FINAHIT 5 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Finahit, 5 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Finahit, 5 mg, and what is it used for
   1. What is benign prostatic hyperplasia
4. Important information before taking Finahit, 5 mg
   1. When not to take Finahit, 5 mg
   2. Warnings and precautions
   3. Mood changes and depression
   4. Children and adolescents
   5. Finahit, 5 mg and other medicines
   6. Finahit, 5 mg with food
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
   9. Finahit, 5 mg contains lactose
   10. Finahit, 5 mg contains sodium
5. How to take Finahit, 5 mg
   1. Patients with liver function disorders
   2. Patients with kidney function disorders
   3. Elderly patients
   4. Taking a higher dose of Finahit, 5 mg than recommended
   5. Missing a dose of Finahit, 5 mg
   6. Stopping treatment with Finahit, 5 mg
6. Possible side effects
   1. Stop taking Finahit, 5 mg and immediately consult a doctor if the patient experiences any of the following symptoms (angioedema):
   2. Reporting side effects
7. How to store Finahit, 5 mg
8. Contents of the packaging and other information
   1. What Finahit, 5 mg contains
   2. What Finahit, 5 mg looks like and contents of the packaging
   3. Marketing authorization holder
   4. Manufacturer/Importer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet: December 2024

Leaflet accompanying the packaging: patient information

Finahit, 5 mg, film-coated tablets

Finasteride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of further doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Finahit, 5 mg, and what is it used for
• 2. Important information before taking Finahit, 5 mg
• 3. How to take Finahit, 5 mg
• 4. Possible side effects
• 5. How to store Finahit, 5 mg
• 6. Contents of the packaging and other information

1. What is Finahit, 5 mg, and what is it used for

Finasteride belongs to a group of medicines called 5-alpha-reductase inhibitors, which work by reducing the size of the prostate gland in men.
Finasteride reduces the size of the prostate gland when it is enlarged. Finasteride is used to treat and prevent benign prostatic hyperplasia. The prostate gland is located below the bladder (found only in men). It produces a fluid that is part of semen. Enlargement of the gland can lead to a disease called benign prostatic hyperplasia (BPH). Finasteride causes the size of the enlarged prostate gland to decrease, improves urine flow, and alleviates symptoms caused by benign prostatic hyperplasia, as well as reduces the risk of acute urinary retention (a condition known as acute urinary retention) and the need for surgical treatment.

What is benign prostatic hyperplasia

Benign prostatic hyperplasia is a disease associated with the enlargement of the prostate gland. This can lead to compression of the urethra, through which urine is excreted.
This can lead to the occurrence of disorders, such as:

• feeling the need to urinate more often than usual, especially at night;
• feeling the need to urinate urgently;
• difficulty urinating;
• weakening of the urine stream;
• urinating in a interrupted stream;
• feeling of incomplete emptying of the bladder.

In some men, this disease can cause more serious disorders, such as:

• urinary tract infection,
• acute urinary retention;
• the need for surgical intervention.

2. Important information before taking Finahit, 5 mg

When not to take Finahit, 5 mg

• If the patient is allergic to finasteride or any of the other ingredients of this medicine (listed in section 6);
• in women (the medicine is intended for use in men);
• in children and adolescents.

If any of the above situations apply to the patient, they should not take Finahit, 5 mg.
In case of doubts, before taking this medicine, consult a doctor or pharmacist.

Warnings and precautions

Before starting treatment with Finahit, 5 mg, discuss it with your doctor or pharmacist:

• If there is a large volume of residual urine and (or) significantly reduced urine flow. In such a case, it is necessary to carefully examine whether the patient has a narrowing of the urinary tract.
• If there are liver function disorders. This may lead to an increase in finasteride concentration in the blood.
• If the patient's sexual partner is pregnant or may become pregnant, the patient should avoid exposing their partner to contact with semen, as it may contain a small amount of the medicine.
• In patients undergoing a PSA test (a test used to detect prostate cancer). The patient should inform their doctor about taking finasteride. Finasteride may affect the concentration of the substance being tested (PSA) in the blood.

Mood changes and depression

In patients taking Finahit, 5 mg, mood changes, such as depressive mood, and depression, as well as suicidal thoughts, have been reported. If any of these symptoms occur, the patient should stop taking Finahit, 5 mg, and immediately consult a doctor for further medical advice.

Children and adolescents

Finahit, 5 mg should not be used in children and adolescents.

Finahit, 5 mg and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, as well as any medicines you plan to take.
Finasteride usually does not interact with other medicines. No significant interactions with other medicines have been found. Tell your doctor or pharmacist about all medicines you are currently taking, or have recently taken, including those that are available without a prescription.

Finahit, 5 mg with food

Finahit, 5 mg can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Finahit, 5 mg is intended for use in men only.The medicine should not be taken by women. Women who are pregnant or may become pregnant should not come into contact with Finahit, 5 mg, especially if they are broken or crushed.
If finasteride is absorbed through the skin or taken orally by a pregnant woman carrying a male fetus, the child may be born with developmental abnormalities of the genital organs.
In case of contact with a broken or crushed tablet by a pregnant woman, consult a doctor.
If the patient's sexual partner is pregnant or may become pregnant, the patient should avoid exposing their partner to contact with semen (e.g., by using a condom) or should stop taking finasteride.

