Leaflet: information for the user

Finasteride Aurovitas 5 mg film-coated tablets EFG

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as 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.

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

2. What you need to know before you start taking Finasteride Aurovitas

3. How to take Finasteride Aurovitas

4. Possible side effects

5. Storage of Finasteride Aurovitas

6. Contents of the pack and additional information

Finasterida Aurovitasbelongs to a group of medications called 5-alpha-reductase inhibitors. These medications act by reducing the size of the prostate gland in men.

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

What is BPH?

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

This can lead to problems such as:

• sensation of needing to urinate more frequently, especially at night,
• sensation of needing to urinate immediately,
• difficulty starting to urinate,
• weak urine flow,
• interruptions of the urine flow,
• sensation that the bladder has not been completely emptied.

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.

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

Consult with your doctor if you have any questions about this.

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 (since this medication 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 volume of residual urine and/or a significant reduction in urine flow. In this case, you should be monitored for the possibility of urinary stricture.
• If you have liver insufficiency, the level of finasteride in your blood may increase.
• If you are to undergo a PSA (test used to detect prostate cancer) analysis. Inform your doctor if you are taking finasteride, as it may alter the levels of the substance to be analyzed in your blood, 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 medication that could affect the normal development of the child's sexual organs.

Consult your doctor if the above circumstances apply to you, even 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 medications and Finasterida Aurovitas

Finasteride does not normally affect other medications.

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

Taking Finasterida 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, it may cause abnormalities in the male fetus's genital organs. 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 interrupting treatment with finasteride.

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

Driving and operating machinery

As far as is known, finasteride has no influence on the ability to drive or operate machinery.

Finasterida Aurovitas contains lactose

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

Finasterida Aurovitas contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; that is, 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.

Adults

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

Tablets can be taken with an empty stomach or with food. Tablets must be swallowed whole, not broken or crushed.

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

Your doctor may prescribe finasteride along with another medication (called doxazosin) to help control your high blood pressure.

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

Patients with liver insufficiency

No experience is available on the use of finasteride in patients with liver insufficiency.

Patients with renal insufficiency

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

Older 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 Finasterida Aurovitas than you should

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

If you forgot to take Finasterida Aurovitas

If you forgot 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 treatment as prescribed.

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following side effects have been described with this medicine:

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

• Difficulty getting an erection (impotence).
• Decreased sexual desire.
• Ejaculation disorders, for example, decreased semen volume expelled during sexual intercourse. This decrease in semen volume does not appear to alter normal sexual function.

These side effects may disappear after some time while continuing to take finasteride. If not, they generally disappear after discontinuing treatment with finasteride.

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

• Swelling and increased sensitivity in the chest.
• Rash.
• Ejaculation problems.

Unknown frequency (cannot be estimated from available data):

• Palpitations (noticing heartbeats).
• Changes in liver function shown by a blood test.
• Testicular pain.
• Allergic reactions:

In case of an allergic reaction, discontinue treatment and seek medical attention immediately. Signs of allergic reaction may include:

• Skin rash, itching, or lumps under the skin (hives).
• Swelling of lips, tongue, throat, and face.

• Depression, decreased libido that continues after treatment is discontinued.
• Continued erectile dysfunction after treatment is discontinued.
• 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 discontinuing treatment with finasteride, normalization or improvement of semen quality has been reported, blood in semen.
• Anxiety.

Inform your doctor immediately of any changes 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 included in this prospectus. It will be helpful if you note what happened, when it started, and how long it lasted.

Combined therapy with doxazosin

The following side effects have been reported more frequently when finasteride was used with the alpha-blocker known as doxazosin: fatigue 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 noted that the PSA value is reduced in patients taking finasteride.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Store below 25°C.

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

Composition of Finasteride Aurovitas

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

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

Excipients of the coating: hydroxypropylcellulose, hypromellose, titanium dioxide (E171), talc, aluminum lake of indigotin (E132), yellow iron oxide (E172).

Appearance of the product and contents of the package

Film-coated tablets of blue color, round, biconvex, with beveled edge and with the inscription “E” on one face 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.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

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:

Last review date of this leaflet: August 2023

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