FINASTERIDE PENSA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Finasteride Pensa 5 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Finasteride Pensa and what is it used for
2. What you need to know before taking Finasteride Pensa
3. How to take Finasteride Pensa
4. Possible side effects
5. Storage of Finasteride Pensa
6. Package contents and additional information

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

Finasteride is a 5-alpha reductase inhibitor that reduces the size of an enlarged prostate.

Your doctor has prescribed this medication because you are suffering from a condition called 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 is making it difficult to urinate.

Finasteride reduces the size of the enlarged prostate and relieves urinary symptoms: frequent need to urinate, pain while urinating, weak urine flow, feeling that the bladder is not completely empty. Finasteride reduces the need for surgical intervention.

2. What you need to know before taking Finasteride Pensa

Do not take Finasteride Pensa

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

The disorder 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 about your current and past medical problems and any allergies you suffer from.

Finasteride is intended only 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 is absorbed after oral use or through the skin by a pregnant woman, the male fetus may be born with abnormalities in its sexual organs. If a pregnant woman comes into contact with the active ingredient of this medication, she should consult her doctor. The tablets of finasteride 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 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, therapy with finasteride may reduce the risk of being unable to urinate and therefore the need for surgery. You should visit 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 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 Finasteride Pensa. If you experience any of these symptoms, consult your doctor as soon as possible.

Using Finasteride Pensa with other medications

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

Taking Finasteride Pensa with food and drinks

Finasteride can be taken with or without food.

Pregnancy and breastfeeding

Finasteride is for use in males only.

Finasteride is not indicated in women or children. (See sections "Do not take Finasteride Pensa" and "Be careful with Finasteride Pensa")

Consult your doctor or pharmacist before using any medication.

Use in children

Finasteride is not indicated in children

Driving and using machines

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

Important information about some of the components of Finasteride Pensa

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

3. How to take Finasteride Pensa

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

Remember to take your medication.

Finasteride is a medication that is administered orally. 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 finasteride along with another medication, called doxazosin, to help you better control your prostate problem.

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

If you take more Finasteride Pensa than you should

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

If you forget to take Finasteride Pensa

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

Do not take a double dose to make up for forgotten doses.

If you stop taking Finasteride Pensa

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

These are rare and do not occur in most cases. Among the side effects caused by finasteride are:

Reproductive system and breast disorders

Frequent (affecting 1 to 10 out of 100 patients): erectile dysfunction (inability to have an erection) and decreased amount of semen ejaculated during sexual intercourse. This decrease in semen does not seem to alter normal sexual function.

Uncommon (affecting 1 to 10 out of 1,000 patients): breast tenderness and swelling, and problems with ejaculation.

Rare (affecting 1 to 10 out of 10,000 patients): testicular pain.

Psychiatric disorders

Frequent (affecting 1 to 10 out of 100 patients): decreased libido.

Frequency not known:anxiety

Skin and subcutaneous tissue disorders

Uncommon (affecting 1 to 10 out of 1,000 patients): skin rash.

Immune system disorders

Rare (affecting 1 to 10 out of 10,000 patients): allergic reactions, including swelling of the lips and face, hives, and itching.

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Finasteride Pensa

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Finasteride Pensa

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

Appearance of the product and package contents

Finasteride Pensa is presented in the form of film-coated tablets. The tablets are white, round, and marked with "F5" on one side.

Each package contains 28 tablets.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Kern Pharma. S.L.

Polígono Ind. Colón II, c/ Venus 72

08228 Terrassa (Barcelona)

This package leaflet was approved in June 2018

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