Driving and using machines

There is no data indicating that Finahit, 5 mg may affect the ability to drive and use machines.

Finahit, 5 mg contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Finahit, 5 mg contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".

3. How to take Finahit, 5 mg

Take this medicine always as directed by your doctor. In case of doubts, consult your doctor or pharmacist. The recommended dose is 1 tablet of Finahit, 5 mg (which corresponds to 5 mg of finasteride).
The film-coated tablets can be taken with or without food. The medicine should be taken orally. The film-coated tablets should be swallowed whole. Do not divide or crush them. Your doctor may prescribe finasteride together with another medicine (called doxazosin) to facilitate control of the disease.
Although improvement can be seen after a short time after taking the medicine, it may be necessary to continue treatment for at least six months to assess whether the response to treatment is satisfactory.
Your doctor will inform you how long to take Finahit, 5 mg. Do not stop treatment earlier, as this may cause the symptoms to return.

Patients with liver function disorders

There is no experience with the use of Finahit, 5 mg in patients with liver function disorders (see also "Warnings and precautions").

Patients with kidney function disorders

No dose adjustment is necessary. So far, no studies have been conducted on the use of Finahit, 5 mg in patients undergoing hemodialysis.

Elderly patients

No dose adjustment is necessary.
If you feel that the effect of Finahit, 5 mg is too strong or too weak, consult your doctor or pharmacist.

Taking a higher dose of Finahit, 5 mg than recommended

In case of taking a higher dose of Finahit, 5 mg than recommended, or if someone else has taken the medicine, go to the nearest emergency department of the hospital. Take the remaining tablets or the empty packaging with you to facilitate the identification of the medicine.

Missing a dose of Finahit, 5 mg

In case of missing a dose of Finahit, 5 mg, take it as soon as you remember, unless it is almost time for the next dose. In this case, take the usual dose of the medicine as directed. Do not take a double dose to make up for the missed dose.

Stopping treatment with Finahit, 5 mg

The patient's condition may improve shortly after starting treatment with Finahit, 5 mg.
However, it may take at least six months to achieve full effectiveness. It is essential to take the medicine for as long as the doctor has prescribed, even if the patient does not feel any improvement in the short term.
In case of further doubts about the use of the medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Finahit, 5 mg can cause side effects, although not everybody gets them.

Stop taking Finahit, 5 mg and immediately consult a doctor if the patient experiences any of the following symptoms (angioedema):

• - swelling of the face, tongue, or throat;
• - difficulty swallowing,
• - hives and difficulty breathing.

Frequent(may occur in 1 in 10 patients):

• ejaculation disorders, e.g., decreased semen volume during ejaculation. Decreased semen volume does not affect other sexual functions.
• impotence (erectile dysfunction),
• decreased libido.

Uncommon(may occur in 1 in 100 patients):

• rash,
• ejaculation disorders persisting after treatment has stopped,
• breast tenderness and swelling.

Frequency not known(cannot be estimated from the available data):

• itching, hives,
• palpitations,
• swelling of the face, lips, tongue, or throat, difficulty swallowing and breathing (angioedema),
• liver function disorders confirmed by laboratory tests,
• testicular pain,
• erectile dysfunction persisting after treatment has stopped,
• male infertility and (or) poor semen quality. Improvement in semen quality has been reported after treatment has stopped.
• depression,
• decreased libido persisting after treatment has stopped,
• anxiety.

In case of changes in the breast, such as lumps, pain, breast enlargement, nipple discharge, immediately consult a doctor, as these may be symptoms of breast cancer.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Finahit, 5 mg

Keep out of the sight and reach of children.
No special precautions for storage are necessary.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month.
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 packaging and other information

What Finahit, 5 mg contains

• The active substance of the medicine is finasteride. Each film-coated tablet contains 5 mg of finasteride.
• The medicine also contains: tablet core - lactose monohydrate, microcrystalline cellulose (E460), maize starch, sodium carboxymethylcellulose (type A), lauryl macrogolglycerides, and magnesium stearate (E572); coating: hypromellose 6 cP (E464), titanium dioxide (E171), macrogol 6000, indigo carmine (E132), and lactose.

What Finahit, 5 mg looks like and contents of the packaging

Film-coated tablet.
The 5 mg film-coated tablets are blue, round, biconvex, coated, with the marking "F5" on one side, and no marking on the other side.
Finahit, 5 mg is packaged in non-transparent, white PVC/PVDC/Aluminum blisters in cardboard boxes containing 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, or 120 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Phone: +48 22 577 28 00

Manufacturer/Importer

Laboratorios Normon S.A.
Ronda de Valdecarrizo 6,
28760 Tres Cantos, Madrid
Spain
Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
Netherlands
Accord Healthcare Single Member S.A.
64th Km National Road Athens Lamia
32009 Schimatari
Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: December 2024