Patient Information Leaflet

Finasteride Sandoz 5 mg Film-coated Tablets

Finasteride
Please read all of 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 they have the same symptoms as you, because 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:

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

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

Finasteride Sandoz contains the active substance finasteride.
Finasteride Sandoz is intended exclusively for use in men and must not be taken by women or children.
Finasteride Sandoz belongs to a group of medicines called 5-alpha-reductase inhibitors, and is used in men to treat and control:

benign prostatic hyperplasia, which is a non-cancerous enlargement of the prostate gland.

Benign prostatic hyperplasia is a benign enlargement of the prostate and is common in men over 50 years of age. Since the prostate is located close to the bladder and ureters, an enlarged prostate can cause problems with urination (for example, frequent urge to urinate, especially at night, reduced urine flow, feeling of incomplete bladder emptying).
Finasteride Sandoz reduces the size of the prostate gland, improving urinary flow and other symptoms of prostate enlargement. Finasteride Sandoz reduces the risk of sudden inability to urinate, a condition that may require surgical intervention.
In some cases, prostate enlargement can lead to serious medical problems, so it is important to consult your doctor regularly.

2. What you should know before taking Finasteride Sandoz

Do not take Finasteride Sandoz
if

you are allergic to finasteride or to any of the other ingredients of this medicine (listed in section 6)
you are a woman (since this medicine is intended only for men; see Pregnancy, breastfeeding and fertility)
you are an adolescent or child under 18 years of age

If you are unsure, consult your doctor or pharmacist.
With regard to medical treatment for an enlarged prostate, it is recommended to consult a urologist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Finasteride Sandoz.
Inform your doctor if any of the following apply to you:

If you have difficulty emptying your bladder or suffer from markedly reduced urinary flow. Your doctor will examine you before starting treatment with Finasteride Sandoz to rule out other possible urinary tract obstructions.
If you need to have a blood test for “PSA”, a protein produced by the prostate gland. Inform your doctor or nurse that you are taking Finasteride Sandoz, as this medicine may affect test results.
If you have reduced liver function.
If you have been diagnosed with a high volume of residual urine (the amount of urine remaining after bladder emptying). Your doctor should perform more frequent and careful monitoring to detect possible complications such as urinary retention or hesitancy at an early stage.
If you notice changes in breast tissue such as lumps, pain, breast enlargement, or nipple discharge. In this case, inform your doctor immediately.
Infertility has been reported in men who have taken finasteride for a long time. Normalization or improvement in sperm quality has been reported after discontinuation of finasteride. Long-term clinical studies on the effect of finasteride on male fertility have not been conducted.

If you are a woman administering Finasteride Sandoz to a male patient
Pregnant women or women of childbearing potential must not come into contact with Finasteride Sandoz, as the active substance could be absorbed through the skin and cause malformations of the external genital organs in a male fetus. The film-coated tablets have a coating that prevents contact with the active substance, thus allowing normal handling as long as the tablets remain intact. (See section “Pregnancy, breastfeeding and fertility”).
Various tests may be required before and during treatment with Finasteride Sandoz. Please undergo these tests as prescribed by your doctor.
Mood changes and depression
Mood changes such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with Finasteride Sandoz. If you experience any of these symptoms, contact your doctor as soon as possible for further advice.
Children and adolescents
Finasteride Sandoz is not intended for use in children and adolescents. The safety and efficacy in children and adolescents have not been established.
Other medicines and Finasteride Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Finasteride Sandoz is not known to affect or be affected by any other medicines.
Finasteride Sandoz with food, drinks and alcohol
Taking Finasteride Sandoz with food or drinks does not affect its action. The tablets should be swallowed with sufficient liquid.
Pregnancy, breastfeeding and fertility
Pregnancy
Finasteride Sandoz must not be used by women.

If your partner is or may be pregnant:

Semen may contain traces of Finasteride Sandoz. Therefore, you must avoid your semen coming into contact with your partner, for example by using a condom. If a pregnant woman comes into contact with the active substance of Finasteride Sandoz, she must consult a doctor.

Pregnant women or women of childbearing potential must not handle crushed or broken film-coated tablets of Finasteride Sandoz. If the active substance of Finasteride Sandoz is ingested or absorbed through the skin by a pregnant woman, a male fetus may be born with malformations of the reproductive organs. The tablets are film-coated specifically to prevent contact with Finasteride Sandoz. The film-coated tablets of Finasteride Sandoz are coated with a film that prevents contact with the active substance during normal handling.

