PATIENT INFORMATION LEAFLET

LITACA 5 mg film-coated tablets

Finasteride

Litace (finasteride) is a 5-alpha reductase inhibitor that reduces the enlargement 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 urinate.

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 fully emptied.

Finasteride reduces the need for surgical intervention.

Do not take Litace:

If you are allergic to finasteride or any of the other components of this medication (listed in section 6).

This condition for which Litace is prescribed only occurs in men, so women and children should not take it.

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to take Litace.

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

Litace is only intended for the treatment of BPH in males. Women should not use finasteride when pregnant or could be pregnant, nor should they be exposed to finasteride when handling crushed or broken tablets. If the active ingredient of Litace 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 Litace, she should consult her doctor.The tablets of Litace 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 small amounts of the medication.

BPH develops over a prolonged period of time. Sometimes symptoms improve right away, 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, finasteride therapy may reduce the risk of urinary retention and thus delay the need for surgery. You should visit your doctor regularly for periodic check-ups and to evaluate 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 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:

Litaceis notindicated for children.

Taking Litace 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 purchased without a prescription.

Taking Litace with food, drinks, and alcohol:

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

Pregnancy, breastfeeding, and fertility:

Litace is for exclusive use in males.

Litaceis notindicated for women.

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

Driving and operating machinery:

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

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.

This medication contains sodium.

This medication contains less than 23 mg of sodium (1 mmol) per tablet, which 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.

Litace is an oral medication. Take one Litace 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 Litace along with another medication, called doxazosina, to help you better control your BPH.

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

If you take more Litace than you should:

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

If you forgot to take Litace:

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 medications,this medication may have side effects, although not all people 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 discontinuing 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 (cannot be estimated from available data): 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): breast swelling and increased sensitivity, and ejaculation problems.

Unknown frequency (cannot be estimated from available data): testicular pain, blood in semen, inability to achieve an erection that continued after discontinuing the medication; ejaculation problems that continued after discontinuing the medication, male infertility, poor semen quality. Semen quality has been reported to improve after discontinuing 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 alter normal sexual function.

Inform your doctor immediately of any changes in breast tissue, such as lumps, pain, swelling, 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 discontinuing 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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:

http://www.notificaram.es. By reporting adverse 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.

No special storage conditions are required.

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.

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 Litace

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

The other components (excipients) are: Lactose monohydrate, carboxymethylcellulose sodium, cornstarch, anhydrous colloidal silica, sodium docusate benzoate, magnesium stearate, Opadry blue (hypromellose, titanium dioxide (E-171), macrogol 6000, indigotin (E-132))

Appearance of the product and contents of the packaging

Litace is presented in the form of round, biconvex, film-coated tablets, smooth on both faces, light blue in color.

Each package contains 28 tablets in a PVC/PVDC-Aluminum blister.

Holder of the marketing authorization

ABABOR PHARMACEUTICALS, S.L.

Chile, 4 - Building 1 - Office 1

The Matas. 28290– The Rozas (Madrid).

Spain

Responsible for manufacturing:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/Laguna 66-68-70. Industrial Park URTINSA II

28923 ALCORCÓN (Madrid)

Spain

This prospectus was approved in February 2022

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