PATIENT INFORMATION LEAFLET

Finacapil 1 mg film-coated tablets

Finasteride
Equivalent medicine
Please read this leaflet carefully before using 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 their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT FINACAPIL IS AND WHAT IT IS USED FOR

Finacapil is intended for use only in male patients and must not be taken by
women or children (< 18 years of age).
Finacapil contains a substance called finasteride. This medicine is used for the treatment of early stages of male pattern hair loss (a condition also known as androgenetic alopecia) in men aged between 18 and 41 years. If, after reading this leaflet, you have any doubts regarding male pattern hair loss, please consult your physician.
Male pattern hair loss is a common condition, believed to be caused by a combination of genetic factors and a particular hormone called dihydrotestosterone (DHT). DHT contributes to shortening the hair growth phase and to hair thinning.
In the scalp, finasteride specifically reduces DHT levels by inhibiting an enzyme (type II 5α-reductase) that converts testosterone into DHT. Only male patients with mild to moderate, but not complete, hair loss, or with bitemporal recession, can expect benefits from the use of Finacapil. In the majority of men treated with finasteride for 5 years, progression of hair loss has been slowed, and at least half of these men have also experienced some degree of improvement in hair growth.

2. WHAT YOU SHOULD KNOW BEFORE TAKING FINACAPIL

Do not take Finacapil

if you are a woman (see also “Pregnancy, breastfeeding and fertility”). In clinical studies, Finacapil 1 mg tablets proved ineffective in the treatment of hair loss (androgenetic alopecia) in women;
if you are allergic to finasteride or to any of the other ingredients of this medicine (listed in section 6);
Finacapil must not be used by men who are taking other medicinal products containing finasteride, or any other 5α-reductase inhibitor for the treatment of benign prostatic hyperplasia or any other condition.

Warnings and precautions
Talk to your doctor before taking Finacapil.
Mood changes and depression
Mood changes, such as depressed mood, depression and, less frequently, suicidal thoughts have been reported in patients treated with finasteride. If you experience any of these symptoms, stop taking Finacapil and contact your doctor as soon as possible for further advice.
Effects on Prostate-Specific Antigen (PSA)
Finacapil may affect the results of a blood test called PSA (Prostate-Specific Antigen) used for prostate cancer screening. If you are about to have a PSA blood test, you must inform your doctor that you are taking Finacapil because finasteride reduces PSA levels.
Serum prostate-specific antigen (PSA) levels should be measured before starting treatment with Finacapil and during treatment.
Breast cancer
Cases of breast cancer have been reported in men taking finasteride during the post-marketing period. Doctors should instruct patients to promptly report any changes in their breast tissue such as lumps, pain, breast enlargement (gynecomastia), or nipple discharge (see section 4).
Children and adolescents
Finacapil must not be used in children. There are no data demonstrating a positive effect or safety of finasteride in children under 18 years of age.
Other medicines and Finacapil
Generally, Finacapil does not interfere with other medicinal products.
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Finacapil with food and drink
Finacapil tablets may be taken with or without food.
Pregnancy, breastfeeding and fertility
Finacapil is intended for the treatment of male pattern hair loss in men. For effects on male fertility, see section 2.

Women must not use Finacapil due to the risk during pregnancy.
Do not handle crushed or broken Finacapil tablets if you are a pregnant woman or potentially pregnant.
If the active substance in Finacapil is absorbed following oral intake or through the skin of a pregnant woman carrying a male fetus, it may result in the male baby being born with abnormalities of the genital organs.
If a pregnant woman comes into contact with the active substance in Finacapil, a doctor should be consulted.
Finacapil tablets are film-coated and prevent contact with the active substance during normal handling.

It is not known whether finasteride is excreted in human breast milk.
Effects on fertility
Infertility has been reported in men who have taken finasteride for a long time and who have had other risk factors that may affect fertility. Normalization or improvement in semen quality have been reported after discontinuation of finasteride.
Long-term clinical studies on the effect of finasteride on male fertility have not been conducted.
If you have any questions, ask your doctor.
Driving and using machines
There are no data suggesting that Finacapil may impair the ability to drive vehicles or operate machinery.
Finacapil contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, please consult him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially ‘sodium-free’.

