Apo-fina

Package Leaflet: Information for the Patient

Apo-Fina, 5 mg, film-coated tablets
Finasteride

Read the package leaflet carefully before taking the medicine.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

Apo-Fina belongs to a group of medicines called 5-alpha reductase inhibitors. The action of these medicines reduces the size of the prostate gland.
Apo-Fina is used to treat and control benign prostatic hyperplasia (BPH). Apo-Fina reduces the size of an enlarged prostate gland, improves urine flow, relieves symptoms caused by BPH, reduces the risk of acute urinary retention, and the need for surgical treatment.

2. Important information before taking Apo-Fina

When not to take Apo-Fina:

• if you are 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 taking Apo-Fina, you should discuss it with your doctor or pharmacist if any of the following points apply to you:

• if you have a large residual urine volume and/or significantly reduced urine flow. In such cases, you should be closely monitored for urinary tract narrowing;
• if you have liver function disorders. In these patients, the finasteride concentration in the blood may be increased (see section "Dosage");
• if your partner is pregnant or plans to become pregnant. During treatment with Apo-Fina, you should use condoms or other mechanical contraceptive methods. This is because semen may contain small amounts of finasteride, which may interfere with the normal development of the genital organs in the child;

this is because finasteride may be absorbed through the skin or taken orally, which can cause congenital anomalies of the external genitalia in male fetuses.

• if you plan to have a prostate-specific antigen (PSA) test. Finasteride may interfere with the results of the PSA test.

You should immediately inform your doctor about any changes in breast tissue, such as lumps, pain, enlargement of the breasts, or discharge from the nipple, as these may be symptoms of a serious disease, such as breast cancer.
Before and during treatment with finasteride, you should be examined (including a rectal examination) and have your prostate-specific antigen (PSA) level measured in your blood.
You should consult your doctor if the above comments apply to you now or have applied in the past.
Mood changes and depression
Patients taking finasteride at a dose of 5 mg have reported mood changes, such as depressive mood, depression, and, less often, suicidal thoughts. If any of these symptoms occur, you should contact your doctor as soon as possible to seek advice.

Apo-Fina and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Finasteride usually 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 fertility

Apo-Fina is used only in men.
Pregnant women or women who may become pregnant should not handle crushed or broken Apo-Fina tablets. If a pregnant woman absorbs finasteride through the skin or takes it orally, it may cause congenital anomalies of the external genitalia in male fetuses.
The coating of the Apo-Fina film-coated tablets protects against contact with finasteride, provided that the tablets are not crushed or broken.
If your sexual partner is pregnant or may become pregnant, you should not expose her to semen that may contain small amounts of finasteride.

Driving and using machines

There are no data indicating that Apo-Fina affects the ability to drive and use machines.

Apo-Fina contains lactose monohydrate

If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking 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 take Apo-Fina

Apo-Fina should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.
The usual dose is one Apo-Fina tablet (5 mg of finasteride) once a day.
The Apo-Fina film-coated tablets can be taken with or without food. The tablets should be swallowed whole, do not divide or crush them.
Even if you quickly notice an improvement, you should take Apo-Fina for at least 6 months, so your doctor can properly assess its effectiveness.
The treatment duration with Apo-Fina is determined by your doctor. Do not stop taking the medicine too early, as prostate symptoms may return.

Liver function disorders

There are no data on the use of Apo-Fina in patients with liver function disorders (see also section "When to be careful with Apo-Fina").

Kidney function disorders

No dose adjustment is necessary. There are no data on the use of Apo-Fina in patients undergoing hemodialysis.

Elderly patients

No dose adjustment is necessary.
If you feel that the effect of Apo-Fina is too strong or too weak, you should consult your doctor or pharmacist.

Overdose of Apo-Fina

If you have taken more Apo-Fina than you should, or if a child has taken the medicine by mistake, you should immediately tell your doctor or pharmacist.

Missed dose of Apo-Fina

If you forget to take Apo-Fina, you should take it as soon as possible, unless it is almost time for your next dose. In this case, you should continue taking the medicine as prescribed. Do not take a double dose to make up for a missed dose.
If you have any further questions about taking Apo-Fina, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Apo-Fina can cause side effects, although not everybody gets them.
After taking Apo-Fina, the following side effects may occur:

Common side effects(less than 1 in 10 patients):

• erectile dysfunction (impotence)
• decreased libido
• decreased semen volume during ejaculation. Decreased semen volume does not affect normal sexual function.

These side effects may disappear after a while of taking Apo-Fina. If this does not happen, these symptoms usually disappear after stopping Apo-Fina.
Uncommon side effects(less than 1 in 100 patients):

• breast tenderness or enlargement
• skin rash, itching, or lumps under the skin
• ejaculation disorders

Unknown frequency(cannot be estimated from available data):

• allergic reactions, such as lip or face swelling
• palpitations
• increased liver enzyme activity
• testicular pain
• depression
• decreased libido, which may persist after stopping the medicine
• male infertility and/or poor semen quality
• anxiety

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Urzad Rejestracji Produktow Leczniczych, Wyrobów Medycznych i Produktow Biobójczych, 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.
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Apo-Fina

Keep the medicine out of the sight and reach of children.
No special precautions for storage.
Do not take Apo-Fina after the expiry date stated on the carton and blister after: Expiry date (EXP). The expiry date refers to the last day of the month.
The batch number is stated after the word "Lot".
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of 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 film-coated tablet contains 5 mg of finasteride.
The other ingredients are:
Core:lactose monohydrate, microcrystalline cellulose, maize starch, lauryl macrogolglycerides, sodium carboxymethylcellulose (type A), magnesium stearate (E 572). Coating:hypromellose, titanium dioxide (E 171), indigo carmine (E 132); lacquer, macrogol 6000.

What Apo-Fina looks like and contents of the pack

Blue, round film-coated tablets, 7 mm in diameter, with the symbol "F5" embossed on one side.
Apo-Fina is available in packs of 30 or 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lok.27
01-909 Warsaw
Poland
Manufacturer/Importer:

Actavis Group PTC

Reykjavíkurvegur 76-78
IS-220 Hafnarfjörður
Iceland

Zentiva, K.S.

U Kabelovny 130,
Dolní Měcholupy,
Praha 10, 102 37,
Czech Republic

Date of revision of the leaflet: 07.2021