Leaflet: Information for the User

Finasteride ratiopharm 5 mg Film-Coated Tablets

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you personally andshould not be given to other people, even if they have the same symptoms, 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.

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

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

Finasterida ratiopharm 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. Finasterida ratiopharm reduces the need for surgical intervention.

Do not take Finasterida ratiopharm:

If you are allergic to the active ingredient or to any of the other components of this medication (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 problems and of any allergies you suffer.

Finasteride is only intended for the treatment of benign prostatic hyperplasia in males. 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 is absorbed after oral use or through the skin by a pregnant woman carrying a male fetus, the baby may be born with abnormalities in its sexual organs. If the pregnant woman has come into contact with the active ingredient finasteride, 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.

If your sexual partner is or could 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 prolonged period. Sometimes symptoms improve immediately, but you may need to take finasteride for at least six months to see if your symptoms improve. Although you may 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 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 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 finasteride. If you experience any of these symptoms, consult your doctor as soon as possible.

Children and adolescents

Finasteride is not indicated for children.

Use of Finasterida ratiopharm with other medications:

Finasteride usually does not interact with other medications.

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

Taking Finasterida ratiopharm with food, drinks, and alcohol:

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

Pregnancy, breastfeeding, and fertility:

Finasteride is for exclusive use in males.

Finasteride is not indicated for women.

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

Driving and operating machinery

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

Finasterida 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 him before taking this medication.

Finasterida ratiopharm 5 mg contains sodium

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

Follow exactly the administration instructions provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Finasterida ratiopharmis a medication that is administered orally.Take one Finasterida ratiopharm tablet (5 mg) per day, with or without food.

Remember that your prostate took many years to grow enough to cause you symptoms. Finasterida ratiopharm will only treat your symptoms and control the disease if you continue to take it over a long period.

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

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

If you take more Finasterida ratiopharm than you should

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

If you forgot to takeFinasterida ratiopharm

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.

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

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

Immune system disorders

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

Mental health disorders

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

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

Cardiac disorders

Unknown frequency (cannot be estimated from available data): irregular heart rate.

Hepatobiliary disorders

Unknown frequency (cannot be estimated from available data):elevated liver enzymes.

Dermatological and subcutaneous tissue disorders

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

Unknown frequency (cannot be estimated from available data): itching, urticaria.

Reproductive and breast disorders

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

Rare (may affect up to 1 in 100 patients): breast tenderness and swelling, and ejaculation problems.

Unknown frequency (cannot be estimated from available data):testicular pain, impotence that continued after stopping the medication; ejaculation problems that continued after stopping the medication, male infertility, and/or poor semen quality. Improved semen quality has been reported after stopping the medication.

Additional diagnostic tests

Frequent (may affect up to 1 in 10 patients):decreased semen volume during sexual intercourse. This decrease in semen volume does not appear 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 difficulty breathing.

You should inform your doctor immediately of any changes in breast tissue, such as lumps, pain, swelling, or nipple discharge, as these may be indicative of a serious condition, such as breast cancer.

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:http://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special storage conditions.

Do not use Finasterida ratiopharmafter the expiration date that appears on the packaging after the abbreviation CAD. 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 pointat 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 Finasterida ratiopharm

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

The other components (excipients) are: sodium lauryl sulfate, pregelatinized cornstarch, lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose type A (from potato) magnesium stearate, hypromellose, and macrogol 8 stearate.

Appearance of the product and content of the packaging

Finasterida ratiopharm 5 mg tablets are presented in the form of film-coated tablets. The tablets are white, round, and marked with “F” and “5” on one of the faces.

Each package contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Responsible for manufacturing

Merckle GmbH

Ludwig Merckle-Strasse 3

89143 Blaubeuren (Germany)

Revision date of this prospectus:April 2022

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/