If you have any questions, consult your doctor.
Breastfeeding
It is not known whether the active substance of Finasteride Sandoz is excreted in human milk.
Fertility
Since the launch of other finasteride-containing products, cases of infertility in men and women and poor sperm quality in men have been reported. In some of these reports, other pre-existing risk factors may have contributed. Normalization or improvement in sperm quality has been reported after discontinuation of finasteride.
Driving and using machines
No studies have been conducted on the effects on the ability to drive or use machinery.
Finasteride Sandoz contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. essentially ‘sodium-free’.

3. How to take Finasteride Sandoz

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 once daily

Route of administration
Swallow the film-coated tablet whole with a glass of water. The tablet may be taken with or without food, but it should always be taken at the same time each day.
Duration of treatment
The duration of treatment will be determined by your doctor.
Although improvement is often observed after a short time, treatment should be continued for at least 6 months.
In patients with impaired renal function and in elderly patients, the recommended dose may be maintained.
There are insufficient data available for patients with impaired hepatic function.
If you take more Finasteride Sandoz than you should
Contact your doctor or pharmacist immediately. To date, an increased incidence of adverse effects following overdose has not been reported.
If you forget to take Finasteride Sandoz
Do not take a double dose to make up for the forgotten dose. Simply take the next dose at the usual time.
If you stop taking Finasteride Sandoz
Do not change or stop treatment unless instructed by your doctor, as doing so may cause serious harm and reduce the effectiveness of therapy.
If you have any doubts about how to use 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 the inability to achieve an erection and a reduction in sexual desire. These side effects occur early during treatment and resolve in most patients with continued treatment.
You must immediately inform your doctor of any changes in breast tissue, such as lumps, pain, breast enlargement, or nipple discharge, as these may be signs of a serious disorder, such as breast cancer.

Allergic reactions
If you experience an allergic reaction, stop treatment immediately and contact your doctor right away. Symptoms may include:

skin rash, itching, or lumps under the skin (urticaria)
swelling of the lips, tongue, throat, and face; difficulty swallowing and breathing (angioedema). The frequency is unknown and cannot be determined based on available data.

Side effects may occur with the frequencies described below
Common (may affect up to 1 in 10 people):

inability to achieve an erection
reduced sexual desire
reduced volume of semen produced

Uncommon (may affect up to 1 in 100 people):

breast tenderness and/or enlargement
breast discharge
ejaculation difficulties
depression
skin rash
erection difficulties
breast lumps, which in some cases require surgical removal

Not known (frequency cannot be determined from available data):

hypersensitivity reactions, such as skin rash and itching
palpitations (awareness of your heartbeat)
increased liver enzymes
testicular pain
inability to achieve an erection, persisting after discontinuation of treatment
reduced sexual desire, persisting after discontinuation of treatment
persistent ejaculation problems after treatment discontinuation
male infertility and/or poor semen quality after treatment discontinuation—normalization or improvement in semen quality has been reported
anxiety
blood in the semen
breast cancer in men
suicidal thoughts

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact 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 Sandoz

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 blister and the carton after the word "Exp.". The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Finasteride Sandoz contains

The active substance is finasteride. Each film-coated tablet contains 5 mg of finasteride.
The other components are sodium docusate, hypromellose, indigo carmine lake (E 132), monohydrate lactose, magnesium stearate, microcrystalline cellulose, povidone K30, propylene glycol, sodium carboxymethylamido (type A), talc, titanium dioxide (E 171).

Description of the appearance of Finasteride Sandoz and package contents
The film-coated tablets are round, blue, biconvex, and smooth on both sides.
The film-coated tablets are packaged in PVC/AL blisters and placed in a carton box.
Pack sizes:
10, 15, 30, 50, 60, 100, 120 film-coated tablets in standard blisters
14, 28 and 56 film-coated tablets in weekly blisters
50 film-coated tablets (50 x 1) in single-dose blisters
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milano
Italy

Manufacturer
SALUTAS Pharma GmbH
Otto-von-Guericke Allee, 1
39179 Barleben (Germany)
LEK S.A.
Ul. Domaniewska 50 C
02-672 Warsaw (Poland)

This medicinal product is authorized in the European Economic Area countries under the following names:
AT Finasterid Sandoz 5 mg – Filmtabletten
DE Finasterid - 1 A Pharma 5 mg Filmtabletten
IT Finasteride Sandoz 5 mg compresse rivestite con film