FINASTERIDE RATIOPHARM 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Finasteride ratiopharm 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, ask your doctor or pharmacist.
• This medication has been prescribed to you personally and you should not give it to others, even if they have the same symptoms, 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 ratiopharm and what is it used for
2. What you need to know before taking Finasteride ratiopharm
3. How to take Finasteride ratiopharm
4. Possible side effects
5. Storage of Finasteride ratiopharm
6. Package contents and additional information

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

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

Your doctor has prescribed Finasteride ratiopharm 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 makes it difficult to urinate.

Finasteride ratiopharm decreases 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 ratiopharm reduces the need for surgical intervention.

2. What you need to know before taking Finasteride ratiopharm

Do not take Finasteride ratiopharm:

If you are allergic to the active ingredient or any of the other ingredients 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 is absorbed after oral use or through the skin by a woman who is pregnant with a male fetus, the fetus may be born with abnormalities in its sexual organs. If a pregnant woman comes into contact with the active ingredient finasteride, she should consult her doctor. The tablets of finasteride are film-coated and this 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.

If your sexual partner is or may be pregnant, you should avoid exposing her to your semen, as it may contain minimal amounts of the drug.

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 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 and may 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. If you experience any of these symptoms, consult your doctor as soon as possible.

Children and adolescents

Finasteride is not indicated in children.

Use of Finasteride ratiopharm with other medications:

Finasteride does not usually interact with other medications.

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those purchased without a prescription.

Taking Finasteride ratiopharm with food, drinks, and alcohol:

Take one finasteride tablet per day, with or without food.

Pregnancy, breastfeeding, and fertility:

Finasteride is for use in males only.

Finasteride is not indicated in women.

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

Driving and using machines

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

Finasteride ratiopharm 5 mg contains lactose

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.

Finasteride ratiopharm 5 mg contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take Finasteride ratiopharm

Follow the administration instructions indicated by your doctor exactly. If you have any doubts, consult your doctor or pharmacist again.

Remember to take your medication.

Finasteride ratiopharm is an oral medication. Take one 5 mg tablet of Finasteride ratiopharm per day, with or without food.

Remember that your prostate took many years to grow enough to cause symptoms. Finasteride ratiopharm will only be able to treat your symptoms and control the disease if you continue to take it long-term.

Your doctor may prescribe Finasteride ratiopharm along with another medication, called doxazosin, to help you better control your prostate problem.

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

If you take more Finasteride ratiopharm than you should

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

If you forget to take Finasteride ratiopharm

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.

4. Possible side effects

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

These are rare and do not occur in most cases. The side effects due to finasteride include:

Immune system disorders

Frequency not known (cannot be estimated from available data): allergic reactions, angioedema (including swelling of the lips, tongue, throat, and face).

Psychiatric disorders

Frequent (may affect up to 1 in 10 patients): decreased libido.

Frequency not known (cannot be estimated from available data): depression, decreased libido that continued after stopping the medication, anxiety.

Cardiac disorders

Frequency not known (cannot be estimated from available data): irregular heartbeat.

Hepatobiliary disorders

Frequency not known (cannot be estimated from available data): elevated liver enzymes.

Skin and subcutaneous tissue disorders

Uncommon (may affect up to 1 in 100 patients): skin rash.

Frequency not known (cannot be estimated from available data): itching, urticaria.

Reproductive system and breast disorders

Frequent (may affect up to 1 in 10 patients): impotence (inability to have an erection).

Uncommon (may affect up to 1 in 100 patients): breast tenderness and enlargement, and problems with ejaculation.

Frequency not known (cannot be estimated from available data): testicular pain, inability to have an erection that continued after stopping the medication; problems with ejaculation that continued after stopping the medication, male infertility and/or poor semen quality. An improvement in semen quality has been reported after stopping the medication.

Investigations

Frequent (may affect up to 1 in 10 patients): decreased semen volume. This decrease in semen volume does not seem to affect normal sexual function.

Stop taking this medication and contact your doctor immediately if you experience any of the following symptoms (angioedema): swelling of the face, tongue, and throat; difficulty swallowing; urticaria and breathing difficulties.

You should inform your doctor immediately of any change in breast tissue, such as lumps, pain, enlargement, or nipple discharge, as these may be signs of a serious disease, such as breast cancer.

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

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 Medicines Surveillance System for Human Use: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Finasteride ratiopharm

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

This medication does not require special storage conditions.

Do not use Finasteride ratiopharm after the expiration date stated on the packaging after the abbreviation EXP. 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 ratiopharm

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

The other ingredients (excipients) are: sodium lauryl sulfate, pregelatinized corn starch, lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose type A (potato), magnesium stearate, hypromellose, and macrogol 8000.

Appearance of the product and package contents

Finasteride ratiopharm 5 mg film-coated tablets are presented in the form of film-coated tablets. The tablets are white, round, and marked with "F" and "5" on one side.

Each package contains 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1ª planta,

Alcobendas, 28108 Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig Merckle-Strasse 3

89143 Blaubeuren (Germany)

Date of the last revision of this package leaflet:April 2022

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