Patient Information Leaflet: Information for the Patient

Finasteride Benel 5 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 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 is Finasteride Benel and what is it used for

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

3. How to take Finasteride Benel

4. Possible side effects

5. Storage of Finasteride Benel

6. Contents of the pack and additional information

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

Finasterida is used in the treatment and control of benign prostatic hyperplasia and in the prevention of complications such as urinary retention or surgery.

Finasterida causes regression of prostate growth, improves urinary flow, and improves symptoms related to BPH.

Do not take Finasterida Benel:

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

Finasteride is not indicated for use in women or children.

Warnings and precautions

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

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

Finasteride is only intended for the treatment of benign prostatic hyperplasia in males. Women should not use finasteride when pregnant or may be pregnant, nor should they be exposed to finasteride by handling crushed or broken tablets. If the active ingredient of Finasterida Benel is absorbed after oral use or through the skin by a pregnant woman carrying a male fetus, the fetus may be born with abnormalities in its sexual organs. If the pregnant woman has come into contact with the active ingredient of Finasterida Benel, she should consult her doctor. Finasterida Benel tablets are coated, which will prevent contact with the active ingredient during normal handling, as long as 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 Finasterida Benel may need to be continued for at least six months to see if symptoms improve. Although you may not notice improvement or change in symptoms, finasteride therapy may reduce the risk of urinary retention and thus postpone the need for surgery. You should visit your doctor regularly for periodic check-ups and to evaluate your progress.

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

Mood changes and depression:

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

Children

Finasterida Benel is not indicated for children.

Taking Finasterida Benel with other medications

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

No adverse interactions of clinical importance have been found with the use of finasteride and other medications.

Taking Finasterida Benel with food and drinks and alcohol

Tablets can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Finasterida Benel is for exclusive use in males.

Finasterida Benel is not indicated for women or children.

Driving and operating machinery

No known data suggest that finasteride may affect the ability to drive or operate machinery.

Finasterida Benel contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will inform you of the duration of your treatment with Finasterida Benel. Do not discontinue treatment prematurely.

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

To alleviate symptomsFinasterida Benelmay be administered in conjunction with doxazosina.

If you estimate that the effect ofFinasterida Benelis too strong or too weak, inform your doctor or pharmacist.

.

If you take more Finasterida Benel than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 0420, indicating the medication and the amount ingested.

If you forgot to take Finasterida Benel

Do not take a double dose to compensate for the missed dose, wait for the next scheduled dose.

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

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

Adverse effects may occur at the following frequencies:

Frequent, may affect up to 1 in 10 people:

• Decreased ejaculation volume, impotence
• Decreased sexual desire.

Possible, may affect up to 1 in 100 people:

• Ejaculation disorders, breast growth, breast hypersensitivity
• Skin rash.

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

• Testicular pain
• Allergic reactions, including itching and swelling of the lips and face.

Unknown frequency:

• anxiety

In some cases, these adverse effects disappeared even when the patient continued takingFinasteride Benel. When symptoms persisted, they generally ceased when stoppingFinasteride Benel.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

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

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Finasteride Benel

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

The other components (excipients) are:

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

Coating: Opadry Y-117000 (hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol), indigotin (E-132).

Appearance of the product and contents of the packaging

Finasteride Benel is presentedin the form of coated tablets with a film coating, blue, round, and biconvex. Each package contains 28 tablets in aluminum-PVC blisters.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

FARMALIDER, S.A

C/ Aragoneses, 15 - Pol. Ind. Alcobendas

28108 Madrid (Spain).

Responsible for manufacturing

WestPharma - Producções de Especialidades Farmacêuticas, S.A.

Rua João de Deus, nº 11, Venda Nova. 2700 Amadora (Portugal).

Date of the last review of this leaflet: September 2019

“Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”