FINASTERIDE 1 mg Film-Coated Tablet

Зміст інструкції

1. Finasteride Pensa 1 mg Film-coated Tablets
   1. What is Finasteride Pensa and what is it used for
   2. What you need to know before taking Finasteride Pensa
   3. How to take Finasteride Pensa
   4. Possible side effects
   5. How to store Finasteride Pensa
   6. Package Contents and Other Information
2. Finasteride Pensa 5 mg Film-coated Tablets
   1. What is Finasteride Pensa and what is it for
   2. What you need to know before taking Finasteride Pensa
   3. How to take Finasteride Pensa
   4. Possible side effects
   5. How to store Finasteride Pensa
   6. Contents of the pack and other information

Finasteride Pensa 1 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, pharmacist or nurse.
• 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, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

Finasteride Pensa contains a medicine called finasteride. This active ingredient belongs to
a group of medicines called “Type II 5-alpha reductase inhibitors”.
Your doctor has prescribed Finasteride Pensa because you suffer from male pattern hair loss (also known as androgenetic alopecia). Finasteride Pensa prevents further hair loss
in men.
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 reducing the hair growth phase and thinning the hair.
On the scalp, Finasteride Pensa specifically decreases DHT levels by blocking an
enzyme (Type II 5-α reductase) that converts testosterone into DHT. Men with mild to moderate, but not complete, hair loss may benefit from using Finasteride.

2. What you need to know before taking Finasteride Pensa

Do not take Finasteride Pensa:

• if you are allergic to finasteride or to any of the other ingredients of this medicine (listed in section 6).
• if you are a child or adolescent.
• if you are a woman (see also the section “Pregnancy and breastfeeding”). Clinical studies have shown that finasteride is ineffective in the treatment of hair loss (androgenic alopecia) in women.
• if you are already taking finasteride or any other 5α-reductase inhibitor for benign prostatic hyperplasia (BPH) or any other condition.

Do not take Finasteride Pensa if you fall into any of the above conditions. If you have any doubts, ask your
doctor or pharmacist.

Changes in mood and depression
Changes in mood, such as depressed mood, depression, and, less frequently, suicidal thoughts
have been reported in patients treated with Finasteride Pensa. If you experience any of these
symptoms, stop taking Finasteride Pensa and contact your doctor as soon as possible for
further information.
Finasteride Pensa should not be used in children.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you are going to undergo a
blood test called PSA (prostate-specific antigen) for the detection of prostate cancer.
This is necessary because Finasteride Pensa can alter the result of this test.
Finasteride Pensa may impair male fertility. Patients who are planning to
become fathers should consider interrupting treatment.
Promptly inform your doctor of any changes in your chest tissue, such as lumps,
swellings, pain, breast enlargement, or nipple discharge, as these could
be signs of a serious condition, such as breast cancer.

Other medicines and Finasteride Pensa
Finasteride Pensa generally does not interfere with other medicines. Tell your doctor or pharmacist
if you are taking, have recently taken, or might take any other medicine.
There is no information available on the concomitant use of Finasteride Pensa and minoxidil for topical use (applied to the skin) in male pattern hair loss. The use of this combination is not
recommended.
Do not take Finasteride Pensa if you are already taking finasteride or dutasteride, used for a problem
with the prostate called benign prostatic hyperplasia (BPH).

Finasteride Pensa with food and drink
Finasteride Pensa can be taken with or without food.

Pregnancy and breastfeeding
Finasteride Pensa is intended for use in men only.
Women who are pregnant or who could potentially be pregnant should not
come into contact with finasteride tablets, especially if broken or crushed. If
finasteride is absorbed through the skin or taken by mouth by a pregnant woman with a male fetus, the baby could be born with birth defects of the
genital organs.
If the patient's sexual partner is pregnant or could be pregnant, the
patient should avoid exposing their partner to their semen (e.g. by using
a condom) or stop treatment with finasteride. If a pregnant woman comes into contact with Finasteride Pensa, she should consult a doctor.
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice.

Driving and using machines
There is no information to suggest that Finasteride Pensa alters the ability to drive vehicles
or use machines.

Finasteride Pensa contains lactose
Finasteride Pensa contains lactose, a sugar from milk. If your doctor has diagnosed you with an
intolerance to certain sugars, contact them before taking this medicine.

