Finasteride Benel 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Finasteride Benel 5 mg film-coated tablets EFG

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

Finasteride belongs to a group of medicines known as type II 5α-reductase enzyme inhibitors.

Finasteride is used in the treatment and management of benign prostatic hyperplasia (BPH), and in the prevention of complications such as urinary retention or the need for surgery.

Finasteride reduces prostate enlargement, improves urinary flow, and improves symptoms related to BPH.

2. What you need to know before starting to take Finasteride Benel

Do not take Finasteride Benel:

If you are allergic to finasteride or to any of the other ingredients of this medicine (listed in section 6).

Finasteride is not intended for use in women or children.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Finasteride Benel.

Inform your doctor about any current or past medical conditions and any allergies you may have.

Finasteride is intended only for the treatment of benign prostatic hyperplasia in men. Women must not use finasteride if they are or could be pregnant, nor should they be exposed to finasteride by handling crushed or broken tablets. If the active substance in Finasteride Benel is absorbed orally or through the skin by a woman who is pregnant with a male fetus, the baby may be born with abnormalities of the genital organs. If a pregnant woman has come into contact with the active substance in Finasteride Benel, she must consult her doctor. Finasteride Benel tablets are film-coated, which prevents contact with the active substance during normal handling, provided the tablets are not crushed or broken. If you have any doubts, ask your doctor.

Benign prostatic hyperplasia develops over a long period of time. Sometimes symptoms improve quickly, but treatment with Finasteride Benel may need to be continued for at least six months to determine whether your symptoms improve. Even if you do not notice improvement or changes in symptoms, finasteride therapy may reduce the risk of urinary retention and thus delay the need for surgery. You should visit your doctor regularly for periodic check-ups and evaluation of your condition.

Although benign prostatic hyperplasia is not cancer and does not cause cancer, both conditions may coexist. Only a doctor can evaluate symptoms and their possible causes. Finasteride may reduce levels of prostate-specific antigen (PSA—a substance in the body that increases when the prostate enlarges). If you have had a PSA test, inform your doctor that you are taking finasteride.

Mood alterations and depression:

Mood changes such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with Finasteride Benel 5 mg. If you experience any of these symptoms, consult your doctor as soon as possible.

Children

Finasteride Benel is not indicated for use in children.

Taking Finasteride Benel with other medicines

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

No evidence of clinically significant adverse interactions has been found between finasteride and other medicines.

Taking Finasteride Benel with food and drink and alcohol

The tablets may be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Finasteride Benel is for use in men only.

Finasteride Benel is not indicated for use in women or children.

Driving and use of machines

There are no known data suggesting that finasteride may affect the ability to drive or operate machinery.

Finasteride Benel 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.

3. How to take Finasteride Benel

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

Your doctor will indicate how long you should take Finasteride Benel. Do not stop treatment prematurely.

The recommended dose is one tablet per day. The tablets should be taken with a sufficient amount of liquid. The tablets may be taken with or without food.

To relieve symptoms, Finasteride Benel may be administered together with doxazosin.

If you think that the effect of Finasteride Benel is too strong or too weak, inform your doctor or pharmacist.

If you take more Finasteride Benel than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 0420, stating the medication and the amount ingested.

If you forget to take Finasteride Benel

Do not take a double dose to make up for a missed dose; wait until the next scheduled dose.

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 may cause adverse effects, although not everyone experiences them.

Adverse effects may occur with the following frequencies:

Frequent – may affect up to 1 in 10 people:

• decreased volume of ejaculate, impotence
• decreased sexual desire.

Uncommon – may affect up to 1 in 100 people:

• ejaculation disorders, breast enlargement, breast tenderness
• skin rash.

Rare – may affect up to 1 in 1,000 people:

• testicular pain
• allergic-type reactions, including itching and swelling of the lips and face.

Frequency not known:

• anxiety
• suicidal thoughts

In some cases, these adverse effects disappeared even while the patient continued taking Finasterida Benel. When symptoms persisted, they usually ceased after stopping treatment with Finasterida Benel.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Finasteride Benel

Store at room temperature, away from moisture and heat. Keep the container tightly closed and protect from light. Keep out of reach of children. Do not store in the bathroom. Dispose of unused medication properly, as directed by your pharmacist.

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

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

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, 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 Benel

The active substance is finasteride. Each tablet contains 5 mg of finasteride.

The other components (excipients) are:

Core: lactose, microcrystalline cellulose, sodium potato starch glycolate, pregelatinized corn starch, sodium docusate, yellow iron oxide (E-172), magnesium stearate.

Coating: Opadry Y-117000 (hypromellose, titanium dioxide, polyethylene glycol), indigo carmine (E-132).

Appearance of the medicinal product and contents of the pack

Finasteride Benel is presented as blue, round, biconvex film-coated tablets. Each pack contains 28 tablets in aluminum-PVC blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

FARMALIDER, S.A.
C/ Aragoneses, 15 - Pol. Ind. Alcobendas
28108 Madrid (Spain).

Manufacturer

West Pharma - Producções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, nº 11, Venda Nova, 2700 Amadora (Portugal).

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

"Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/"