FINASTERIDE SANDOZ 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Finasteride Sandoz 1 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Finasteride Sandoz and what is it used for
2. What you need to know before taking Finasteride Sandoz
3. How to take Finasteride Sandoz
4. Possible side effects
5. Storage of Finasteride Sandoz
6. Package contents and additional information

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

Finasteride Sandoz is for exclusive use in men and its use is not indicated in women or children (under 18 years).

Finasteride Sandoz contains a medication called finasteride. This medication is used to treat the early stages of male pattern hair loss (also known as androgenetic alopecia) in men between 18 and 41 years old. If after reading this package leaflet you have any questions regarding male pattern hair loss, consult your doctor.

Male pattern hair loss is a common disorder that is believed to be caused by a combination of genetic factors and a particular hormone, called dihydrotestosterone (DHT). The hormone DHT contributes to shortening the hair growth phase and making the hair thinner.

In the scalp, finasteride decreases the levels of the hormone DHT by blocking the enzyme (type II 5-alpha reductase) that converts testosterone into DHT. Only men with mild to moderate alopecia who have not lost all their hair or have lost it on both sides of the head may expect to benefit from the use of finasteride. In most men who have been treated with finasteride for 5 years, hair loss slowed down and, in at least half of these men, hair growth also improved to some extent.

2. What you need to know before taking Finasteride Sandoz

Do not take Finasteride Sandoz

• if you are a woman (see also the section "Pregnancy, breastfeeding, and fertility"). Clinical trials have shown that finasteride is ineffective in treating hair loss (androgenetic alopecia) in women,
• if you are allergic (hypersensitive) to finasteride or any of the other components of this medication (listed in section 6),
• men being treated with any other medication containing finasteride or any other 5-alpha reductase inhibitor for benign prostatic hyperplasia or any other condition should not take finasteride.

Warnings and precautions

Consult your doctor or pharmacist before starting to take finasteride.

Mood changes and depression

Mood changes, such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with finasteride. If you experience any of these symptoms, stop taking this medication and consult your doctor as soon as possible to seek medical advice.

Effects on Prostate-Specific Antigen (PSA)

Finasteride may affect a blood test called PSA (Prostate-Specific Antigen) for detecting prostate cancer. If you have had a PSA test, you should inform your doctor that you are taking finasteride because it decreases PSA levels.

The determination of prostate-specific antigen in serum should be performed before starting treatment with finasteride and during treatment.

Breast cancer

Breast cancer has been reported during the post-marketing period in men taking finasteride 1 mg. Doctors should inform their patients to immediately report any changes in breast tissue, such as lumps, pain, breast enlargement (gynecomastia), or nipple discharge (see section 4).

Children and adolescents

Finasteride should not be used in children. There is no data demonstrating the efficacy and safety of finasteride in children under 18 years old.

Other medications and Finasteride Sandoz

Finasteride Sandoz does not usually interfere with treatment with other medications.

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication.

Taking Finasteride Sandoz with food and drinks

Finasteride Sandoz can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Finasteride is intended for the treatment of male pattern hair loss exclusively in men. For effects on fertility in men, see section 2.

• Women should not use finasteride due to the risk during pregnancy.
• Pregnant women should not touch crushed or broken Finasteride Sandoz tablets.
• If a pregnant woman with a male fetus absorbs the active ingredient of Finasteride Sandoz after ingesting it orally or through the skin, her son may be born with genital anomalies.
• If a pregnant woman comes into contact with the active ingredient of Finasteride Sandoz, she should consult a doctor.
• The tablets of Finasteride Sandoz are film-coated to prevent contact with the active ingredient during normal handling.

It is not known whether finasteride is excreted in breast milk.

Effects on fertility

Infertility has been reported in men who took finasteride for a long period and had other risk factors affecting fertility. Normalization and improvement of semen quality have been reported after discontinuation of finasteride. Long-term studies have been conducted on the effect of finasteride on fertility in men.

In case of doubt, ask your doctor.

Driving and using machines

There is no data indicating that finasteride affects the ability to drive or use machines.