Finasteride Pensa contains sodium
Finasteride Pensa contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take Finasteride Pensa

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
The recommended dose is one tablet a day (equivalent to 1 mg of finasteride).
The film-coated tablets can be taken both on an empty stomach and with meals. The
film-coated tablets must be swallowed whole and must not be divided or
crushed.
Finasteride Pensa does not work faster or better if you take more than one tablet a day.
Male pattern baldness is a condition that develops over a long period of time.
In general, continued daily use for 3-6 months may be necessary before you notice an
increase in hair density or a reduction in hair loss.
Your doctor will help you assess whether Finasteride Pensa is producing the desired effects. It is
important to continue taking Finasteride Pensa for the entire period of time prescribed by
your doctor.

Patients with impaired liver function
There is no experience with the use of finasteride in patients with impaired liver function.

Patients with impaired renal function
No dosage adjustment is required in patients with impaired renal function.

If you take more Finasteride Pensa than you should
If you have taken more tablets than prescribed, or if someone else has taken the tablets,
contact the emergency room of the nearest hospital. Bring with you the remaining tablets or the empty box
of the medicine to allow identification of the medicine taken.

If you forget to take Finasteride Pensa
If you forget to take a dose of Finasteride Pensa, continue with the next dose as usual. Do not take a double dose to compensate for the missed dose.

If you stop taking Finasteride Pensa
Continued use of Finasteride Pensa is recommended to obtain maximum benefit. If the
treatment is discontinued during the therapy cycle, any hair that has regrown may fall out within
the next 9-12 months.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects have generally been temporary with continued treatment or have regressed with discontinuation of treatment.
The following side effects may occur with the use of this medicine:
Uncommon (affects less than 1 in 100 patients):

• decreased sexual desire
• difficulty in achieving an erection
• problems with ejaculation such as reduced amount of semen released
• depressed mood

Frequency not known:

• allergic reactions such as skin rash, itching, swellings under your skin (urticaria) and angioedema (including swelling of the lips, tongue, throat and face)
• breast enlargement or tenderness
• testicular pain
• fast heartbeat
• persistent difficulty in having an erection after stopping treatment
• persistent reduction in sexual drive after stopping treatment
• persistent problems with ejaculation after stopping treatment
• infertility has been reported in men who have taken finasteride for a long period and had other risk factors that may affect fertility. After discontinuation of finasteride, normalization or improvement of semen quality has been reported. No long-term clinical studies on the effects of finasteride on fertility have been conducted in humans
• elevated liver enzymes
• anxiety

You should immediately report to your doctor any changes to breast tissue such as
lumps, swelling, pain, increase in breast tissue volume or nipple discharge
because these changes may be signs of a serious condition, such as breast cancer.
Stop taking Finasteride Pensa and talk to your doctor immediately if you have any of the
following symptoms:

• swelling of your face, tongue or throat
• difficulty swallowing
• swellings under your skin (urticaria)
• difficulty breathing

If any of these side effects get worse, or if you notice any other effects
It may be helpful to make a note of the type of side effect, when it occurred and how long
it lasted.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at https://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 Pensa

Keep this medicine out of the sight and reach of children.
Store at temperatures not exceeding 25°C.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry
date refers to the last day of that month.
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.
Pregnant women or women who could potentially be pregnant should not
come into contact with finasteride tablets, especially if crushed or broken, due to
the possibility of finasteride absorption and the resulting potential risk to a male
fetus (see section Pregnancy and breastfeeding).

6. Package Contents and Other Information

What Finasteride Pensa Contains

• The active ingredient is finasteride. Each film-coated tablet contains 1 mg of finasteride.
• The other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, pregelatinized starch
• (1500), sodium starch glycolate (type A), sodium docusate, magnesium stearate. Film coating ( Opadry Brown 03A86790): hypromellose (E464), titanium dioxide (E171), talc, yellow iron oxide (E172), red iron oxide (E172).

