Finasteride Alter 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Finasteride Alter 5 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking 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 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.

Leaflet contents

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

1. What Finasteride Alter is and what it is used for

Finasteride is a 5-alpha reductase inhibitor that reduces the enlargement of the prostate gland.

Your doctor has prescribed Finasteride Alter because you have a condition called benign prostatic hyperplasia (BPH). Your prostate, a gland located near the urinary bladder that produces the fluid in which sperm are transported, has increased in size and is making it difficult to pass urine.

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

2. What you need to know before taking Finasteride Alter

Do not take Finasteride Alter

• 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 Alter is prescribed occurs only in men, so it must not be taken by women or children.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Finasteride Alter

• Inform your doctor about any current or past medical conditions and any allergies you may have.
• Finasteride Alter is intended only for the treatment of BPH in men. Women must not use Finasteride Alter if they are or could be pregnant, and they should also avoid exposure to this medicine by handling crushed or split tablets. If the active ingredient in Finasteride Alter is absorbed following 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 has been exposed to the active ingredient in Finasteride Alter, she should consult her doctor. Finasteride Alter tablets are film-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 minimal amounts of the drug.

• BPH develops over a long period of time. Sometimes symptoms improve quickly, but you may need to take Finasteride Alter for at least six months to determine whether your symptoms improve. Even if you do not feel improvement or notice changes in symptoms, treatment with Finasteride Alter 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 occur simultaneously. Only a doctor can evaluate symptoms and their possible causes.

• Finasteride Alter 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 Alter.

Mood changes and depression

Mood changes such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with Finasteride Alter. If you experience any of these symptoms, consult your doctor as soon as possible.

Children and adolescents

Finasteride Alter is not indicated for use in women or children.

Other medicines and Finasteride Alter

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

Finasteride Alter is not usually associated with interactions with other medicines.

Taking Finasteride Alter with food and drink

Take one Finasteride Alter tablet daily, with or without food.

Pregnancy, breastfeeding and fertility

Finasteride Alter is for use in men only.

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

Finasteride Alter contains lactose

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

3. How to take Finasterida Alter

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

Remember to take your medication.

Finasterida Alter is a medicine taken orally. Take one Finasterida Alter tablet daily, with or without food.

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

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

If you think the effect of Finasterida Alter is too strong or too weak, tell your doctor or pharmacist.

If you take more Finasterida Alter than you should

Contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Finasterida Alter

If you miss 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 missed 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 will experience them.

The following adverse effects may occur with this medicine:

Allergic reactions

Stop taking this medicine and see your doctor immediately if you experience any of the following symptoms:

• swelling of the lips, face, tongue or throat, difficulty swallowing and breathing, hives (angioedema)
• skin rash, itching, lumps under the skin (rash)

Other adverse effects may include:

• inability to achieve an erection (impotence)
• reduced desire for sexual intercourse
• problems with ejaculation, for example a decrease in the amount of semen released during sexual activity. This decrease in semen volume does not appear to affect normal sexual function.

These adverse effects may disappear after some time if you continue taking this medicine. If not, they usually resolve when finasteride is discontinued.

Other adverse effects reported in men with unknown frequency are:

• Breast swelling or tenderness
• Palpitations (awareness of heartbeat)
• Changes in liver function, which may be observed in blood tests
• Testicular pain
• Inability to achieve an erection that may persist after stopping treatment
• Male infertility and/or poor semen quality. Cases of improvement in semen quality after discontinuation of treatment have been reported.
• Depression
• Anxiety
• Suicidal thoughts
• Decreased libido that may persist after stopping treatment
• Ejaculation problems that may persist after stopping the medicine.

You should 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 condition, such as breast cancer.

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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Finasteride Alter

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

This medicine does not require any special storage conditions.

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.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Finasterida Alter

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

Core: Lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, sodium carboxymethyl starch (type A) (from potato), polysorbate 80 (E433), magnesium stearate.

Coating: Hypromellose, triacetin, titanium dioxide (E171), and indigotine (E132, indigo carmine).

Appearance of the product and contents of the pack

Finasterida Alter is presented as tablets. The tablets are round and blue in color. Each pack contains 28 tablets in an Al/PVC blister.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.
C/ Mateo Inurria 30
28036 Madrid
Spain

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

Detailed and up-to-date 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/