Propecia

Package leaflet: Information for the user

PROPECIA, 1 mg, film-coated tablets
Finasteride
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

MEDICINE INTENDED FOR USE IN MEN ONLY
Contents of the leaflet

1. What Propecia is and what it is 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 Propecia is and what it is used for

Propecia is a film-coated tablet containing the active substance finasteride.
Finasteride inhibits the activity of type II 5α-reductase, an enzyme involved in the metabolism
of testosterone. In men with androgenetic alopecia, finasteride reduces the concentration in the body
of a metabolite of testosterone that contributes to male-pattern (androgenic) hair loss.
The medicine inhibits the miniaturization process of hair follicles on the scalp, thereby reversing
the hair loss process. The best treatment outcomes are achieved in men with mild to moderate hair loss.
Finasteride has not been shown to be effective in the treatment of androgenetic alopecia in women.
Indications
Propecia is indicated for the treatment of male-pattern hair loss (androgenetic alopecia). It is used
in men to increase hair growth and to prevent further hair loss.
This medicine may be used only in men.
It is not intended for use in women or 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 using finasteride or other type II 5α-reductase inhibitors for the treatment of benign prostatic hyperplasia or other conditions.

Warnings and precautions
Before starting treatment with Propecia, discuss this with your doctor or pharmacist.
Effect on prostate-specific antigen (PSA)
Inform your doctor that you are taking Propecia when undergoing blood tests to measure prostate-specific antigen (PSA) levels. Before interpreting PSA test results, your doctor should consider doubling the PSA value in men taking Propecia.
Breast cancer
See section 4.
Mood changes and depression
Mood changes such as depressed mood, depression, and rarely suicidal thoughts have been reported in patients taking Propecia. If any of these symptoms occur, treatment with Propecia should be discontinued immediately and medical advice should be sought without delay.
Children and adolescents
Propecia should not be used in children and adolescents. There is a lack of data on the efficacy and safety of finasteride in children and adolescents under 18 years of age.
Propecia and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or plan to take any other medicines.
Pregnancy, breastfeeding and effects on fertility
Pregnancy
Propecia is contraindicated in women.
Propecia must not be used during pregnancy or if pregnancy is suspected.
Handling crushed or damaged tablets may result in absorption of the medicine through the skin and may lead to developmental abnormalities in male fetuses.
Pregnant women, women who may be pregnant, and women of childbearing potential should not handle crushed or damaged Propecia tablets.
Propecia tablets are film-coated, which prevents direct contact with the active substance, provided the tablets are not damaged or crushed.
Breastfeeding
Propecia is contraindicated in women.
Propecia must not be used during breastfeeding.
Effect on fertility
There are no data on the effect on fertility in humans.
Cases of infertility have been reported in men taking finasteride for a prolonged period, in whom other risk factors affecting fertility were also present. However, no studies have been conducted on the effect of finasteride on male fertility.
Driving and operating machinery
There are no data indicating that Propecia affects the ability to drive or operate machinery.
Propecia contains lactose monohydrate
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Propecia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Propecia

This medicine should always be taken as directed by the physician. If in doubt, consult a doctor or pharmacist.
The recommended dose is 1 mg (1 tablet) once daily. The medicine should be taken orally, with or without food.
It is important to continue taking Propecia for as long as recommended by the physician, as the medicine only works over an extended period. To increase hair growth and prevent further hair loss, daily use of the medicine is required for at least 3 months. To maintain treatment results, continuous use of the medicine is recommended. Discontinuation of the medicine leads to reversal of its effects within 9 to 12 months.
Taking more Propecia than recommended
If more tablets have been taken than recommended, contact a doctor immediately.
Missing a dose of Propecia
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Symptoms related to the use of this medicine may include reduced interest in sex and difficulty in achieving erection (erection).
Treatment with Propecia should be discontinued and medical advice should be sought immediately if any of the following symptoms occur (angioedema): swelling of the face, tongue or throat; difficulty in swallowing; urticaria and breathing difficulties.
Any changes observed in breast tissue, such as lumps, tenderness, breast enlargement or nipple discharge, should be reported immediately to the treating physician, as they may be symptoms of a serious disease, such as male breast cancer.

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

• decreased libido,
• erectile dysfunction,
• ejaculation disorders, e.g. reduced ejaculate volume (amount of semen),
• depression.

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

• allergic reactions, including rash, itching,
• breast enlargement and/or tenderness,
• testicular pain,
• blood in semen,
• palpitations,
• persistent erectile dysfunction after discontinuation of treatment,
• persistent decreased libido after discontinuation of treatment,
• persistent ejaculation disorders after discontinuation of treatment,
• infertility,
• increased liver enzyme activity,
• male breast cancer,
• anxiety,
• suicidal thoughts.

If allergic reactions occur, the medicine should be discontinued and the doctor should be informed immediately.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the 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.
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Propecia

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

6. Contents of the pack and other information

What Propecia contains

• The active substance is finasteride. Each coated tablet contains 1 mg of finasteride.
• Other components are: tablet core: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium carboxymethyl starch type A, sodium lauryl sulfate, magnesium stearate; coating: hypromellose, hydroxypropylcellulose, 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 coated tablet.
Pack:
28 coated tablets (4 blisters with 7 tablets each) in a cardboard box.
Marketing Authorisation Holder
Organon Polska Sp. z o.o.
Marszałkowska Street 126/134
00-008 Warsaw
Tel.: +48 22 306 57 64
[email protected]
Manufacturer/Importer
Merck Sharp & Dohme B.V., Waarderweg 39, Haarlem, 2031BN, The Netherlands.
Organon Heist bv, Industriepark 30, 2220 Heist-op-den-Berg, Belgium.