Finasteride Kern Pharma 1 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Finasteride Kern Pharma 1 mg film-coated tablets EFG
Finasteride
Read the entire leaflet carefully before you start taking this medicine.
- 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 and you should not give it to others, even if they have the same symptoms, as it may harm them.
- If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Leaflet contents:
- What Finasteride Kern Pharma is and what it is used for
- Before you take Finasteride Kern Pharma
- How to take Finasteride Kern Pharma
- Possible side effects
- How to store Finasteride Kern Pharma
- Further information
1. What Finasteride Kern Pharma is and what it is used for
Finasteride Kern Pharma is for use in men only and must not be taken by women or children.
Finasteride Kern Pharma contains a medicine called finasteride.
Finasteride is used to treat male-pattern hair loss (also known as androgenetic alopecia). If, after reading this leaflet, you have any questions about male-pattern hair loss, please consult your doctor.
Male-pattern hair loss is a common condition 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 causes the hair to become thinner.
In the scalp, finasteride specifically reduces levels of DHT by blocking an enzyme (type II 5-alpha-reductase) that converts testosterone into DHT. Only men with mild to moderate, but not complete, hair loss can expect benefit from using Finasteride Kern Pharma. In many men treated with finasteride for 5 years, 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 medicine is intended for men only, see Pregnancy section). Clinical trials have shown that finasteride is not effective in women with hair loss.
- If you are allergic (hypersensitive) to finasteride or to any of the other components of Finasteride Kern Pharma (listed in section 6). If you are unsure, consult your doctor or pharmacist.
Take special care with Finasteride Kern Pharma
- Children and adolescents under 18 years of age must not take finasteride.
- Inform your doctor or pharmacist about your current and past medical conditions, and any allergies you have experienced.
- If you are due to have a prostate-specific antigen (PSA) test, tell your doctor or pharmacist that you are taking Finasteride, as it may affect the test 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.
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 information card is provided with the Finasteride Kern Pharma packaging, reminding you of the information above.
Use of other medicines
Finasteride Kern Pharma can usually be used together with other medicines. Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained 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 in men only.
- Women must not use finasteride due to the risk during pregnancy.
- Women who are or may be pregnant must not handle crushed or broken finasteride tablets.
- If a pregnant woman absorbs the active ingredient of Finasteride Kern Pharma orally or through the skin, a male fetus may be born with abnormalities of the genital organs.
- If a woman comes into contact with the active substance in Finasteride Kern Pharma, she should consult a doctor.
- Finasteride Kern Pharma tablets are film-coated to prevent contact with the active ingredient during normal handling.
If your partner is pregnant or may be pregnant, you should avoid exposing her to your semen (for example, by using a condom).
If in doubt, consult your doctor.
Driving and using machines
There are no data indicating that finasteride affects the ability to drive vehicles or operate machinery.
Important information about some of the components of Finasteride Kern Pharma
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Finasteride Kern Pharma
Follow exactly the dosing instructions for finasteride provided by your doctor. If you have any doubts, consult your doctor or pharmacist.
- The usual dose is one tablet daily.
- Tablets may be taken with or without food.
- Taking more than one tablet per day will not make finasteride work faster or better.
Your doctor will help determine whether Finasteride Kern Pharma is effective in your case. It is important to take finasteride for the entire duration recommended by your doctor. Finasteride only works long-term if treatment is maintained.
If you take more Finasteride Kern Pharma than you should
If you accidentally take too many tablets, seek medical advice immediately.
In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Finasteride Kern Pharma
- If you miss a dose, skip the missed dose.
- Resume your regular schedule of one tablet per day.
- Do not take a double dose to make up for forgotten doses.
If you stop taking Finasteride Kern Pharma
It may be necessary to take the medication for 3 to 6 months before an effect is noticeable. It is important to try to take finasteride for the full period of time prescribed by your doctor. If you stop taking finasteride, you will likely lose the hair you have gained within 9 to 12 months after stopping treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Finasteride Kern Pharma may cause adverse effects, although not everyone experiences them.
Adverse effects have usually been temporary during continued treatment or disappeared when treatment was discontinued.
Uncommon (occur in less than 1 in 100 patients):
- decreased sexual desire
- difficulty achieving erection
- problems with ejaculation, including a reduction in the amount of semen ejaculated
- depression
Frequency unknown (cannot be estimated from available data):
- allergic reactions including rash, itching, lumps under the skin (hives), and swelling of the lips and face
- breast tenderness and breast enlargement
- testicular pain
- rapid heartbeat
- persistent difficulty in achieving 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 in semen quality has been observed after discontinuation of finasteride. Long-term clinical studies on the effect of finasteride on male fertility have not been conducted.
- elevated liver enzymes
- anxiety
- Suicidal thoughts
You should immediately inform your doctor 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.
Stop taking Finasteride Kern Pharma and contact your doctor immediately if you experience any of the following symptoms:
- swelling of your face, tongue or throat
- difficulty swallowing
- lumps under the skin (hives)
- difficulty breathing
- Suicidal thoughts
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Finasteride Kern Pharma
Keep out of the reach and sight of children.
This medicine does not require any special storage conditions.
Do not use Finasteride Kern Pharma after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This way you can help protect the environment.
6. Additional Information
Composition of Finasteride Kern Pharma
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The active substance is finasteride. Each tablet contains 1 mg of finasteride.
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The other components are:
Tablet core: monohydrate lactose, 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 contents of the container
Film-coated tablet.
Finasteride Kern Pharma 1 mg tablets are orange-pink in color, round, and marked “F1” on one side.
Finasteride Kern Pharma is available in blister packs containing 28 and 98 tablets.
Only certain 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 most recent review of this leaflet: August 2025.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.