Description of the Appearance of Finasteride Pensa and Package Contents
Film-coated tablet.
Film-coated tablets of brown color, round in shape, engraved with “H” on one side and “36”
on the other side.
Finasteride Pensa tablets are available in blister packs containing 7, 28, 30, 50, 84,
98 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan - Italy

Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola, PLA 3000, Malta

Finasteride Pensa 5 mg Film-coated Tablets

Finasteride
Generic medicine

Read this leaflet carefully before you start 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 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, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is Finasteride Pensa and what is it for

Finasteride belongs to a group of medicines called “5-alpha reductase inhibitors”.
These work by reducing the size of the prostate gland in men.
Finasteride is indicated for the treatment and control of benign prostatic hyperplasia (BPH), also known
as prostatic hypertrophy, characterized by a benign enlargement of the prostate.
Finasteride improves urinary flow and symptoms associated with BPH.

2. What you need to know before taking Finasteride Pensa

Do not take Finasteride Pensa:

• 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 (see also the section “Pregnancy and breastfeeding”).
• if you are a child.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Finasteride Pensa.

• If you have a considerable amount of residual urine in your bladder after urinating and/or a severely reduced urinary flow, you should be carefully monitored for possible narrowing of the urinary tract.
• If your liver function is reduced, the level of finasteride in the blood may be increased.
• If your sexual partner is pregnant or could potentially be pregnant, you should avoid exposing her to contact with your semen, which may contain small amounts of the drug.
• If you need to have a PSA test (a test used to detect prostate cancer), tell your doctor that you are taking finasteride. Finasteride can alter the levels in the blood of the substance being tested, namely PSA.

Tell your doctor if you currently or in the past have experienced any of the conditions mentioned above.
Promptly inform your doctor of any changes in your chest tissue such as nodules,
swellings, pain, breast enlargement or nipple discharge, as these could
be signs of a serious condition, such as breast cancer.

Changes in mood and depression
Changes in mood, such as depressed mood, depression, and, less frequently, suicidal thoughts
have been reported in patients treated with Finasteride Pensa. If you experience any of these
symptoms, stop taking Finasteride Pensa and contact your doctor as soon as possible for
further information.

Children and adolescents
Finasteride is not indicated for use in pediatric patients as safety and efficacy in children have not
been established.

Other medicines and Finasteride Pensa
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
No clinically significant interactions between Finasteride and other medicines have been identified. In
particular, no significant interactions have been found with the following medicines:

• propranolol (used to treat high blood pressure and angina pectoris);
• digoxin (used to treat heart rhythm problems);
• glibenclamide (used to lower blood sugar levels);
• warfarin (used to prevent blood clots);
• theophylline (used to treat asthma);
• phenazone (used to treat inflammation).

Finasteride Pensa with food and drink
Finasteride Pensa can be taken with or without food.

Pregnancy and breastfeeding
Finasteride Pensa is intended for use in men only.
Pregnancy
Pregnant women or women who could potentially be pregnant should not
come into contact with finasteride tablets, especially if broken or crushed. If
finasteride is absorbed through the skin or taken by mouth by a pregnant woman with a male fetus, the child may be born with birth defects
of the genital organs.
If the patient's sexual partner is pregnant or could be pregnant, the
patient should avoid exposing his partner to his semen (e.g. by using
a condom) or discontinue treatment with finasteride. If a pregnant woman comes into contact with Finasteride Pensa, a doctor should be consulted.
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice.
Breastfeeding
It is not known whether finasteride is excreted in human milk; in any case, if you are a woman, you should not
take Finasteride Pensa.

Driving and using machines
There is no information to suggest that Finasteride Pensa impairs the ability to drive vehicles
or use machines.

Finasteride Pensa contains lactose
Finasteride Pensa contains lactose, a sugar from milk. If you have been diagnosed with
lactose intolerance, contact your doctor before taking this medicine.

Finasteride Pensa contains sodium
Finasteride Pensa contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take Finasteride Pensa

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
The recommended dose is one tablet a day (equivalent to 5 mg of finasteride).
The film-coated tablets can be taken both on an empty stomach and with meals. The
film-coated tablets must be swallowed whole and must not be divided or
crushed. Your doctor may prescribe Finasteride Pensa together with another medicine,
doxazosin, to improve the control of benign prostatic hyperplasia.
Although improvements are visible in a short time, treatment may need to be continued
for at least six months to assess whether a favorable response has been achieved.
Your doctor will tell you how long you will need to continue taking Finasteride Pensa. Do not
interrupt treatment prematurely, because the symptoms may recur .
Patients with impaired liver function
There is no experience on the use of finasteride in patients with impaired liver function
(see also paragraph “Warnings and Precautions”).

