Finasteride Medreg

Package leaflet: Information for the patient

Finasteride Medreg 5 mg film-coated tablets

finasteride
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Finasteride Medreg is and what it is used for
2. What you need to know 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 the active substance finasteride. This active substance belongs to a group of medicines called "5-alpha reductase inhibitors".
Finasteride Medreg works by reducing the size of the prostate gland in men when it is enlarged.
The prostate gland is located below the bladder (but only in men). It produces the fluid found in semen.
An enlarged prostate gland can lead to a condition called "benign prostatic hyperplasia" or BPH.
What is BPH?
If you have BPH, it means your prostate gland is enlarged. It may press on the tube through which urine passes as it leaves the body.
This can lead to problems such as:

• feeling the need to urinate more often, especially at night
• feeling the need to urinate urgently
• difficulty starting to urinate
• weak urine stream when urinating
• urine stream that starts and stops during urination
• feeling that the bladder is not completely emptied

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

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

What else should you know about BPH?

• BPH is not cancer, nor can it turn into cancer; however, both conditions can coexist.
• Before starting Finasteride Medreg, your doctor will perform some simple tests to check for prostate cancer.

For any questions, please consult your doctor.

2. What you need to know before taking Finasteride Medreg

Do not take Finasteride Medreg:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Finasteride Medreg.

• If your partner is pregnant or planning to become pregnant. During treatment with Finasteride Medreg, you must use a condom or another effective contraceptive method. This is because semen may contain a small amount of the medicine, which could affect the normal development of the baby's sex organs.
• If you are due to have a blood test called PSA. This is because Finasteride Medreg can affect the results of this test.

Mood changes and depression
Mood changes such as depressed mood, depression, and less frequently suicidal thoughts, have been reported in patients treated with Finasteride Medreg. If you experience any of these symptoms, consult your doctor as soon as possible for further advice.
If you have any doubts, talk to your doctor or pharmacist before taking Finasteride Medreg.
Children
Finasteride Medreg must not be used in children.
Other medicines and Finasteride Medreg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Finasteride Medreg (finasteride) usually does not interfere with other medicines.
Finasteride Medreg with food and drink
Finasteride Medreg can be taken with or without food.
Pregnancy and breastfeeding
Finasteride Medreg must not be taken by women.

• Do not touch crushed or broken tablets of Finasteride Medreg if you are a woman who is pregnant or planning to become pregnant (the tablets are film-coated to prevent contact with the medicine during normal handling). This is because the medicine may affect the normal development of the baby's sex organs.
• If a pregnant woman comes into contact with crushed or broken Finasteride Medreg tablets, she should consult her doctor.

Driving and using machines
It is unlikely that Finasteride Medreg will affect your ability to drive vehicles or operate tools or machinery.
Finasteride Medreg contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially “sodium-free”.

3. How to take Finasteride Medreg

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Use of the medicine

• The recommended dose is one tablet daily.
• The tablets can be taken with or without food. The tablets must be swallowed whole and must not be divided or crushed.

If you take more Finasteride Medreg than you should
If you have taken more tablets than indicated, or if someone else has taken them, contact the emergency department of the nearest hospital. Bring along any remaining tablets or the empty packaging to assist in identification.
If you forget to take Finasteride Medreg

• If you forget to take a tablet, skip the missed dose.
• Take the next dose as usual.
• Do not take a double dose to make up for the missed dose.

If you stop taking Finasteride Medreg
After starting Finasteride Medreg, you may initially notice an improvement in your condition. However, it may take at least six months to achieve the full effect. It is important to continue taking Finasteride Medreg for the entire duration indicated by your doctor, even if you do not immediately notice any benefit.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you have an allergic reaction, stop taking the medicine and contact your doctor immediately. Signs may include:

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

Other side effects may include:
Common (may affect up to 1 in 10 people):

• changes in ejaculation (such as reduced amount of semen released during intercourse, which does not appear to interfere with normal sexual function)
• impotence (inability to achieve an erection)
• decreased sexual desire.

Uncommon (may affect up to 1 in 100 people):

• problems with ejaculation that may continue after stopping the medicine, swelling or tenderness of the breast.
• skin rash (see above)
• breast tenderness, breast enlargement.

Not known (frequency cannot be estimated from the available data):

• hypersensitivity reactions such as swelling of the lips, tongue, throat and face (see above)
• testicular pain
• decreased sexual desire that may continue after stopping the medicine
• erectile dysfunction that may continue after stopping the medicine
• depression
• anxiety
• male infertility and/or poor semen quality. Improvement in semen quality has been reported after discontinuation of the medicine.
• palpitations (awareness of heartbeat)
• itching, urticaria (see above)
• changes in liver function, which may be detected through blood tests, increased liver enzymes.
• suicidal thoughts

Report immediately to your doctor any changes in breast tissue (mammary gland) such as lumps, pain, enlargement or nipple discharge, as these may be signs of a serious condition such as breast cancer.
If any of the side effects become severe, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist. It may be helpful to record what occurred, when it started and how long it lasted.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Finasteride Medreg

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after “Exp.” and/or “EXP”. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Finasteride Medreg contains

• The active substance is finasteride. Each film-coated tablet contains 5 mg of finasteride.
• The other components are:
  • Tablet core: lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate (type A), docusate sodium, magnesium stearate.
  • Film coating: hypromellose (E464), titanium dioxide (E171), indigotine, indigo carmine on an aluminium base (E132), talc, yellow iron oxide (E172).

Description of the appearance of Finasteride Medreg and package contents
Round, film-coated blue tablets, with "H" engraved on one side and "37" on the other side,
packaged in aluminum/aluminum blisters.
Pack sizes: 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

Manufacturers
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

This medicinal product is authorized in the European Economic Area countries under the
following names:
Italy: Finasteride Medreg
Poland: Finasteride Medreg