Package leaflet: Information for the user

FINASTERIDE PHARMACARE

1 mg tablets
finasteride
Generic medicine
Please read this leaflet carefully before taking this medicine as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
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 adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What FINASTERIDE PHARMACARE is and what it is used for

FINASTERIDE PHARMACARE contains the active substance finasteride, which belongs to a group
of medicines called type II 5-alpha reductase inhibitors.
FINASTERIDE PHARMACARE must be used only in men.
FINASTERIDE PHARMACARE is used in the treatment of early stages of male pattern hair loss
(also called androgenetic alopecia) in men aged between 18 and 41 years.
If, after reading this leaflet, you have any questions about male hair loss, please consult your doctor.
Male 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 growth phase
of hair and to thinning of the hair.
On the scalp, FINASTERIDE PHARMACARE specifically reduces levels of DHT by blocking an enzyme
(type II 5-alpha reductase) that converts testosterone into DHT. Only men with mild to moderate, but
not complete, hair loss can expect benefit from using FINASTERIDE PHARMACARE. In most men
treated with FINASTERIDE PHARMACARE for 5 years, progression of hair loss has been slowed, and
at least half of these men also experienced some degree of improvement in hair growth.

2. What you need to know before using FINASTERIDE PHARMACARE

Do not take FINASTERIDE PHARMACARE

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 (because this medicine is for men). Clinical studies have shown that finasteride is not effective in women with hair loss
if you are already taking finasteride 5 mg or dutasteride for a prostate condition called benign prostatic hyperplasia (BPH) or for any other condition.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking FINASTERIDE PHARMACARE.
.
Effect on prostate-specific antigen (PSA)
FINASTERIDE PHARMACARE can affect a blood test called PSA (prostate-specific antigen) used to monitor prostate cancer. This is because finasteride may alter the result of this test. If you have had a PSA test, inform your doctor that you are taking FINASTERIDE PHARMACARE, as FINASTERIDE PHARMACARE decreases PSA levels.
Effects on fertility
Infertility has been reported in men who have taken finasteride for a long time and who had other risk factors that may affect fertility. After stopping finasteride, normalization or improvement in semen quality has been reported. No long-term clinical studies in humans have been conducted on the effects of finasteride on fertility.
Breast cancer
See section 4.
FINASTERIDE PHARMACARE is intended only for men.
Mood changes and depression
Mood changes such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with FINASTERIDE PHARMACARE. If you experience any of these symptoms, stop taking FINASTERIDE PHARMACARE and contact your doctor as soon as possible for further advice.
In some patients, impaired sexual function has been reported, which may contribute to mood changes, including suicidal thoughts. If you develop symptoms of impaired sexual function, contact your doctor for further advice. Your doctor may consider discontinuing treatment (see section 4 below for further information on these side effects).
A patient reminder card highlighting the above information is provided in the FINASTERIDE PHARMACARE packaging.
Children and adolescents
Finasteride tablets 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 PHARMACARE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take FINASTERIDE PHARMACARE if you are already taking finasteride or dutasteride, used for a prostate condition called benign prostatic hyperplasia (BPH).
Pregnancy, breastfeeding and fertility
FINASTERIDE PHARMACARE is indicated only for male-pattern hair loss.
For effects on fertility, see section 2.

FINASTERIDE PHARMACARE tablets must not be taken by women due to the risk during pregnancy.
Pregnant women or women who may become pregnant must not handle crushed or broken FINASTERIDE PHARMACARE tablets.
If finasteride is absorbed through the skin or taken orally by a pregnant woman carrying a male fetus, the baby may be born with malformed genital organs.
The tablets are film-coated, which prevents contact with finasteride as long as the tablets are not broken or crushed.
If you suspect that a pregnant woman has been exposed to finasteride, you must contact a doctor.

Ask your doctor or pharmacist for advice if you have any questions.
Driving and use of machines
There is no evidence suggesting that FINASTERIDE PHARMACARE affects the ability to drive or operate machinery.
FINASTERIDE PHARMACARE contains lactose monohydrate
FINASTERIDE PHARMACARE contains lactose monohydrate. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
FINASTERIDE PHARMACARE contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially "sodium-free".
.
Use of other male-pattern hair loss medicines with FINASTERIDE PHARMACARE
No information is available on the use of FINASTERIDE PHARMACARE with minoxidil, another type of medicine for male-pattern hair loss applied to the scalp.

