FINASTERIDE AUROVITAS 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Finasteride Aurovitas 5 mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

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

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

Finasteride Aurovitas belongs to a group of medicines called 5-alpha-reductase inhibitors. These medicines work by reducing the size of the prostate in men.

The prostate gland is located below the bladder (only in men), it produces the fluid that is found in semen. Inflammation of the prostate gland can lead to a disorder called “benign prostatic hyperplasia” or BPH.

What is BPH?

If you suffer from BPH, it means your prostate is inflamed. This can put pressure on the tube through which urine passes to leave the body.

This can lead to problems such as:

• feeling the need to urinate more frequently, especially at night,
• feeling the need to urinate immediately,
• difficulty starting to urinate,
• weak urine flow,
• interrupted flow when urinating,
• feeling that the bladder is not completely empty.

In some men, BPH can lead to more serious problems, such as:

• urinary tract infections,
• sudden inability to urinate (acute urinary retention),
• need for surgical intervention.

Finasteride Aurovitas is used for the treatment and control of benign prostatic hyperplasia (BPH) caused by an enlarged prostate. This medicine reduces the enlarged prostate, improves urine flow, and the symptoms caused by BPH, and reduces the risk of acute urinary retention and the need for surgical intervention.

Consult your doctor if you have any questions about this.

2. What you need to know before you take Finasteride Aurovitas

Do not take Finasteride Aurovitas

• If you are allergic to finasteride or any of the other ingredients of this medicine (listed in section 6).
• If you are a woman (since this medicine is for men).
• If you are a child.

Warnings and precautions

Consult your doctor or pharmacist before starting to take finasteride:

• If you have a large amount of residual urine and/or a significant reduction in urine flow. In this case, you should be monitored for the possibility of a urinary stricture.
• If you have liver failure, the level of finasteride in your blood may increase.
• If you are going to have a PSA (prostate-specific antigen) test. Inform your doctor if you are taking finasteride, as it may alter the blood levels of the substance being tested, the PSA.
• If your partner is or may become pregnant, as you should avoid exposing her to your semen, which may contain a small amount of the medicine that could affect the normal development of the baby's sexual organs.

Consult your doctor if any of the above circumstances apply to you, even if it was in the past.

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, consult your doctor as soon as possible.

Children

Finasteride is contraindicated in children.

Other medicines and Finasteride Aurovitas

Finasteride does not normally affect other medicines.

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

Taking Finasteride Aurovitas with food, drinks, and alcohol

Finasteride can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Women who are or may become pregnant should not handle crushed or broken finasteride tablets. If finasteride is absorbed through the skin or taken by a pregnant woman of a male fetus, it may cause the male fetus to be born with genital malformations. Finasteride tablets have a coating that prevents contact with finasteride when handled normally, as long as the tablets are not crushed or broken.

If your partner is or may become pregnant, you should avoid exposing her to your semen (for example, by using a condom) or stop taking finasteride.

Consult your doctor or pharmacist for advice before starting to take any medicine.

Driving and using machines

As far as is known, finasteride does not affect the ability to drive or use machines.

Finasteride Aurovitas contains lactose

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

Finasteride Aurovitas contains sodium

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

3. How to take Finasteride Aurovitas

Follow exactly the instructions of administration of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults

The recommended dose is one tablet a day (equivalent to 5 mg of finasteride).

The tablets can be taken with an empty stomach or with food. The tablets should be swallowed whole, not broken or crushed.

Although improvement may be seen in a short period of time, it may be necessary to treat for at least 6 months to determine if a satisfactory response to treatment has been achieved.

Your doctor may prescribe finasteride along with another medicine (called doxazosin) to help control your BPH.

Your doctor will indicate the duration of treatment with finasteride. Do not stop treatment before, as symptoms may reappear.

Patients with liver failure

There is no experience with the use of finasteride in patients with liver failure.

Patients with kidney failure

No dose adjustment is required (see “Adults”). The use of finasteride in patients on hemodialysis has not been studied.

Elderly patients

No dose adjustment is required (see “Adults”).

Please inform your doctor or pharmacist if you feel that the effect of finasteride is too strong or too weak.

If you take more Finasteride Aurovitas than you should

If you take more finasteride than you should or if a child has taken this medicine by accident, consult your doctor or pharmacist immediately or the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount taken.

If you forget to take Finasteride Aurovitas

If you forget to take a dose of finasteride, take it as soon as you remember, unless it is almost time to take the next dose; in that case, continue with the treatment as prescribed.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been described with this medicine:

Common (may affect up to 1 in 10 people):

• Impotence.
• Decreased libido.
• Ejaculation disorders, such as decreased semen volume. This decrease in semen volume does not seem to alter normal sexual function.

These side effects may disappear over time while continuing to take finasteride. If not, they usually disappear after stopping treatment with finasteride.

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

• Breast tenderness and enlargement.
• Rash.
• Ejaculation disorders.

Frequency not known (cannot be estimated from the available data):

• Palpitations (feeling your heartbeat).
• Changes in liver function shown by a blood test.
• Testicular pain.
• Allergic reactions:

In case of an allergic reaction, stop treatment and consult your doctor immediately. The signs of an allergic reaction may include:

• Skin rash, itching, or hives.
• Swelling of the lips, tongue, throat, and face.

• Depression, decreased libido that continues after stopping treatment.
• Erectile dysfunction that continues after stopping treatment.
• Male infertility and/or poor semen quality. Cases of infertility have been reported in men who took finasteride for a long time and developed other risk factors that may affect fertility. After stopping treatment with finasteride, normalization or improvement of semen quality has been reported, including blood in the semen.
• Anxiety.

Inform your doctor immediately of any change in breast tissue, such as lumps, pain, breast enlargement, or nipple discharge, as these may be signs of a serious disease, such as breast cancer.

If you experience any of these symptoms, consult your doctor or pharmacist. This includes any side effect not listed in this leaflet. It will be helpful if you note what happened, when it started, and how long it lasted.

Combination therapy with doxazosin

The following side effects have been reported more frequently when finasteride was used with the alpha-blocker doxazosin: asthenia 16.8% (placebo 7.1%), postural hypotension 17.8% (placebo 8.0%), dizziness 23.2% (placebo 8.1%), and ejaculation disorders 14.1% (placebo 2.3%).

Laboratory parameters

When measuring the level of prostate-specific antigen (PSA), it should be taken into account that the PSA value is reduced in patients taking finasteride.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Finasteride Aurovitas

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 carton after EXP. The expiry date is the last day of the month stated.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Place the empty pack and any remaining tablets in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the pack and any remaining tablets. This will help protect the environment.

6. Contents of the pack and other information

Composition of Finasteride Aurovitas

• The active substance is finasteride. Each film-coated tablet contains 5 mg of finasteride.
• The other ingredients (excipients) are:

Core excipients: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A) (derived from potato starch), pregelatinized corn starch, sodium docusate, magnesium stearate.

Coating excipients: hydroxypropylcellulose, hypromellose, titanium dioxide (E171), talc, aluminum lake of indigo carmine (E132), yellow iron oxide (E172).

Appearance and packaging of the product

Blue, round, biconvex film-coated tablets with a beveled edge and engraved with “E” on one side and “61” on the other.

Finasteride Aurovitas 5 mg film-coated tablets are available in blister packs.

Package sizes:10, 20, 28, 30, 50, 60, and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avenida de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

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 under the following names:

Date of last revision of this leaflet: August 2023

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