Finasteride Normon 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Finasteride Normon 1 mg film-coated tablets EFG

Finasteride

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you think that any of the side effects you experience is serious or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist. See section 4.

What the leaflet contains:

1. What Finasteride Normon is and what it is used for
2. Before you take Finasteride Normon
3. How to take Finasteride Normon
4. Possible side effects
5. How to store Finasteride Normon
6. Further information

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

Finasteride Normon 1 mg contains an active substance called finasteride. Finasteride belongs to a group of medicines known as 5-alpha reductase inhibitors.

Your doctor has prescribed finasteride 1 mg for the treatment of male pattern hair loss (also known as androgenetic alopecia). Finasteride 1 mg prevents further hair loss in men. Men with mild to moderate hair loss (but not complete baldness) may benefit from using finasteride 1 mg. Finasteride 1 mg blocks an important enzyme (Type II 5α-reductase), which plays a role in regulating the hair follicle.

In the scalp, finasteride 1 mg specifically reduces levels of DHT, one of the main causes of male pattern hair loss. Thus, finasteride 1 mg helps reduce the progression of baldness and prevent further hair loss.

2. Before taking Finasteride Normon 1 mg tablets

Do not take Finasteride Normon 1 mg:

• If you are allergic (hypersensitive) to finasteride or to any of the other ingredients of
  Finasteride Normon 1 mg.

• If you are a woman (also see section ‘Pregnancy, breastfeeding and fertility’). Clinical studies have shown that Finasteride Normon 1 mg tablets are not effective in the treatment of hair loss (androgenetic alopecia) in women.

Warnings and precautions

Consult your doctor or pharmacist before taking Finasteride Normon 1 mg.

Effects on Prostate-Specific Antigen (PSA)

Finasteride Normon 1 mg may affect a blood test known as PSA (Prostate-Specific Antigen) used to detect prostate cancer. If you have had a PSA test, you must inform your doctor or pharmacist that you are taking Propecia, as it reduces PSA levels.

Effects on fertility

Cases of infertility have been reported in adult males who took finasteride for a prolonged period and who had other risk factors that could affect fertility. Normalization or improvement in semen quality has been reported after discontinuation of finasteride treatment. Long-term clinical studies on the effects of finasteride on fertility in adult males have not been conducted.

Breast cancer

See section 4.

Mood changes and depression

Cases of mood alterations, such as depressed mood, depression, and less frequently, suicidal thoughts, have been reported in patients treated with Finasteride Normon 1 mg tablets.

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

Sexual dysfunction has been reported in some patients, which may contribute to mood disturbances, including suicidal thoughts. If you experience symptoms of sexual dysfunction, contact your doctor for additional medical advice. Your doctor may consider discontinuing treatment (see section 4 below for more information on these adverse effects).

A patient information card is provided with the packaging of Finasteride Normon 1 mg tablets, summarizing the above information.

Children and adolescents

Finasteride Normon 1 mg must not be used in children. There are no data demonstrating the efficacy or safety of finasteride in children under 18 years of age.

Other medicines and Finasteride Normon 1 mg:

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

Use of Finasteride Normon 1 mg with food and drinks:

Finasteride Normon 1 mg may be taken with or without food.

Pregnancy, breastfeeding and fertility:

Finasteride Normon 1 mg is indicated for the treatment of male-pattern hair loss only. For effects on fertility in men, see section 2.

• Women must not take Finasteride Normon 1 mg due to the risk during pregnancy.
• Women who are or may be pregnant must not handle crushed or broken Finasteride Normon 1 mg tablets. If a pregnant woman absorbs the active ingredient of Finasteride Normon 1 mg orally or through the skin, a male fetus may be born with abnormalities of the genital organs.
• If a pregnant woman comes into contact with the active substance of Finasteride Normon 1 mg, she must consult a doctor.
• Finasteride Normon 1 mg tablets are film-coated to prevent contact with the active ingredient during normal handling.

Driving and use of machines:

There are no data indicating that Finasteride Normon 1 mg affects the ability to drive or operate machinery.

Important information about certain ingredients of Finasteride Normon 1 mg:

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult 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 Finasterida Normon

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

The recommended dose is one 1 mg finasteride tablet daily (equivalent to 1 mg of finasteride).

Film-coated tablets may be taken with or without food. The coated tablets must be swallowed whole and must not be split or crushed.

• Finasteride does not work better or faster if more than one tablet per day is taken.

• Male pattern hair loss is a condition that develops gradually over a long period of time. Generally, daily use for three to six months may be needed before any increase in hair thickness or reduction in hair loss becomes noticeable.

• Your doctor will help you assess whether finasteride is producing results. It is important to continue taking finasteride for the full duration recommended by your doctor.

Patients with liver disorders

There are no data on the use of finasteride in patients with liver disorders.

Patients with kidney disorders

Dose adjustment is not required in patients with kidney disorders.

If you take more Finasterida 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 number: 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 Finasterida Normon:

If you forget to take a dose of finasteride 1 mg, continue with the next dose as usual. Do not take a double dose to make up for a missed dose.

If you stop taking Finasterida Normon:

Continuous use of finasteride 1 mg is recommended to achieve maximum effect. If treatment is stopped, you are likely to lose the hair regained within the following 9 to 12 months.

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 1 mg can cause adverse effects, although not everyone will experience them. Usually, adverse effects have been temporary during continued treatment or disappeared once treatment was stopped.

Stop taking Finasteride Normon 1 mg and contact your doctor immediately if you experience any of the following:

• Symptoms of an allergic reaction: swelling of the lips, face, tongue, and throat; difficulty swallowing; lumps under the skin (urticaria), and difficulty breathing. Suicidal thoughts.

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

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

• decreased sexual desire
• difficulty achieving an erection
• problems with ejaculation such as reduced amount of semen released during sexual activity
• depression

Frequency not known: frequency cannot be estimated from available data:

• allergic reactions such as skin rash, itching, lumps under the skin (urticaria), and swelling of the lips and face
• breast swelling or tenderness

•

• testicular pain
• blood in the semen
• increased heart rate
• persistent difficulty achieving an erection after stopping treatment
• persistent decrease in sexual desire after stopping treatment
• persistent problems with ejaculation after stopping treatment
• cases of infertility have been reported in men who took finasteride for a long period and who had other risk factors that could affect fertility. Normalization or improvement in semen quality has been observed after stopping finasteride treatment. Long-term clinical studies on the effect of finasteride on male fertility have not been conducted.
• changes in liver function, which may be detected by a blood test
• anxiety
• suicidal thoughts

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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

• 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 is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Finasteride Normon:

The active substance is finasteride.

One film-coated tablet contains 1 mg of finasteride.

The other components are:

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

Coating: hypromellose (E464), titanium dioxide (E171), macrogol 6000, iron oxide red (E172), iron oxide yellow (E172).

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

Film-coated tablet.

Finasteride Normon 1 mg tablets are film-coated, reddish-brown in color, round, biconvex, and marked with 'F1' on one side.

Finasteride Normon 1 mg tablets are available in aluminum/aluminum blister packs containing 28, 30, 84, and 98 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:

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

The Netherlands

or

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 Single Member S.A.

64th Km National Road Athens, Lamia, 32009,

Greece

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

Date of the most recent review of this leaflet: November 2025.

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