Package leaflet: Information for the patient

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

1. What Proscar is and what it is used for

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

2. What you need to know before taking Proscar

Do not take Proscar

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 Proscar.
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 more 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 Proscar. If you experience any of these symptoms, contact your doctor as soon as possible for further advice.
Children and adolescents
Proscar is not indicated for pediatric use, as its safety and efficacy in children have not been established.
Other medicines and Proscar
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No clinically significant interactions between Proscar and other medicines have been identified. 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 disorders);
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.
Women who are pregnant or suspect they may be pregnant must not take Proscar (see section “Do not take Proscar”). Additionally, they must not handle crushed or broken Proscar tablets, as the active ingredient in the tablets may be absorbed through the skin and interfere with the normal development of a male fetus.
Intact Proscar 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, women must not take Proscar.
Driving and using machines
No effects on the ability to drive or operate machinery are known.
Proscar contains lactose
Proscar contains lactose, a milk sugar. If your doctor has diagnosed you with an intolerance to certain sugars, please consult him or her before taking this medicine.
Proscar contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dosage unit, i.e. essentially “sodium-free”.

3. How to take Proscar

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 independently of meals.
Your doctor may prescribe Proscar to you in combination with another medicine, doxazosin, used to improve the management of benign prostatic hyperplasia.
Although improvement is often observed after a short period, treatment may need to be continued for at least six months. Your doctor will advise you how long to take Proscar.

Use in patients with renal impairment
If you have reduced kidney function (renal impairment), no dose adjustment of Proscar is necessary.

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

If you take more Proscar than you should
If you accidentally take an excessive dose of Proscar, inform your doctor immediately or go to the nearest hospital.
Undesirable effects have not been observed in patients who have taken high doses of Proscar for periods up to three months.

If you forget to take Proscar
Do not take a double dose to make up for the missed dose.

If you stop taking Proscar
If you have any doubts about how to use 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.
Impotence and decreased sexual desire are the most common adverse reactions. These adverse
reactions occur during the initial phase of treatment and resolve in most patients during continued
treatment.

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)

skin 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, hives, and swelling (angioedema) of various parts of the body including lips, tongue, throat, and face
increased liver enzymes
testicular pain
blood in the 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),
be aware that finasteride may alter the results of this test.
Promptly inform your doctor of 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
breast cancer.
Discontinue treatment with Proscar and contact your doctor immediately if you experience any of the
following symptoms of angioedema:

swelling of the face, tongue, or throat
difficulty swallowing
hives
difficulty breathing

Reporting of side effects
If you experience any side effects, 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.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Proscar

This medicine does not require any special storage conditions.
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.
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 Proscar contains

The active substance is finasteride. Each tablet contains 5 mg of finasteride.
The other components are monohydrate lactose, pregelatinized starch, sodium carboxymethylstarch, yellow iron oxide, sodium docusate, microcrystalline cellulose, magnesium stearate, hypromellose, hydroxypropylcellulose, titanium dioxide, talc, and E 132 indigo carmine on hydrated alumina.

Description of the appearance of Proscar and the contents of the pack
5 mg film-coated tablets (packs of 15 and 30 tablets).
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome
Italy
Manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium