Finahit

Package leaflet: Information for the patient

Finahit, 5 mg, film-coated tablets
Finasteride
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for you.

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

Table of contents of the leaflet:

1. What Finahit, 5 mg is and what it is 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 pack and other information

1. What Finahit, 5 mg is and what it is used for
Finasteride belongs to a group of medicines known as 5-alpha-reductase inhibitors, which act by reducing the size of the prostate gland in men.
Finasteride reduces the size of an enlarged prostate gland. Finasteride is used in the treatment and prevention of benign prostatic hyperplasia (BPH). The prostate gland is located below the urinary bladder (and occurs only in men). It produces a fluid that is part of semen. Enlargement of the gland may lead to a condition called benign prostatic hyperplasia (BPH – benign prostatic hyperplasia). Finasteride reduces the size of the enlarged prostate gland, improves urine flow, relieves symptoms caused by benign prostatic hyperplasia, and 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 condition associated with enlargement of the prostate gland. This may lead to pressure on the urethra, the tube through which urine passes. This may result in disturbances such as:

• feeling the need to urinate more often than usual, especially at night;
• feeling a sudden need to urinate;
• difficulty in starting urination;
• weakened urinary stream;
• interrupted urine stream;
• feeling of incomplete bladder emptying.

In some men, this condition may lead to more serious complications, such as:

• urinary tract infection;
• sudden inability to urinate (acute urinary retention);
• need for surgical intervention.

2. Important information before taking Finahit, 5 mg

When not to take Finahit, 5 mg

• If you are 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 only);
• in children and adolescents.

If any of the above situations apply to you, do not take Finahit, 5 mg.
If in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions
Before starting Finahit, 5 mg, discuss the following with your doctor or pharmacist:

• If you have a large volume of residual urine and/or significantly reduced urine flow. In such cases, it is important to rule out urethral obstruction.
• If you have liver function disorders. In such cases, finasteride concentration in plasma may increase.
• If your sexual partner is pregnant or may become pregnant, you should avoid exposing her to contact with semen, as it may contain small amounts of the medicine.
• If you are undergoing a PSA test (a test used to detect prostate cancer), inform your doctor that you are taking finasteride. Finasteride may affect the blood levels of PSA.

Mood changes and depression
Mood changes such as depressive mood and depression, and less frequently suicidal thoughts, have been reported in patients taking Finahit, 5 mg. If any of these symptoms occur, discontinue use of Finahit, 5 mg immediately and consult your doctor for further medical advice without delay.

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

Finahit, 5 mg and 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 interact with other medicines. No significant drug interactions have been observed. Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those available without a prescription.

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

Pregnancy, breastfeeding, and effects on fertility
Finahit, 5 mg is intended for use in men only. This medicine must not be used by women. Pregnant women or women who may become pregnant must not handle Finahit, 5 mg tablets, 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 congenital malformations of the genital organs. If a pregnant woman comes into contact with broken or crushed tablets, consult a doctor immediately.
If your sexual partner is pregnant or may become pregnant, you should avoid exposing her to contact with semen (e.g., by using a condom) or discontinue finasteride treatment.

Driving and operating machinery
There are no data indicating that Finahit, 5 mg may affect the ability to drive or operate machinery.

Finahit, 5 mg contains lactose
If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

Finahit, 5 mg contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is considered "sodium-free".

3. How to take Finahit, 5 mg

This medicine should always be taken as directed by the physician. In case of doubt, consult
your doctor or pharmacist. The recommended dose is 1 tablet of Finahit, 5 mg
(corresponding to 5 mg of finasteride).
The coated tablets may be taken on an empty stomach or with food. This medicine is for oral use.
The coated tablets should be swallowed whole. Do not split or crush them. Your doctor may prescribe
finasteride together with another medicine (called doxazosin) to help control the disease.
Although improvement may be noticed shortly after starting treatment, treatment should be continued
for at least six months to assess whether the response to treatment is satisfactory.
Your doctor will inform you how long you should continue taking Finahit, 5 mg. Do not stop treatment
earlier, as this may lead to a recurrence of symptoms.

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

Patients with renal function impairment
Dosage adjustment is not necessary. There have been no studies conducted on the use of
Finahit, 5 mg in patients undergoing hemodialysis.

Elderly patients
Dosage adjustment is not necessary.
If you feel that the effect of Finahit, 5 mg is too strong or too weak, consult your doctor or pharmacist.

Taking more Finahit, 5 mg than recommended
If you take more Finahit, 5 mg than recommended, or if someone else takes this medicine,
go immediately to the nearest hospital emergency department. Bring any remaining tablets or the
empty packaging to help identify the medicine.

Missing a dose of Finahit, 5 mg
If you miss a dose of Finahit, 5 mg, take it as soon as you remember, unless it is almost time for
the next dose. In that case, take your usual dose as recommended. Do not take a double dose to
make up for a missed dose.

Stopping treatment with Finahit, 5 mg
Your condition may improve shortly after starting Finahit, 5 mg. However, it may take at least
6 months to achieve full effectiveness. It is important to continue taking the medicine for as long as
your doctor recommends, even if you do not notice any improvement in the short term.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Finahit 5 mg may cause adverse reactions, although not everyone experiences them.

Discontinue use of Finahit 5 mg and seek immediate medical attention if the patient experiences any of the following symptoms (angioedema):

• swelling of the face, tongue or throat;
• difficulty swallowing;
• urticaria and breathing difficulties.

Common (may occur in up to 1 in 10 patients):

• ejaculation disorders, e.g. reduced semen volume during ejaculation. Decreased semen volume does not affect other sexual functions.
• inability to achieve erection (impotence),
• loss of interest in sex.

Uncommon (may occur in up to 1 in 100 patients):

• rash,
• ejaculation disorders persisting after discontinuation of treatment,
• breast swelling and tenderness.

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

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

If any changes in the breast occur, such as lumps, pain, enlargement of breast tissue, or nipple discharge, contact a doctor immediately, as these may be symptoms of breast cancer.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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 to provide more information on the safety of this medicine.

5. How to store Finahit 5 mg

Keep the medicine out of the sight and reach of children.
No special precautions for storage are required.
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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
what to do with medicines no longer required. Such measures will help protect
the environment.

6. Contents of the packaging and other information

What Finahit 5 mg contains

• The active substance is finasteride. Each coated tablet contains 5 mg of finasteride.
• Other components are: tablet core – monohydrate lactose, microcrystalline cellulose (E460), pregelatinized corn starch, sodium carboxymethyl starch (type A), glyceryl monostearate and magnesium stearate (E572); film-coating composition: hypromellose 6 cP (E464), titanium dioxide (E171), polyethylene glycol 6000, indigo carmine (E132), lac.

What Finahit 5 mg looks like and contents of the pack
Coated tablet.
The 5 mg coated tablets are blue, round, biconvex, film-coated, marked with
“F5” on one side and unmarked on the other side.
Finahit 5 mg is packed in opaque white PVC/PVDC/Aluminium blisters,
packed 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 Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Tel: + 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
The Netherlands
Accord Healthcare Single Member S.A.
64th Km National Road Athens Lamia
32009 Schimatari
Greece
This medicinal product is authorised in the European Economic Area countries under the following names: