Finaride
Poland
Table of Contents
Patient Information Leaflet
Finaride, 5 mg, film-coated tablets
Finasteride
FOR USE IN MEN ONLY
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any further questions, please ask your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Leaflet Contents
- What Finaride is and what it is used for
- Important information before taking Finaride
- How to take Finaride
- Possible side effects
- How to store Finaride
- Contents of the pack and other information
1. What Finaride is and what it is used for
Finaride film-coated tablets contain finasteride as the active substance – a medicine which inhibits the conversion of the male sex hormone testosterone into the more potent androgen dihydrotestosterone. Finasteride reduces dihydrotestosterone levels in the blood and in the prostate gland, leading to a reduction in prostate volume, improved urinary flow through the urethra, and decreased tone of the bladder sphincter muscle.
Finaride is used in the treatment and management of benign prostatic hyperplasia (BPH) to:
- reduce the size of an enlarged prostate gland,
- improve urinary flow,
- relieve symptoms associated with benign prostatic hyperplasia,
- reduce the risk of acute urinary retention and the need for surgical treatment.
This medicine should be used in patients with an enlarged prostate gland (approximate gland volume greater than 40 ml).
2. Important information before using Finaride
When not to use Finaride
if the patient is allergic to finasteride or any of the other ingredients of this medicine
(listed in section 6),
in women, especially pregnant women or women of childbearing age due to the risk to the male fetus,
in children.
Warnings and precautions
Before starting treatment with Finaride, discuss this with your doctor if the patient currently has or has previously had:
kidney function disorders,
liver function disorders.
If the patient notices any changes in the breasts during treatment (such as lumps, pain, breast enlargement, or nipple discharge), they should immediately report this to their doctor.
If the patient is planning to father a child, they should consult their doctor, as discontinuation of Finaride may be indicated.
Mood changes and depression
Mood changes such as depressive mood, depression, and rarely suicidal thoughts have been reported in patients taking Finaride. If any of these symptoms occur, the patient should immediately seek medical advice from their doctor.
Children and adolescents
There is no indication for the use of finasteride in children and adolescents.
Finaride with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take. This includes herbal medicines, health foods, or dietary supplements available without a prescription.
Clinically significant interactions with other medicines have not been observed.
Finaride with food and drink
The medicine can be taken regardless of meals. Tablets should be swallowed whole (without dividing or chewing) with water.
Pregnancy and breastfeeding
This medicine is intended for men only. Its use in women (especially pregnant women or women of childbearing age) is contraindicated.
Women who are pregnant or of childbearing age should not handle crushed or broken Finaride tablets due to the possibility of drug absorption through the skin and the risk of abnormal development of external genital organs in a male fetus. Finaride coated tablets have a protective film coating that prevents contact with the active substance, provided the tablets are not broken or crushed.
It is unknown whether exposure of a pregnant woman to semen from a patient treated with finasteride may have harmful effects on a male fetus. Therefore, if a sexual partner of a patient treated with finasteride is pregnant or may become pregnant, the patient should either avoid exposing the partner to contact with semen (e.g. by using a condom) or discontinue taking Finaride after consulting with their doctor.
Driving and operating machinery
There are no data indicating any influence of Finaride on the ability to drive or operate machinery.
Finaride contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
3. How to take Finaride
This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult the doctor or pharmacist.
The usual dose is 1 tablet (5 mg) once daily.
Dosing in patients with renal impairment
Dosage adjustment is not necessary in patients with kidney dysfunction.
Dosing in patients with liver function disorders
The doctor will determine the appropriate dose for patients with liver function disorders.
Dosing in elderly patients
Dosage adjustment is not necessary.
Duration of treatment
Symptom relief may occur relatively quickly, but only after 6 months of treatment can the doctor assess whether a beneficial treatment response has been achieved. The medicine should be taken for as long as directed by the doctor.
Taking more Finaride than recommended
If too much medicine has been taken, consult a doctor or pharmacist.
There are no specific recommendations for the treatment of finasteride overdose.
Missing a dose of Finaride
If a dose is missed, the next dose should be taken at the usual time. Do not take a double dose to make up for the missed dose.
Stopping Finaride
Do not stop taking Finaride without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The most common adverse reactions are impotence and reduced libido,
which usually occur at the beginning of treatment and resolve during continued treatment.
Cases of breast cancer associated with the use of finasteride have been reported.
The following adverse reactions have been observed during finasteride treatment:
Frequent (may affect less than 1 in 10 people):
impotence, decreased libido, reduced ejaculate volume
Uncommon (may affect less than 1 in 100 people):
breast tenderness, breast enlargement, ejaculation disorders, skin rash
Very rare (may affect less than 1 in 10,000 people):
breast discharge, breast lumps
Frequency not known (cannot be estimated from available data):
hypersensitivity reactions such as angioedema (including swelling of the lips, tongue, throat and face,
difficulty swallowing, urticaria and breathing difficulties)*, palpitations, increased liver enzyme activity,
testicular pain, itching, urticaria, depression, anxiety, persistent decrease in libido after discontinuation of treatment, persistent erectile dysfunction after discontinuation of treatment, persistent ejaculation disorders after discontinuation of treatment, male infertility and/or poor semen quality
* If any symptoms of angioedema occur, the patient should stop taking the medicine immediately and seek medical advice without delay.
Laboratory test results
During the first months of treatment, a rapid decrease in serum prostate-specific antigen (PSA) concentration to about half the pretreatment value is observed.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a 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, 02-222 Warsaw
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Finaride
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the stated month.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the pack and other information
What Finaride contains
The active substance is finasteride. One tablet contains 5 mg of finasteride.
The other ingredients are: monohydrate lactose, microcrystalline cellulose, povidone, sodium lauryl sulfate,
magnesium stearate, talc, sodium carboxymethyl starch.
Coating: hypromellose, propylene glycol, titanium dioxide, talc, indigo carmine (E132).
What Finaride looks like and contents of the pack
Finaride coated tablets are blue, round, biconvex, with a diameter of approximately 8 mm.
The pack contains 30 or 90 coated tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Synoptis Pharma sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
Importer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
ul. Domaniewska 50 C
02-672 Warszawa
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz
For further information, please contact:
Synoptis Pharma sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa