Finasteride Stada 1 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Finasteride Stada 1 mg Film-coated Tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What is Finasterida Stada and what is it used for?

Finasteride must be used only by males, not by women or children.

Finasterida Stada contains a substance called finasteride. Finasteride is used for the treatment of early stages of male-pattern hair loss (also called androgenetic alopecia) in men aged 18 to 41 years. If, after reading this leaflet, you have questions about male-pattern hair loss, consult your doctor.

Male-pattern hair loss is a common condition caused by a combination of genetic factors and a specific hormone called dihydrotestosterone (DHT). DHT contributes to shortening the hair growth phase, causing the hair to become thinner.

In the scalp, finasteride specifically reduces levels of DHT by blocking an enzyme (Type II 5α-reductase) that converts testosterone into DHT. Only men with mild to moderate, but not complete, hair loss, or bitemporal recession, can expect to benefit from the use of finasteride. In the majority of men treated with finasteride for 5 years, progression of hair loss slowed, and at least half of these men experienced some degree of improvement in hair growth.

2. What you need to know before taking Finasterida Stada

DO NOT take Finasterida Stada:

• If you are allergic to finasteride or to any of the other ingredients of this medicine (listed in section 6).
• If you are a woman (see also “Pregnancy and breastfeeding”). Clinical studies have shown that Finasteride 1 mg is not effective in the treatment of hair loss (androgenetic alopecia) in women.
• If you are a man taking other medicines containing finasteride or other 5α-reductase inhibitors for benign prostatic hyperplasia or any other condition.

Warnings and precautions

Talk to your doctor or pharmacist before starting Finasterida Stada.

Finasterida Stada should not be used in children and adolescents (< 18 years of age).

Women who are or may be pregnant must not handle crushed or broken finasteride tablets. There is a possibility that finasteride could be absorbed through the skin, which may interfere with the development of external genitalia in a male embryo. Pregnant women who come into contact with finasteride (active substance) should inform their doctor immediately.

You should inform your doctor as soon as possible 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.

Finasteride tablets may affect the results of a blood test called PSA. If you have had a blood test to check your prostate, inform your doctor that you are taking finasteride.

Serum prostate-specific antigen (PSA) measurement should be performed before starting treatment with finasteride and during treatment.

Finasteride may affect fertility in men. Male patients planning to father a child should consider discontinuing treatment.

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 finasteride and consult your doctor as soon as possible.

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

A patient reminder card is provided with the finasteride packaging to highlight the above points.

Other medicines and Finasterida Stada

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

Finasteride is not usually known to interfere with other medicines.

There are no available data on the use of finasteride in combination with topical minoxidil (applied to the skin) for male pattern hair loss.

Use of Finasterida Stada with food and drinks

Finasteride may be taken with or without food.

Pregnancy and breastfeeding

Finasterida Stada must not be used by women. Women who are or may be pregnant must not handle finasteride tablets, especially if they are broken or crushed. If a pregnant woman carrying a male fetus absorbs finasteride through the skin or by oral ingestion, her baby boy may be born with abnormalities of the genital organs. The tablets are film-coated to prevent contact with finasteride, provided the tablets are not broken or crushed.

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

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

There is no evidence to suggest that finasteride may affect the ability to drive or operate machinery.

Finasterida Stada contains lactose and sodium

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 23 mg of sodium (1 mmol) per tablet, which is essentially “sodium-free”.

3. How to take Finasterida Stada

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

Unless otherwise directed by your doctor, the usual dose for all patients is one tablet daily.

Follow your doctor's instructions. Do not change the dose or stop treatment without first consulting your doctor.

Finasteride will not work faster or better if you take more than one tablet a day. To achieve an increase in hair density or reduce hair loss, you must take this medicine daily for 3–6 months or longer. You and your doctor will be able to determine whether finasteride treatment has been effective. During treatment with finasteride, there is no need to change the way you care for your hair.

