Finasteride Pensà

Package leaflet: Information for the user

Finasteride Pensa 1 mg Film-coated tablets

Finasteride
Generic medicine
Please read this leaflet carefully before 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 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, 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 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

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

Finasteride Pensa contains a medicine called finasteride. This active substance belongs to a group of medicines known as 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 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 Pensa specifically reduces levels of DHT 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 section “Pregnancy and breastfeeding”). Clinical studies have shown that finasteride is ineffective in the treatment of hair loss (androgenetic alopecia) in women.
• if you are already taking finasteride or any other 5α-reductase inhibitor for benign prostatic hyperplasia (BPH) or for any other condition.

Do not take Finasteride Pensa if any of the above conditions apply to you. If in doubt, consult your doctor or pharmacist.
Mood changes and depression
Mood changes 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 advice.
Finasteride Pensa must not be used in children.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you are due to have a blood test called PSA (prostate-specific antigen) for the detection of prostate cancer. This is necessary because Finasteride Pensa may affect the result of this test.
Finasteride Pensa may impair male fertility. Patients planning to father children should consider discontinuing treatment.
Promptly inform your doctor of any changes in your breast tissue, such as lumps, swelling, 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. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
There is no information available on the concomitant use of Finasteride Pensa and topical minoxidil (applied to the skin) for 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 prostate condition called benign prostatic hyperplasia (BPH).
Finasteride Pensa with food and drink
Finasteride Pensa may be taken with or without food.
Pregnancy and breastfeeding
Finasteride Pensa is intended for use in men only.
Pregnant women or women who may potentially be pregnant must not handle finasteride tablets, especially if they are broken or crushed. If finasteride is absorbed through the skin or taken orally by a pregnant woman carrying a male fetus, the baby may be born with abnormalities 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 seminal fluid (e.g. by using a condom) or discontinue treatment with finasteride. If a pregnant woman comes into contact with Finasteride Pensa, medical advice must be sought.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist.
Driving and using machines
There is no information suggesting that Finasteride Pensa affects the ability to drive or operate machinery.
Finasteride Pensa contains lactose
Finasteride Pensa contains lactose, a milk sugar. If your doctor has diagnosed you with an intolerance to certain sugars, 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 exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one tablet per day (equivalent to 1 mg of finasteride).
The film-coated tablets may be taken on an empty stomach or with food. 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 per day.
Male hair loss is a condition that develops over a long period of time. Generally, continuous daily use for 3–6 months may be needed 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 duration 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 kidney function
No dose adjustment is required in patients with impaired kidney 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 department of your nearest hospital immediately. Take the remaining tablets or the empty medicine pack with you to help identify the medicine taken.

If you forget to take Finasteride Pensa
If you forget to take a dose of Finasteride Pensa, take the next dose as usual. Do not take a double dose to make up for the forgotten dose.

If you stop taking Finasteride Pensa
Continuous use of Finasteride Pensa is recommended to achieve maximum benefit. If treatment is stopped during the course of therapy, the regrown hair may be lost again within the following 9–12 months.

If you have any questions 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 everyone experiences them.
The side effects were generally temporary with continued treatment or resolved upon discontinuation of treatment.
The following side effects may occur with the use of this medicine:
Uncommon (occurs in less than 1 in 100 patients):

• decreased sexual desire
• difficulty in achieving an erection
• ejaculation problems such as reduced volume of ejaculated semen
• depressed mood

Frequency not known:

• allergic reactions such as skin rash, itching, swelling under the skin (urticaria), and angioedema (including swelling of the lips, tongue, throat, and face)
• breast swelling or tenderness
• testicular pain
• rapid heartbeat
• persistent difficulty in obtaining an erection after stopping treatment
• persistent reduction in sexual desire after stopping treatment
• persistent ejaculation problems after stopping treatment
• 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 discontinuation of finasteride, normalization or improvement in semen quality has been reported. Long-term clinical studies on the effects of finasteride on fertility in humans have not been conducted
• elevated liver enzymes
• anxiety

You must immediately inform your doctor of any changes in breast tissue, such as lumps, swelling, pain, increase in breast size, or nipple discharge, as these changes may be signs of a serious condition, such as breast cancer.
Stop taking Finasteride Pensa and contact your doctor immediately if you experience any of the following symptoms:

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

If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
It may be helpful to keep a record of the type of side effect, when it occurred, and how long it lasted.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via 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 stated on the label 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.
Pregnant women or women who may potentially be pregnant must not handle finasteride tablets, especially if crushed or broken, due to the possibility of absorption of finasteride and the consequent potential risk to a male fetus (see section Pregnancy and breastfeeding).

