Package Leaflet: Information for the User

Finasteride Combix 1mg Film-Coated Tablets

Read this 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. Do not give it to others even if they have similar symptoms to you, as it may harm them.

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

Finasterida contains the active ingredient finasteride.

Finasterida is for exclusive use in males.

Finasterida is used for the treatment of male pattern hair loss (also known as androgenetic alopecia) in males 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 disorder 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 males with mild to moderate hair loss, but not complete, can expect a benefit from using finasteride. In many males treated with finasteride for 5 years, the progression of hair loss became slower, and at least half of those males also showed some improvement in hair growth.

Do not takeFinasterida Combix

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Finasterida Combix

Effects on Prostate-Specific Antigen (PSA)

Finasteride may affect a blood test called Prostate-Specific Antigen (PSA) for detecting prostate cancer. If you have had a PSA test, you must 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 stopping 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 is no evidence to demonstrate the efficacy and safety of finasteride in children under 18 years old.

Other medications and Finasterida Combix

Inform your doctor or pharmacist if you are taking, have taken recently, 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 males. For the effects on male fertility, see section 2.

• Women cannot use finasteride due to the risk of pregnancy.
• Women who are or may be pregnant should not touch crushed or broken finasteride tablets.
• If a pregnant woman with a male fetus absorbs the active ingredient of finasteride after oral ingestion or through the skin, her child may be born with genital organ abnormalities.
• 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.

In case of doubt, ask your doctor.

Driving and operating machines

There is no evidence to indicate that finasteride affects the ability to drive or operate machines.

Finasterida Combix contains lactose

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

Finasterida Combix contains sodium

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

Follow exactly the administration instructions for 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. Tablets can be taken with or without food.

Your doctor will help you determine if finasteride works for you. It is important to take finasteride for the entire time your doctor tells you to. Finasteride only acts in the long term if its administration is maintained.

If you take more Finasterida Combix than you should

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

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

If you forgot to take Finasterida Combix

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Finasterida 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 period of time indicated by your doctor. If you stop taking finasteride, you will probably lose the hair you gained in the 9 to 12 months following the interruption of treatment.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Adverse effects have been, normally, transient with continued treatment or have disappeared when treatment is interrupted.

Stop taking finasteride and immediately inform your doctor 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 must immediately inform your doctor 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.

Rare: may affect up to 1 in 100 people

• Decreased libido
• Difficulty achieving an erection
• Problems with ejaculation, including a decrease in the amount of semen ejaculated
• Depression

Frequency unknown: the frequency cannot be estimated from available data

• Allergic reactions, including rash and itching
• Mastalgia and breast tenderness
• Testicular pain
• Blood in semen
• Fast heart rate
• Persistent difficulty achieving an erection after interrupting treatment
• Persistent decrease in libido after interrupting treatment
• Persistent problems with ejaculation after interrupting treatment
• Male infertility and/or poor semen quality
• Elevated liver enzymes
• Anxiety

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging 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 drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Finasterida Combix

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

Core of the tablet:monohydrate lactose,carboxymethylcellulose sodium type A,pregelatinized cornstarch, sodium docusate, microcrystalline cellulose, magnesium stearate.

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

Appearance of the product and contents of the packaging

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

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization

Combix Laboratories, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

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

Last review date of this leaflet:October 2022

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