Finasteride Combix 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Finasteride Combix 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 other people, even if they have the same symptoms as you, because 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.

Contents of the leaflet

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

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

Finasteride contains the active substance finasteride.

Finasteride 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 specific 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 DHT levels 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 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 Combix

Do not take Finasteride Combix

• if you are a woman (because this medicine is for men only, see Pregnancy section). Clinical trials have shown that finasteride is not effective in women with hair loss.
• if you are allergic to the active substance (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 to take Finasteride Combix.

Effects on Prostate-Specific Antigen (PSA)

Finasteride may affect a blood test known as PSA (Prostate-Specific Antigen), which is 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 a long time and who had other risk factors that could affect fertility. Normalization or improvement in semen quality has been reported after stopping treatment with finasteride. Long-term clinical studies on the effect of finasteride on male fertility have not been conducted.

Breast cancer

See section 4.

Mood alterations and depression

Sexual dysfunction, which may contribute to mood disturbances including suicidal thoughts, has been reported in some patients. 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, reminding of the above information, is provided with the Finasteride Combix 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 Combix

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

Pregnancy, breastfeeding and fertility

Finasteride is intended for the treatment of male-pattern hair loss exclusively 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 absorbs the active ingredient of finasteride orally or through the skin, a male fetus 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 coated to prevent contact with the active ingredient during normal handling.

If in doubt, ask your doctor.

Driving and use of machines

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

Finasteride Combix contains lactose

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

Finasteride Combix contains sodium

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

3. How to take Finasterida Combix

Follow exactly the instructions for use provided by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet daily. The tablets can 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 directs. Finasteride only works long-term if treatment is maintained.

If you take more Finasterida Combix than you should

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

Contact your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20 immediately, indicating the medication and amount taken. It is recommended to bring the medication packaging and leaflet to the healthcare professional.

If you forget to take Finasterida Combix

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

If you stop taking Finasterida Combix

It may take 3 to 6 months to notice the effect of the medication. It is important to try to take finasteride for the entire duration prescribed 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 experiences them.

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

Stop taking finasteride 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.

Inform your doctor immediately of any changes in breast tissue, such as lumps, pain, increase in 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 erection
• problems with ejaculation, including a decrease in the amount of semen ejaculated
• depression

Frequency not known: frequency 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 in achieving 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. Finasterida Combix Storage

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 the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Finasterida Combix

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

Tablet core: lactose monohydrate, sodium carboxymethyl starch (from potato) type A, pregelatinized starch (from corn), sodium docusate, microcrystalline cellulose, magnesium stearate.

Coating: hypromellose, hydroxypropyl cellulose, titanium dioxide (E171), talc, iron oxide red (E172), iron oxide yellow (E172).

Appearance of the product and contents of the pack

Finasterida Combix is a film-coated tablet, brown in colour, round, biconvex, and smooth on both sides, with an approximate diameter of 6.4 mm. The tablets are presented in blisters available in pack sizes of 28 and 98 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

Or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Or

Netpharmalab Consulting Services

Carretera de Fuencarral 22

28108 Alcobendas, Madrid

Spain

Or

Pharmex Advanced Laboratories S.L.

Ctra. A-431 Km. 19

14720 Almodóvar del Río (Córdoba)

Spain

Or

Flavine Pharma France

3 Voie d’Allemagne

13127 Vitrolles

France

Date of the most recent review of this leaflet: September 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/)