Finasteride Vir 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Finasteride VIR 5 mg film-coated tablets EFG

Package leaflet contents:

1. What Finasteride VIR 5 mg tablets is and what it is used for
2. Before taking Finasteride VIR 5 mg tablets
3. How to take Finasteride VIR 5 mg tablets
4. Possible side effects
5. How to store Finasteride VIR 5 mg tablets
6. Further information

1. What Finasteride Vir 5 mg Tablets Are and What They Are Used For

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

Finasteride VIR is used in the treatment of benign prostatic hyperplasia. The prostate is a gland that surrounds the urethra, and when it enlarges, it can gradually constrict the urethra, making it difficult to pass urine.

Finasteride VIR 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 VIR reduces the need for surgical intervention.

2. Before taking Finasteride VIR 5 mg tablets

Do not take Finasteride VIR:

You must not take Finasteride VIR if you are allergic (hypersensitive) or have had any allergic reaction to finasteride or to any of the other components of this medicine.

The condition for which Finasteride VIR is prescribed occurs only in men; therefore, women and children must not take it.

Take special care with Finasteride VIR:

Inform your doctor about any current or past medical problems and any allergies you may have.

Finasteride VIR is intended only for the treatment of benign prostatic hyperplasia in men.

Women must not use Finasteride VIR if they are or may be pregnant, nor should they be exposed to Finasteride VIR by handling crushed or broken tablets. If the active ingredient in Finasteride VIR is absorbed orally 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 come into contact with the active ingredient in Finasteride VIR, she must consult her doctor.

If your partner is pregnant or could become pregnant, you must avoid contact with your semen, which may contain a small amount of finasteride, by using a condom.

Finasteride VIR 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.

Benign prostatic hyperplasia develops over a long period of time. Sometimes symptoms improve quickly, but treatment with finasteride may need to continue for at least six months to determine whether your symptoms improve. Even if you do not notice improvement or changes in your symptoms, treatment with Finasteride VIR 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 evaluation of your progress.

Although benign prostatic hyperplasia is not cancer and does not cause cancer, both conditions can coexist. Only a doctor can evaluate symptoms and their possible causes.

Finasteride VIR may decrease 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 VIR.

Mood changes and depression

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

Use of other medicines:

Finasteride usually does not interact with other medicines. However, inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.

Taking Finasteride VIR with food and drinks:

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

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine.

Finasteride VIR is for use in men only.

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

Driving and using machines:

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

Important information about some of the components of Finasteride VIR

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

This medicine does not contain gluten.

3. How to take Finasteride VIR 5 mg tablets

Follow exactly the instructions for use of Finasteride VIR as given by your doctor. Consult your doctor or pharmacist if you have any doubts. The usual dose is one Finasteride VIR tablet daily, with or without food.

Remember that your prostate took many years to grow large enough to cause symptoms. Finasteride VIR will only treat your symptoms and control the disease if taken long-term.

To relieve symptoms, Finasteride VIR may be administered together with doxazosin.

If you think that the effect of Finasteride VIR is too strong or too weak, tell your doctor or pharmacist.

If you take more Finasteride VIR than you should:

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service (Tel: 91 562 04 20), indicating the medicine and the amount ingested.

If you forget to take Finasteride VIR:

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 product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Finasteride VIR may cause adverse effects, although not everyone experiences them.

These are uncommon and do not occur in most cases. The side effects associated with Finasteride VIR include:

Disorders of the reproductive system and breasts

Frequent (>1/100, <1/10): impotence (inability to initiate and maintain an erection) and decreased volume of semen ejaculated during sexual activity. This reduction in semen volume does not appear to affect normal sexual function.

Uncommon (>1/1,000, <1/100): swelling and increased breast sensitivity, and problems with ejaculation.

Rare (>1/10,000, <1/1,000): testicular pain.

Psychiatric disorders

Frequent (>1/100, <1/10): reduced sexual desire.

Frequency not known: anxiety, suicidal thoughts.

Skin and subcutaneous tissue disorders

Uncommon (>1/1,000, <1/100): skin rash.

Immune system disorders

Rare (>1/10,000, <1/1,000): allergic-type reactions including swelling of the lips and face and itching.

In some cases, these adverse effects disappeared despite the patient continuing finasteride treatment. When symptoms persisted, they usually resolved after stopping finasteride.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Finasteride Vir 5 mg Tablets

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use this medicinal product after the expiry date stated on the container, following “EXP”. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Additional Information

Composition of Finasteride VIR 5 mg Tablets

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

The other components (excipients) are: lactose monohydrate, sodium carboxymethyl starch, gluten-free 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 medicinal product and contents of the pack

Finasteride VIR 5 mg tablets are presented as round, biconvex, film-coated tablets, smooth on both sides and light blue in colour.

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

Marketing Authorization Holder and Manufacturer

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.
C/ Laguna 66-68-70, 28923 ALCORCÓN (Madrid)

This leaflet was last revised in September 2025.