Package leaflet: Information for the patient

Nezyr, 1 mg, coated tablets
Finasteride
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, 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.

Table of contents

What Nezyr is and what it is used for
Important information before taking Nezyr
How to take Nezyr
Possible side effects
How to store Nezyr
Contents of the pack and other information

1. What Nezyr is and what it is used for

This medicine contains an active substance called finasteride.
Nezyr is intended for use in men only.
Nezyr is used in the treatment of male pattern hair loss (also known as androgenetic alopecia) in men aged 18 to 41 years. If, after reading this leaflet, the patient has any questions regarding male pattern hair loss, he should consult his doctor.
Male pattern hair loss is a common condition caused by a combination of genetic factors and a specific hormone – DHT (dihydrotestosterone).
DHT shortens the hair growth phase and reduces hair thickness.
Finasteride reduces the level of DHT in the scalp by inhibiting the enzyme (5-alpha-reductase type II) that converts testosterone into DHT. Benefit from Nezyr treatment can be expected only in men with mild to moderate, but not complete, hair loss. In most men treated with Nezyr for 5 years, progression of hair loss has been slowed, and at least half of these men also experienced improved hair growth.

2. Important information before using Nezyr

When not to use Nezyr

if the patient is a woman (because this medicine is intended for men only, see section 2 "Pregnancy"). Clinical studies have shown that finasteride 1 mg is not effective in treating hair loss in women.
if the patient is allergic to finasteride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to take Nezyr, discuss this with your doctor or pharmacist.
Effect on prostate-specific antigen (PSA)
Finasteride may affect a blood test called PSA (prostate-specific antigen) used in screening for prostate cancer. If the patient intends to have a PSA test, he should inform the doctor or pharmacist that he is taking Nezyr, because finasteride may reduce PSA levels.
Breast cancer
See section 4 "Possible side effects".
Mood changes and depression
Depressed mood, depression and, less frequently, suicidal thoughts have been reported in patients taking finasteride. If any of these symptoms occur, treatment with Nezyr should be discontinued and medical advice should be sought immediately.
In some patients, sexual dysfunction has been reported, which may contribute to mood changes, including suicidal thoughts. If symptoms of sexual dysfunction occur, medical advice should be sought. The doctor may consider discontinuing treatment (see section 4 below for further information on these side effects).
A Patient Warning Card reminding of the above has been included in the Nezyr packaging.
Children and adolescents
Nezyr must not be used in children or adolescents. There is a lack of data on the efficacy and safety of finasteride in children or adolescents under 18 years of age.
Nezyr and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Pregnancy, breastfeeding and effects on fertility
Nezyr 1 mg is used in the treatment of male pattern hair loss exclusively in men.

Nezyr must not be used in women due to potential risks related to pregnancy.
Pregnant women or women who suspect they may be pregnant must not handle crushed or damaged Nezyr tablets.
If the active substance of Nezyr is absorbed through the skin or taken orally by a pregnant woman carrying a male fetus, the baby may be born with genital abnormalities.
If a pregnant woman has had contact with the active substance of Nezyr, she should seek medical advice.
Nezyr tablets are film-coated to prevent contact with the active substance during normal handling.

Effect on fertility
Cases of infertility in men taking finasteride for a prolonged period have been reported, in whom other risk factors affecting fertility were present. Normalization or improvement in semen quality has been observed after discontinuation of finasteride treatment. However, long-term studies on the effect of finasteride on male fertility have not been conducted.
If in doubt, consult your doctor.
Driving and operating machinery
There are no data suggesting that Nezyr affects the ability to drive or operate machinery.
Nezyr contains lactose
Each film-coated tablet contains 83.41 mg of lactose (as monohydrate lactose).
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Nezyr contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Nezyr

This medicine should always be used as directed by a doctor. If in doubt, consult a doctor or pharmacist.
The recommended dose is one tablet per day. The coated tablet may be taken with food or independently of meals.
Your doctor will help assess the effectiveness of Nezyr. It is important to take Nezyr for as long as your doctor recommends.
Nezyr may work over a long period if taken continuously.
Use of a higher than recommended dose of Nezyr
If an overdose of Nezyr tablets is accidentally swallowed, contact a doctor immediately.
Nezyr will not work faster or better if taken more than once a day.
Missing a dose of Nezyr
Do not take a double dose to make up for a missed dose.
Stopping treatment with Nezyr
It may take 3 to 6 months to achieve the full treatment effect. It is important to continue taking Nezyr for as long as your doctor recommends. If treatment is stopped prematurely, the patient will likely lose the hair that grew during treatment over the next 9 to 12 months.
If you have any further doubts regarding 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 will experience them.
Adverse reactions are usually transient during continued treatment or resolve after treatment has been discontinued.
Treatment with Nezyr should be discontinued and immediate medical advice sought if any of the following symptoms occur: swelling of the lips, face, tongue or throat, difficulty swallowing, subcutaneous nodules (urticaria), and breathing difficulties.
Any changes observed in breast tissue, such as lumps, pain, breast enlargement or nipple discharge, should be promptly reported to the treating physician, as they may indicate a serious disease such as breast cancer.

Uncommon (may occur in not more than 1 in 100 patients):

Decreased libido
Difficulties in achieving erection
Ejaculation disorders, e.g. reduced ejaculate volume
Depression

Frequency unknown (frequency cannot be estimated from available data):

Hypersensitivity reactions, including rash, itching
Breast enlargement or tenderness
Testicular pain
Blood in semen
Increased heart rate
Persistence, after discontinuation of treatment, of erectile dysfunction, reduced libido or ejaculation disorders
Male infertility and (or) poor semen quality
Increased liver enzyme activity
Anxiety

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department for Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 provide more information on the safety of this medicine.

5. How to store Nezyr

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following EXP. The expiry date refers to the last day of the specified month.
No special precautions regarding storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Doing so helps protect the environment.

6. Contents of the package and other information

What Nezyr contains

The active substance is finasteride. Each coated tablet contains 1 mg of finasteride.
The other ingredients are: monohydrate lactose (200 M), microcrystalline cellulose (PH 102), pregelatinized corn starch, sodium carboxymethyl starch (type A), sodium docusate, magnesium stearate. Coating Opadry Brown 03A86790: HPMC 2910/Hypromellose 6 cP, titanium dioxide (E 171), talc, yellow iron oxide (E 172), red iron oxide (E 172).

What Nezyr looks like and contents of the pack
Coated tablet.
Brown, round coated tablets with "H" debossed on one side and "36" on the other side.
Nezyr is available in blister packs containing: 7, 28 or 84 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aristo Pharma Sp. z o.o.
Baletowa 30 Street
02-867 Warsaw
Poland
Manufacturer/Importer:
Pharmadox Healthcare, Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
Aristo Pharma GmbH
Wallenroder Strasse 8-10
13435 Berlin
Germany
This medicinal product is authorised in the European Economic Area member states under the following names:
Germany Finaristo 1 mg Filmtabletten
Poland Nezyr