FINASTERIDE CINFA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

finasteride cinfa 5 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is finasteride cinfa and what is it used for
2. What you need to know before you take finasteride cinfa
3. How to take finasteride cinfa
4. Possible side effects
5. Storage of finasteride cinfa
6. Contents of the pack and other information

1. What is finasteride cinfa and what is it used for

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

Your doctor has prescribed finasteride because you are suffering from a condition called benign prostatic hyperplasia (BPH). 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 reduces the size of the enlarged prostate and relieves urinary symptoms: frequent need to urinate, pain when urinating, weak stream of urine, feeling that the bladder is not completely empty. Finasteride reduces the need for surgical intervention.

2. What you need to know before you take finasteride cinfa

Do not take finasteride cinfa

• If you are allergic to finasteride or any of the other ingredients of this medicine (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

Talk to your doctor or pharmacist before you start taking finasteride cinfa.

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

Finasteride is only intended for the treatment of BPH in men. 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 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 of 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.

BPH 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 not being able to urinate and therefore the need for surgery. You should see your doctor regularly so that he can perform periodic check-ups and assess your progress.

Although BPH 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. If you experience any of these symptoms, consult your doctor as soon as possible.

Children and adolescents

Finasteride is not indicated in children.

Other medicines and finasteride cinfa

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

Finasteride is not expected to interact with other medicines.

Taking finasteride cinfa with food and drinks

Take one finasteride tablet a day, 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 or pharmacist for advice before taking this medicine.

Finasteride is for use in men only.

Finasteride is not indicated in women.

Driving and using machines

Finasteride is not expected to affect your ability to drive or use machines.

finasteride cinfa 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.

finasteride cinfa contains sodium benzoate

This medicine contains 0.50 mg of sodium benzoate in each tablet.

finasteride cinfa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take finasteride cinfa

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Finasteride is a medicine that is taken orally. Take one finasteride tablet a day, with or without food.

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

Your doctor may prescribe finasteride along with another medicine, called doxazosin, to help you better control your BPH.

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

If you take more finasteride cinfa 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 04 20, indicating the medicine and the amount taken.

If you forget to take finasteride cinfa

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 have any other questions about 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.

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

Immune system disorders

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

Psychiatric disorders

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

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

Cardiac disorders

Frequency not known (cannot be estimated from the available data): irregular heart rate.

Hepatobiliary disorders

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

Reproductive system and breast disorders

Common (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 the available data): testicular pain, blood in the semen, inability to have an erection that continued after stopping the medication; problems with ejaculation that continued after stopping the medication, male infertility or poor semen quality. Improvement in semen quality has been reported after stopping the medication.

Investigations

Common (may affect up to 1 in 10 patients): decrease in the amount of semen ejaculated during sexual intercourse. This decrease in semen amount does not seem to affect normal sexual function.

You should immediately inform your doctor 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 even though the patient continued to take finasteride. When the symptoms persisted, they usually disappeared after stopping finasteride.

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via their website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of finasteride cinfa

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of finasteride cinfa

• The active substance is finasteride. Each tablet contains 5 mg of finasteride.
• The other ingredients are:

Core of the tablet: lactose monohydrate, sodium carboxymethyl starch (type A) (from potato), maize starch, colloidal anhydrous silica, sodium benzoate, and magnesium stearate.

Tablet coating: macrogol 6000, titanium dioxide (E-171), hypromellose, and indigo carmine (E-132).

Appearance and packaging

Finasteride cinfa is presented as light blue, cylindrical, biconvex, film-coated tablets with smooth surfaces on both sides.

It is available in PVC-PVDC/Aluminum blisters. Each pack contains 28 or 500 (clinical pack) tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of last revision of this leaflet:September 2025

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

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67857/P_67857.html

QR code to: https://cima.aemps.es/cima/dochtml/p/67857/P_67857.html