Apo-fina

Package leaflet: Information for the patient

Apo-Fina, 5 mg, film-coated tablets
Finasteridum
Read the entire leaflet before using the medicine.

• Keep this leaflet for future reference.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Apo-Fina is and what it is used for
2. Important information before taking Apo-Fina
3. How to take Apo-Fina
4. Possible side effects
5. How to store Apo-Fina
6. Contents of the pack and other information

1. What Apo-Fina is and what it is used for

Apo-Fina belongs to a group of medicines called 5-alpha reductase inhibitors. These medicines reduce the size of the prostate gland.
Apo-Fina is used in the treatment and management of benign prostatic hyperplasia (BPH). Apo-Fina reduces the size of the enlarged prostate gland, improves urine flow, relieves BPH-related symptoms, and reduces the risk of acute urinary retention and the need for surgical treatment.

2. Important information before using Apo-Fina

When not to use Apo-Fina:

• if the patient is allergic to finasteride or any of the other ingredients of this medicine (listed in section 6);
• in women (see also section “Pregnancy and breastfeeding”);
• in children.

Warnings and precautions
Before starting treatment with Apo-Fina, discuss with your doctor or pharmacist if any of the following apply to you:

• if the patient has a large volume of residual urine and/or significantly reduced urine flow. In such cases, the patient should be closely monitored for urinary tract obstruction;

• if the patient has impaired liver function. In these patients, serum finasteride concentrations may be increased (see section “Dosage”);

• if the patient’s partner is pregnant or planning pregnancy. During treatment with Apo-Fina, condoms or other mechanical contraceptive methods should be used. This is because semen may contain small amounts of finasteride, which may interfere with the normal development of genital organs in the child;

• if the patient is planning to have a blood test for prostate-specific antigen (PSA). Finasteride may affect the results of serum PSA testing.

Any changes in breast tissue such as lumps, pain, breast enlargement, or nipple discharge should be reported to a doctor immediately, as these may be symptoms of a serious condition, such as breast cancer.
Before starting treatment with finasteride and during treatment, the patient should undergo physical examination (including digital rectal examination) and have serum prostate-specific antigen (PSA) levels measured.
Consult your doctor if any of the above conditions currently apply to you or have applied in the past.

Mood changes and depression
Mood changes such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients taking finasteride 5 mg. If any of these symptoms occur, contact your doctor as soon as possible for advice.

Apo-Fina with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Finasteride generally does not affect the action of other medicines.

Apo-Fina with food and drink
Apo-Fina can be taken with or without food.

Pregnancy, breastfeeding and effects on fertility
Apo-Fina is intended for use in men only.
Pregnant women or women who may become pregnant should not handle crushed or broken Apo-Fina tablets. If finasteride is absorbed through the skin or ingested orally by a pregnant woman, it may cause congenital malformations of the external genitalia in male fetuses. The coating of Apo-Fina film-coated tablets protects against contact with finasteride, provided the tablets are not crushed or broken.
If the patient’s sexual partner is pregnant or may become pregnant, the patient should avoid exposing her to semen, which may contain small amounts of finasteride.

Driving and operating machinery
There are no data indicating that Apo-Fina affects the ability to drive or operate machinery.

Apo-Fina contains lactose monohydrate
If the patient has been previously diagnosed with intolerance to certain sugars, consult a doctor before using Apo-Fina.

Apo-Fina contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially “sodium-free”.

3. How to use Apo-Fina

Apo-Fina should always be used as directed by a doctor or pharmacist. If in doubt,
contact your doctor or pharmacist again.
The usual dose is one coated tablet of Apo-Fina (5 mg of finasteride) once daily.
Apo-Fina coated tablets may be taken on an empty stomach or with food. The tablets
should be swallowed whole and must not be split or crushed.
Even if clinical improvement occurs quickly, Apo-Fina should be taken for at least
6 months so that the doctor can properly assess its effectiveness.
The duration of treatment with Apo-Fina is determined by the doctor. Do not discontinue
treatment prematurely, as prostate-related symptoms may recur.
Liver function disorders
There is no data available on the use of Apo-Fina in patients with liver function disorders
(see also section "When to be cautious with Apo-Fina").
Kidney function disorders
Dose adjustment is not necessary. There is no data on the use of Apo-Fina in patients
undergoing hemodialysis.
Elderly patients
Dose adjustment is not necessary.
If you feel that the effect of Apo-Fina is too strong or too weak, contact your
doctor or pharmacist.
Taking more Apo-Fina than recommended
If a patient has taken more than the recommended dose of Apo-Fina or if a child has
accidentally ingested the medicine, inform a doctor or pharmacist immediately.
Missed dose of Apo-Fina
If a patient forgets to take Apo-Fina, they should take it as soon as possible unless the
next dose is due soon. In that case, the patient should continue taking the medicine
according to the prescribed dosing schedule. Do not take a double dose to make up for
a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Apo-Fina can cause adverse reactions, although not everyone experiences them. The following adverse reactions may occur after using Apo-Fina:
Common adverse reactions (less than 1 in 10 patients):

• inability to achieve an erection (impotence)
• reduced sexual desire
• decreased semen volume during ejaculation. Reduced semen volume does not affect normal sexual function.

The above adverse reactions may resolve after some time of continued Apo-Fina use. If not, these symptoms usually resolve after discontinuation of Apo-Fina.
Uncommon adverse reactions (less than 1 in 100 patients):

• enlargement or tenderness of the breasts
• skin rash, itching, or subcutaneous pimples
• ejaculation disorders.

Unknown frequency (cannot be estimated from available data):

• allergic reactions such as swelling of the lips and face
• palpitations
• increased liver enzyme activity
• testicular pain
• depression
• reduced sexual desire, which may persist after discontinuation of Apo-Fina
• male infertility and/or poor semen quality
• anxiety
• suicidal thoughts.

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. 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, PL-02 222 Warsaw, Tel: +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 or the representative of the marketing authorization holder in Poland.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Apo-Fina

Keep this medicine out of sight and reach of children.
No special storage instructions apply.
Do not use Apo-Fina after the expiry date stated on the cardboard box and
blister pack following: Expiry date (EXP). The expiry date refers to the last day of the specified month.
The batch number follows the abbreviation "Lot".
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist what to do with medicines no longer required. This will help
protect the environment.

6. Contents of the pack and other information

What Apo-Fina contains
The active substance is finasteride.
Each coated tablet contains 5 mg of finasteride.
The other ingredients are:
Tablet core: monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch,
glyceryl macrogol ricinoleate, sodium carboxymethyl starch (type A), magnesium stearate (E 572).
Coating: hypromellose, titanium dioxide (E 171), indigo carmine (E 132), shellac, polyethylene glycol 6000.

What Apo-Fina looks like and contents of the pack
Blue, round coated tablets, 7 mm in diameter, with the imprint “F5” on one side.
Apo-Fina is available in packs containing 30 or 90 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lok.27
01-909 Warszawa
Poland

Manufacturer/Importer:
Actavis Group PTC
Reykjavíkurvegur 76-78
IS-220 Hafnarfjörður
Iceland

Zentiva, K.S.
U Kabelovny 130,
Dolní Měcholupy,
Prague 10, 102 37,
Czech Republic