FINASTERIDE BENEL 5 mg FILM-COATED TABLETS

2. What you need to know before taking Finasteride Benel

Do not take Finasteride Benel:

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

The use of finasteride is not indicated in women or children.

Warnings and precautions

Talk to your doctor or pharmacist before taking Finasteride Benel.

Tell your doctor about your current and past medical problems and any allergies you suffer from.

Finasteride is only intended for the treatment of benign prostatic hyperplasia in males. Women should not use finasteride when they are or may be pregnant, nor should they be exposed to finasteride by handling crushed or broken tablets. If the active ingredient of Finasteride Benel is absorbed after oral use or through the skin by a pregnant woman, the male fetus may be born with abnormalities of the genital organs. If a pregnant woman comes into contact with the active ingredient of Finasteride Benel, she should consult her doctor. The tablets of Finasteride Benel are film-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 the symptoms improve quickly, but it is possible that treatment with Finasteride Benel may need to be continued for at least six months to check if symptoms improve. Even if you do not notice an improvement or change in symptoms, therapy with finasteride may reduce the risk of urinary retention and thus postpone the need for surgery. You should see your doctor regularly for periodic check-ups and to assess your progress.

Although benign prostatic hyperplasia is not cancer and does not cause cancer, both conditions can exist at the same time. Only a doctor can evaluate the symptoms and their possible causes. Finasteride may decrease the levels of prostate-specific antigen (PSA, a substance in the body that increases when the prostate grows). If you have had a PSA test, tell 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 Finasteride Benel 5 mg. If you experience any of these symptoms, talk to your doctor as soon as possible.

Children

Finasteride Benel is not indicated in children.

Taking Finasteride Benel with other medicines

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

No significant adverse interactions have been found with the use of finasteride and other medicines.

Taking Finasteride Benel with food and drinks and alcohol

The tablets can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Finasteride Benel is for use in males only.

Finasteride Benel is not indicated in women or children.

Driving and using machines

There are no known data to suggest that finasteride may affect the ability to drive or use machines.

Finasteride Benel 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.

3. How to take Finasteride Benel

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

Your doctor will tell you how long to take Finasteride Benel. Do not stop treatment before.

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

To alleviate symptoms, Finasteride Benel may be administered with doxazosin.

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

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If you take more Finasteride Benel than you should

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

If you forget to take Finasteride Benel

Do not take a double dose to make up for forgotten doses, wait for the next dose.

If you have any further questions on 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.

Side effects may occur with the following frequencies:

Common, may affect up to 1 in 10 people:

• decreased volume of ejaculate, impotence
• decreased libido.

Uncommon, may affect up to 1 in 100 people:

• ejaculation disorders, breast tenderness, gynaecomastia
• 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.

Frequency not known:

• anxiety

In some cases, these side effects disappeared even though the patient continued to take Finasteride Benel. When symptoms persisted, they usually stopped when Finasteride Benel was discontinued.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Finasteride Benel

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 packaging after EXP. The expiry date is the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste.Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point.If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Finasteride Benel

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

The other ingredients (excipients) are:

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

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

Appearance and packaging of the product

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

Marketing authorisation holder and manufacturer

Marketing authorisation 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 last revision of this leaflet: September 2019

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