FINASTERIDE TARBIS 5 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET

FINASTERIDE TARBIS 5 mg FILM-COATED TABLETS EFG

Contents of the pack:

1. What FINASTERIDE TARBIS 5 mg film-coated tablets are and what they are used for
2. Before taking FINASTERIDE TARBIS 5 mg film-coated tablets
3. How to take FINASTERIDE TARBIS 5 mg film-coated tablets
4. Possible side effects
5. Storage of FINASTERIDE TARBIS 5 mg film-coated tablets
6. Further information

1. What Finasteride Tarbis 5 mg film-coated tablets are and what they are used for

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

FINASTERIDE TARBIS 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 urinate.

FINASTERIDE TARBIS decreases the size of the enlarged prostate and relieves urinary symptoms: frequent need to urinate, painful urination, weak urine flow, feeling that the bladder is not completely empty.

FINASTERIDE TARBIS reduces the need for surgical intervention.

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

Do not take FINASTERIDE TARBIS:

If you are allergic (hypersensitive) to finasteride or any of the other ingredients of this medicine.

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

Warnings and precautions:

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

FINASTERIDE TARBIS is only intended for the treatment of benign prostatic hyperplasia in males. Women should not use FINASTERIDE TARBIS when they are or may be pregnant, nor should they be exposed to FINASTERIDE TARBIS by handling crushed or broken tablets. If the active ingredient of FINASTERIDE TARBIS 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 a pregnant woman comes into contact with the active ingredient of FINASTERIDE TARBIS, she should consult her doctor. The tablets of FINASTERIDE TARBIS are film-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 long period. 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 symptoms improve. Although you may not notice an improvement or change in symptoms, therapy with FINASTERIDE TARBIS may reduce the risk of urine 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 TARBIS may decrease the levels of 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 FINASTERIDE TARBIS.

Mood changes and depression:

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

Use of other medicines:

Finasteride is not expected to interact with other medicines. However, tell your doctor or pharmacist if you are using, or have recently used, other medicines, including those obtained without a prescription.

Taking FINASTERIDE TARBIS with food and drinks:

Take one FINASTERIDE TARBIS tablet daily, with or without food.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine.

FINASTERIDE TARBIS is for use in males only.

Use in children:

FINASTERIDE TARBIS is not indicated in children.

Driving and using machines:

FINASTERIDE TARBIS is unlikely to affect your ability to drive or use machines.

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

Follow exactly the administration instructions of FINASTERIDE TARBIS given by your doctor. Ask your doctor or pharmacist if you have any doubts.

Remember to take your medicine.

The normal dose is one FINASTERIDE TARBIS tablet per day, with or without food.

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

To relieve symptoms, FINASTERIDE TARBIS may be administered with doxazosin.

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

If you take more FINASTERIDE TARBIS than you should:

If you have taken more FINASTERIDE TARBIS than you should, consult your doctor or pharmacist immediately or contact the Toxicology Information Service (Tel: 91 562 04 20).

If you forget to take FINASTERIDE TARBIS:

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 further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, FINASTERIDE TARBIS can cause side effects, although not everybody gets them.

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

Disorders of the reproductive system and breast

Frequent (at least 1 in 100 patients): impotence (inability to initiate and maintain an erection) and decreased amount of semen ejaculated during sexual intercourse. This decrease in semen amount does not seem to alter normal sexual function.

Uncommon (at least 1 in 1000 patients): breast swelling and tenderness, and ejaculation disorders.

Rare (at least 1 in 10,000 patients): testicular pain.

Psychiatric disorders

Frequent (at least 1 in 100 patients): decreased libido.

Frequency not known: anxiety.

Disorders of the skin and subcutaneous tissue

Uncommon (at least 1 in 1000 patients): skin rash.

Immune system disorders

Rare (at least 1 in 10,000 patients): allergic reactions, including lip and face swelling and itching.

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

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

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

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date stated on the packaging. 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 TARBIS 5 mg film-coated tablets

The active substance is finasteride. 5 mg

The other ingredients are: Core excipients: microcrystalline cellulose, corn starch, sodium glycolate, iron oxide, sodium docusate, magnesium stearate, and purified water. Coating excipients: carmine aluminum lake (E132), methylhydroxypropyl cellulose, hydroxypropyl cellulose, titanium dioxide, and talc.

APPEARANCE OF THE PRODUCT AND PACKAGING CONTENTS

FINASTERIDE TARBIS 5 mg film-coated tablets are presented as light blue, round, biconvex, and scored on one side. Each pack contains 28 tablets in PVC/PVDC-Aluminum blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder: TARBIS FARMA, S.L. Gran Vía Carlos III, 94. 08028-Barcelona. Spain.

Manufacturer: Pharmaten, S.A.; Devernakion 6 (Pallini) – 15351 - Greece

or

KLEVA S.A. Parnithos Ave, 189 , Acharnai, Attiki Greece

Date of last revision of this leaflet: August 2018