Litace 5 mg film-coated tablets EFG
Spain
Table of Contents
Package Leaflet: Information for the User
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
LITACE 5 mg film-coated tablets EFG
Finasteride
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
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Package leaflet contents:
- What Litace is and what it is used for
- What you need to know before taking Litace
- How to take Litace
- Possible side effects
- How to store Litace
- Contents of the pack and other information
1. What Litace is and what it is used for
Litace (finasteride) is a 5-alpha reductase inhibitor that reduces the enlargement of the prostate.
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: need to urinate frequently, pain when urinating, weak urine stream, feeling that the bladder has not emptied completely.
Finasteride reduces the need for surgical intervention.
2. What you need to know before taking Litace
Do not take Litace:
If you are allergic to finasteride or to any of the other components of this medicine (listed in section 6).
The condition for which Litace is prescribed occurs only in men, so it should not be taken by women or children.
Warnings and precautions:
Talk to your doctor, pharmacist, or nurse before starting to take Litace.
Inform your doctor about any current or past medical conditions and any allergies you may have.
Litace is intended only for the treatment of benign prostatic hyperplasia (BPH) in men. Women must not take finasteride if they are or could be pregnant, nor should they be exposed to finasteride by handling crushed or split tablets. If the active ingredient in Litace is absorbed following oral intake 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 been exposed to the active ingredient in Litace, she should consult a doctor. Litace tablets are coated, which prevents 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 could be pregnant, you should avoid exposing her to your semen, as it may contain very small, minimal amounts of the drug.
BPH develops over a long 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 urinary retention and thereby delay the need for surgery. You should visit your doctor regularly for periodic check-ups and evaluation of your progress.
Although BPH is not cancer and does not cause cancer, both conditions can exist simultaneously. 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
Litace is not indicated for use in children.
Taking Litace with other medicines:
Finasteride usually does not interact with other medicines.
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
Taking Litace with food, drinks, and alcohol:
Take one Litace tablet daily, with or without food.
Pregnancy, breastfeeding, and fertility:
Litace is for use in men only.
Litace is not indicated for use in women.
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Finasteride is not expected to affect your ability to drive or operate machinery.
This medicine contains lactose.
If your doctor has informed you of an intolerance to certain 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 for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Remember to take your medicine.
Litace is a medicine taken orally. Take one Litace tablet daily, with or without food.
Please remember that it took many years for your prostate 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 Litace together with another medicine called doxazosin to help you better control your BPH.
If you think that the effect 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Litace:
If you forget to take a dose, do not take an extra 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 can cause adverse effects, although not everyone experiences them.
These are uncommon and do not occur in most cases. Adverse effects due to 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
Common (may affect up to 1 in 10 patients): reduced libido.
Frequency not known (cannot be estimated from available data): depression, decreased libido that continued after stopping treatment, 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): rash.
Frequency not known (cannot be estimated from available data): itching, urticaria.
Reproductive system and breast disorders
Common (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 semen, inability to achieve an erection that continued after stopping treatment; problems with ejaculation that continued after stopping treatment; male infertility, poor semen quality. Improvement in semen quality has been reported after discontinuation of treatment.
Investigations
Common (may affect up to 1 in 10 patients): decrease in the amount of semen released 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 side effects disappeared 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, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products:
http://www.notificaram.es. By reporting adverse 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 stated on the packaging, following “EXP”. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and their packaging should be taken to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Litace
The active substance is finasteride. Each tablet contains 5 mg of finasteride.
The other components (excipients) are: Monohydrate lactose, sodium carboxymethyl starch, corn starch, anhydrous colloidal silica, sodium docusate benzoate, magnesium stearate, Opadry blue (hypromellose, titanium dioxide (E-171), macrogol 6000, indigo carmine (E-132)).
Appearance of the product and contents of the pack
Litace is presented as round, biconvex, film-coated tablets, smooth on both sides, light blue in colour.
Each pack contains 28 tablets in a PVC/PVDC-Aluminium blister.
Marketing Authorization 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 September 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/