FINASTERIDE NORMON 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Finasteride Normon 5 mg Film-Coated Tablets EFG

Finasteride

Read all of this leaflet carefully before taking this medicine, because it contains important information for you.

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

Contents of the Package Leaflet:

1. What is Finasteride Normon and what is it used for
2. What you need to know before taking Finasteride Normon
3. How to take Finasteride Normon
4. Possible side effects
5. Storing Finasteride Normon
6. Contents of the pack and further information.

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

Finasteride belongs to a group of medicines called 5-alpha reductase inhibitors, which work by reducing the size of the prostate in men.

Finasteride 5 mg reduces the size of the prostate when it is enlarged. Finasteride 5 mg is used in the treatment and control of benign prostatic hyperplasia (BPH), a non-cancerous enlargement of the prostate. The prostate is a gland located under the urinary bladder (only in men) that produces the fluid in which sperm are transported. Inflammation of the prostate can lead to a disease called benign prostatic hyperplasia (BPH). Finasteride reduces the size of the enlarged prostate, improves urine flow, and the symptoms caused by BPH, and also reduces the risk of developing sudden inability to urinate (known as acute urinary retention) and the need for surgical intervention.

What is BPH?

If you have BPH, it means you have an inflamed prostate. This can put pressure on the tube through which urine passes to leave the body.

This can lead to problems such as:

• Feeling the need to urinate more often, especially at night.
• Feeling the need to urinate immediately.
• Difficulty urinating.
• Weak urine flow.
• Interruptions of urine flow while urinating.
• Feeling that the bladder is not completely empty.

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

• Urinary tract infections
• Sudden inability to urinate
• The need for surgical intervention

What else should you know about BPH?

• BPH is not cancer and does not lead to cancer, but the two conditions can be present at the same time.

• Before starting treatment with finasteride, your doctor will perform some simple tests to check if you have prostate cancer.

Talk to your doctor if you have any questions about this.

2. What you need to know before taking Finasteride Normon 5 mg Tablets

Do not take Finasteride Normon 5 mg:

• If you are allergic to finasteride or any of the other ingredients of this medicine.
• If you are a child.
• If you are a woman (since this medicine is for men)

Do not take finasteride if you are in any of the above situations. If you are not sure, talk to your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Finasteride Normon 5 mg.

• If you have a large amount of urine in the bladder after urinating and/or you have a significant decrease in urine flow. In these cases, you should be monitored for the possibility of a narrowing of your urinary tract.
• If you have liver function disorders. The level of finasteride in the blood may be increased in this case.
• If your sexual partner is or may be pregnant, you should avoid exposing her to your semen (e.g., by using a condom) or stop treatment with finasteride.
• If you are going to have a blood test called PSA (a test to detect prostate cancer). Tell your doctor that you are taking finasteride. Finasteride may affect the levels in the blood of the substance being analyzed, PSA.

Mood changes and depression

There have been reports of mood changes, such as depressed mood, depression, and less frequently, suicidal thoughts, in patients treated with Finasteride Normon 5 mg tablets.

If you experience any of these symptoms, contact your doctor for further medical advice as soon as possible.

Children

Finasteride Normon 5 mg is not indicated in children.

Taking Finasteride Normon with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines.

Finasteride Normon 5 mg usually does not interfere with other medicines. No significant interactions with other medicines have been identified. Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicine, including medicines that do not require a prescription.

Taking Finasteride Normon 5 mg with food and drinks:

Finasteride Normon 5 mg can be taken with or without food.

Pregnancy, breastfeeding, and fertility:

Finasteride Normon 5 mg is for use in men only.

Finasteride Normon 5 mg is not indicated in women.

Pregnant women should not handle Finasteride Normon 5 mg, especially if the tablets are broken or crushed. If a pregnant woman with a male fetus absorbs the active ingredient finasteride after taking it orally or through the skin, the baby may be born with genital anomalies. If a pregnant woman comes into contact with broken or crushed Finasteride tablets, she should talk to her doctor.

If your partner is or may be pregnant, you should avoid exposing her to your semen (e.g., by using a condom) or stop treatment with finasteride.

Driving and using machines:

There is no data to indicate that Finasteride Normon 5 mg affects the ability to drive and use machines.

Important information about some of the ingredients of Finasteride Normon 5 mg tablets:

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, talk to them before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Finasteride Normon

Follow exactly the instructions of your doctor for taking this medicine. If you are not sure, talk to your doctor or pharmacist again.

The recommended dose is one tablet a day (equivalent to 5 mg of finasteride).

The film-coated tablets can be taken with or without food. This medicine is for oral use; the tablets should be swallowed whole and not broken or crushed. Your doctor may prescribe finasteride along with another medicine (called doxazosin) to help you better control your BPH.

Although an improvement can be seen in a short period of treatment, it may take at least 6 months of treatment to determine if a satisfactory response to treatment has been achieved.

Your doctor will tell you how long to take finasteride. Do not stop treatment before then, as symptoms may return.

Patients with liver disorders

There is no data on the use of finasteride in patients with liver disorders (see also "Be careful with Finasteride Normon 5 mg").

Patients with kidney disorders

No dose adjustment is necessary in patients with kidney disorders. The use of finasteride has not been studied in patients who require hemodialysis.

Patients of advanced age

No dose adjustment is necessary in patients of advanced age.

Talk to your doctor or pharmacist if you think the effect of finasteride is too strong or too weak.

If you take more Finasteride Normon than you should:

If you have taken more finasteride than prescribed, or if someone else has taken any amount of finasteride, call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken. Go to your nearest hospital and take all the remaining tablets or the empty package to facilitate identification.

If you forget to take Finasteride Normon

If you forget to take a dose of finasteride 5 mg, take it as soon as you remember, unless it is almost time to take the next dose; in that case, continue with the treatment as usual.

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

If you stop taking Finasteride Normon:

Your condition may show early improvement after taking finasteride. However, it may take at least six months for the full effect to occur. It is important to continue taking finasteride for the time your doctor indicates, even if you do not feel any immediate benefit.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Finasteride Normon 5 mg can cause side effects, although not everybody gets them.

Stop taking finasteride and contact your doctor immediately if you experience any of the following symptoms (angioedema):

• Swelling of the face, tongue, or throat
• Difficulty swallowing
• Hives and difficulty breathing

The most common side effects are impotence and decreased libido. These effects usually occur at the start of treatment but do not usually persist for long if treatment continues.

Frequent (may affect up to 1 in 10 patients)

• Problems with ejaculation, such as a decrease in the amount of semen released during sex. This decrease in semen does not seem to affect normal sexual function.
• Difficulty getting an erection (impotence)
• Decreased libido

Uncommon (may affect up to 1 in 100 patients)

• Rash
• Ejaculation problems that may persist after stopping treatment
• Breast tenderness or enlargement

Frequency not known:

• Itching, hives
• Palpitations (perception of heartbeat)
• Swelling of the tongue, face, or throat, difficulty swallowing, and difficulty breathing (angioedema)
• Changes in liver function, which can be detected with a blood test
• Testicular pain
• Difficulty getting an erection that may persist after stopping treatment
• Male infertility and/or decreased semen quality. Improvements in semen quality have been observed after stopping treatment
• Depression
• Decreased libido that may persist after stopping treatment
• Anxiety

You should immediately inform your doctor of any change in breast tissue, such as lumps, pain, breast enlargement, or nipple discharge, as these can be signs of a serious disease, such as breast cancer

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if you think they are not serious. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Finasteride Normon Tablets

• 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 expiration date stated on the package after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the package and any unused medicine in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the package and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Finasteride Normon:

The active ingredient is finasteride. Each film-coated tablet contains 5 mg of finasteride.

The other ingredients are:

Core of the tablet:lactose monohydrate, microcrystalline cellulose (E460), pregelatinized corn starch, sodium starch glycolate (type A), lauroyl macrogolglycerides, magnesium stearate (E572).

Coating:hypromellose (E464), titanium dioxide (E171), indigo carmine (E132), macrogol 6000.

Appearance of the product and pack contents of Finasteride Normon:

Film-coated tablet.

Finasteride Normon 5 mg tablets are film-coated, blue, round, biconvex, and have "F5" engraved on one side.

Finasteride Normon 5 mg tablets are available in white, opaque PVC-PVdC/Aluminum blister packs of 28 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo 6, 28760 Tres Cantos, Madrid, Spain

Manufacturer

LABORATORIOS NORMON, S.A

Ronda de Valdecarrizo 6, 28760 Tres Cantos, Madrid, Spain

or

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland

or

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

The Netherlands

or

Accord Healthcare Single Member S.A.

64th Km National Road Athens, Lamia, 32009, Greece

This medicine is authorized in the Member States of the EEA under the following names:

Date of the last revision of this leaflet: September 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es