Finasteride CINFA 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

finasteride cinfa 5 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

finasteride cinfa is a 5-alpha reductase inhibitor that reduces prostate enlargement.

Your doctor has prescribed finasteride because you have 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 is making it difficult to pass urine.

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

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

Do not take finasteride cinfa

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

The condition for which finasteride is prescribed occurs only in men; therefore, women and children must not take it.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take finasteride cinfa.

Inform your doctor about any current or past medical conditions and any allergies you may have.

Finasteride is intended only for the treatment of BPH (benign prostatic hyperplasia) in men. Women must not use finasteride if they are or could be pregnant, and they should also avoid exposure to finasteride by handling crushed or split tablets. If the active ingredient finasteride is absorbed orally or through the skin by a woman who is pregnant with a male fetus, the fetus may be born with abnormalities of the genital organs. If a pregnant woman has come into contact with the active ingredient of finasteride, she must consult her doctor. Finasteride tablets are film-coated, which prevents contact with the active substance during normal handling, provided 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.

BPH develops over a prolonged period of time. Sometimes symptoms improve quickly, but you may need to take finasteride for at least six months to determine whether your symptoms improve. Even if you do not feel any improvement or change in symptoms, treatment with finasteride may reduce the risk of being unable to pass urine and thus the need for surgery. You should visit your doctor regularly for periodic check-ups and assessment of your progress.

Although BPH is not cancer and does not cause cancer, both conditions may coexist. Only a doctor can evaluate symptoms and their possible causes.

Finasteride may reduce levels of prostate-specific antigen (PSA—a substance in the body that increases when the prostate enlarges 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 for use in children.

Other medicines and finasteride cinfa

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

Finasteride usually does not interact with other medicines.

Taking finasteride cinfa with food and drinks

Take one finasteride tablet daily, with or without food.

Pregnancy and breastfeeding

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

Finasteride is for use in men only.

Finasteride is not indicated for use in women.

Driving and using machines

Finasteride is not expected to affect your ability to drive or operate machinery.

finasteride cinfa contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

finasteride cinfa contains sodium docusate

This medicine contains 0.50 mg of sodium docusate per tablet.

finasteride cinfa contains sodium

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

3. How to take finasteride cinfa

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Finasteride is a medicine taken by mouth. Take one finasteride tablet daily, with or without food.

Please remember that it took your prostate many years to grow large enough to cause symptoms. Finasteride can only treat your symptoms and control the disease if you continue taking it long-term.

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

If you feel that 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take finasteride cinfa

If you forget to take a dose, do not take a double dose; simply take the next tablet as usual.

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

These are uncommon and do not occur in most cases. The side effects associated with finasteride include:

Immune system disorders

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

Psychiatric disorders

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

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

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 and breast disorders

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

Uncommon (may affect up to 1 in 100 patients): swelling and increased sensitivity in the breasts, and problems with ejaculation.

Frequency not known (cannot be estimated from available data): testicular pain, blood in the semen, inability to achieve 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 discontinuation of the medication.

Additional investigations

Frequent (may affect up to 1 in 10 patients): decreased volume of semen ejaculated during sexual activity. This reduction in semen volume does not appear to affect normal sexual function.

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

In some cases, these adverse effects resolved even while the patient continued taking finasteride. When symptoms persisted, they usually resolved 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; or breathing difficulties.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and additional information

Composition of finasteride cinfa

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

Tablet core: monohydrate lactose, sodium carboxymethylstarch (type A) (from potato), maize starch, anhydrous colloidal silica, sodium docusate benzoate, and magnesium stearate.

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

Appearance of the product and contents of the container

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the most recent review of this leaflet: September 2025

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

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. 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