Package Leaflet: Information for the User

Finasteride Aurovitas 1 mg 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 yours, 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 Aurovitas 1 mg film-coated tablets contain the active ingredient finasteride.
• Finasterida Aurovitas is for exclusive use in males.
• Finasterida Aurovitas is used for the treatment of male pattern hair loss (also known as androgenetic alopecia) in males aged 18-41 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 makes the hair thinner.
• In the scalp, Finasterida Aurovitas specifically reduces DHT levels by blocking an enzyme (5-alpha-reductase Type II) that converts testosterone to DHT. Only males with mild to moderate hair loss, but not complete, can expect a benefit from using Finasterida Aurovitas. In many males treated with Finasterida Aurovitas for 5 years, the progression of hair loss became slower, and at least half of those males also experienced some improvement in hair growth.

Do not take Finasterida Aurovitas

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Finasterida Aurovitas.

Mood changes and depression

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

Effects on Prostate-Specific Antigen (PSA)

Finasterida Aurovitas may affect a blood test called PSA (Prostate-Specific Antigen) for detecting prostate cancer. If you have had a PSA test, inform your doctor or pharmacist that you are taking Finasterida Aurovitas, 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.

Children and adolescents

Finasterida Aurovitas should not be used in children. There is no evidence to demonstrate the efficacy and safety of finasteride in children under 18 years old.

Use of Finasterida Aurovitas with other medications

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medication.

Pregnancy, breastfeeding, and fertility

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

• Women cannot use Finasterida Aurovitas due to the risk of pregnancy.
• Do not touch crushed or broken Finasterida Aurovitas tablets if you are pregnant or may be pregnant.
• If a pregnant woman with a male fetus absorbs the active component of Finasterida Aurovitas 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 component of Finasterida Aurovitas, she should consult a doctor.
• Finasterida Aurovitas tablets are coated to prevent contact with the active component during normal handling.

Consult your doctor if you are unsure.

Driving and operating machinery

There is no evidence to indicate that Finasterida Aurovitas affects the ability to drive or operate machinery.

Finasterida Aurovitas contains lactose

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

Finasterida Aurovitas 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 or pharmacist. 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 Finasterida Aurovitas works for you. It is essential to take Finasterida Aurovitas for the entire time your doctor indicates. Finasterida Aurovitas only acts in the long term if its administration is maintained.

If you take more Finasterida Aurovitas than you should

If you have taken too many tablets by mistake, contact your doctor immediately. Finasterida Aurovitas will not act 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Finasterida Aurovitas

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

If you interrupt the treatment with Finasterida Aurovitas

To appreciate the maximum effect, it may be necessary to take the medication for 3 to 6 months. It is essential that you try to take Finasterida Aurovitas for the entire period of time indicated by your doctor. If you stop taking Finasterida Aurovitas, you will probably lose the hair you gained in the 9 to 12 months following the interruption of treatment.

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

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

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

Stop taking Finasterida Aurovitas 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, breast tissue enlargement, 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 sexual desire,
• 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 available data):

• allergic reactions including rash and itching,
• sensitivity and breast enlargement,
• testicular pain,
• blood in the semen,
• rapid heart rate,
• persistent difficulty achieving an erection after stopping treatment,
• persistent decrease in sexual desire after stopping treatment,
• persistent problems with ejaculation after stopping 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 they are possible adverse effects not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: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.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the box, blister pack, and bottle label after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Finasteride Aurovitas

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

Core of the tablet:monohydrate lactose, microcrystalline cellulose, sodium carboxymethylcellulose (type A) (derived from potato starch), pregelatinized cornstarch, sodium docusate, magnesium stearate.

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

Appearance of the product and contents of the package

Film-coated tablet.

Brown, octagonal, biconvex film-coated tablets, engraved with “J” on one face and with “81” on the other face.

Finasteride Aurovitas film-coated tablets are available in PVC/PE/PVdC/Aluminum blister packs and in high-density polyethylene (PEAD) bottles with a polypropylene cap containing silica gel as a desiccant.

Package sizes:

Blister pack: 28, 56, 84, and 98 film-coated tablets.

PEAD bottle: 30 and 1000 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16 D

28036, Madrid

Spain

Responsible for manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Finasterid Aurobindo 1 mg Filmtabletten

Spain:Finasterida Aurovitas 1 mg film-coated tablets EFG

France:FINASTERIDE ARROW LAB 1 mg, coated tablet

Italy:Finasteride Aurobindo Pharma Italia 1 mg film-coated tablets

Portugal:Finasterida Aurobindo

Last review date of this leaflet:July 2021

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es.