FINASTERIDE CINFA 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

finasteride cinfa 1 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

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

Contents of the Package Leaflet

1. What is finasteride cinfa and what is it used for
2. What you need to know before taking finasteride cinfa
3. How to take finasteride cinfa
4. Possible side effects
5. Storage of finasteride cinfa
6. Contents of the pack and further information

1. What is finasteride cinfa and what is it used for

Finasteride cinfa contains the active ingredient finasteride.

Finasteride cinfa is for use in men only.

Finasteride is used to treat male pattern hair loss (also known as androgenetic alopecia) in men aged 18 to 41 years. If you have any questions about male pattern hair loss after reading this package leaflet, consult your doctor.

Male pattern hair loss is a common disorder that is thought 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 making the hair thinner.

In the scalp, finasteride specifically reduces 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 hair loss, can expect a benefit from using finasteride. In many 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. What you need to know before taking finasteride cinfa

Do not take finasteride cinfa

• If you are a woman (because this medication is for men, see section Pregnancy, breastfeeding, and fertility). Clinical trials have shown that finasteride is not effective in women with hair loss.
• If you are allergic to finasteride or any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take finasteride cinfa.

Effects on Prostate-Specific Antigen (PSA)

Finasteride may affect a blood test called PSA (Prostate-Specific Antigen) for detecting prostate cancer. If you have had a PSA test, you should inform your doctor or pharmacist that you are taking finasteride, as it decreases PSA levels.

Effects on fertility

Infertility has been reported 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 reported after discontinuing finasteride treatment. No long-term clinical studies have been conducted on the effect of finasteride on male fertility.

Breast cancer

See section 4.

Mood changes and depression

Mood changes, such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with finasteride cinfa 1 mg. If you experience any of these symptoms, stop taking finasteride cinfa 1 mg and consult your doctor as soon as possible.

Children and adolescents

Finasteride should not be used in children. There are no data to demonstrate the efficacy and safety of finasteride in children under 18 years of age.

Other medications and finasteride cinfa

Inform your doctor or pharmacist if you are taking, have recently taken, or may take any other medication.

Taking finasteride cinfa with food and drinks

Finasteride can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Finasteride is intended for the treatment of male pattern hair loss in men only. For effects on fertility in men, see section 2.

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

In case of doubt, ask your doctor.

Driving and using machines

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

Finasteride cinfa contains lactose

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.

Finasteride cinfa contains sodium docusate benzoate

This medication contains 0.50 mg of sodium docusate benzoate per tablet.

Finasteride cinfa contains sodium

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

3. How to take finasteride cinfa

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet per day. The tablets can be taken with or without food.

Your doctor will help you determine if finasteride 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 cinfa than you should

If you take too many tablets by mistake, go to the doctor immediately. Finasteride will not work faster or better by taking more than one tablet per day.

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. It is recommended to take the packaging and the package leaflet of the medication to the healthcare professional.

If you forget to take finasteride cinfa

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 the missed doses.

If you stop taking finasteride cinfa

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 time 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 discontinuation.

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

4. Possible side effects

Like all medications, this medication 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 discontinued.

Stop taking finasteride and inform your doctor immediately if you experience any of the following symptoms: swelling of the lips, face, tongue, and throat; difficulty swallowing; lumps under the skin (hives) and difficulty breathing.

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

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

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

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

• allergic reactions, including rash and itching
• breast tenderness and enlargement
• testicular pain
• blood in the semen
• rapid heartbeat
• persistent difficulty having an erection after discontinuing treatment
• persistent decrease in sexual desire after discontinuing treatment
• persistent problems with ejaculation after discontinuing treatment
• male infertility and/or poor semen quality
• elevated 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 package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) online system: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of finasteride cinfa

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

Do not use this medication after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

6. Contents of the pack and further information

Composition of finasteride cinfa

• The active ingredient is finasteride. Each tablet contains 1 mg of finasteride.
• The other ingredients are:

Core of the tablet:lactose monohydrate, corn starch, sodium carboxymethylcellulose (type A) (from potato), colloidal anhydrous silica, sodium docusate benzoate, and magnesium stearate.

Coating:hypromellose, titanium dioxide (E-171), polyethylene glycol 6000, brown iron oxide (E-172), and red iron oxide (E-172).

Appearance of the product and contents of the pack

The tablets are film-coated, cylindrical, scored, and reddish in color.

The tablets are available in PVC-PVDC/Aluminum blisters.

Each pack contains 28 or 98 tablets.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the last revision of this package leaflet:September 2021

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

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76704/P_76704.html

QR code to: https://cima.aemps.es/cima/dochtml/p/76704/P_76704.html