Package leaflet: Information for the user

Finasteride SaneXcel, 5 mg, film-coated tablets
Finasteridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What Finasteride SaneXcel is and what it is used for
Important information before taking Finasteride SaneXcel
How to take Finasteride SaneXcel
Possible side effects
How to store Finasteride SaneXcel
Contents of the pack and other information

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

Finasteride SaneXcel is a film-coated tablet containing 5 mg of finasteride as the active substance.
Your doctor has prescribed Finasteride SaneXcel because you have a condition called benign
prostatic hyperplasia (BPH). BPH is a non-cancerous enlargement of the prostate gland that commonly
occurs in men over the age of 50. The prostate gland (located near the urinary bladder) has enlarged,
causing difficulties with urination. Symptoms may include the need to urinate frequently, especially at
night, sudden urge to urinate, difficulty starting urination, weak or interrupted urine stream, or the
feeling that the bladder cannot be completely emptied.
In some men, BPH may lead to serious complications such as urinary tract infections, sudden inability
to urinate (acute urinary retention), or the need for surgical intervention. For this reason, men with BPH
symptoms should consult a doctor.
Finasteride SaneXcel belongs to a group of medicines known as 5-α-reductase inhibitors. It works by
reducing the size of the enlarged prostate gland in men. Finasteride SaneXcel may reduce the risk of
sudden inability to urinate (known as acute urinary retention) and the need for surgery.
BPH develops gradually over time. Some patients may experience early symptom improvement, but
treatment with Finasteride SaneXcel for at least 6 months may be necessary to determine whether
symptoms have improved.

2. Important information before using Finasteride SaneXcel

When not to use Finasteride SaneXcel

If the patient is allergic to finasteride or any of the other ingredients of this medicine (listed in section 6).
Finasteride SaneXcel must not be used by pregnant women or women of childbearing age. They should also not handle crushed or broken Finasteride SaneXcel tablets (see "Pregnancy and breastfeeding").
Finasteride SaneXcel is prescribed exclusively for men. Women and children must not take Finasteride SaneXcel.

Inform your doctor about all current or past medical conditions and
about any allergies.
Warnings and precautions
Finasteride SaneXcel is intended solely for the treatment of BPH in men.
Finasteride SaneXcel may affect a blood test called prostate-specific antigen (PSA). If undergoing a PSA test, inform your doctor that you are taking Finasteride SaneXcel.
Mood changes and depression
Mood changes such as low mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with Finasteride SaneXcel. If any of these symptoms occur, consult your doctor as soon as possible to obtain further medical advice.
Finasteride SaneXcel and other medicines
Finasteride SaneXcel generally does not affect the action of other medicines.
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Finasteride SaneXcel with food and drink
Finasteride SaneXcel may be taken with or without food.
Pregnancy and breastfeeding
Pregnant women or women who may become pregnant must not handle crushed or broken Finasteride SaneXcel tablets due to the risk of absorption of finasteride and the potential risk to a male fetus.
It is not known whether finasteride passes into human breast milk.
Finasteride tablets are coated and prevent contact with the active substance during normal handling, provided the tablets are not broken or crushed.
If the active substance of Finasteride SaneXcel is absorbed into the body after oral administration or through skin contact by a woman expecting a male child, it may cause developmental abnormalities of the genital organs in the child. If a pregnant woman comes into contact with the active substance contained in Finasteride SaneXcel, consult a doctor.
If the patient's sexual partner is pregnant or of childbearing age, she should avoid contact with semen, which may contain traces of the medicine.
Driving and operating machinery
There are no data indicating that Finasteride SaneXcel affects the ability to drive or operate machinery.
Finasteride SaneXcel contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Finasteride SaneXcel contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use the medicine Finasteride SaneXcel

This medicine should always be used as directed by a physician. If in doubt, consult
your doctor or pharmacist.
The recommended dose is one tablet per day.
Taking more than the recommended dose of Finasteride SaneXcel
If a patient takes too many tablets, they should contact their doctor immediately.
Missing a dose of Finasteride SaneXcel
Finasteride SaneXcel should be taken as directed by the physician. Do not take a double dose to make up for a missed dose. Take the next tablet at the usual scheduled time.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been reported with the use of finasteride:

reduced amount of semen released during ejaculation, impotence (inability to achieve erection), problems with ejaculation
decreased libido
palpitations
skin rash, itching and urticaria, swelling of the lips and face
increased liver enzyme activity
swelling or tenderness of the breasts
testicular pain
depression
decreased libido (sex drive) persisting after discontinuation of treatment
erectile dysfunction persisting after discontinuation of treatment
male infertility and (or) poor semen quality. Improvement in semen quality has been observed after stopping treatment.
anxiety
suicidal thoughts

Any changes in the breasts, such as lumps, pain, enlargement or nipple discharge, should be reported immediately to a doctor, as these may be symptoms of a serious condition, such as breast cancer.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Finasteride SaneXcel

Keep this medicine out of the sight and reach of children.
Do not store at temperatures above 30ºC.
Do not use this medicine after the expiry date stated on the cardboard package after:
EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Finasteride SaneXcel contains

The active substance is finasteride. Each coated tablet contains 5 mg of finasteride.
The other components are:
Core: lactose monohydrate, microcrystalline cellulose (E 460), sodium carboxymethyl starch (Type A), pregelatinized starch (maize), sodium docusate, iron(III) oxide yellow (E 172), magnesium stearate.
Coating: hypromellose, titanium dioxide (E 171), macrogol 400, indigo carmine (E 132).

What Finasteride SaneXcel looks like and contents of the pack
Coated tablets.
Finasteride SaneXcel 5 mg coated tablets are blue, round, biconvex tablets with a diameter of 8.0 mm.
Finasteride SaneXcel is available in 5 mg tablets in packs containing 100 tablets.

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder:
J.J. Bishop Health a.s.
Rybná 682/14, Staré Město
110 00 Prague 1
Czech Republic
e-mail: [email protected]

Importer:
Tecnimede-Sociedade Técnico-Medicinal S.A.
Quinta da Cerca, Caixaria
2565-187 Dois Portos, Lisbon
Portugal

This medicinal product is authorised in the following European Economic Area countries under the following names:
Bulgaria: Финастерид SaneXcel 5 mg филмирани таблетки
Czech Republic: Finasterid SaneXcel
Poland: Finasteride SaneXcel
Romania: Finasteridă SaneXcel 5mg, comprimate filmate
Slovakia: Finasterid SaneXcel
Portugal: Finasterida JJ Bishop