PATIENT INFORMATION LEAFLET

Finasteride VIR 5 mg Film-Coated Tablets

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

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

Finasterida VIR reduces the size of the enlarged prostate and alleviates urinary symptoms: frequent need to urinate, pain while urinating, weak urine stream, sensation that the bladder has not been completely emptied.

Finasterida VIRreduces the need for surgical intervention.

Do not take Finasterida VIR:

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

The condition for which Finasterida VIR is prescribed only occurs in men, so women and children should not take it.

Be especially careful with Finasterida VIR:

Inform your doctor of your current and past medical problems and any allergies you suffer.

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

Women should not use Finasterida VIR when pregnant or could be pregnant, nor should they be exposed to Finasterida VIR by handling crushed or broken tablets. If the active ingredient of Finasterida VIR is absorbed after oral use or through the skin by a pregnant woman carrying a male fetus, the fetus may be born with abnormalities in its sexual organs. If the pregnant woman has come into contact with the active ingredient of Finasterida VIR, she should consult her doctor.

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

Finasterida VIR tablets are coated, which 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 prolonged period of time. Sometimes symptoms improve quickly, but it is possible that finasteride treatment may need to be continued for at least six months to see if symptoms improve. Although you may not notice improvement or change in symptoms, Finasterida VIR therapy may reduce the risk of urinary retention and thus postpone the need for surgery. You should attend 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 symptoms and their possible causes.

Finasterida VIR may decrease levels of the prostate-specific antigen (PSA, a substance in the body that increases when the prostate grows and can cause obstruction). If you have had a PSA test, tell your doctor that you are taking Finasterida VIR.

Mood alteration and depression

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

Use of other medications:

Finasteride usually does not interact with other medications. However, inform your doctor or pharmacist if you are using, or have recently used, any other medication, including those acquired without a prescription.

Finasterida VIR with food and beverages:

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

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medication

Finasterida VIR is for exclusive use in males.

Finasterida VIR is not indicated for women or children.

Driving and operating machinery:

Finasterida VIR should not affect your ability to drive or operate machines.

Important information about some of the components of Finasterida VIR

This medication contains lactose. If your doctor has indicated that you have a intolerance to certain sugars, consult with him before taking this medication.

This medication does not contain gluten.

Follow exactly the administration instructions for Finasterida VIR as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. The usual dose is one Finasterida VIR tablet per day, with or without food.

Remember that your prostate took many years to grow enough to cause you symptoms. Finasterida VIR will only treat your symptoms and control the disease if you continue to take it over the long term.

Finasterida VIR can be administered with doxazosina to alleviate symptoms.

If you estimate that the action of Finasterida VIR is too strong or too weak, inform your doctor or pharmacist.

If you take more Finasterida VIR than you should:

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

If you forget to take Finasterida VIR:

If you forget to take a dose, do not take an extra dose; limit yourself to taking the next tablet as usual. Do not take a double dose to compensate for the missed doses.

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

Like all medications,Finasteride VIR may have adverse effects, although not all people will experience them.

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

Reproductive and breast disorders

Frequent (>1/100, <1/100)

Infrequent (>1/1,000, <1/1,000)

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

Psychiatric disorders

Frequent (>1/100, <1/100)

Unknown frequency: anxiety

Skin and subcutaneous tissue disorders

Infrequent (>1/1,000, <1/1,000)

Immune system disorders

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

In some cases, these adverse effects disappeared despite the patient continuing to take finasteride. When symptoms persisted, they generally disappeared after stopping finasteride.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effects not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

No special storage conditions are required.

Do not use this medication after the expiration date indicated on the packaging, after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of unused medications. This will help protect the environment.

Composition of Finasteride VIR 5 mg Tablets

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

The other components (excipients) are: lactose monohydrate, carboxymethylcellulose sodium, cornstarch gluten-free, anhydrous colloidal silica, sodium docusate benzoate, magnesium stearate, Opadry blue (hypromellose, titanium dioxide (E-171), macrogol 6000, indigotin (E-132))

Appearance of the Product and Contents of the Package

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

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

Holder of the Marketing Authorization and Responsible Manufacturer

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-68-70, 28923 ALCORCÓN (Madrid)

This leaflet has been reviewed in August 2018.