FINASTERIDE KERN PHARMA 1 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Finasteride Kern Pharma 1 mg film-coated tablets EFG

Finasteride

Read the entire package leaflet carefully before starting to take the medication.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist. See section 4.

Contents of the package leaflet:

1. What Finasteride Kern Pharma is and what it is used for
2. Before taking Finasteride Kern Pharma
3. How to take Finasteride Kern Pharma
4. Possible side effects
5. Storage of Finasteride Kern Pharma
6. Additional information

1. What Finasteride Kern Pharma is and what it is used for

Finasteride Kern Pharma is for exclusive use in males and should not be taken by women or children.

Finasteride Kern Pharma contains a medication called finasteride.

Finasteride is used for the treatment of male pattern hair loss (also known as androgenetic alopecia). If after reading this package leaflet, you have any questions about male pattern hair loss, ask 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). DHT contributes to shortening the hair growth phase and makes the hair thinner.

In the scalp, finasteride specifically decreases DHT levels by blocking an enzyme (type II 5-alpha-reductase) that converts testosterone to DHT. Only men with mild to moderate hair loss, but not complete, can expect a benefit from using Finasteride Kern Pharma. In many of the men treated with finasteride for 5 years, the progression of hair loss slowed down, and in at least half of these men, hair growth also improved to some extent.

2. Before taking Finasteride Kern Pharma

Do not take Finasteride Kern Pharma

• If you are a woman (because this medication is for men, see section Pregnancy). Clinical trials have shown that finasteride is not effective in women with hair loss.
• If you are allergic (hypersensitive) to finasteride or any of the other components of Finasteride Kern Pharma (listed in section 6). If you are unsure, consult your doctor or pharmacist.

Be careful with Finasteride Kern Pharma

• Children and adolescents under 18 years of age should not take finasteride.
• Tell your doctor or pharmacist about your current and past medical problems and any allergies you have suffered from.
• If you are going to have a prostate-specific antigen (PSA) test, tell your doctor or pharmacist that you are taking Finasteride, as it may affect the results.

Mood changes and depression

Mood changes, such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with Finasteride Kern Pharma. If you experience any of these symptoms, stop taking Finasteride Kern Pharma and consult your doctor as soon as possible.

Use of other medications

Finasteride Kern Pharma can be used normally with other medications. Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Taking Finasteride Kern Pharma with food and drinks

Finasteride Kern Pharma can be taken with or without food.

Pregnancy and breastfeeding

Finasteride is intended for the treatment of male pattern hair loss exclusively in males.

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

If your partner is or may be pregnant, you should avoid exposing her to your semen (e.g., by using a condom).

In case of doubt, ask your doctor.

Driving and using machines

There are no data to indicate that finasteride affects the ability to drive vehicles or operate machines.

Important information about some of the components of Finasteride Kern Pharma

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

3. How to take Finasteride Kern Pharma

Follow the exact administration instructions for finasteride indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

• The normal dose is one tablet per day.
• The tablets can be taken with or without food.
• Finasteride will not work faster or better by taking more than one tablet per day.

Your doctor will help you determine if Finasteride Kern Pharma is effective in your case. It is essential to take finasteride for the entire time your doctor indicates. Finasteride only works in the long term if its administration is maintained.

If you take more Finasteride Kern Pharma than you should

If you take too many tablets by mistake, go to the doctor immediately.

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 Kern Pharma

• If you forget a dose, skip the missed dose.
• Resume your regular regimen of one tablet once a day.
• Do not take a double dose to make up for missed doses.

If you stop treatment with Finasteride Kern Pharma

To appreciate the effect, it may be necessary to take the medication for 3 to 6 months. It is essential that you try to take finasteride for the entire period indicated by your doctor. If you stop taking finasteride, you will likely lose the hair you have gained in the 9 to 12 months following treatment interruption.

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

4. Possible side effects

Like all medications, Finasteride Kern Pharma can cause side effects, although not everyone will experience them.

Side effects have usually been transient with continued treatment or have disappeared when treatment is interrupted.

Uncommon (occurring in less than 1 to 100 patients):

• decreased sexual desire
• difficulty getting an erection
• problems with ejaculation, including a decrease in the amount of semen ejaculated
• depression

Frequency unknown (cannot be estimated from available data):

• allergic reactions, including rash, itching, hives, and swelling of the lips and face
• breast tenderness and enlargement
• testicular pain
• rapid heartbeat
• persistent difficulty having an erection after stopping treatment
• infertility has been observed in men who took finasteride for a long time and had other risk factors that could affect fertility. Normalization or improvement of semen quality has been observed after stopping finasteride. No long-term clinical studies have been conducted on the effect of finasteride on male fertility.
• elevated liver enzymes
• anxiety

You should immediately inform your doctor of 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.

Stop taking Finasteride Kern Pharma and inform your doctor immediately if you experience any of the following symptoms:

• swelling of your face, tongue, or throat
• difficulty swallowing
• hives
• difficulty breathing

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Finasteride Kern Pharma

Keep out of the reach and sight of children.

This medication does not require special storage conditions.

Do not use Finasteride Kern Pharma after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any questions, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional information

Composition of Finasteride Kern Pharma

• The active ingredient is finasteride. Each tablet contains 1 mg of finasteride.

• The other components are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose (E-460), pregelatinized corn starch, sodium starch glycolate type A (potato starch), sodium lauryl sulfate, magnesium stearate (E-470b).

Coating: talc, hypromellose (E-464), propylene glycol, titanium dioxide (E-171), yellow iron oxide (E-172), and red iron oxide (E-172).

Appearance of the product and packaging content

Film-coated tablet.

The tablets of Finasteride Kern Pharma 1 mg are orange-pink, round, and have "F1" engraved on one side.

Finasteride Kern Pharma is available in blister packs of 28 and 98 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the last revision of this package leaflet: August 2018.

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