Taking the tablets

? The tablets should be swallowed whole with a little water.

? They must not be broken or crushed.

? They can be taken with food or on an empty stomach.

If you take more Finasterida Stada than you should

If you have accidentally taken more tablets than you should, contact your doctor or hospital. In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service at telephone: (91) 562 04 20, indicating the medicine and the amount taken.

If you forget to take Finasterida Stada

Do not take a double dose to make up for forgotten doses. Take the next tablet at your usual time.

If you stop taking Finasterida Stada

To maintain the benefits of treatment, continued use is recommended. If you stop treatment with finasteride, any improvement in hair density achieved during treatment will be lost within 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, this medicine can cause adverse effects, although not everyone will experience them.

You should stop taking finasteride and consult your doctor immediately if you experience symptoms of angioedema (frequency not known [frequency cannot be estimated from available data]), such as:

• swollen face, lips, tongue or throat
• difficulty swallowing
• hives
• difficulty breathing

Stop taking finasteride and speak to your doctor if you experience:

• suicidal thoughts

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 disease, such as breast cancer.

The possible adverse effects of finasteride are generally mild and temporary.

Adverse effects have usually been temporary with continued treatment or disappeared when treatment was stopped.

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

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

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

• allergic reactions such as rashes, itching, skin swelling (urticaria)
• breast tenderness or enlargement
• testicular pain
• tachycardia (rapid heartbeat)
• persistent difficulty achieving an erection after stopping treatment
• persistent decrease in sexual desire after stopping treatment
• persistent problems with ejaculation after stopping treatment
• infertility has been reported in men receiving long-term finasteride treatment who also had other risk factors that could affect fertility. Normalization and improvement in semen quality have been reported after stopping finasteride treatment. Long-term clinical studies on the effect of finasteride on male fertility have not been conducted.
• increased liver enzymes
• anxiety
• suicidal thoughts

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in the Spanish System of Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Finasterida Stada

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

Do not use Finasterida Stada after the expiry date stated on the packaging, following “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Plastic container (HDPE) with screw cap (LDPE).

Use within 4 months after first opening the container.

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

6. Contents of the pack and other information

Composition of Finasterida Stada

The active substance is finasteride.

Each tablet contains 1 mg of finasteride.

The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, lauryl macroglycerides, sodium starch glycolate from potato, and magnesium stearate.

Tablet coating: hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), and macrogol 6000.

Appearance of the medicinal product and contents of the pack

Finasterida Stada 1 mg film-coated tablets are round, biconvex, reddish-brown tablets marked with "F1" on one side.

Finasterida Stada is available in the following pack types:

Blister (Aluminum/PVC or Aluminum/Aluminum):
Pack sizes:
7, 14, 28, 30, 84, 98, 100 film-coated tablets

HDPE plastic bottle with LDPE screw cap:
Pack sizes:
7, 14, 28, 30, 84, 98, 100 film-coated tablets

Not all authorized pack sizes will be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.
Frederic Mompou 5
08960 Sant Just Desvern (Barcelona)
Spain
[email protected]

Manufacturer:

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

or

Actavis Group PTC ehf
Reykjavikurvegur 76-78
IS-220 Hafnarfjörður
Iceland

or

Zentiva k.s
U Kabelovny 130
102 37 Praha 10
Czech Republic

This medicinal product is authorized in the European Economic Area member states under the following names:

Denmark: Finastad, filmovertrukne tabletter

France: FINASTERIDE EG 1 mg, comprimé pelliculé

Germany: Finasterid STADA 1 mg Filmtabletten

Iceland: Finasterid STADA 1 mg filmuhúðaðar töflur

Italy: FINASTERIDE EG STADA 1 mg compresse rivestite con film

Spain: Finasterida STADA 1 mg comprimidos recubiertos con película EFG

Sweden: Finasterid Stada, 1 mg filmdragerad tablett

Date of the most recent revision of this leaflet: October 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.gob.es/