Leaflet: information for the user

Finasteride 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, 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.

Finasteride is a 5-alpha reductase inhibitor that reduces the enlargement of the prostate.

Your doctor has prescribed this medication because you suffer from a condition known as benign prostatic hyperplasia. Your prostate, a gland located near the urinary bladder that produces a fluid in which sperm are transported, has increased in size and makes it difficult to expel urine.

Finasteride reduces the size of the enlarged prostate and alleviates urinary symptoms: frequent need to urinate, pain while urinating, weak urine stream, sensation that the bladder has not been completely emptied. Finasteride reduces the need for surgical intervention.

Do not take Finasterida Pensa

• if you are allergic (hypersensitive) to finasteride or any of the other ingredients of this medicine (listed in section 6)

This condition for which finasteride is prescribed only occurs in men, so women and children should not take it.

Warnings and precautions

Consult your doctor or pharmacist before starting to take finasteride

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 men. Women should not use finasteride when pregnant or could be pregnant, nor should they be exposed to finasteride by handling crushed or broken tablets. If the active ingredient of finasteride 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 this medicine, she should consult her doctor. Finasteride 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 prolonged period of time. Sometimes symptoms improve right away, but you may need to take finasteride for at least six months to see if your symptoms improve. Even if you do not feel any improvement or change in symptoms, finasteride therapy may reduce the risk of being unable to urinate and therefore the need for surgery. You should visit your doctor regularly so that he can perform periodic check-ups and 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 your 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 and can cause obstruction). 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 Finasterida Pensa. If you experience any of these symptoms, consult your doctor as soon as possible.

Use of Finasterida Pensa with other medicines

Finasteride usually does not interact with other medicines. However, inform your doctor or pharmacist if you are using, or have recently used, any other medicine, including those purchased without a prescription.

Taking Finasterida Pensa with food and drink

Finasteride can be taken with or without food.

Pregnancy and breastfeeding

Finasteride is for exclusive use in men.

Finasteride is not indicated for women or children. (see sections “Do not take Finasterida Pensa” and “Be particularly careful with Finasterida Pensa”)

Consult your doctor or pharmacist before using any medicine.

Use in children

Finasteride is not indicated for children

Driving and operating machinery

Finasteride should not affect your ability to drive or operate machinery.

Important information about some of the components of Finasterida Pensa

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

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

Remember to take your medication.

Finasterida is an oral medication. Take one tablet of this medication per day, with or without food. The tablets should be swallowed whole with some water. Do not chew or crush them.

Your doctor may prescribe finasterida along with another medication, called doxazosina, to help you better control your prostate problem.

If you estimate that the action of finasterida is too strong or too weak, inform your doctor or pharmacist.

If you take more Finasterida Pensa than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Finasterida Pensa

If you forget to take a dose, do not take an extra dose; limit yourself to taking the next tablet as usual.

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

If you interrupt treatment with Finasterida Pensa

Your doctor will indicate the duration of treatment with this medication. Do not suspend treatment before. Remember that your prostate took many years to grow enough to cause you symptoms. Finasterida will only treat your symptoms and control the disease if you continue to take it over the long term.

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

These are infrequent and do not appear in most cases. Among the side effects due to finasteride are:

Reproductive System and Breast Disorders

Frequent (affect between 1 and 10 of every 100 patients): erectile dysfunction (impossibility of having an erection) and decreased semen volume during sexual intercourse. This decrease in semen volume does not appear to alter normal sexual function.

Infrequent (affect between 1 and 10 of every 1,000 patients): breast swelling and increased sensitivity, and ejaculation problems.

Rare (affect between 1 and 10 of every 10,000 patients): testicular pain.

Mental Health Disorders

Frequent (affect between 1 and 10 of every 100 patients): decreased libido.

Frequency unknown:anxiety

Skin and Subcutaneous Tissue Disorders

Infrequent (affect between 1 and 10 of every 1,000 patients): skin rash.

Immune System Disorders

Rare (affect between 1 and 10 of every 10,000 patients): allergic reactions including lip and face swelling, skin rash appearance, and itching.

In some cases, these adverse effects disappeared despite the patient continuing to take Finasteride 5 mg tablets. When symptoms persisted, they generally disappeared after stopping Finasteride 5 mg tablets.

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 Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

No special storage conditions are required.

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. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at 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 Pensa

• The active ingredient is finasteride. Each tablet contains 5 mg of finasteride.
• The other components are: sodium lauryl sulfate, pregelatinized cornstarch, lactose monohydrate, microcrystalline cellulose (E-460), sodium starch glycolate, magnesium stearate (E-470b), hypromellose (E-464), and magnesium stearate macrogol 8 ester.

Appearance of the product and contents of the packaging

Finasteride Pensa is presented in the form of coated tablets. The tablets are white, round, and marked with “F5” on one face.

Each package contains 28 tablets.

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Kern Pharma. S.L.

Polígono Ind. Colón II, c/ Venus 72

08228 Terrassa (Barcelona)

This prospectus was approved in June 2018

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