Finasteride CINFA 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

finasteride cinfa 1 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this 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, and you should not give it to others, even if they have the same symptoms as you, since it could harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

finasteride cinfa contains the active substance finasteride.

finasteride cinfa is for use in males only.

Finasteride is used for the treatment of male-pattern hair loss (also known as androgenetic alopecia) in men aged 18 to 41 years. If, after reading this leaflet, you have any questions about male-pattern hair loss, 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 to DHT. Only men with mild to moderate, but not complete, hair loss can expect benefit from using finasteride. In many men treated with finasteride for 5 years, progression of hair loss slowed, and in at least half of these men, hair growth also improved to some extent.

2. What you need to know before starting finasteride cinfa

Do not take finasteride cinfa

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

Warnings and precautions

Talk to your doctor or pharmacist before starting finasteride cinfa.

Effect on Prostate-Specific Antigen (PSA)

Finasteride may affect a blood test known as PSA (Prostate-Specific Antigen) used to detect prostate cancer. If you have had a PSA test, you must inform your doctor or pharmacist that you are taking finasteride, as it reduces PSA levels.

Effects on fertility

Infertility has been reported in men who took finasteride for prolonged periods and who had other risk factors that could affect fertility. Normalization or improvement in semen quality has been reported after discontinuation of finasteride treatment. Long-term clinical studies on the effect of finasteride on male fertility have not been conducted.

Breast cancer

See section 4.

Mood changes and depression

Mood alterations 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.

Sexual dysfunction has been reported in some patients, 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, which reminds of the above information, is provided with the finasteride cinfa packaging.

Children and adolescents

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

Other medicines and finasteride cinfa

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Taking finasteride cinfa with food and drinks

Finasteride may be taken with or without food.

Pregnancy, lactation and fertility

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

• 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 carrying a male fetus absorbs the active ingredient of finasteride orally or through the skin, her child may be born with abnormalities of the genital organs.
• If a pregnant woman comes into contact with the active ingredient of finasteride, she should consult a doctor.
• Finasteride tablets are film-coated to prevent contact with the active ingredient during normal handling.

If in doubt, ask your doctor.

Driving and using machines

There are no data indicating that finasteride affects the ability to drive or operate machinery.

finasteride cinfa contains lactose

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

finasteride cinfa contains sodium docusate benzoate

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

finasteride cinfa contains sodium

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

3. How to take finasteride cinfa

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet daily. The tablets may be taken with or without food.

Your doctor will help determine whether finasteride is effective in your case. It is important to take finasteride for as long as your doctor recommends. Finasteride only works long-term if treatment is maintained.

If you take more finasteride cinfa than you should

If you take too many tablets by mistake, contact a doctor immediately. Finasteride will not work faster or better if more than one tablet per day is taken.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you forget to take finasteride cinfa

If you miss a dose, skip the missed dose.

Resume your regular schedule of one tablet daily.

Do not take a double dose to make up for missed doses.

If you stop taking finasteride cinfa

It may be necessary to take the medicine for 3 to 6 months before an effect is seen. It is important that you try to take finasteride for the entire period of time indicated by your doctor. If you stop taking finasteride, you will likely lose the hair you 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, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects have usually been temporary with continued treatment or disappeared when treatment was discontinued.

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

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

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

• reduced 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 available data):

• allergic reactions including rash and itching
• breast tenderness and breast enlargement
• testicular pain
• blood in the semen
• rapid heartbeat
• persistent difficulty in achieving an erection after stopping treatment
• persistent decrease in sexual desire after stopping treatment
• persistent ejaculation problems after stopping treatment
• male infertility and/or poor semen quality
• elevated liver enzymes
• anxiety
• suicidal thoughts

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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Finasteride cinfa

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of finasteride cinfa

• The active substance is finasteride. Each tablet contains 1 mg of finasteride.
• The other components are:

Tablet core: lactose monohydrate, corn starch, sodium carboxymethylstarch (type A) (from potato), colloidal anhydrous silica, docusate sodium 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 pack contents

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

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

Each pack contains 28 or 98 tablets.

Marketing Authorisation Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the most recent revision of this leaflet: September 2025

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

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following web 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