FINASTERIDE COMBIX 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Finasteride Combix 1mg 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 Combix and what is it used for
2. What you need to know before taking Finasteride Combix
3. How to take Finasteride Combix
4. Possible side effects
5. Storage of Finasteride Combix
6. Package Contents and Additional Information

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

Finasteride contains the active ingredient finasteride.

Finasteride is for use in men only.

Finasteride is used to treat male pattern hair loss (also known as androgenetic alopecia) in men between 18 and 41 years old. 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 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 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, 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 Combix

Do not takeFinasteride Combix

• 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 to the active ingredient (finasteride) or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Finasteride Combix

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. If you experience any of these symptoms, stop taking finasteride and consult your doctor as soon as possible for medical advice.

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 old.

Other Medications and Finasteride Combix

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

Pregnancy, Breastfeeding, and Fertility

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

• Women should not use finasteride due to the risk of pregnancy.
• Pregnant women or women who may be pregnant 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 child may be born with genital abnormalities.
• 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 Combix 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 Combix contains Sodium

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

3. How to take Finasteride Combix

Follow the exact instructions for administration of this medication as indicated by your doctor. 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 Combix 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.

Consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the package and package leaflet of the medication to the healthcare professional.

If you forget to take Finasteride Combix

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

If you stop taking Finasteride Combix

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 other 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.

The side effects have been, normally, 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 sex drive
• difficulty achieving an erection
• problems with ejaculation, including a decrease in the amount of semen ejaculated
• depression

Frequency not known: the 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 having an erection after discontinuing treatment
• persistent decrease in sex drive 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 type of side effect, consult your doctor or pharmacist, even if it is not listed in this package leaflet. You can also report them directly through the Spanish Medication Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Finasteride Combix

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

Do not use this medication after the expiration date stated on the package after CAD. 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. Deposit the packages and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Finasteride Combix

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

Core of the tablet:lactose monohydrate, sodium carboxymethyl starch (type A potato), pregelatinized starch (corn), sodium docusate, microcrystalline cellulose, magnesium stearate.

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

Appearance of the Product and Package Contents

Finasteride Combix is a film-coated tablet, brown in color, round, biconvex, and smooth on both sides, with a diameter of approximately 6.4 mm. The tablets are available in blister packs in packages of 28 and 98 tablets.

Only some package 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

O

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

O

Netpharmalab Consulting Services

Carretera de Fuencarral 22

28108 Alcobendas, Madrid

Spain

O

Pharmex Advanced Laboratories S.L.

Ctra. A-431 Km. 19

14720 Almodóvar del Río (Córdoba)

Spain

O

Flavine Pharma France

3 Voie d’Allemagne

13127 Vitrolles

France

Date of the last revision of this package leaflet:October 2022

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/)