FINASTERIDE STADA 1 mg FILM-COATED TABLETS

Introduction

Leaflet: Information for the user

Finasteride Stada 1 mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take the medicine, as 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 or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

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

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

Male pattern hair loss is a common disorder caused by a combination of genetic factors and a specific hormone called dihydrotestosterone (DHT). DHT contributes to reducing the hair growth phase and makes the hair thinner.

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

2. What you need to know before taking Finasteride Stada

Do not take Finasteride Stada:

• If you are allergic to finasteride or any other component of this medicine (listed in section 6).
• If you are a woman (see also "pregnancy and breastfeeding"). Finasteride 1 mg has been shown to be ineffective in treating hair loss (androgenetic alopecia) in women in clinical trials.

Finasteride should not be used by men who take other medicines containing finasteride or other 5α-reductase inhibitors for benign prostatic hyperplasia or any other condition.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Finasteride Stada.

Finasteride Stada should not be used in children and adolescents (<18 years).< p>

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

You should inform your doctor as soon as possible about any changes in breast tissue, such as lumps, pain, enlargement of the breast, or nipple discharge, as these can be signs of a serious disease, 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, you should inform your doctor that you are taking Finasteride Stada.

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

Finasteride may affect fertility in men. Male patients who are planning to have a child should consider stopping 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 Stada. If you experience any of these symptoms, stop taking Finasteride Stada and consult your doctor as soon as possible.

Other medicines and Finasteride Stada

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Finasteride does not usually interfere with other medicines.

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

Use of Finasteride Stada with food and drinks

Finasteride Stada can be taken with or without food.

Pregnancy and breastfeeding

Finasteride should not be used by women. Women who are or may be pregnant should not handle broken or crushed finasteride tablets. If a pregnant woman of a male fetus absorbs finasteride through the skin or after oral ingestion, her son may be born with genital abnormalities. The tablets are coated to prevent contact with finasteride as long as the tablets are not broken or crushed.

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

There is no evidence to suggest that finasteride can affect the ability to drive or operate machines.

Finasteride Stada contains lactose and sodium

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

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

3. How to take Finasteride Stada

Follow the instructions for administration of this medicine indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Unless your doctor tells you otherwise, the usual dose for all patients is one tablet per day.

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

Finasteride will not work faster or better by taking more than one tablet per day. To achieve an increase in hair density or reduce hair loss, you should take this medicine daily for 3-6 months or more. You and your doctor can determine if treatment with finasteride has been effective. During treatment with finasteride, it is not necessary to change the way you care for your hair.

Taking the tablets

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

? They should not be broken or crushed.

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

If you take more Finasteride 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, phone: (91) 562 04 20, indicating the medicine and the amount administered.

If you forget to take Finasteride Stada

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

If you stop treatment with Finasteride Stada

To maintain the benefit of treatment, continued use is recommended. If you stop treatment with Finasteride Stada, any improvement in hair density achieved during treatment will be lost within 9-12 months.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets 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

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

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

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

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

• Decreased sexual desire.
• Depression.
• Difficulty having an erection.
• Difficulty with ejaculation, such as reduced semen volume.

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

• Allergic reactions, such as rash, itching, skin swelling (hives).
• Breast tenderness or enlargement.
• Testicular pain.
• Tachycardia (rapid heart rate).
• Persistent difficulty having an erection after stopping treatment.
• Persistent decreased sexual desire after stopping treatment.
• Persistent problems with ejaculation after stopping treatment.
• Infertility has been reported in men under long-term treatment with finasteride who had other risk factors that could affect fertility. Improvement and normalization of semen quality have been reported after stopping finasteride treatment. No long-term clinical studies have been conducted on the effect of finasteride on male fertility.
• Increased liver enzymes.
• Anxiety.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the national reporting system included in the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Finasteride Stada

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

Do not use Finasteride Stada after the expiration date stated on the packaging, after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Plastic container (HDPE) with screw cap (LDPE)

Use within 4 months after first opening the container.

Medicines should not be disposed of via wastewater or household waste. Dispose of the container and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the container and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Finasteride Stada

The active ingredient is finasteride.

Each tablet contains 1 mg of finasteride.

The other ingredients are:

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

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

Appearance of the product and package contents

Finasteride STADA 1 mg film-coated tablets are round, biconvex, reddish-brown, and bear the mark "F1" on one side.

Finasteride STADA is available in:

Blister packs (Aluminum/PVC; Aluminum/Aluminum)

Formats:

7, 14, 28, 30, 84, 98, 100 film-coated tablets

Plastic container (HDPE) with screw cap (LDPE)

Formats:

7, 14, 28, 30, 84, 98, 100 film-coated tablets

Not all authorized formats will be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorio STADA, S.L.

C/ Frederic Mompou 5

08960 Sant Just Desvern (Barcelona)

[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

Date of the last revision of this leaflet:October 2019

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