FINASTERIDE 5 mg Film-Coated Tablets

Зміст інструкції

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

FINASTERIDE ABC 5 mg film-coated tablets

Finasteride

Generic medicine

Read this 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 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 FINASTERIDE ABC is and what it is used for
• 2. What you need to know before you take FINASTERIDE ABC
• 3. How to take FINASTERIDE ABC
• 4. Possible side effects
• 5. How to store FINASTERIDE ABC
• 6. Contents of the pack and other information

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

FINASTERIDE ABC contains the active ingredient 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 control of benign prostatic hyperplasia (BPH), also known
as prostatic hypertrophy, 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 any of the other ingredients of this medicine (listed in section 6);
• If you are a woman or a child;
• If you are a woman who is pregnant or suspects she may be pregnant (see section “Pregnancy and breastfeeding”)

Warnings and precautions
Talk to your doctor or pharmacist before taking FINASTERIDE ABC.
Although BPH is not a malignant tumor, nor can it become one, the two conditions can coexist.
Only a doctor is able to assess your symptoms, possible causes and the correct treatment for you.
Tell your doctor:

• if you have or have had any illness or medical problems or allergies;
• if you have difficulty completely emptying your bladder or a significant reduction in urine flow.

Tell your doctor if you have been taking finasteride for 6 months or more and if you need to undergo blood tests to
determine PSA levels (an indicator of the possible presence of prostate cancer), as
finasteride may alter the results of this test.

Changes in mood and depression
Changes in mood, 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 information.

Use in children
FINASTERIDE ABC is not indicated for use in pediatric patients as safety and efficacy in children have not
been established.

Other medicines and Finasteride ABC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No clinically significant interactions between FINASTERIDE ABC and other medicines have been identified. In
particular, no significant interactions have been found 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, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If your sexual partner is pregnant or suspects she may be pregnant, you should not avoid exposing her to your
sperm as this may contain a small amount of the medicine.
If a woman is pregnant or suspects she may be pregnant, she should not take FINASTERIDE ABC (see
section “Do not take FINASTERIDE ABC”). Also, she should not touch FINASTERIDE ABC tablets if they are
crushed or broken, as the active ingredient present in the tablets could be
absorbed and 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 manual contact, provided the tablets have not been crushed or
broken.
Breastfeeding
It is not known whether finasteride is excreted in human milk; in any case, if you are a woman, you should not take
FINASTERIDE ABC.

Driving and using machines
No effects on the ability to drive or operate machines are known.

FINASTERIDE ABC contains lactose.
FINASTERIDE ABC contains lactose, a sugar from milk. If your doctor has told you that you have
intolerance to some sugars, contact your doctor before taking this medicine.

FINASTERIDE ABC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially ‘sodium-free’.

3. How to take FINASTERIDE ABC

Take this medicine following exactly the instructions of 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 independently of
meals.
Your doctor may prescribe FINASTERIDE ABC together with another medicine, doxazosin, used to
improve the control of benign prostatic hyperplasia.
Although improvement is often noticed after a short period, treatment may need to be continued for at
least six months. Your doctor will tell you how long to take FINASTERIDE ABC.

Use in patients with renal impairment
If you have reduced kidney function (renal impairment) it is not necessary to modify the dose of
FINASTERIDE ABC.

Use in elderly patients
If you are elderly it is not necessary to modify the dose of FINASTERIDE ABC, although in patients over
70 years of age finasteride is eliminated in smaller amounts.

If you take more FINASTERIDE ABC than you should
If you accidentally take an excessive dose of FINASTERIDE ABC, inform your doctor immediately or
go to the nearest hospital.
No undesirable effects have been reported in patients who have taken high doses of FINASTERIDE ABC for
periods of up to three months.

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

If you stop taking FINASTERIDE ABC
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 everybody gets them.
Impotence and decreased libido are the most frequent adverse reactions. These adverse reactions
occur in the initial phase of therapy and in most patients resolve during the course of therapy.

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

• decreased semen volume
• impotence
• decreased libido

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

• skin rash
• ejaculation disorders
• breast tenderness
• breast enlargement

Side effects with unknown frequency (frequency cannot be estimated based on 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 persist after discontinuation of finasteride
• male infertility and/or poor semen quality, which normalizes or improves after discontinuation of finasteride
• male breast cancer
• depression
• persistent decrease in sexual drive after discontinuation of treatment
• persistent ejaculation problems after discontinuation of treatment
• anxiety
• suicidal thoughts

Diagnostic tests:
If you need to have blood tests to determine PSA levels (an indicator of possible
prostate cancer), be aware that finasteride may alter the results of this test.
Immediately report to your doctor any changes in breast tissue (mammary gland) such as lumps, pain, breast tissue enlargement in males, or nipple discharge, as these may be signs of a serious condition such as 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 get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 that is reported on the packaging after exp. The expiry
date refers to the last day of that month. The expiry date refers to the product in
intact packaging, correctly stored.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Finasteride ABC contains

• The active ingredient is finasteride. One film-coated tablet contains 5 mg of finasteride.
• The other ingredients are: Lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate, sodium lauryl sulfate, yellow iron oxide (E172). Coating: hypromellose, hydroxypropylcellulose, titanium dioxide, macrogol, indigotine blue lacquer (E132), talc.

Description of the appearance of Finasteride ABC and contents of the pack
Film-coated tablets - 15 tablets in blisters.

Marketing Authorisation 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