PROPECIA 1 mg Tablets

Contents of the leaflet

1. PATIENT INFORMATION LEAFLET
2. Leaflet attached to the packaging: information for the user
3. PROPECIA, 1 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Propecia and what is it used for
   1. Indications for use
5. Important information before taking Propecia
   1. When not to take Propecia
   2. Warnings and precautions
   3. Effect on prostate-specific antigen (PSA)
   4. Breast cancer
   5. Mood changes and depression
   6. Children and adolescents
   7. Propecia and other medicines
   8. Pregnancy, breastfeeding, and fertility
   9. Driving and using machines
   10. Propecia contains lactose monohydrate
   11. Propecia contains sodium
6. How to take Propecia
   1. Taking more Propecia than recommended
   2. Missing a dose of Propecia
7. Possible side effects
   1. Reporting side effects
8. How to store Propecia
9. Contents of the pack and other information
   1. What Propecia contains
   2. What Propecia looks like and contents of the pack:
   3. Marketing authorization holder
   4. Manufacturer/Importer
   5. Date of last revision of the leaflet: 07/2024

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the user

PROPECIA, 1 mg, film-coated tablets

Finasteride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

THIS MEDICINE IS FOR USE IN MEN ONLY

Table of contents of the leaflet

• 1. What is Propecia and what is it used for
• 2. Important information before taking Propecia
• 3. How to take Propecia
• 4. Possible side effects
• 5. How to store Propecia
• 6. Contents of the pack and other information

1. What is Propecia and what is it used for

Propecia is a film-coated tablet that contains the active substance finasteride.
Finasteride inhibits the activity of 5α-reductase type II, an enzyme involved in the metabolism of testosterone.
In men with androgenetic alopecia, finasteride reduces the concentration in the body of the testosterone metabolite that contributes to male pattern hair loss (androgenetic alopecia).
The medicine slows down the process of hair follicle miniaturization on the scalp, leading to a reversal of the hair loss process. The best treatment results are achieved in men with mild to moderate hair loss.
Finasteride does not have an effect on the treatment of androgenetic alopecia in women.

Indications for use

Propecia is indicated for the treatment of male pattern hair loss (androgenetic alopecia). It is used in men to increase hair growth and prevent further hair loss.
The medicine can only be used in men.
The medicine is not intended for use in women and children.

2. Important information before taking Propecia

When not to take Propecia

• in women,
• if the patient is allergic to finasteride or any of the other ingredients of this medicine (listed in section 6),
• in men taking finasteride or other 5α-reductase type II inhibitors for the treatment of benign prostatic hyperplasia or other conditions.

Warnings and precautions

Before starting to take Propecia, discuss it with your doctor or pharmacist.

Effect on prostate-specific antigen (PSA)

Inform your doctor that you are taking Propecia if your prostate-specific antigen (PSA) blood levels are being checked.
Before evaluating PSA test results, your doctor should consider doubling the PSA level in men taking Propecia.

Breast cancer

See section 4.

Mood changes and depression

Patients taking Propecia have reported mood changes, such as depressive mood and depression, and less frequently, suicidal thoughts.
If any of these symptoms occur, stop taking Propecia and immediately consult your doctor for further medical advice.

Children and adolescents

Do not use Propecia in children and adolescents. There are no data on the efficacy or safety of finasteride in children and adolescents under 18 years of age.

Propecia and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

Pregnancy
Propecia is contraindicated in women.
Taking Propecia is contraindicated in women who are pregnant or suspected to be pregnant.
Handling damaged or crushed tablets can cause the medicine to be absorbed through the skin and lead to fetal developmental abnormalities in male fetuses.
Women who are pregnant or suspected to be pregnant, as well as women of childbearing age, should not handle crushed or damaged Propecia tablets.
Propecia tablets are film-coated, which prevents direct contact with the medicine, provided the tablets are not damaged or crushed.
Breastfeeding
Propecia is contraindicated in women.
Taking Propecia is contraindicated during breastfeeding.
Fertility
There are no data on the effect on fertility in humans.
There have been reports of infertility in men taking finasteride for a long time, who had other fertility risk factors. However, no studies have been conducted on the effect of finasteride on fertility in men.

Driving and using machines

There are no data indicating that Propecia affects the ability to drive or use machines.

Propecia contains lactose monohydrate

If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

Propecia contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Propecia

Always take this medicine exactly as your doctor has told you.
If you are unsure, consult your doctor or pharmacist.
The recommended dose is 1 mg (1 tablet) once a day.
Take the medicine orally, with or without food.
It is important to take Propecia for as long as your doctor recommends, as the medicine only works after a longer period of time.
To increase hair growth and prevent further hair loss, it is necessary to take the medicine daily for at least 3 months.
To maintain treatment results, continuous use of the medicine is recommended.
Stopping the medicine causes the effects to disappear within 9 to 12 months.

Taking more Propecia than recommended

If you have taken more tablets than recommended, contact your doctor immediately.

Missing a dose of Propecia

Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Propecia can cause side effects, although not everybody gets them.
Side effects associated with Propecia may include decreased interest in sex and difficulty achieving an erection.
Stop taking Propecia and immediately consult your doctor if you experience any of the following symptoms (angioedema): swelling of the face, tongue, or throat; difficulty swallowing; hives; and difficulty breathing.
Immediately report any changes in breast tissue, such as lumps, pain, enlargement of the breasts, or discharge from the nipples, to your doctor, as they may be a sign of a serious disease, such as breast cancer.
Uncommon(may affect up to 1 in 100 people)

• decreased sex drive,
• erectile dysfunction,
• ejaculation disorders (e.g., reduced semen volume),
• depression. Frequency not known(cannot be estimated from the available data)
• allergic reactions, including rash, itching,
• breast tenderness or enlargement,
• testicular pain,
• blood in semen,
• palpitations,
• persistent erectile dysfunction after stopping treatment,
• persistent decreased sex drive after stopping treatment,
• persistent ejaculation disorders after stopping treatment,
• infertility,
• increased liver enzyme activity,
• male breast cancer,
• anxiety,
• suicidal thoughts. If you experience an allergic reaction, stop taking the medicine and immediately consult your doctor.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Propecia

Keep the medicine out of the sight and reach of children.
Store in a temperature below 30°C.
Store the blisters in the outer packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
This will help protect the environment.

6. Contents of the pack and other information

What Propecia contains

• The active substance is finasteride. Each film-coated tablet contains 1 mg of finasteride.
• The other ingredients are: tablet core: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium carboxymethyl cellulose type A, docusate sodium, magnesium stearate; coating: hypromellose, hydroxypropyl cellulose, titanium dioxide (E 171), talc, yellow iron oxide (E 172), red iron oxide (E 172).

What Propecia looks like and contents of the pack:

Propecia is a film-coated tablet.
Packaging
28 film-coated tablets (4 blisters of 7 tablets) in a cardboard box.

Marketing authorization holder

Organon Polska Sp. z o.o.
ul. Marszałkowska 126/134
00-008 Warsaw
Tel.: +48 22 105 50 01
[email protected]

Manufacturer/Importer

Merck Sharp & Dohme B.V., Waarderweg 39, Haarlem, 2031BN, Netherlands.
Organon Heist bv, Industriepark 30, 2220 Heist-op-den-Berg, Belgium.

Date of last revision of the leaflet: 07/2024