Finasteride medreg

Package leaflet: Information for the patient

Finasteride Medreg, 5 mg, film-coated tablets
Finasteridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• 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 pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Finasteride Medreg is and what it is used for

Finasteride Medreg contains an active substance called finasteride. Finasteride belongs to a group of medicines known as 5-α-reductase inhibitors.
Finasteride Medreg reduces the size of the prostate gland in men when it is enlarged.
The prostate gland is located below the urinary bladder (this gland is present only in men). It produces a fluid found in semen.
An enlarged prostate gland may lead to a condition called benign prostatic hyperplasia or BPH.

What is BPH?
If you have been diagnosed with BPH, it means your prostate gland is enlarged. It may press on the tubes (urethra) through which urine leaves the body.
This may lead to problems such as:

• needing to urinate more often, especially at night
• urgency to urinate
• difficulty starting urination
• weak urine stream
• interrupted urine stream
• feeling that the bladder has not emptied completely

In some men, BPH may lead to serious problems such as:

• urinary tract infections
• sudden inability to urinate (acute urinary retention)
• need for surgery

What else should you know about BPH?

• BPH is not cancer and does not cause cancer, but both conditions may be present at the same time.
• Before starting treatment with Finasteride Medreg, your doctor will perform several simple tests to check whether you have prostate cancer.

If you have any questions, please consult your doctor.

2. Important information before using Finasteride Medreg

Do not use Finasteride Medreg

• if the patient is allergic to finasteride or any of the other ingredients of this medicine (listed in section 6).
• in women (as this is a medicine intended for men).

Warnings and precautions
Before starting treatment with Finasteride Medreg, discuss with your doctor or
pharmacist:

• if the patient's partner is pregnant or planning to become pregnant. The patient should use a condom or another mechanical contraceptive method during treatment with Finasteride Medreg. This is because a small amount of the medicine may be present in the patient's semen, which could affect the normal development of the child's sex organs.
• if the patient is due to have a blood test called PSA. This is because Finasteride Medreg may affect the result of this test.

Mood changes and depression
Mood changes such as low mood, depression, and rarely suicidal thoughts have been reported
in patients treated with Finasteride Medreg. If any of these symptoms occur, treatment with Finasteride Medreg should be discontinued and the patient should consult a doctor as soon as possible to obtain further medical advice.
If the patient has any doubts, they should contact their doctor or pharmacist before taking
Finasteride Medreg.
Children
Finasteride Medreg must not be used in children.
Finasteride Medreg 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 use.
Finasteride Medreg generally does not affect the action of other medicines.
Food and drink
Finasteride Medreg may be taken with or without food.
Pregnancy, breastfeeding and fertility
Finasteride Medreg must not be used in women.

• Women who are pregnant or planning to become pregnant must not handle Finasteride Medreg tablets, especially broken or crushed tablets (intact tablets are coated, which minimizes contact with the active substance during normal handling). This medicine may affect the normal development of the child's sex organs.
• If a pregnant woman has come into contact with broken or crushed tablets containing finasteride, she should consult her doctor.

Driving and operating machinery
There are no data suggesting that Finasteride Medreg affects the ability to drive or operate machinery.
Finasteride Medreg contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Finasteride Medreg

This medicine should always be used exactly as prescribed by the doctor. In case of doubts, consult
your doctor or pharmacist.
How to use this medicine:

• The recommended dose is 1 tablet per day.
• Tablets may be taken on an empty stomach or with food. Tablets should be swallowed whole and must not be split or crushed.

Taking more than the recommended dose of Finasteride Medreg
If more than the recommended dose of Finasteride Medreg has been taken, or if any tablets have
been taken by someone else, contact the emergency department of the nearest hospital immediately.
Bring any remaining tablets or empty packaging to assist with identification.
Missed dose of Finasteride Medreg

• If the patient forgets to take the next dose, that dose should be skipped.
• The patient should take the next dose at the usual time.
• The patient must not take a double dose to make up for a missed dose.

Stopping treatment with Finasteride Medreg
The patient's condition may improve quickly after starting Finasteride Medreg.
It takes approximately 6 months to achieve the full therapeutic effect. It is important to continue
taking Finasteride Medreg for as long as prescribed by the doctor, even if the patient does not notice
a significant improvement.
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 will experience them.
The following frequency scale has been used to assess adverse reactions:
If the patient experiences an allergic reaction, the medicine should be discontinued and medical advice should be sought immediately. Symptoms that may occur include:

• skin rash, itching or hives (urticaria)
• swelling of the face, lips, tongue or throat, causing difficulty in swallowing or breathing (angioedema).

Other adverse reactions may include:
Common (occur in fewer than 1 in 10 patients):

• changes in semen (such as reduced volume of ejaculate during sexual intercourse, which does not affect the ability to have intercourse)
• impotence (inability to achieve an erection)
• reduced sexual desire.

Uncommon (occur in fewer than 1 in 100 patients):

• ejaculation disorders (emission of semen), which may persist after discontinuation of the medicine, breast swelling or tenderness
• rash (see above)
• breast tenderness, breast enlargement.

Unknown frequency (cannot be estimated from available data):

• hypersensitivity reactions, including swelling of the lips, tongue, throat and face (see above)
• testicular pain
• reduced libido, which may persist after discontinuation of treatment
• depression
• inability to achieve an erection, which may persist after discontinuation of treatment
• anxiety
• male infertility and (or) poor semen quality. Improvement in semen quality has been observed after discontinuation of treatment
• palpitations (rapid or irregular heartbeat)
• itching, urticaria (see above)
• changes in liver function observed in blood tests, increased liver enzyme activity
• suicidal thoughts.

Any changes in the breasts, such as lumps, pain, enlargement or nipple discharge, should be reported to a doctor immediately, as these may be symptoms of a serious condition, such as breast cancer.
If any adverse reactions worsen or if any adverse symptoms not listed in this leaflet occur, inform a doctor or pharmacist. It will be helpful if the patient notes down what happened, when it started and how long it lasted.
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 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 can 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 Finasteride Medreg

Keep this medicine out of sight and reach of children.
There are no special storage instructions for this medicine.
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.
The marking on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot indicates the batch number.
Medicines must 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 packaging and other information

What Finasteride Medreg contains

• The active substance is finasteride. Each coated tablet contains 5 mg of finasteride.
• The other ingredients are: lactose monohydrate; microcrystalline cellulose; pregelatinized starch (corn); sodium carboxymethyl starch (type A); sodium docusate; magnesium stearate. Coating: hypromellose 6 cP; titanium dioxide (E 171); indigo carmine (E 132), aluminium lake; talc; yellow iron oxide (E 172).

What Finasteride Medreg looks like and contents of the pack
Blue, round coated tablets, embossed with "H" on one side and "37" on the other side.
Pack sizes: 7, 10, 14, 15, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 112, 120, 250, 300,
500 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

Manufacturer/Importer
Medis International a.s.
Výrobní závod Bolatice
Průmyslová 961/16
747 23 Bolatice
Czech Republic
Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

For more detailed information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic