Finasteride Normon 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Finasteride Normon 5 mg film-coated tablets EFG

Finasteride

Read the entire leaflet carefully before you start 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Finasteride Normon is and what it is 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 an enlarged prostate. Finasteride 5 mg is used in the treatment and management of benign (i.e. non-cancerous) enlargement of the prostate (benign prostatic hyperplasia - BPH). The prostate is a gland located below the urinary bladder (in men only) that produces the fluid in which sperm are transported. Enlargement of the prostate can lead to a condition called benign prostatic hyperplasia (BPH). Finasteride reduces the size of the enlarged prostate, improves urinary flow and symptoms caused by BPH, and also reduces the likelihood 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 enlarged prostate. This can put pressure on the tube through which urine passes out of the body.

This may 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 stream.
• Interruptions in the flow when urinating.
• Feeling that the bladder has not emptied completely.

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 both conditions can be present at the same time.

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

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

2. What you need to know before starting to take Finasteride NORMON 5 mg tablets

Do not take Finasteride NORMON 5 mg:

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

Do not take finasteride if you are in any of the situations listed above. If you are unsure, speak with 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 volume of urine remaining in your bladder after urination and/or suffer from a significant decrease in urinary flow. In such cases, the possibility of a narrowing of your urinary tract should be monitored.
• If you have impaired liver function. Blood levels of finasteride may be increased in this case.
• If your sexual partner is pregnant or could be pregnant, you must avoid exposing her to your semen, as it may contain a small amount of the medicine.
• If you are due to have a blood test called PSA (a test to detect prostate cancer). Inform your doctor that you are taking finasteride. Finasteride may affect blood levels of the substance being measured, PSA.

Mood disorders and depression

Cases of mood disturbances, such as depressed mood, depression, and less frequently, suicidal thoughts, have been reported 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 for use in children.

Taking Finasteride NORMON with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Finasteride NORMON 5 mg generally 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 need to use any other medicines, including medicines not requiring a prescription.

Taking Finasteride NORMON 5 mg with food and drink:

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 for use in women.

Women who are or may be pregnant must not handle Finasteride NORMON 5 mg tablets, especially if the tablets are broken or crushed. If a pregnant woman absorbs the active substance finasteride orally or through the skin, a male fetus may be born with genital abnormalities. If a pregnant woman comes into contact with broken or crushed Finasteride tablets, speak with her doctor.

If your partner is pregnant or could be pregnant, you must avoid exposing her to your semen (for example, by using a condom) or discontinue treatment with finasteride.

Driving and using machines:

There are no data indicating that Finasteride NORMON 5 mg affects the ability to drive or operate machinery.

Important information about some of the components of Finasteride NORMON 5 mg tablets:

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is considered essentially “sodium-free”.

3. How to take Finasteride Normon

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

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

Although improvement may be seen within a short period of treatment, treatment may need to continue for at least 6 months to determine whether a satisfactory response to treatment has been achieved.

Your doctor will determine the duration of treatment with finasteride. Do not stop treatment prematurely, as symptoms may recur.

Patients with hepatic disorders

There are no data on the use of finasteride in patients with liver disorders (see also “Take special care with Finasteride Normon 5 mg”).

Patients with renal disorders

Dose adjustment is not necessary in patients with renal disorders. The use of finasteride has not been studied in patients requiring hemodialysis.

Elderly patients

Dose adjustment is not necessary in elderly patients.

Consult your doctor or pharmacist if you think that 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 at telephone: 91 562 04 20, indicating the medicine and the amount ingested. Go to your nearest hospital and bring with you any remaining tablets or the empty packaging to assist 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 for your next dose; in that case, continue with your regular dosing schedule.

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 to achieve the full effect. It is important to continue taking finasteride for as long as your doctor directs, 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 adverse effects

Like all medicines, Finasteride Normon 5 mg may cause adverse effects, although not everyone experiences 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 adverse effects are impotence and decreased sexual desire. These effects usually occur at the beginning of treatment, but in most patients they do not persist for long if treatment continues.

Common (may affect up to 1 in 10 people)

• Problems with ejaculation, such as a decrease in the amount of semen released during sexual intercourse. This reduction in semen volume does not appear to affect normal sexual function.
• Difficulty achieving an erection (impotence)
• Decreased sexual desire

Uncommon (may affect up to 1 in 100 people)

• Skin rash
• Problems with ejaculation that may persist after stopping treatment
• Swelling or tenderness of the breasts

Frequency not known:

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

You should immediately inform your doctor of any changes in breast tissue, such as lumps, pain, breast enlargement or nipple discharge, as these may be signs of a serious illness, such as breast cancer.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point located in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Finasterida Normon:

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

The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose (E460), pregelatinized corn starch, sodium starch glycolate from potato (type A), lauroyl macroglycerides, magnesium stearate (E572).

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

Appearance of the product and contents of the container of Finasterida Normon:

Film-coated tablet.

Finasterida Normon 5 mg tablets are blue, round, biconvex, film-coated tablets, marked with "F5" on one side.

Finasterida Normon 5 mg tablets are supplied in opaque white PVC-PVdC/aluminum blister packs containing 28 tablets.

Only certain 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 medicinal product is authorized in EEA Member States under the following names:

Date of the last revision of this leaflet: September 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es