FINASTERIDE TECNIGEN 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Finasteride TecniGen 5 mg film-coated tablets EFG

Finasteride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Finasteride TecniGen 5 mg film-coated tablets are and what they are used for
2. What you need to know before taking Finasteride TecniGen 5 mg film-coated tablets
3. How to take Finasteride TecniGen 5 mg film-coated tablets
4. Possible side effects
5. Storage of Finasteride TecniGen 5 mg film-coated tablets
6. Package Contents and Additional Information

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

Finasteride TecniGen are film-coated tablets containing 5 mg of finasteride as the active ingredient.

Your doctor has prescribed Finasteride TecniGen because you have a condition known as benign prostatic hyperplasia (BPH). BPH is a non-cancerous growth of the prostate common in men after the age of 50.

Your prostate (located near your bladder) has enlarged and is obstructing the flow of urine. You may have symptoms such as frequent need to urinate, especially at night, a sense of urgency to urinate, difficulty starting to urinate, a weak or interrupted flow of urine, or the feeling that you have not completely emptied your bladder.

In some men, BPH can cause serious problems such as urinary tract infections, sudden inability to urinate (acute urinary retention), and the need for surgical treatment. For this reason, a man with these symptoms should see a doctor.

Finasteride TecniGen belongs to a group of medications called 5-alpha reductase inhibitors. It works by reducing the size of the prostate gland in men. Finasteride TecniGen also reduces the risk of developing sudden inability to urinate (known as acute urinary retention) and the need for surgical intervention.

BPH develops over a long period. Some patients show rapid improvement of symptoms, but you may need to take Finasteride TecniGen for at least 6 months to see if your symptoms improve.

2. What you need to know before taking Finasteride TecniGen 5 mg film-coated tablets

Do not take Finasteride TecniGen:

if you are allergic to finasteride or any of the other ingredients of this medication (listed in section 6).

• If you are a woman and are or may be pregnant, you should not use Finasteride TecniGen, nor should you handle crushed or broken Finasteride TecniGen tablets (see Pregnancy and Breastfeeding).
• Finasteride TecniGen is prescribed only to men. It should not be used in women or children.

Warnings and Precautions

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

Finasteride TecniGen is intended only for the treatment of benign prostatic hyperplasia in men. Finasteride TecniGen may decrease the levels of prostate-specific antigen (PSA, a substance in the body that increases when the prostate grows). If you have had a PSA test, inform your doctor that you are taking Finasteride TecniGen.

Mood changes and depression

Mood changes, such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with Finasteride TecniGen 5 mg. If you experience any of these symptoms, consult your doctor as soon as possible.

Consult your doctor or pharmacist before starting to take Finasteride TecniGen 5 mg film-coated tablets.

Use of Finasteride TecniGen with other medications

Finasteride TecniGen 5 mg film-coated tablets do not normally interfere with other medications. However, inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those obtained without a prescription.

Taking Finasteride TecniGen with food, drinks, and alcohol

Finasteride TecniGen 5 mg film-coated tablets can be taken with or without food.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Women who are or may be pregnant should not be exposed to Finasteride TecniGen by handling crushed or broken tablets, due to the potential risk of absorption of finasteride and the consequent potential risk to the male fetus.

The tablets of Finasteride TecniGen 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 the active ingredient of Finasteride TecniGen 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 of the genital organs. If a pregnant woman comes into contact with the active ingredient of Finasteride TecniGen, she should consult a doctor.

If your sexual partner is or may be pregnant, you should avoid exposing her to your semen, which may contain residual amounts of the medication.

Driving and using machines

There are no data to suggest that Finasteride TecniGen affects the ability to drive or use machines.

Finasteride TecniGen 5 mg film-coated tablets contain lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Finasteride TecniGen 5 mg film-coated tablets contain sodium

This medication contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially "sodium-free".

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

Follow the instructions for administration of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one Finasteride TecniGen tablet per day.

If you take more Finasteride TecniGen 5 mg film-coated tablets than you should

If you have taken more Finasteride TecniGen than you should, contact your doctor or pharmacist or the nearest hospital.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 0420. You should also inform your doctor immediately.

If you forget to take Finasteride TecniGen 5 mg film-coated tablets

Do not take a double dose to make up for forgotten doses. Wait for the next dose.

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

4. Possible side effects

Like all medications, Finasteride TecniGen can cause side effects, although not everyone gets them. The following side effects have been reported with finasteride:

• decreased volume of semen released during sex, impotence (inability to get or maintain an erection), ejaculation disorders
• decreased sex drive
• palpitations
• rash, itching, and hives, swelling of the lips and face
• elevated liver enzymes
• breast tenderness or enlargement

testicular pain

• depression
• decreased libido that continues after treatment is stopped
• erectile dysfunction that continues after treatment is stopped, male infertility, and/or poor semen quality. An improvement in semen quality has been reported after treatment is stopped.
• anxiety (frequency not known).

You should inform your doctor immediately of any changes in your breast tissue, such as lumps, pain, gynecomastia, or nipple discharge, as these may be signs of a serious disease, such as breast cancer.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use. Website: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medication.

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

Keep this medication out of the sight and reach of children. No special storage conditions are required.

Do not use this medication after the expiration date stated on the carton after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Finasteride TecniGen 5 mg film-coated tablets The active ingredient is finasteride. Each tablet contains 5 mg of finasteride.

• The other ingredients (excipients) are:

Core: lactose monohydrate, microcrystalline cellulose (E460), sodium starch glycolate (Type A), pregelatinized corn starch (gluten-free), sodium docusate, yellow iron oxide (E172), magnesium stearate.

Coating: hypromellose, titanium dioxide (E171), macrogol 400, indigo carmine (E132).

Appearance of the product and package contents

Film-coated tablet.

The Finasteride TecniGen 5 mg tablets are blue, round, biconvex, film-coated.

Finasteride TecniGen 5 mg is available in packages of 10, 14, 28, 30, 60, 90, 100, and 500 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid), España

Manufacturer

Tecnimede – Sociedade Técnico Medicinal, S.A.

Quinta da Cerca, Caixaria

2565-187 Dois Portos

Portugal

or

One Pharma Industrial Pharmaceutical Company Societe Anonyme 60th Km N.N.R.

Athens-Lamia. Postal Code 32009

Greece

This medication is authorized in the Member States of the EEA under the following names:

Portugal: Finasterida Impruve 5 mg film-coated tablets

Spain: Finasteride TecniGen 5 mg film-coated tablets

Greece: Glopisine

Czech Republic: Finard

Hungary: Finasteride Pharmacenter

Date of last revision of this leaflet: August 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/