3. HOW TO TAKE FINACAPIL

Always take this medicine exactly as instructed by your physician or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the usual dose for all patients is one tablet per day.
Follow your doctor's instructions. Do not change the dosage or stop taking the medicine without first consulting your doctor.
To achieve increased hair density or to reduce hair loss, you must take this medicinal product daily for a period of 3–6 months or longer. Only after this time will you be able to evaluate, together with your doctor, the benefits of treatment with Finacapil. During treatment with Finacapil, no changes to your normal hair care routine are necessary.
If you think the effects of this medicine are too weak or too strong, consult your physician or pharmacist.
The tablets must be swallowed whole with water. They must not be crushed or split. Tablets may be taken with or without food.

If you take more Finacapil than you should
If you have accidentally taken an excessive amount of tablets, consult your doctor or seek medical attention at a hospital immediately. This medicine does not work faster or better if taken more than once a day.

If you forget to take Finacapil
Do not take a double dose to make up for the missed dose. Continue treatment according to the usual dosing schedule.

If you stop taking Finacapil
To maintain the benefits achieved from treatment, it is recommended to use this medicinal product continuously. If you stop treatment with Finacapil, you are likely to lose the hair that grew back within 9–12 months.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Generally, the potential adverse reactions of Finacapil are mild and transient in nature.
Stop treatment with Finacapil and consult your doctor immediately if you experience any of the following
symptoms (angioedema): swelling of the lips, face, tongue or throat; difficulty swallowing; hives and difficulty
breathing. Frequency is not known (cannot be estimated based on the available data).
Promptly report to your doctor any changes in breast tissue such as lumps, pain, breast enlargement or nipple
discharge, as these may be signs of a serious illness, such as breast cancer. Frequency is not known (cannot be
estimated based on the available data).
Adverse reactions have generally been transient during continued treatment or disappeared after treatment was
discontinued.

Uncommon (may affect up to 1 in 100 people)

Decreased sexual desire
Depression
Erectile difficulties
Ejaculation problems, such as reduced volume of semen produced

Frequency not known (cannot be estimated based on the available data)

Allergic reactions such as skin rashes and itching
Breast swelling or tenderness
Testicular pain
Presence of blood in semen
Increased heart rate
Persistent difficulties in achieving erection after stopping treatment
Persistent decrease in sexual desire after stopping treatment
Persistent problems with ejaculation after stopping treatment
Male infertility and/or poor semen quality
Elevated liver enzymes
Anxiety
Suicidal thoughts

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist.
You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE FINACAPIL

Keep out of the sight and reach of children.
Do not use this medicinal product after the expiry date which is stated on the packaging and on the bottle/blister after the wording “EXP”. The expiry date refers to the last day of the stated month.
This medicinal product requires no special storage precautions.
HDPE bottle and LDPE screw cap: use within 4 months after first opening.
Do not dispose of any medicinal product via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Finacapil contains
The active substance is: finasteride.
Each tablet contains 1 mg of finasteride.
The other components are:
Tablet core: monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch,
lauryl macrogol glycerides, sodium carboxymethylstarch (type A) and magnesium stearate (E572).
Tablet coating: hypromellose, titanium dioxide (E171), red and yellow iron oxide (E172) and
macrogol 6000.

Description of the appearance of Finacapil and packaging contents
Finacapil 1 mg film-coated tablets are round, biconvex, brownish-red tablets, film-coated, marked with the inscription "F1" on one side.

Finacapil 1 mg film-coated tablets are available in the following pack sizes:
Blister (Aluminum/PVC; Aluminum/Aluminum)
Pack sizes: 7, 28, 30, 56, 84, 98 film-coated tablets
HDPE bottle with LDPE screw cap
Pack sizes: 7, 28, 30, 56, 84, 98 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
Giuliani S.p.A. – Via Palagi, 2 – 20129 Milan, Italy

Manufacturers
Actavis hf. - Reykjavíkurvegi 78 - 222 Hafnarfjördur (Iceland)
Lek Pharmaceuticals d.d. - Verovskova 57 - 1526 Ljubljana (Slovenia)
Lek S.A. - Ul. Podlipie - 95-010 Stryków (Poland)
Salutas Pharma GmbH - Otto-von-Guericke Allee 1 - 39179 Barleben (Germany)
Actavis Group PTC ehf - Reykholturvegur 76 – 78 - 220 Hafnarfjördur (Iceland)

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
France FINASTERIDE Sandoz 1 mg, film-coated tablet
Germany Finasterid – 1 A Pharma 1 mg Filmtabletten
Italy FINACAPIL
Spain Finasterida Sandoz 1 mg film-coated tablets EFG