6. Package contents and other information

What Finasteride Pensa contains

• The active substance is finasteride. Each film-coated tablet contains 1 mg of finasteride.
• The other components are: Tablet core: monohydrate lactose, 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 contents of the pack
Film-coated tablet.
Brown, round, film-coated tablets, 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

Patient Information Leaflet: Information for the user

Finasteride Pensa 5 mg Film-coated Tablets

Finasteride
Generic medicine
Please read this entire 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 their symptoms are the same as yours, as 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

1. What Finasteride Pensa is and what it is 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. Contents of the pack and other information

1. What Finasteride Pensa is and what it is used 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 management of benign prostatic hyperplasia (BPH), also
known as prostate enlargement, which is 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 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 significant amount of residual urine in your bladder after urination and/or severely reduced urinary flow, you should be carefully monitored for possible narrowing of the urinary tract.
• If you have reduced liver function, the level of finasteride in your blood may be increased.
• If your sexual partner is pregnant or could potentially be pregnant, you must avoid exposing her to contact with your semen, which may contain small amounts of the medicine.
• If you are due to have a PSA test (a test used to detect prostate cancer), inform your doctor that you are taking finasteride. Finasteride can alter blood levels of the substance being measured, namely PSA.

Inform your doctor if you currently have or have previously had any of the conditions listed above.
Promptly inform your doctor of any changes in the tissue of your chest, such as lumps, swelling, pain, breast enlargement, or nipple discharge, as these could be signs of a serious condition, such as breast cancer.
Mood changes and depression
Mood changes, 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 advice.
Children and adolescents
Finasteride is not indicated for pediatric use, as the safety and efficacy in children have not been established.
Other medicines and Finasteride Pensa
Inform 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 observed 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 must not handle finasteride tablets, especially if they are broken or crushed. If finasteride is absorbed through the skin or taken orally by a pregnant woman carrying a male fetus, the baby may be born with malformations of the genital organs.
If the patient’s sexual partner is pregnant or could be pregnant, the patient must avoid exposing her to his semen (e.g. by using a condom) or discontinue treatment with finasteride. If a pregnant woman comes into contact with Finasteride Pensa, medical advice must be sought immediately.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist.
Breastfeeding
It is not known whether finasteride is excreted in human breast milk; however, women must not take Finasteride Pensa.
Driving and using machines
There is no information suggesting that Finasteride Pensa affects the ability to drive or operate machinery.
Finasteride Pensa contains lactose
Finasteride Pensa contains lactose, a milk sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him 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 exactly as prescribed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose is one tablet per day (equivalent to 5 mg of finasteride).
The film-coated tablets may be taken either on an empty stomach or with food. The
film-coated tablets must be swallowed whole and must not be split or crushed.
Your doctor may prescribe Finasteride Pensa together with another medicine, doxazosin,
to improve the management of benign prostatic hyperplasia.
Although improvements may become apparent within a short time, treatment should be continued
for at least six months to assess whether a favourable response has been achieved.
Your doctor will advise you on how long you should continue taking Finasteride Pensa. Do not
stop treatment prematurely, as symptoms may return.

Patients with impaired hepatic function
There is no experience with the use of finasteride in patients with impaired liver function
(see also section "Warnings and Precautions").

Patients with impaired renal function
No dose adjustment is required. The use of Finasteride Pensa in patients undergoing haemodialysis has not been studied.

Elderly patients
No dose adjustment is required.

If you feel that the effects of Finasteride Pensa are too strong or too weak,
consult your doctor or pharmacist.

If you take more Finasteride Pensa than you should
If you have taken more tablets than prescribed, or if someone else has taken your tablets,
contact the emergency department of your nearest hospital immediately. Bring along any remaining tablets or the empty medicine pack to allow identification of the ingested drug.

If you forget to take Finasteride Pensa
If you forget to take a dose of Finasteride Pensa, you may take it as soon as you remember, unless it is almost time for your next dose. In this case, simply continue with your regular dosing schedule. Do not take a double dose to make up for the missed dose.

If you stop taking Finasteride Pensa
Do not stop taking Finasteride Pensa unless your doctor tells you to do so.
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.
The following frequency categories have been used to assess side effects:
Very common – affects more than 1 in 10 people
Common – affects more than 1 in 100 but less than 1 in 10 people
Uncommon – affects less than 1 in 100 but more than 1 in 1,000 people
Rare – affects less than 1 in 1,000 but more than 1 in 10,000 people
Very rare – affects less than 1 in 10,000 people, including isolated reports

The most common side effects are impotence and decreased sexual desire. 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)

• decreased semen volume
• impotence
• decreased sexual desire

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 from the available data)

• irregular heartbeat
• hypersensitivity reactions such as itching, hives, and swelling (angioedema) in 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 stopping finasteride
• male breast cancer
• depression
• persistent reduction in sexual desire after stopping treatment
• persistent ejaculation problems after stopping treatment
• anxiety

Diagnostic tests:
If you need to have blood tests to determine your 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 enlargement in males, or nipple discharge, as these may be signs of a serious condition such as male 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 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 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 via wastewater 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 may potentially be pregnant must not handle finasteride tablets, especially if they are crushed or broken, due to the possibility of absorption of finasteride and the consequent potential risk to a male fetus (see section Pregnancy and breastfeeding).

6. Package contents and other information

What Finasteride Pensa contains

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

Description of the appearance of Finasteride Pensa and package contents
Film-coated tablet.
Blue, round, film-coated tablets, marked with 'H' 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 Authorization Holder and Manufacturer
Marketing Authorization 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