Finasteride Medreg

Leaflet attached to the packaging: patient information

Finasteride Medreg, 5 mg, film-coated tablets

Finasteridum

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Finasteride Medreg and what is it 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 packaging and other information

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

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

What is BPH?

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

• the need to urinate more frequently, especially at night
• the need to urinate urgently
• difficulty starting to urinate
• weak urine flow
• interrupted urine flow
• a feeling of not being able to empty the bladder completely.

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

• urinary tract infections
• sudden inability to urinate
• the need for surgery.

What else should you know about BPH?

• BPH is not cancer and does not lead to cancer, but these two conditions can be present at the same time.
• Before starting treatment with Finasteride Medreg, your doctor will perform a few simple tests to check if you have prostate cancer.

If you have any questions, you should consult your doctor.

2. Important information before taking Finasteride Medreg

Do not take Finasteride Medreg

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

Warnings and precautions

Before starting treatment with Finasteride Medreg, you should discuss it with your doctor or pharmacist:

• if your partner is pregnant or plans to become pregnant. You should use a condom or other mechanical contraceptive method during treatment with Finasteride Medreg. This is because a small amount of the medicine may be present in your semen, which may affect the normal development of the sex organs of the child.
• if you plan 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 decreased mood, depression, and rarely suicidal thoughts, have been reported in patients treated with Finasteride Medreg. If you experience any of these symptoms, you should stop taking Finasteride Medreg and consult your doctor as soon as possible to receive further medical advice.
If you have any doubts, you should contact your doctor or pharmacist before taking Finasteride Medreg.

Children

Finasteride Medreg should not be used in children.

Finasteride Medreg and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Finasteride Medreg usually does not affect the action of other medicines.

Finasteride Medreg with food and drink

Finasteride Medreg can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Finasteride Medreg should not be used in women.

• Women who are pregnant or plan to become pregnant should not touch Finasteride Medreg tablets, especially if they are broken or crushed (intact tablets are coated to minimize contact with the medicine during normal use). This medicine may affect the normal development of the sex organs of the child.
• If a pregnant woman has come into contact with broken or crushed Finasteride Medreg tablets, she should consult her doctor.

Driving and using machines

There are no data suggesting that Finasteride Medreg affects the ability to drive or use machines.

Finasteride Medreg contains lactose and sodium

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking Finasteride Medreg.
This 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 Finasteride Medreg

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should consult your doctor or pharmacist.

How to take this medicine:

• The recommended dose is one tablet per day.
• The tablets can be taken with or without food. The tablets should be swallowed whole, without dividing or crushing them.

Taking more than the recommended dose of Finasteride Medreg

If you have taken more than the recommended dose of Finasteride Medreg or if someone else has taken any of your tablets, you should immediately contact the emergency department of your nearest hospital. You should take any remaining tablets or the empty packaging with you to facilitate identification.

Missing a dose of Finasteride Medreg

• If you forget to take a dose, you should skip it.
• You should take the next dose at the usual time.
• You should not take a double dose to make up for the missed dose.

Stopping treatment with Finasteride Medreg

Your condition may improve quickly after taking Finasteride Medreg.
It may take about 6 months to achieve the full effect of treatment. It is important to continue taking Finasteride Medreg for as long as your doctor recommends, even if you do not feel any significant improvement.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Finasteride Medreg can cause side effects, although not everybody gets them.
The following frequency categories have been used to classify the side effects:

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

Other side effects may include:

Common (occurring in less than 1 in 10 patients):

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

Uncommon (occurring in less than 1 in 100 patients):

• ejaculation disorders (which may persist after stopping treatment), breast tenderness or swelling
• skin rash (see above)
• breast tenderness or swelling.

Unknown (frequency cannot be estimated from available data):

• hypersensitivity reactions, including swelling of the lips, tongue, throat, and face (see above)
• testicular pain
• decreased libido, which may persist after stopping treatment
• depression
• impotence, which may persist after stopping treatment
• anxiety
• male infertility and/or poor semen quality. Improvement in semen quality has been reported after stopping treatment.
• palpitations (heart pounding)
• itching, hives (see above)
• changes in liver function, as seen in blood tests, increased liver enzyme activity.

You should immediately inform your doctor of any changes in your breasts, such as lumps, pain, enlargement, or discharge from the nipple, as these may be signs of a serious condition, such as breast cancer.
If any of the side effects get worse or if you notice any side effects not listed in this leaflet, you should tell your doctor or pharmacist. It will be helpful if you note what happened, when it started, and how long it lasted.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 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 Finasteride Medreg

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage.
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 month stated.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Finasteride Medreg contains

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

What Finasteride Medreg looks like and contents of the packaging

Blue, round, film-coated tablets with the inscription "H" on one side and "37" on the other side.
Packaging contains: 7, 10, 14, 15, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 112, 120, 250, 300, 500 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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
To obtain more detailed information about this medicine, you should contact the local representative of the marketing authorization holder.
Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

Date of last revision of the leaflet: 12/2022