NEZYR 1 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Nezyr, 1 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Nezyr and what is it used for
   1. Nezyr is intended for use by men only.
4. Important information before taking Nezyr
   1. When not to take Nezyr
   2. Warnings and precautions
   3. Effect on Prostate-Specific Antigen (PSA)
   4. Breast Cancer
   5. Mood Changes and Depression
   6. Children and Adolescents
   7. Nezyr and other medicines
   8. Pregnancy, Breast-feeding, and Fertility
   9. Effects on Fertility
   10. Driving and Using Machines
   11. Nezyr contains Lactose
   12. Nezyr contains Sodium
5. How to take Nezyr
   1. Taking more than the recommended dose of Nezyr
   2. Missing a dose of Nezyr
   3. Stopping treatment with Nezyr
6. Possible side effects
   1. Reporting side effects
7. How to store Nezyr
8. Contents of the pack and other information
   1. What Nezyr contains
   2. What Nezyr looks like and contents of the pack
   3. Marketing Authorization Holder and Manufacturer
   4. Marketing Authorization Holder:
   5. Manufacturer/Importer:
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the Patient

Nezyr, 1 mg, Film-Coated Tablets

Finasteride

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Nezyr and what is it used for

This medicine contains the active substance finasteride.

Nezyr is intended for use by men only.

Nezyr is used to treat male pattern hair loss (also known as androgenetic alopecia) in men aged 18 to 41 years. If, after reading this leaflet, you have any questions about male pattern hair loss, you should consult your doctor.
Male pattern hair loss is a common condition that is caused by a combination of genetic factors and a specific hormone - DHT (dihydrotestosterone).
DHT causes the hair growth phase to shorten and the hair to become thinner.
Finasteride lowers the level of DHT in the scalp by blocking the enzyme (5-alpha-reductase type II) that converts testosterone to DHT. Only men with mild to moderate, but not complete, hair loss can expect to benefit from Nezyr. In most men treated with Nezyr for 5 years, the progression of hair loss has slowed down, and in at least half of these men, there has also been an improvement in hair growth.

2. Important information before taking Nezyr

When not to take Nezyr

Warnings and precautions

Before taking Nezyr, discuss it with your doctor or pharmacist.

Effect on Prostate-Specific Antigen (PSA)

Finasteride may affect a blood test called PSA (Prostate-Specific Antigen) for prostate cancer. If you are going to have a PSA test, tell your doctor or pharmacist that you are taking Nezyr, as finasteride may affect the PSA levels.

Breast Cancer

See section 4 "Possible side effects".

Mood Changes and Depression

Patients taking finasteride have reported depressed mood, depression, and less frequently, suicidal thoughts. If you experience any of these symptoms, stop taking Nezyr and consult your doctor immediately.

Children and Adolescents

Nezyr should not be taken by children or adolescents. There is no data on the efficacy or safety of finasteride in children or adolescents under 18 years of age.

Nezyr and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take.

Pregnancy, Breast-feeding, and Fertility

Nezyr, 1 mg is used to treat male pattern hair loss, in men only.

• Nezyr must not be taken by women, due to the possible risk of pregnancy.
• Women who are pregnant or think they may be pregnant should not handle crushed or broken Nezyr tablets.
• If the active substance of Nezyr is absorbed through the skin or taken orally by a woman carrying a male fetus, the child may be born with genital malformations.
• If a pregnant woman has come into contact with the active substance of Nezyr, she should consult her doctor.
• The tablets of Nezyr are film-coated to prevent contact with the active substance during normal use.

Effects on Fertility

There have been reports of infertility in men taking finasteride for a long time, who had other risk factors for fertility. Normalization or improvement of semen quality has been observed after discontinuation of finasteride treatment. However, no long-term studies have been conducted on the effects of finasteride on fertility in men.
In case of doubt, consult your doctor.

Driving and Using Machines

There is no data suggesting that Nezyr affects the ability to drive or use machines.

Nezyr contains Lactose

Each film-coated tablet contains 83.41 mg of lactose (as lactose monohydrate).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Nezyr contains Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is essentially 'sodium-free'.

3. How to take Nezyr

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
The recommended dose is one tablet a day. The film-coated tablet can be taken with or without food.
Your doctor will help you assess the effectiveness of Nezyr. It is important to take Nezyr for as long as your doctor tells you. Nezyr may take a long time to work if you take it continuously.

Taking more than the recommended dose of Nezyr

If you accidentally swallow more than the recommended dose of Nezyr, contact your doctor immediately.
Nezyr will not work faster or better if you take it more than once a day.

Missing a dose of Nezyr

Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Nezyr

It may take from 3 to 6 months to achieve the full effect of treatment. It is important to continue taking Nezyr for as long as your doctor tells you. If treatment is stopped, you will probably lose the hair that grew back within 9 to 12 months.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nezyr can cause side effects, although not everybody gets them.
Side effects are usually temporary during continued treatment or disappear after treatment is stopped.
Stop taking Nezyr and contact your doctor immediately if you experience any of the following symptoms: swelling of the lips, face, tongue, and throat, difficulty swallowing, hives, and difficulty breathing.
Immediately report to your doctor any changes in breast tissue, such as lumps, pain, enlargement of the breasts, or discharge from the nipples, as these may be signs of a serious condition, such as breast cancer.
Uncommon(may affect up to 1 in 100 people)

• decreased libido
• difficulty getting an erection
• ejaculation disorders (e.g., decreased semen volume)
• depression.

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

• allergic reactions, including rash, itching
• breast enlargement or tenderness
• testicular pain
• blood in semen
• rapid heartbeat
• persistent erectile dysfunction, decreased libido, or ejaculation disorder after stopping treatment
• male infertility and/or poor semen quality
• increased liver enzyme activity
• anxiety.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nezyr

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

What Nezyr contains

• The active substance is finasteride. Each film-coated tablet contains 1 mg of finasteride.
• The other ingredients are: lactose monohydrate (200 M), microcrystalline cellulose (PH 102), pregelatinized maize starch, sodium starch glycolate (type A), docusate sodium, magnesium stearate. Film 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

Film-coated tablet.
Brown, round film-coated tablets with "H" embossed on one side and "36" on the other side.
Nezyr is available in blisters containing: 7, 28, or 84 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aristo Pharma Sp. z o.o.
ul. Baletowa 30
02-867 Warsaw

Manufacturer/Importer:

Pharmadox Healthcare, Ltd.
KW20A Kordin Industrial ParkPaola, PLA 3000
Malta
Aristo Pharma GmbH
Wallenroder Strasse 8-10
13435 Berlin
Germany

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

Germany
Finaristo 1 mg Filmtabletten
Poland
Nezyr
Date of last revision of the leaflet:November 2023