Finasteride Alter

Patient Information Leaflet

FINASTERIDE ALTER 5 mg film-coated tablets

Finasteride
Equivalent medicine
Please read all of 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 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, talk to 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 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

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

FINASTERIDE ALTER contains the active substance finasteride, which belongs to a group of medicines called 5-alpha-reductase inhibitors. This medicine works by reducing the size of the prostate gland in men when it is enlarged, a condition known as benign prostatic hyperplasia (non-cancerous enlargement). Thus, FINASTERIDE ALTER reduces prostate enlargement and improves urine flow, reducing the risk of potential surgical intervention 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 to 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 reduced urine flow and/or if your bladder does not empty completely after urination (urinary retention). In such cases, take this medicine under direct medical supervision, as your doctor may assess the need for surgical intervention.
• you notice any symptoms affecting the breast, such as hardness, pain, enlargement (gynecomastia), or discharge from the nipple, as these may be signs of male breast cancer. In this case, inform your doctor immediately.
• your partner is or could potentially be pregnant, you must avoid exposing her to crushed or broken finasteride tablets and to your semen. Indeed, semen may contain a small amount of the medicine (see section "Pregnancy and breastfeeding"). Before starting treatment with this medicine and periodically thereafter, specific tests (such as digital rectal examinations) are recommended to assess the presence of prostate cancer. Treatment with this medicine causes a decrease in levels of a substance known as Prostate-Specific Antigen (PSA). This reduction should be taken into account by your doctor when measuring PSA levels, as they may remain altered for 6 months or longer. This precaution is important for the timely detection of 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
Inform 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 intended for use in men only.
If your partner is or could potentially be pregnant, you must avoid exposing her to your semen. Indeed, semen may contain a small amount of the medicine.
Pregnant women or women who may become pregnant must not handle crushed or broken Finasteride Alter tablets. If this medicine is absorbed through the skin or taken orally by a woman carrying a male fetus, the baby may be born with congenital malformations of the genital organs.
The tablets are film-coated; this prevents contact with the active substance unless the tablets are crushed or broken.

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

Driving and operating machinery
There are no data available to determine whether this medicine affects 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, consult him before taking this medicine.

3. How to take Finasteride Alter

Always use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet per day.
Take the tablet regardless of meals.
Your doctor may consider it necessary to prescribe Finasteride Alter together with another medicine, doxazosin, to achieve better control of your condition.
Your health condition may improve even after short periods of treatment. However, treatment periods of at least six months are necessary to determine whether this medicine is effective in controlling the disease.
If you take more Finasteride Alter than you should
In case of accidental ingestion/overdose 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 forgotten 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
side 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)

• reduced amount of semen;
• sexual disorders (impotence, decreased libido).

Uncommon (may affect up to 1 in 100 people)

• skin irritation (rash);
• ejaculation disorders;
• breast enlargement and tenderness.

Not known (frequency cannot be estimated from the available data)

• sensation of increased heartbeat (palpitations);
• skin disorders (pruritus and urticaria);
• allergic reactions, including swelling around the lips and eyes (angioedema);
• alteration of liver function (increase in 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 quality of seminal fluid.

In clinical studies and/or post-marketing use, the following adverse reactions have been reported: breast cancer in men (see section “Warnings and precautions”).
Laboratory tests
When measuring PSA levels, it should be borne in mind that PSA levels are reduced during treatment with this medicine (see section “Warnings and precautions”).
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.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 which is stated on the packaging after "Exp.".
The expiry date refers to the last day of that month. The expiry date applies to the product in its original,
undamaged packaging and properly stored.
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 ALTER contains

• The active substance is finasteride. Each tablet contains 5 mg of finasteride.
• The other components are monohydrate lactose, microcrystalline cellulose, pregelatinized starch, sodium carboxymethylamide A, polysorbate 80, magnesium stearate, and SeleCoat™ AQ-01440 blue (hypromellose, glycerol triacetate, titanium dioxide, indigo carmine on aluminum hydrate).

Description of the appearance of FINASTERIDE ALTER and package contents
Pack containing 15 film-coated tablets.
Marketing Authorization Holder and Manufacturer
Laboratori Alter S.r.l.
Via Egadi, 7
20144 Milan
Manufacturer
Laboratorios Alter, S.A.
Mateo Inurria, 30
28036 Madrid
Spain