Leaflet: information for the user

Finasteride cinfa 5 mg film-coated tablets

Read this leaflet carefully before you start to take this medicine, because 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 must not give it to others even if they have the same symptoms as you, 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.

finasteride cinfa is a 5-alpha reductase inhibitor that reduces the increase in size of the prostate.

Your doctor has prescribed finasteride because you suffer 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 expel urine.

Finasteride 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. Finasteride reduces the need for surgical intervention.

Do not take finasteride cinfa

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

Inform your doctor of your current and past medical problems and of any allergies you suffer.

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 pregnant woman carrying a male fetus, the fetus may be born with abnormalities in its sexual organs. If the pregnant woman has come into contact with the active ingredient of finasteride, she should consult her doctor. Finasteride tablets are coated, which will prevent contact with the active ingredient 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 may be pregnant, you should avoid exposing her to your semen since it may contain minimal amounts of the drug.

BPH develops over a prolonged period of time. Sometimes symptoms improve right away, but you may have 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 so that he can perform periodic check-ups and assess your progress.

Although BPH 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.

Other medicines and finasteride cinfa

Inform your doctor or pharmacist if you are taking, have taken recently, or may have to take any other medicine.

Finasteride usually does not interact with other medicines.

Taking finasteride cinfa with food and drink

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

Pregnancy and breastfeeding

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

Finasteride is for exclusive use in men.

Finasteride is not indicated for women.

Driving and operating machinery

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

finasteride cinfa contains lactose

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

finasteride cinfa contains docusate sodium benzoate

This medicine contains 0.50 mg of docusate 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".

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

Remember to take your medication.

Finasteride is an oral medication. Take one finasteride tablet per day, with or without food.

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

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

If you estimate that the action of finasteride is too strong or too weak, inform 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 Toxicological Information Service at telephone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take finasteride cinfa

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.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

Immune system disorders

Unknown frequency (cannot be estimated from available data): allergic reactions such as 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.

Skin and subcutaneous tissue disorders

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

Unknown frequency:itching, urticaria.

Reproductive and mammary 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):swelling and increased sensitivity in the breast and ejaculation problems.

Unknown frequency:testicular pain, blood in semen, impotence that continued after stopping the medication; ejaculation problems that continued after stopping the medication, male infertility or poor semen quality. Semen quality improvement has been reported after stopping the medication.

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 alter 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 disease, 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.

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; hoarseness and difficulty breathing.

Reporting of side effects

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

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of finasteride cinfa

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

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

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

Appearance of the product and contents of the packaging

Finasteride cinfa is presented in the form of blue-green, cylindrical, biconvex, film-coated, and smooth tablets on both sides.

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

Only some package sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Last review date of this leaflet:June 2021

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

You can access detailed and updated information about this medication 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 link to:https://cima.aemps.es/cima/dochtml/p/67857/P_67857.html