Finasteride Aurovitas 5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Finasteride Aurovitas 5 mg Film-coated Tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 others, even if they have the same symptoms as you, because it may 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.

Leaflet Contents

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

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

Finasteride 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 (in men only) and produces the fluid found in semen. Inflammation of the prostate gland may lead to a condition called "benign prostatic hyperplasia" or BPH.

What is BPH?

If you have BPH, it means your prostate is enlarged. This can put pressure on the tube through which urine passes out of the body.

This may lead to symptoms such as:

• feeling the need to urinate more frequently, especially at night,
• feeling a sudden need to urinate immediately,
• difficulty starting to urinate,
• weak urine stream,
• interruptions in the urine stream while urinating,
• feeling that the bladder has not emptied completely.

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 is used for the treatment and management of benign prostatic hyperplasia (BPH) caused by an enlarged prostate. This medicine reduces the enlarged prostate, improves urinary flow and symptoms caused by BPH, and reduces the risk of acute urinary retention and the need for surgery.

Talk to your doctor if you have any questions about this.

2. What you need to know before taking Finasteride Aurovitas

Do not take Finasteride Aurovitas

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

Warnings and precautions

Consult your doctor or pharmacist before starting finasteride:

• If you have a large post-void residual urine volume and/or a significantly reduced urinary flow. In such cases, you should be monitored for possible urinary obstruction.
• If you have liver impairment, blood levels of finasteride may increase.
• If you are due to have a PSA test (a test used to detect prostate cancer). Inform your doctor that you are taking finasteride, as it may alter blood levels of PSA, the substance being measured.
• If your partner is or may become pregnant, since you must avoid exposing her to your semen, which could contain a small amount of the medicine that might affect normal development of the male fetus's genital organs.

Please consult your doctor if any of the above situations apply to you, even if they occurred 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.

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

Taking Finasteride Aurovitas with food, drinks and alcohol

Finasteride may be taken with or without food.

Pregnancy, breastfeeding and fertility

Women who are or may become pregnant must not handle crushed or broken finasteride tablets. If finasteride is absorbed through the skin or taken orally by a pregnant woman carrying a male fetus, the male fetus may be born with congenital abnormalities of the genital organs. Finasteride tablets have a coating that prevents contact with finasteride during normal handling, provided the tablets are not broken or crushed.

If your partner is or may be pregnant, you must avoid exposing her to your semen (for example, by using a condom) or discontinue treatment with finasteride.

Consult your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

To the extent known, finasteride has no influence on the ability to drive or operate machinery.

Finasteride Aurovitas contains lactose

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

Finasteride Aurovitas contains sodium

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

3. How to take Finasteride Aurovitas

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults

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

The tablets may be taken on an empty stomach or with food. The tablets should be swallowed whole and must not be split or crushed.

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

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

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

Patients with hepatic impairment

There is no experience regarding the use of finasteride in patients with hepatic impairment.

Patients with renal impairment

Dose adjustment is not required (see “Adults”). The use of finasteride in patients undergoing haemodialysis has not been studied.

Elderly patients

Dose adjustment is not 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 accidentally taken this medicine, contact your doctor or pharmacist or the Poison Information Service immediately (telephone 91 562 04 20), stating the medicine and the amount ingested.

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 for your next dose; in that case, continue with your prescribed treatment schedule.

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

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 will experience them.

The following adverse effects have been reported with this medicine:

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

• Inability to achieve an erection (impotence).
• Decreased sexual desire.
• Ejaculation disorders, for example, reduced amount of semen ejaculated during sexual activity. This reduction in semen volume does not appear to affect normal sexual function.

These adverse effects may disappear over time while continuing finasteride treatment. If not, they usually resolve after stopping finasteride treatment.

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

• Swelling and increased sensitivity in the breast.
• Rash.
• Problems with ejaculation.

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

• Palpitations (awareness of heartbeats).
• Changes in liver function shown by blood tests.
• Testicular pain.
• Allergic reactions:

If you experience an allergic reaction, stop treatment and contact your doctor immediately. Signs of an allergic reaction may include:

• Skin rash, itching, or lumps under the skin (hives).

• Swelling of the lips, tongue, throat, and face.

• Difficulty swallowing and breathing.

• Depression, decreased libido that persists after stopping treatment.

• Erectile dysfunction that persists after stopping treatment.

• Male infertility and/or poor semen quality. Cases of infertility have been reported in men who took finasteride for a long period and developed other risk factors that may affect fertility. After stopping finasteride treatment, normalization or improvement in semen quality has been reported.

• Blood in the semen.

• In rare cases, male breast cancer.

• Anxiety.

• Suicidal thoughts.

Immediately inform your doctor of any changes in breast tissue, such as lumps, pain, breast enlargement, or nipple discharge, as these may be signs of a serious condition, such as breast cancer.

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

Combination therapy with doxazosin

The following adverse effects have been reported more frequently when finasteride was used together 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 prostate-specific antigen (PSA) levels, it should be taken into account that PSA values are reduced in patients taking finasteride.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through 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. Storage of Finasteride Aurovitas

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

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

Store below 25ºC.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. 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 components (excipients) are:

Excipients of the core: lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch (type A) (derived from potato starch), pregelatinized maize starch, sodium docusate and magnesium stearate.

Excipients of the coating: hydroxypropyl cellulose, hypromellose, titanium dioxide (E171), talc, indigo carmine aluminium lake (E132) and yellow iron oxide (E172).

Appearance of the product and contents of the pack

Film-coated blue, round, biconvex tablets with bevelled edges, marked with the inscription “E” on one side and “61” on the other.

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. 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 medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: July 2025

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