FINASTERIDE VIR 5 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Finasteride VIR 5 mg film-coated tablets EFG

Contents of the pack:

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

1. What is Finasteride VIR 5 mg film-coated tablets and what is it used for

Finasteride VIR is a 5-alpha reductase inhibitor that reduces the size of an enlarged prostate.

Finasteride VIR is used in the treatment of benign prostatic hyperplasia. The prostate is a gland that surrounds the urethra and, if it grows, it can gradually narrow it, making it difficult to urinate.

Finasteride VIR reduces the size of the enlarged prostate and relieves urinary symptoms: frequent need to urinate, pain while urinating, weak stream of urine, feeling that the bladder is not completely empty.

Finasteride VIRreduces the need for surgical intervention.

2. Before taking Finasteride VIR 5 mg film-coated tablets

Do not take Finasteride VIR:

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

The disorder for which Finasteride VIR is prescribed only occurs in men, so it should not be taken by women or children.

Be careful with Finasteride VIR:

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

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

Women should not use Finasteride VIR when they are or may be pregnant, nor should they be exposed to Finasteride VIR by handling crushed or broken tablets. If the active ingredient of Finasteride VIR 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 in its sexual organs. If a pregnant woman comes into contact with the active ingredient of Finasteride VIR, she should consult her doctor.

If your partner is pregnant or may become pregnant, you should avoid coming into contact with your semen, as it may contain a small amount of finasteride, using a condom.

The tablets of Finasteride VIR 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.

Benign prostatic hyperplasia develops over a long period of time. Sometimes the symptoms improve quickly, but it is possible that treatment with finasteride may need to be continued for at least six months to check if the symptoms improve. Although you may not notice an improvement or change in symptoms, therapy with Finasteride VIR may reduce the risk of urinary retention and thus postpone the need for surgery. You should see your doctor regularly for periodic check-ups and to assess your progress.

Although benign prostatic hyperplasia 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 VIR 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 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 does not usually interact with other medicines. However, tell your doctor or pharmacist if you are using, or have recently used, any other medicine, 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 males only.

Finasteride VIR is not indicated in women or children.

Driving and using machines:

Finasteride VIR should not affect your ability to drive or use machines.

Important information about some of the ingredients of Finasteride VIR

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

This medicine does not contain gluten.

3. How to take Finasteride VIR 5 mg film-coated tablets

Follow exactly the administration instructions of Finasteride VIR indicated by your doctor. Consult your doctor or pharmacist if you have doubts. The normal dose is one Finasteride VIR tablet per day, with or without food.

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

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

If you think the action 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, consult your doctor or pharmacist immediately, or 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; just take the next tablet as usual. Do not take a double dose to make up for forgotten doses.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Finasteride VIRcan have side effects, although not everybody gets them.

These are uncommon and do not occur in most cases. Among the side effects due to Finasteride VIR are:

Disorders of the reproductive system and breast

Frequent (>1/100, <1>

Uncommon (>1/1,000, <1>

Rare (>1/10,000, <1>

Psychiatric disorders

Frequent (>1/100, <1>

Frequency not known: anxiety

Disorders of the skin and subcutaneous tissue

Uncommon (>1/1,000, <1>

Disorders of the immune system

Rare (>1/10,000, <1>

In some cases, these side effects disappeared despite the patient continuing to take finasteride. When the symptoms persisted, they generally disappeared when finasteride was stopped.

If you experience any of the side effects, inform your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storage of Finasteride VIR 5 mg film-coated tablets

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the packaging after “EXP”. The expiry date is the last day of the month stated.

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

6. Further information

Composition of Finasteride VIR 5 mg film-coated tablets

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

The other ingredients (excipients) are: lactose monohydrate, sodium carboxymethyl starch, maize starch without gluten, colloidal anhydrous silica, sodium docusate benzoate, magnesium stearate, Opadry blue (hypromellose, titanium dioxide (E-171), macrogol 6000, indigo carmine (E-132))

Appearance and packaging of the product

Finasteride VIR 5 mg film-coated tablets are presented in the form of round, biconvex, film-coated tablets, smooth on both sides, light blue in color.

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

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 August 2018.