Patients with impaired renal function
No dosage adjustment is required. The use of Finasteride Pensa in patients who have to
undergo hemodialysis has not yet been studied.

Elderly patients
No dosage adjustment is required.
Contact your doctor or pharmacist if you feel that the effects of Finasteride Pensa are too strong or
too weak.

If you take more Finasteride Pensa than you should
If you have taken more tablets than prescribed, or if someone else has taken the tablets,
contact the emergency room of the nearest hospital. Bring with you the remaining tablets or the empty box
of the medicine to allow identification of the medicine taken.

If you forget to take Finasteride Pensa
If you forget to take a dose of Finasteride Pensa, you can take it as soon as you remember unless it is already time to take the next dose. In this case, continue with
taking the medicine as prescribed. Do not take a double dose to make up for the
forgotten dose.

If you stop taking Finasteride Pensa
Do not stop taking Finasteride Pensa unless your doctor tells you that you can.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following categories of frequency have been used to assess side effects:
Very common – may affect more than 1 in 10 people
Common – may affect up to 1 in 10 people
Uncommon – may affect up to 1 in 100 people
Rare – may affect up to 1 in 1,000 people
Very rare – may affect up to 1 in 10,000 people, including isolated reports
The most common side effects are impotence and decreased libido. These
effects usually occur at the beginning of treatment but generally do not last long in
most patients if treatment is continued.

Common side effects (may affect up to 1 in 10 people)

• decrease in semen volume
• impotence
• decreased libido

Uncommon side effects (may affect up to 1 in 100 people)

• skin rash
• ejaculation disorders
• breast tenderness
• breast enlargement

Side effects with unknown frequency (frequency cannot be estimated based on available
data)

• irregular heartbeat
• hypersensitivity reactions such as itching, hives and swelling (angioedema) of various parts of the body including lips, tongue, throat and face
• increased liver enzymes
• testicular pain
• erectile dysfunction, which may persist after discontinuation of finasteride
• male infertility and/or poor semen quality, which normalizes or improves after discontinuation of finasteride
• male breast cancer
• depression
• persistent decrease in sexual drive after discontinuation of treatment
• persistent ejaculation problems after discontinuation of treatment
• anxiety

Diagnostic tests:
if you need to have blood tests to determine PSA levels (an indicator of
possible prostate cancer), be aware that finasteride may alter the results
of this test.
Immediately report to your doctor any changes in breast tissue (mammary
gland) such as lumps, pain, breast tissue enlargement in males, or nipple discharge,
as they may be signs of a serious condition such as breast cancer.
Stop treatment with Finasteride Pensa and contact your doctor immediately if
you experience any of the following symptoms of angioedema:

• swelling of the face, tongue or throat
• difficulty swallowing
• hives
• difficulty breathing

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 https://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 Pensa

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry
date refers to the last day of that month.
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.
Pregnant women or women who could potentially be pregnant must not
come into contact with finasteride tablets, especially if crushed or broken, due to
the possibility of finasteride absorption and the resulting potential risk to a male
fetus (see section Pregnancy and breastfeeding).

6. Contents of the pack and other information

What Finasteride Pensa contains

• The active ingredient is finasteride. Each film-coated tablet contains 5 mg of finasteride.
• The other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, pregelatinized starch
• (1500), sodium starch glycolate (type A), sodium docusate, magnesium stearate. Film coating (Opadry Blue 03A80928): hypromellose (E464), titanium dioxide (E171), indigo carmine aluminum lake (E132), talc, yellow iron oxide (E172).

Description of the appearance of Finasteride Pensa and contents of the pack
Film-coated tablet.
Film-coated tablets of blue color, round in shape, with ‘H’ imprinted on one side and ‘37’ on the other
side.
Finasteride Pensa tablets are available in blister packs containing 14, 15, 20, 28, 30,
50, 56, 60, 84, 90, 98, 100, 112 or 120 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan – Italy

Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola, PLA 3000, Malta