FINASTERIDE 5 mg Film-Coated Tablets

Зміст інструкції

1. FINASTERIDE ALTER 5 mg film-coated tablets
   1. What is FINASTERIDE ALTER and what is it used for
   2. What you need to know before taking Finasteride Alter
   3. How to take Finasteride Alter
   4. Possible side effects
   5. How to store FINASTERIDE ALTER
   6. Contents of the pack and other information

FINASTERIDE ALTER 5 mg film-coated tablets

Finasteride

Generic medicine

Read 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What FINASTERIDE ALTER is and what it is used for
• 2. What you need to know before you take FINASTERIDE ALTER
• 3. How to take FINASTERIDE ALTER
• 4. Possible side effects
• 5. How to store FINASTERIDE ALTER
• 6. Contents of the pack and other information

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

FINASTERIDE ALTER contains the active ingredient finasteride, belonging to the group of medicines
called 5alpha-reductase enzyme inhibitors. This medicine works by reducing the size of the
prostate in men when it is enlarged, a condition called benign prostatic hyperplasia (not
associated with tumors). In this way, FINASTERIDE ALTER reduces the swelling of the prostate and
improves urine flow, reducing the risks of possible surgical operation and the symptoms associated
with benign prostatic hyperplasia.

2. What you need to know before taking Finasteride Alter

Do not take Finasteride Alter

• if you are allergic to finasteride or any of the other ingredients of this medicine (listed in section 6);
• if you are a woman;
• if the patient is a child;
• if you are pregnant (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Finasteride Alter.
Pay particular attention to the use of this medicine if:

• you have a reduced urine flow and/or if after urination, the bladder does not empty completely (urinary retention). In these cases, take this medicine under the direct supervision of your doctor, who may assess the need for surgery.
• you notice any symptoms affecting the breast, such as hardening, pain, enlargement (gynecomastia) or leakage of fluid from the nipple, as these may be signs of breast cancer in men. In this case, inform your doctor immediately.
• your partner is or potentially could become pregnant, you must prevent her from coming into contact with crushed or broken finasteride tablets and with your semen. In fact, semen may contain a reduced amount of the medicine (see section “Pregnancy and breastfeeding”). Before starting treatment with this medicine and periodically once started, it is recommended to undergo specific tests (such as digital rectal examinations) to assess the presence of prostate cancer. Treatment with this medicine causes a decrease in the levels of a substance, Prostate Specific Antigen (PSA). This reduction must be taken into consideration by the doctor when measuring PSA levels, which may be altered for 6 months or more. This precaution is important in order to be able to diagnose any prostate cancer.

Children
The use of this medicine is not recommended in children as safety and efficacy have not been
established.

Other medicines and Finasteride Alter
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No interactions with other medicines have been reported.

Pregnancy and breastfeeding
Pregnancy
Finasteride Alter is for use only in men.
If your partner is or potentially may become pregnant, you must prevent her from coming into contact with your
semen. In fact, semen may contain a reduced amount of the medicine.
Women who are pregnant or for whom there is a possibility of becoming pregnant must not
come into contact with broken or crushed Finasteride Alter tablets. If this medicine is
absorbed through the skin or taken by mouth by a woman expecting a male baby,
the baby may be born with genital malformations.
The tablets are film-coated; this prevents contact with the medicine, unless the
tablets are broken or crushed.

Breastfeeding
The use of Finasteride Alter is not indicated in women. It is not known whether this medicine is excreted in
breast milk.

Driving and using machines
There is no data to establish that this medicine interferes with the ability to drive or operate
machinery.

Finasteride Alter contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to
certain sugars, contact him/her before taking this medicine.

3. How to take Finasteride Alter

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
The recommended dose is one tablet a day.
Take the tablet independently of meals.
Your doctor may consider it necessary to prescribe Finasteride Alter together with another medicine,
doxazosina, to obtain better control of your condition.
Your health condition may improve even after short periods of treatment. However, to establish
whether the treatment with this medicine is effective in controlling the disease, treatment periods of at least
six months are necessary.

If you take more Finasteride Alter than you should
In case of accidental ingestion/taking of an excessive dose of this medicine, contact
your doctor immediately or go to the nearest hospital.

If you forget to take Finasteride Alter
Do not take a double dose to make up for the missed tablet.
If you have any doubts 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 everybody gets them.
The most common side effects are sexual disorders such as impotence and decreased libido. These
effects usually occur at the beginning of treatment and resolve during treatment in the
majority of patients.

Common(may affect up to 1 in 10 people)

• reduction in the amount of semen;
• sexual disorders (impotence, decreased libido).

Uncommon(may affect up to 1 in 100 people)

• skin irritation (rash);
• ejaculation disorders;
• enlargement and sensitivity of the breast.

Not known(frequency cannot be estimated from available data)

• feeling of increased heartbeats (palpitations);
• skin disorders (itching and hives);
• allergic-type reactions, including swelling around the lips and eyes (angioedema);
• alteration of liver function (increased liver enzymes);
• testicular pain;
• depression, persistent reduction in sexual desire even after discontinuation of treatment;
• anxiety.
• persistent erectile dysfunction after discontinuation of treatment, male infertility and/or poor semen quality

In clinical studies and/or post-marketing use, the following side effects have been reported: breast cancer in
men (see section “Warnings and precautions”).

Laboratory tests
When measuring PSA levels, it should be noted that PSA levels are decreased during
treatment with this medicine (see section “Warnings and precautions”).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet. You can also report side effects directly through the national reporting system at the address: 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 ALTER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the pack after “Exp.”.
The expiry date refers to the last day of that month. The expiry date refers to the product in
intact packaging and correctly stored.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FINASTERIDE ALTER contains

• The active ingredient is finasteride. Each tablet contains 5 mg of finasteride.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium carboxymethylcellulose A, polysorbate 80, magnesium stearate, SeleCoatTM AQ-01440 blue (hypromellose, triacetin, titanium dioxide, indigotine on hydrated aluminum).

Description of the appearance of FINASTERIDE ALTER and pack contents
Pack of 15 film-coated tablets.

Marketing authorisation holder and manufacturer
Laboratori Alter S.r.l.
Via Egadi, 7
20144 Milan

Manufacturer
Laboratorios Alter, S.A.
Mateo Inurria, 30
28036 Madrid
Spain