correctly stored.
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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Finasteride ABC contains

The active substance is finasteride. One film-coated tablet contains 5 mg of finasteride.
The other components are: 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 ABC and pack contents
Film-coated tablets – 15 tablets in blisters.
Marketing Authorization Holder
ABC Farmaceutici S.p.A.
Corso Vittorio Emanuele II, 72
10121 Torino
Manufacturer
Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore – Piacenza