LITACE 5 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

LITACE 5 mg film-coated tablets EFG

Finasteride

Contents of the pack:

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

1. What is Litace and what is it used for

Litace (finasteride) 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 is making it difficult to urinate.

Finasteride decreases 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 Litace

Do not take Litace:

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

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

Warnings and precautions:

Talk to your doctor or pharmacist before starting to take Litace.

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

Litace is only intended for the treatment of BPH in males. 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 Litace 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 of the genital organs. If a pregnant woman comes into contact with the active ingredient of Litace, she should consult her doctor. The tablets of Litace 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 small 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 urinary retention and thus postpone 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 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, talk to your doctor as soon as possible.

Children and adolescents

Litace is not indicated in children.

Taking Litace with other medicines:

Finasteride is not expected to interact with other medicines.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained 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 use in men only.

Litace is not indicated in women.

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.

Driving and using machines

Finasteride is unlikely to affect your ability to drive or use machines.

This medicine contains lactose.

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

This medicine contains sodium.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially "sodium-free".

3. How to take Litace

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

Remember to take your medicine.

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

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

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

If you think that the action of finasteride is too strong or too weak, tell 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Litace:

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 further questions on 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. The side effects due to finasteride include:

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.

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, ejaculation disorders.

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; ejaculation disorders that continued after stopping the medication, male infertility, poor semen quality. Improvement in semen quality has been reported after stopping the medication.

Investigations

Common (may affect up to 1 in 10 patients):decreased semen volume. This decrease in semen volume 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 despite the patient continuing 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 via the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Litace

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month.

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 further information

Composition of Litace

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

The other ingredients (excipients) are: lactose monohydrate, sodium carboxymethyl starch, corn starch, colloidal anhydrous silica, sodium docusate, magnesium stearate, Opadry blue (hypromellose, titanium dioxide (E-171), macrogol 6000, indigo carmine (E-132)).

Appearance of the product and pack contents

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

Each pack contains 28 tablets in PVC/PVDC-aluminum blisters.

Marketing authorisation holder

ABABOR PHARMACEUTICALS, S.L.

Chile, 4 - Building 1 - Office 1

Las Matas. 28290 – Las Rozas (Madrid).

Spain

Manufacturer

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

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

28923 ALCORCÓN (Madrid)

Spain

This leaflet was approved in February 2022

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