Package Leaflet: Information for the patient

Finasteride Mylan Italia 5 mg film-coated tablets

finasteride
Generic medicine
For use in men only.
Please read all of 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 give it to others, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Finasteride Mylan Italia is and what it is used for

Finasteride Mylan Italia belongs to a class of medicines known as 5-alpha-reductase inhibitors.
These medicines work by reducing the enlargement of the prostate gland in men.
Finasteride Mylan Italia is indicated for the treatment and management of benign prostatic hyperplasia (BPH), also
known as benign prostatic hypertrophy, which is characterized by a benign enlargement of the prostate.
Finasteride Mylan Italia improves urinary flow and the symptoms associated with BPH.

2. What you need to know before taking Finasteride Mylan Italia

Do not take Finasteride Mylan Italia

if you are a woman or a child
if you are allergic to finasteride or to any of the other ingredients of this medicine (listed in section 6)
if you are a pregnant woman or if you could potentially be pregnant (see section “Pregnancy and breastfeeding”)

Warnings and precautions
Talk to your doctor or pharmacist before taking Finasteride Mylan Italia.
Although benign prostatic hyperplasia (BPH) is not a malignant tumour and cannot become one, both conditions may coexist. Only a doctor can evaluate your symptoms, possible causes, and appropriate treatment.
Inform your doctor if you have or have had any medical conditions, diseases, or allergies.
Mood changes and depression
Mood changes, such as depressed mood, depression, and less frequently suicidal thoughts, have been reported in patients treated with Finasteride Mylan Italia. If you experience any of these symptoms, contact your doctor as soon as possible for further advice.
Take special care with Finasteride Mylan Italia

if you have reduced liver function;
if you have difficulty completely emptying your bladder or have a significantly reduced urinary flow. In such cases, your doctor must examine you carefully before starting treatment with Finasteride Mylan Italia to rule out other urinary tract obstructions.
if you need to undergo a blood test called “PSA” (a marker for possible prostate cancer). Make sure to inform your doctor before the test, as finasteride may affect test results.

It is recommended that a digital rectal examination, as well as other evaluations for prostate cancer, be performed before starting treatment with Finasteride Mylan Italia and periodically thereafter.
Breast cancer in men
During clinical studies and the post-marketing period, cases of breast cancer have been reported in men taking finasteride 5 mg. Doctors should instruct patients to promptly report any changes in breast tissue, such as lumps, pain, enlargement (gynecomastia), or nipple discharge.
Children and adolescents
Finasteride Mylan Italia is not indicated for pediatric use, as safety and efficacy in children have not been established.
Other medicines and Finasteride Mylan Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Finasteride Mylan Italia tablets can normally be taken with other medicines.
Finasteride Mylan Italia with food and drink
Finasteride Mylan Italia may be taken with or without food.
Pregnancy and breastfeeding
Finasteride Mylan Italia is intended for use in men only.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Pregnant women or women who could potentially become pregnant must not handle crushed or broken tablets of Finasteride Mylan Italia, due to the possible absorption of finasteride and the potential risk to a male fetus.
If finasteride is absorbed through the skin or taken by a woman, the baby may be born with malformations of the genital organs.
The tablets are film-coated; this prevents contact with finasteride as long as the tablets are not crushed or broken.
If your sexual partner is pregnant or suspects she might be pregnant, you should avoid exposing her to your seminal fluid (for example, by using a condom), which may contain a small amount of the drug.
Breastfeeding
It is not known whether finasteride is excreted in human breast milk; however, women must not take Finasteride Mylan Italia.
Driving and using machines
There are no data indicating that Finasteride Mylan Italia may affect the ability to drive or operate machinery.
Finasteride Mylan Italia contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Finasteride Mylan Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Finasteride Mylan Italia

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one film-coated tablet per day.
The tablet must be swallowed whole and must not be split or crushed. It can be taken with or without food.
Your doctor may prescribe Finasteride Mylan Italia together with another medicine, doxazosin, used to improve the management of benign prostatic hyperplasia.
Although improvement is often observed within a short time, treatment may need to be continued for at least 6 months.
Do not change the dose or stop treatment without first consulting your doctor.

Use in patients with renal impairment
If you have reduced kidney function (renal insufficiency), no dose adjustment of Finasteride Mylan Italia is required.

Use in elderly patients
If you are elderly, no dose adjustment of Finasteride Mylan Italia is required, although finasteride is eliminated to a lesser extent in patients over 70 years of age.

If you take more Finasteride Mylan Italia than you should
Contact your doctor, the nearest emergency department, or a poison control center immediately. There are no specific recommended treatments for finasteride overdose.
No adverse effects have been reported in patients who took high doses of Finasteride Mylan Italia for periods up to three months.

If you forget to take Finasteride Mylan Italia
Do not take a double dose to make up for the missed tablet; take the next tablet at your usual time.

If you stop taking Finasteride Mylan Italia
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 everybody gets them.

Side effects observed with Finasteride Mylan Italia are:

Common (may affect up to 1 in 10 people):

Decreased sex drive
Difficulty in achieving an erection (impotence)
Decreased amount of ejaculated semen

Uncommon (may affect up to 1 in 100 people):

Rash
Ejaculation disorders
Breast tenderness
Enlargement of the breast

Frequency not known (frequency cannot be estimated from the available data):

Hypersensitivity reactions such as itching, hives, and swelling (angioedema) of the lips, tongue, throat, and face
Depression
Persistent decrease in sexual desire even after stopping treatment
Palpitations
Increased liver enzymes
Testicular pain
Blood in the semen
Persistent difficulty in achieving an erection even after stopping treatment
Male infertility and/or poor semen quality, which normalizes or improves after stopping finasteride
Breast cancer in men
Anxiety
Suicidal thoughts

Diagnostic tests:
If you need to have blood tests to determine your PSA levels (a marker for the possible presence of prostate cancer), be aware that finasteride may affect the results of this test.

Immediately report to your doctor any changes in breast tissue (mammary gland), such as lumps, pain, breast enlargement in males, or nipple discharge, as these may be signs of a serious condition such as male breast cancer.

Stop treatment with Finasteride Mylan Italia and contact your doctor immediately if you experience any of the following symptoms (angioedema): swelling of the face, tongue or throat, difficulty swallowing, hives, and breathing difficulties.

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 Mylan Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton 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 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 Mylan Italia contains

The active substance is finasteride. Each tablet contains 5 mg of finasteride.
The other ingredients in the tablet are: lactose monohydrate, pregelatinized corn starch, sodium starch glycolate (Type A) (Ph.Eur.), sodium docusate, microcrystalline cellulose, povidone K30, magnesium stearate (Ph.Eur.).
The other ingredients in the film coating are: hypromellose, hydroxypropylcellulose, talc, titanium dioxide (E171), indigo carmine aluminium lake (E132).

Description of the appearance of Finasteride Mylan Italia and pack contents
Finasteride Mylan Italia are film-coated, light blue, biconvex tablets.
Finasteride Mylan Italia is available in blisters containing 15, 30, 50 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy
Manufacturer
Doppel Farmaceutici S.r.l., Via Martiri delle Foibe 1, Cortemaggiore (PC), Italy

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Italy: Finasteride Mylan Italia 5 mg film-coated tablets