Patient Information Leaflet

Finasteride Biorga 1 mg film-coated tablets

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

1. What Finasteride Biorga is and what it is used for

Finasteride Biorga contains the active substance called "finasteride".
Finasteride Biorga must be used exclusively by men.
Finasteride Biorga is used for the treatment, in the early stages, of male hair loss (a condition known as androgenetic alopecia), in men aged between 18 and 41 years.
If, after reading this leaflet, you have any doubts about male hair loss, consult your doctor.
Male hair loss is a common condition believed to be caused by a combination of genetic factors and a specific hormone called dihydrotestosterone (DHT). DHT contributes to shortening the hair growth phase and causes the hair to become thinner.
Finasteride specifically reduces DHT levels in the scalp by inhibiting an enzyme (type II 5-alpha-reductase) that converts testosterone into DHT. Only male subjects with mild to moderate, but not complete, hair loss can expect to benefit from the use of Finasteride Biorga. In many males treated with finasteride for 5 years, progression of hair loss has been slowed and hair growth has improved to some extent in at least half of these subjects.

2. What you should know before taking Finasteride Biorga

Do not take Finasteride Biorga

If you are a woman (because this medicine is intended for males only, see section "Pregnancy"). Clinical studies have shown that finasteride is not effective in women with hair loss.
If you are allergic to finasteride or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Finasteride Biorga.
Effect on Prostate-Specific Antigen (PSA)
Finasteride Biorga may affect a blood test called PSA (prostate-specific antigen) used to monitor prostate cancer. If you have had a PSA test, tell your doctor or pharmacist that you are taking Finasteride Biorga, because Finasteride Biorga reduces PSA levels.
Effects on fertility
Infertility has been reported in men who took finasteride for a prolonged period and who had other risk factors affecting fertility. After stopping finasteride, normalization or improvement of semen quality has been reported. Long-term clinical studies in men evaluating the effects of finasteride on fertility have not been conducted.
Breast cancer
See section 4.
Mood changes and depression
Mood changes such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with Finasteride Biorga. If you experience any of these symptoms, stop taking Finasteride Biorga and contact your doctor as soon as possible for further advice.
Children and adolescents
Finasteride Biorga must not be used in children. There are no data demonstrating the efficacy or safety of finasteride in children under 18 years of age.
Other medicines and Finasteride Biorga
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Finasteride Biorga with food, drinks and alcohol
Finasteride Biorga can be taken with or without food.
Pregnancy, breastfeeding and fertility
Finasteride Biorga is indicated only for the treatment of hair loss in males. For effects on fertility, see section 2.

Women must not use finasteride due to risks during pregnancy.
Women who are or may be pregnant must not handle crushed or broken tablets.
If a pregnant woman carrying a male fetus absorbs the active substance of Finasteride Biorga orally or through the skin, the baby may be born with abnormalities of the external genitalia.
If a woman comes into contact with the active substance of Finasteride Biorga, she should consult a doctor.
Finasteride Biorga tablets are film-coated to prevent contact with the active substance during normal handling.

If you have any doubts, consult your doctor.
Driving and using machines
No studies have been conducted on the effects of finasteride on the ability to drive vehicles or operate machinery.
Finasteride Biorga contains lactose
If you have been diagnosed by your doctor with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Finasteride Biorga

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet per day. The tablets can be taken with or without
food.
Your doctor will help determine whether Finasteride Biorga may be effective in your case. It
is important that you take finasteride for as long as your doctor has prescribed. Finasteride
Biorga works only in the long term if taken continuously.
If you take more Finasteride Biorga than you should
If you accidentally take too many tablets, contact your doctor immediately. Finasteride Biorga does
not work faster or better if taken more than once a day.
If you forget to take Finasteride Biorga
Do not take a double dose to make up for the forgotten dose.
If you stop taking Finasteride Biorga
It may take 3–6 months of treatment before an effect is noticed. It is important to try to take Finasteride Biorga for as long as your doctor has prescribed. If
you stop taking Finasteride Biorga, you will likely lose the hair you have gained within 9–
12 months after stopping treatment.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Finasteride Biorga can cause side effects, although not everyone experiences them.
Side effects are generally temporary if treatment is continued, or they disappear when treatment is discontinued.

Stop taking Finasteride Biorga and contact your doctor immediately if you experience any of the following symptoms of an allergic reaction: swelling of the lips, face, tongue, or throat; difficulty swallowing; swelling under the skin (urticaria), and breathing difficulties.

You must immediately report to your doctor any changes in breast tissue, such as lumps, pain, enlargement of breast tissue, or nipple discharge, as these symptoms may be signs of a serious condition, such as breast cancer.

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

Decreased sexual desire
Difficulty in achieving an erection
Ejaculation problems, such as reduced amount of semen released
Depression

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

Allergic reactions such as skin rash and itching
Breast tenderness and enlargement
Testicular pain
Increased heart rate
Persistent difficulties in achieving an erection after stopping treatment
Persistent reduction in sexual desire after discontinuation of treatment
Persistent ejaculation problems after discontinuation of treatment
Male infertility and/or poor semen quality
Elevated liver enzymes

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Finasteride Biorga

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Finasteride Biorga contains

The active substance is finasteride. Each tablet contains 1 mg of finasteride.
The excipients are: Tablet core: monohydrate lactose, microcrystalline cellulose (E-460), pregelatinized starch, sodium starch glycolate type A, sodium lauryl sulfate, magnesium stearate (E-470b). Coating: talc, hypromellose (E-464), propylene glycol, titanium dioxide (E-171), yellow iron oxide (E-172) and red iron oxide (E-172).

Description of the appearance of Finasteride Biorga and package contents
Film-coated tablets.
Finasteride Biorga 1 mg tablets are pink-orange in colour, round, and marked "F1" on one side.
Finasteride Biorga is available in blisters containing 7, 28, 30, 84 and 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Laboratoires Bailleul S.A.
10-12 Avenue Pasteur
L-2310 Luxembourg
LUXEMBOURG

Manufacturer
Kern Pharma, S.L.
Polígono Ind. Colón II,
Venus 72
08228 Terrassa (Barcelona)
Spain

More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (www.agenziafarmaco.gov.it/)