Package leaflet: Information for the patient

Finastid 5 mg film-coated tablets

Finasteride
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 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Finastid is and what it is used for

Finastid contains the active substance finasteride and belongs to a group of medicines known as 5α-reductase inhibitors. These medicines work by reducing the size of the prostate gland in men.
Finastid is indicated for the treatment and management of benign enlargement of the prostate (benign prostatic hyperplasia). It acts by reducing the size of the enlarged prostate gland in men, improving urinary flow and symptoms caused by benign prostatic hyperplasia.
Finastid is intended for use in male patients only.

2. What you need to know before taking Finastid

Do not take Finastid if:

you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
you are a woman;
you are a child;
you are a pregnant woman or potentially could be pregnant (see section “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Finastid.
Although benign prostatic hyperplasia is not a malignant tumour, nor can it become one, both conditions may coexist. Before starting treatment with Finastid and periodically during treatment, your doctor will likely perform some simple tests to rule out the possibility of prostate cancer. These tests include digital rectal examination and a blood test to determine the level of prostate-specific antigen (PSA).
Exercise particular caution with Finastid:
if you have difficulty completely emptying your bladder or have a markedly reduced urinary flow. In such cases, your doctor should carefully examine you before starting treatment with Finastid;
if you need to undergo a blood test called “PSA”. Make sure to inform your doctor before having the test, as Finastid may affect test results;
if you notice lumps, pain, swelling of the breast or nipple discharge. Promptly report any changes in breast tissue to your doctor, as these may be signs of a serious condition, such as breast cancer;
if your sexual partner is or could be pregnant, you must avoid exposing her to finasteride. Avoid exposing her to your semen, as it may contain small amounts of finasteride (see section “Pregnancy, breastfeeding and fertility”).
Mood changes, such as depressed mood, depression and, less frequently, suicidal thoughts, have been reported in patients treated with Finastid. If you experience any of these symptoms, contact your doctor as soon as possible for further advice.

Children and adolescents
Finastid is not indicated for use in children.

Other medicines and Finastid
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No significant interactions with other medicines have been observed.

Pregnancy, breastfeeding and fertility
Finastid is intended for use in men only and must not be taken by women (see section “Do not take Finastid if”).
Pregnant women or women who suspect they might be pregnant must not come into contact with crushed or broken Finastid tablets, as the potential absorption of finasteride by a woman carrying a male fetus may interfere with the normal development of the baby's sex organs.
Intact Finastid tablets have a coating that prevents contact with the active substance during normal handling, provided the tablets have not been crushed or broken.
If your sexual partner is or could be pregnant, avoid exposing her to your semen, as it may contain a small amount of the medicine.

Driving and using machines
There are no data suggesting that Finastid may impair the ability to drive or use machinery.

Finastid contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Finastid

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is one 5 mg film-coated tablet per day. It can be taken with or
without food.
Although improvement is often observed within a short time, treatment may need to be continued for at least 6 months.
Your doctor may prescribe Finastid together with another medicine containing doxazosin to improve the management of benign prostatic hyperplasia.
Use in the elderly
Although elimination of finasteride from the body may be slightly reduced in elderly patients over 70 years of age, no dose adjustment is required.
Use in children and adolescents
Finastid is not indicated for use in children.
If you take more Finastid than you should
If you have taken more Finastid tablets than prescribed, contact your doctor immediately or go to the nearest hospital.
There are no specific recommended treatments in case of finasteride overdose.
If you forget to take Finastid
Do not take a double dose to make up for the forgotten dose.
If you stop taking Finastid
If you have any questions about using 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 impotence (inability to achieve an erection) and reduced sexual desire. These side effects occur at the beginning of treatment and resolve during treatment in most patients.
The following side effects have been reported with the use of finasteride:
Common (may affect up to 1 in 10 people)

decrease in the amount of semen released during sexual intercourse (reduced ejaculate volume);
impotence (inability to achieve an erection);
reduced sexual desire.

Uncommon (may affect up to 1 in 100 people)

skin rash;
ejaculation disorders, breast tenderness, breast enlargement.

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

palpitations (fast and/or irregular heartbeat);
itching, hives;
allergic reactions, such as swelling of the lips and face;
increased liver enzymes;
testicular pain, impotence continuing after discontinuation of treatment, male infertility and/or poor semen quality (which may normalize or improve after stopping treatment), male breast cancer (see section “Warnings and precautions”);
depression;
reduced sexual desire, inability to achieve an erection, ejaculation problems, continuing after discontinuation of treatment.

Diagnostic tests: the use of finasteride may alter blood test results used to determine PSA levels.
When finasteride and doxazosin are used together, an increased frequency of ejaculation disorders has been observed compared to either medicine used alone.
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 http://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 Finastid

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
This medicine does not require any 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 Finastid contains

The active substance is finasteride. One film-coated tablet contains 5 mg of finasteride.
The other ingredients are: monohydrate lactose, pregelatinized starch, sodium carboxymethylstarch, yellow iron oxide, sodium dioctyl sulfosuccinate, microcrystalline cellulose, magnesium stearate, hypromellose, hydroxypropylcellulose, titanium dioxide, talc, E132 indigotine on hydrated aluminium oxide.

Description of the appearance of Finastid and contents of the pack
Finastid film-coated tablets are contained in opaque PVC/PE/PVDC and aluminium blisters.
Available in packs of 15 and 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Neopharmed Gentili S.r.l.
Via San Giuseppe Cottolengo 15,
20143 Milan, Italy

Manufacturer
Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore (Piacenza), Italy