3. How to take FINASTERIDE PHARMACARE

Take this medicine exactly as directed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is
1 tablet (1 mg) daily.
The tablet must be swallowed whole and must not be split or crushed. It can be taken with or without food.
Your doctor can help you assess whether FINASTERIDE PHARMACARE is effective for you. It is important to take FINASTERIDE PHARMACARE for the duration prescribed by your doctor.
FINASTERIDE PHARMACARE only works over the long term when used continuously.

If you take more FINASTERIDE PHARMACARE than you should
If you (or someone else) swallow several tablets at the same time, or if you think a child has swallowed one or more tablets, contact the emergency department of the nearest hospital or your doctor immediately.

If you forget to take FINASTERIDE PHARMACARE
Do not take a double dose to make up for the forgotten tablet. Take the next dose as scheduled.

If you stop taking FINASTERIDE PHARMACARE
It may take between 3 and 6 months to achieve the full effect. It is important to continue taking FINASTERIDE PHARMACARE for the entire duration indicated by your doctor. If you stop treatment with FINASTERIDE PHARMACARE, you are likely to lose the hair you have gained within 9–12 months.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Side effects have generally been temporary with continued treatment and have resolved upon discontinuation of treatment.
Stop taking FINASTERIDE PHARMACARE tablets and contact your doctor immediately if you develop any of the following symptoms of an allergic reaction:

swelling of the lips, face, tongue or throat, difficulty swallowing, rash, itching, lumps under the skin (urticaria), and difficulty breathing
suicidal thoughts.

You must immediately inform your doctor of any changes in breast tissue, such as lumps, pain, enlargement of breast tissue, or nipple discharge, as these may be signs of a serious condition such as breast cancer.
Uncommon (may affect up to 1 in 100 people):

Inability to achieve an erection
Reduced sexual desire
Problems with ejaculation, for example a reduced amount of semen released during sexual activity
Depression

Frequency not known: frequency cannot be estimated from the available data

Allergic reactions such as rash and itching
breast swelling or tenderness
testicular pain
palpitations
elevated liver enzymes
anxiety
persistent difficulty in achieving an erection after stopping treatment
persistent reduction in sexual desire after stopping treatment
persistent problems with ejaculation after stopping treatment
male infertility and/or poor semen quality
presence of blood in the semen
suicidal thoughts.

Reporting of side effects
If you experience any side effect, 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 www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FINASTERIDE PHARMACARE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, carton or bottle after 'exp.'. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
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 PHARMACARE contains

The active substance is finasteride 1 mg.
The other components are lactose monohydrate, microcrystalline cellulose, pregelatinized starch, macrogol lauryl glycol, sodium starch glycolate type A, magnesium stearate, hypromellose, titanium dioxide (E 171), yellow and red iron oxide (E 172), and macrogol 6000.

Description of the appearance of FINASTERIDE PHARMACARE and package contents
FINASTERIDE PHARMACARE film-coated tablets are round, biconvex, brownish-red in colour, marked with “F1”.
They are available in:
Blister packs containing 28 tablets
Plastic bottles containing 28 tablets

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharmacare srl
Via Marghera, 29
20149 Milano
Italy

Manufacturer
Actavis Group PTC ehf.
Reykjavikurvegur 76-78
IS-220 Hafnarfjörður
Iceland

This medicinal product is authorised in the European Economic Area countries with the following names:
IT: FINASTERIDE PHARMACARE

Patient leaflet
FINASTERIDE PHARMACARE may cause adverse reactions, including mood disturbances, depression, and suicidal thoughts. If you experience any mood changes, stop taking finasteride and contact your doctor as soon as possible for further advice.
In some patients, sexual dysfunction may contribute to mood disturbances, including suicidal thoughts. If you experience symptoms of sexual dysfunction, contact your doctor for further advice.