Leaflet: Information for the user

Finasteride Stada 1 mg Film-coated Tablets EFG

Read this leaflet carefully before you start taking the 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 or pharmacist.

- This medicine has been prescribed for you only. Do not give it to others, 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 not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Finasteride Stada.

3. How to take Finasteride Stada.

4. Possible side effects.

5. Storage of Finasteride Stada.

6. Contents of the pack and additional information

Finasterida must only be used by males, not by females or children.

Finasterida Stada contains a substance called finasteride. Finasteride is used for the treatment of the early stages of male pattern hair loss (also known as androgenetic alopecia) in males aged 18-41 years.

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

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

Do not take Finasterida Stada:

- If you are allergic to finasteride or any of the other components of this medication (listed in section 6).

- If you are a woman (also see “pregnancy and breastfeeding”). Finasteride 1 mg has been observed to be ineffective in the treatment of hair loss (androgenetic alopecia) in women in clinical studies.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Finasterida Stada

Finasterida Stada should not be used in children and adolescents (<18

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

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 disease, such as breast cancer.

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

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

Finasteride may affect fertility in men. Male patients planning to have 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 Finasterida Stada. If you experience any of these symptoms, stop taking Finasterida Stada and consult your doctor as soon as possible.

Other medications and Finasterida Stada

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

Finasteride usually does not interfere with other medications.

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

Use of Finasterida Stada with food and beverages

Finasterida Stada can be taken with or without food.

Pregnancy and breastfeeding

Finasteride should not be used by women. Pregnant women should not handle broken or crushed finasteride tablets. If a pregnant woman with a male fetus absorbs finasteride through the skin or ingests it orally, her child may be born with genital organ 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, avoid exposure to semen (e.g., by using a condom) or discontinue finasteride treatment.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Finasterida Stada contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

Follow exactly the administration instructions for this medication as 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 given by your doctor. Do not change the dose or interrupt treatment without consulting your doctor first.

Finasterida 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 must take this medication daily for 3-6 months or more. You and your doctor can determine if the treatment with finasterida has been effective. During treatment with finasterida, there is no need to change how you care for your hair.

Tablet Taking

?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 Finasterida Stada Than You Should

If you have taken an accidental overdose of tablets, contact your doctor or hospital. In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: (91) 562 04 20, indicating the medication and the amount administered.

If You Forget to Take Finasterida Stada

Do not take a double dose to compensate for the missed doses. Simply take the next tablet at the usual time.

If You Interrupt Treatment with Finasterida Stada

To maintain the benefits of treatment, it is recommended to continue treatment. If you interrupt treatment with Finasterida Stada, any improvement in hair density achieved during treatment will be lost within a time frame of 9 to 12 months.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

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

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

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

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

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

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

- Decreased libido.

- Depression.

- Difficulty achieving an erection.

- Difficulty with ejaculation, such as reduced semen volume.

Unknown frequency (the frequency cannot be estimated from the available data):

- Allergic reactions such as rashes, itching, skin swelling (hives).

- Breast tenderness or sensitivity.

- Testicular pain.

- Tachycardia (rapid heartbeat).

- Persistent difficulty achieving an erection after treatment discontinuation

- Persistent decrease in libido after treatment discontinuation.

- Persistent problems with ejaculation after treatment discontinuation

- Infertility has been reported in men under long-term treatment with finasteride and who had other factors that could affect fertility. Normalization and improvement of semen quality have been reported after finasteride treatment discontinuation. No long-term clinical studies have been conducted on the effect of finasteride on male fertility.

- Elevated liver enzymes.

- Anxiety.

Reporting of side effects

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

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

Do not use Finasterida Stada after the expiration date that appears on the packaging, after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

HDPE plastic container with a screw cap (LDPE)

Use within 4 months after the first opening of the container.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers 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 containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Finasterida Stada

The active ingredient is finasteride.

Each tablet contains 1 mg of finasteride.

The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, lauril macroglycérides, 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 contents of the packaging

Finasterida STADA 1 mg film-coated tablets are round, biconvex, brown-red tablets with the mark “F1” on one face.

Finasterida STADA is available in packaging of

Blister (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

All authorized formats will not be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

STADA, S.L.

Frederic Mompou 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Responsible 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

Last review date of this leaflet:October 2019

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