Finaran

Package leaflet: Information for the patient

FINARAN, 5 mg, film-coated tablets
Finasteride
MEDICINAL PRODUCT FOR USE IN MEN ONLY
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Contents of the leaflet:

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

1. What Finaran is and what it is used for

Finasteride, the active substance in Finaran, is a 5-alpha reductase inhibitor, an enzyme that converts testosterone (a male sex hormone) into the more potent dihydrotestosterone (DHT). Finaran reduces the volume of the prostate gland.
Finaran is used in a condition called benign prostatic hyperplasia.
The prostate gland, located near the urinary bladder, has enlarged, causing difficulties in urination.
This medicine is indicated for the treatment of benign prostatic hyperplasia to:

• relieve symptoms,
• reduce the risk of acute urinary retention,
• reduce the risk of needing surgical treatment, including transurethral resection of the prostate (TURP) and prostatectomy (surgical removal of the prostate gland).

2. Important information before using Finaran

What you should know before and during treatment with Finaran
If the patient's sexual partner is pregnant or suspected of being pregnant,
exposure to the patient's semen, which may contain small amounts of the medicine,
should be avoided.

When not to take Finaran

• if the patient is allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• in pregnant women and in women of childbearing potential. Finaran is not indicated for use in women.

Warnings and precautions

Before starting treatment with Finaran, discuss this with your doctor.
Inform your doctor about any current or past medical conditions and about any allergies.
Benign prostatic hyperplasia is a condition that develops over a long period of time. In some
patients, symptoms may improve shortly after starting treatment. However, treatment for at least 6 months may be necessary to achieve significant improvement. Regardless of whether symptoms improve, treatment with Finaran may reduce the risk of acute urinary retention and the need for surgical intervention. To monitor treatment progress, the patient should remain under continuous medical supervision.
Benign prostatic hyperplasia is not cancer and does not lead to cancer development; however, both conditions may coexist. Only a doctor can properly assess symptoms and their probable cause.
This medicine may interfere with the results of the PSA test (prostate-specific antigen). Therefore, before undergoing this test, inform your doctor that you are taking Finaran. This medicine is indicated for men only, for the treatment of benign prostatic hyperplasia.

Mood changes and depression
Mood changes such as depressed mood and depression, and less frequently suicidal thoughts, have been reported in patients taking Finaran. If any of these symptoms occur, seek immediate medical advice from your doctor.

Children
Finaran is not indicated for use in children.

Finaran with other medicines
Inform your doctor about all medicines currently used, recently taken, or planned for use. Finaran generally does not affect the action of other concomitantly used medicines.

Pregnancy and breastfeeding

Pregnancy
Pregnant women and women of childbearing age must not take this medicine. They should also avoid touching crushed or broken Finaran tablets. If the active substance of the medicine enters a woman's body (by oral administration or through skin contact), particularly a woman expecting a male child, it may cause developmental disorders of the fetal genital organs. In the event of exposure of a pregnant woman to the active substance of Finaran, inform the doctor immediately. The tablets are film-coated, which prevents direct contact with the active substance, provided the tablets are not damaged or crushed. Your doctor can provide further information on this subject.

Breastfeeding
It is unknown whether finasteride passes into human milk.

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

Finaran contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Finaran contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Finaran

This medicine should always be used as directed by the physician. If you have any doubts,
please consult your doctor.
The recommended dose is one 5 mg tablet per day, regardless of meals.
The medicine should be taken orally.
Please remember that benign prostatic hyperplasia progresses slowly over many years before
symptoms become noticeable. Finaran may relieve symptoms and help control the progression of
the disease, provided it is taken regularly over a prolonged period.
Use of Finaran in patients with renal and/or hepatic impairment
Dosage adjustment is not required in patients with any degree of renal and/or hepatic impairment.
Use of Finaran in elderly patients
Dosage adjustment is not required in elderly patients.
Taking more than the recommended dose of Finaran
If more tablets than recommended have been taken, contact your doctor immediately.
Missed dose of Finaran
Finaran should be taken as directed by the physician. However, if a dose is missed, do not take
an extra tablet. Resume the prescribed dosing schedule the next day.
If you have any further questions concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Finaran may cause adverse effects, although not everyone experiences them.

Common (may occur in 1 to 10 out of 100 people):

• decreased libido,
• impotence (inability to achieve an erection),
• reduced ejaculate volume (amount of semen). This does not affect normal sexual function.

In some cases, these symptoms may resolve during treatment. However, if adverse effects persist, you should consult your doctor, who may decide to discontinue therapy.

Uncommon (may occur in 1 to 10 out of 1,000 people):

• rash,
• ejaculation disorders,
• breast enlargement and/or tenderness.

Frequency unknown (frequency cannot be estimated from available data):
Discontinue use of this medicine and contact your doctor immediately if any of the following symptoms occur (angioedema): swelling of the face, tongue or throat, difficulty swallowing, urticaria, and breathing difficulties.

• allergic reactions: swelling of the lips, tongue, throat and face,
• depression,
• persistent decrease in libido after stopping treatment,
• blood in semen,
• palpitations,
• changes in liver function, which may be observed in blood tests,
• itching, urticaria,
• testicular pain,
• persistent inability to achieve erection after discontinuation of the medicine,
• persistent ejaculation disorders after discontinuation of the medicine,
• male infertility and/or poor semen quality (improvement in semen quality has been reported after discontinuation of the medicine),
• in rare cases, development of breast cancer,
• anxiety,
• suicidal thoughts.

Any changes in breast glandular tissue should be reported to a doctor immediately,
such as lumps, pain, breast enlargement or nipple discharge, as they may be signs of serious conditions,
such as breast cancer.

Reporting of adverse effects

If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 effects can also be reported to the marketing authorization holder.

Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store the medicine Finaran

Keep the medicine out of sight and reach of children.
There are no special precautions regarding storage conditions.
Do not use the medicine after the expiry date stated on the blister and outer packaging. 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. This will help protect the environment.

6. Contents of the pack and other information

What Finaran contains

• The active substance is finasteride. One coated tablet contains 5 mg of finasteride.
• The other ingredients are: monohydrate lactose, microcrystalline cellulose, pregelatinized maize starch, sodium carboxymethyl starch (type A), magnesium stearate, sodium lauryl sulphate. Sepifilm 002 coating: hypromellose, microcrystalline cellulose, polyglycol stearate (type I).

What Finaran looks like and contents of the pack
Finaran coated tablets are white, round, biconvex, 7 mm in diameter,
with the imprint ‘F’ and ‘5’ on one side.
Finaran PVC/PVDC/Aluminium blisters are available in pack sizes of 15, 30 and 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Ranbaxy (Poland) Sp. z o.o., Idzikowskiego Street 16, 00–710 Warsaw
Manufacturer:
Siegfried Malta Ltd
HHF070 Hal Far Industrial Estate
Hal Far BBG3000
Malta
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster, Germany