Finasteride Sandoz contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

3. How to take Finasteride Sandoz

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

Unless your doctor tells you otherwise, the usual dose is 1 tablet per day.

Do not change the dose or stop taking this medication without consulting your doctor first.

To achieve greater hair thickness or reduce hair loss, you should take this medication every day for 3 to 6 months or more. You and your doctor should then assess whether treatment with finasteride is beneficial for you. You do not need to make any changes to your usual hair care during treatment with finasteride.

If you feel that the effect of this medication is too weak or too strong, please consult your doctor or pharmacist.

The tablets should be swallowed whole with a little water. They should not be broken or crushed. You can take the tablets with food or on an empty stomach.

If you take more Finasteride Sandoz than you should

If you accidentally take too many tablets, please contact your doctor or hospital immediately for advice. This medication will not work faster or better if you take more than one tablet per day.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Finasteride Sandoz

Do not take a double dose to make up for forgotten doses. Just take the next tablet at the usual time and continue your treatment as normal.

If you stop taking Finasteride Sandoz

To maintain the benefit of treatment, continuous use of this medication is recommended. If you stop taking finasteride, you will likely lose any increase in hair thickness you have experienced within 9 to 12 months after stopping treatment.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

The nature of the side effects of finasteride is usually mild and temporary.

Stop taking finasteride and inform your doctor immediately if you experience any of the following symptoms (angioedema): swelling of the lips, face, tongue, or throat; difficulty swallowing; hives; and difficulty breathing.The frequency is unknown (cannot be estimated from the available data).

You should inform your doctor immediately if you notice any changes 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.The frequency is unknown (cannot be estimated from the available data).

Side effects have normally been temporary with continued treatment or have disappeared once treatment was stopped.

Uncommon (may affect up to 1 in 100 people)

• decreased sexual desire,
• depression,
• difficulty getting an erection,
• difficulty ejaculating, such as decreased semen volume.

Frequency not known (cannot be estimated from the available data)

• allergic reactions, including rash and itching,
• swelling or tenderness of the breasts,
• testicular pain,
• blood in the semen,
• rapid heartbeat,
• persistent difficulty maintaining an erection after stopping treatment,
• persistent decreased sexual desire after stopping treatment,
• persistent ejaculation problems after stopping treatment,
• male infertility and/or poor semen quality,
• elevated liver enzymes,
• anxiety,
• suicidal thoughts.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Finasteride Sandoz

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the packaging and on the blister or bottle after "EXP". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

HDPE containers with a screw cap of LDPE: use within 4 months after first opening the container.

Medications should not be disposed of through wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Finasteride Sandoz

• The active ingredient is finasteride. Each film-coated tablet contains 1 mg of finasteride.
• The other ingredients are:
• • Tablet core: lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, lauryl macrogolglycerides, sodium carboxymethyl cellulose (Type A) of potato, and magnesium stearate (E572).
  • Tablet coating: hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), and macrogol 6000.

Appearance of the product and package contents

Round, biconvex tablets, reddish-brown in color, and bear the imprint "F1" on one side.

Finasteride Sandoz 1 mg film-coated tablets are available in the following formats:

Blister packs (aluminum/PVC, aluminum/aluminum): 7, 14, 28, 30, 56, 84, and 98 film-coated tablets.

HDPE containers with a screw cap of LDPE: 7, 14, 28, 30, 56, 84, and 98 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Manufacturer

Lek Pharmaceuticals d.d.

Verovskova 57

1526 Ljubljana

Slovenia

or

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

39179 Barleben

Germany

or

Lek S.A.

ul. Podlipie

95-010 Strykow

Poland

or

Actavis Group PTC ehf

Reykhavikurvegur 76 - 78

220 Hafnarfjordur

Iceland

or

Zentiva k.s.

U Kabelovny 130

102 37 Praha 10

Czech Republic

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany: Finasterid-1A PharmA 1 mg film-coated tablets

France: Finasteride Sandoz 1mg, film-coated tablet

Italy: FINACAPIL

This package leaflet was approved in:March 2025

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