Package Leaflet: Information for the User

Finasteride Normon 5 mg Film-Coated Tablets

Finasteride

Read this 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse. See section 4.

Finasterida belongs to a group of medications called 5-alpha reductase inhibitors, which act by reducing the size of the prostate in men.

Finasterida 5 mg reduces the size of the prostate when it is enlarged. Finasterida 5 mg is used in the treatment and control of benign enlargement (i.e., non-cancerous) of the prostate (benign prostatic hyperplasia - BPH). 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). Finasterida reduces the size of the enlarged prostate, improves urine flow, and reduces 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 suffer from BPH, it means that your prostate is inflamed. This can put pressure on the tube through which urine passes to be expelled from the body.

This can lead to problems such as:

• Sensation of needing to urinate more frequently, especially at night.
• Sensation of needing to urinate immediately.
• Difficulty urinating.
• Weak urine flow.
• Interruptions of the urine flow.
• Sensation that the bladder has not been completely emptied.

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

• Urinary tract infections
• Sudden inability to urinate
• Necessity for surgical intervention

What else should be known 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 finasterida, 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.

Do not take Finasterida NORMON 5 mg:

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

Do not take finasteride if you are in any of the above situations. If you are unsure, speak with your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Finasterida NORMON 5 mg.

• If you experience a large volume of urine in the bladder after urinating and/or suffer a significant decrease in urine flow. In these cases, it is necessary to monitor the possibility of a narrowing of your urinary tract.
• If you experience liver function alteration. 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, as it may contain a small amount of the medication.
• If you are to undergo a blood test called PSA (test to detect prostate cancer). Inform your doctor that you are taking finasteride. Finasteride may affect the levels of the substance being analyzed in the blood, PSA.

Mood changes and depression

Cases of mood alteration, such as depressed mood, depression, and less frequently, suicidal thoughts, have been reported in patients treated with Finasterida Normon 5 mg tablets.

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

Children

Finasterida NORMON 5 mg is not indicated for children

Taking Finasterida NORMON with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication.

Finasterida NORMON 5 mg usually does not interfere with other medications. No significant interactions have been identified with other medications. Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including non-prescription medications.

Taking Finasterida NORMON 5 mg with food and drinks:

Finasterida NORMON 5 mg can be taken with or without food.

Pregnancy, breastfeeding, and fertility:

Finasterida NORMON 5 mg is for exclusive use in males.

Finasterida NORMON 5 mg is not indicated for women.

Women who are or may be pregnant should not handle Finasterida 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 oral ingestion or through the skin, the baby may be born with genital organ abnormalities. If a pregnant woman comes into contact with broken or crushed Finasterida tablets, speak with her doctor.

If your partner is or may be pregnant, you should avoid exposure to your semen (for example, by using a condom) or interrupt treatment with finasteride.

Driving and operating machinery:

No data indicate that Finasterida NORMON 5 mg affects the ability to drive and operate machinery.

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

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

This medication contains less than 1 mmol (23 mg) of sodium per tablet, making it essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

Coated tablets can be taken with or without food. This medication is for oral use, tablets must be swallowed whole and should not be broken or crushed. Your doctor may prescribe finasteride along with another medication (called doxazosina), to help you better control your HBP.

Although you may notice an improvement in a short period of treatment, it may be necessary to have treatment for at least 6 months to determine if a satisfactory response to treatment has been achieved.

Your doctor will indicate the duration of treatment with finasteride. Do not discontinue treatment beforehand, as symptoms may reappear.

Patients with liver disorders

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

Patients with renal disorders

No dose adjustment is necessary in patients with renal disorders. Finasteride has not been studied in patients who require hemodialysis.

Patients of advanced age

No dose adjustment is necessary in patients of advanced age.

Consult your doctor or pharmacist if you feel 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Go to your nearest hospital and bring with you all remaining tablets or the empty packaging to facilitate identification.

If you forgot 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 treatment as usual.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with 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 essential to continue taking finasteride for the time indicated by your doctor, even if you do not feel any immediate benefit.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Finasterida Normon 5 mg can cause side effects, although not everyone will experience 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
• Urticaria and difficulty breathing

The most common side effects are impotence and decreased libido. These side effects usually occur at the beginning of treatment, but in most patients, they do not persist for a long time 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 sexual intercourse. This decrease in semen volume does not appear to affect normal sexual function.
• Difficulty achieving an erection (impotence)
• Decreased libido

Rare (may affect up to 1 in 100 patients)

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

Unknown frequency:

• Pruritus, urticaria
• Palpitations (perception of heartbeats)
• Swelling of the tongue, face, or throat, difficulty swallowing, and difficulty breathing (angioedema)
• Changes in liver function, which may be detected by blood tests
• 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 libido 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 they may be signs of a serious disease, such as breast cancer

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• This medication does not require special conditions for conservation.
• Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Finasteride Normon:

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

The other components are:

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

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

Appearance of the product and contents of the package of Finasteride Normon:

Film-coated tablet.

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

Finasteride Normon 5 mg tablets are presented in PVC-PVdC/Aluminum blisters, opaque and white, containing 28 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder:

LABORATORIOS NORMON, S.A.

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

Responsible for manufacturing:

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 the Member States of the EEA with the following names:

Last review date of this leaflet: September 2022

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es