Finasteride Tecnigen 5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Finasteride TecniGen 5 mg film-coated tablets EFG

Finasteride

Please read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Finasteride TecniGen 5 mg tablets are and what they are used for
2. What you need to know before taking Finasteride TecniGen 5 mg tablets
3. How to take Finasteride TecniGen 5 mg tablets
4. Possible side effects
5. How to store Finasteride TecniGen 5 mg tablets
6. Contents of the pack and other information

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

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

Your doctor has prescribed Finasteride TecniGen because you have a condition known as benign prostatic hyperplasia (BPH). BPH is a benign enlargement of the prostate gland 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 experience symptoms such as frequent need to urinate, especially at night, a strong urge to urinate, difficulty starting urination, a weak or interrupted urine stream, or a sensation that your bladder has not emptied completely.

In some men, BPH can lead to serious complications such as urinary tract infections, sudden inability to urinate (acute urinary retention), and the need for surgical treatment. For this reason, men experiencing these symptoms should consult a doctor.

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

BPH develops over a long period of time. Some patients experience a rapid improvement in symptoms, but you may need to take Finasteride TecniGen for at least 6 months to determine whether your symptoms improve.

2. What you need to know before starting to take Finasteride TecniGen 5 mg tablets

Do not take Finasteride TecniGen:

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

• If you are a woman and are or could be pregnant, you must not use Finasteride TecniGen, nor should you handle crushed or split tablets of Finasteride TecniGen (see Pregnancy and breastfeeding).
• Finasteride TecniGen is prescribed only for men. It must not be used in women or children.

Warnings and precautions

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

Finasteride TecniGen is intended only for the treatment of benign prostatic hyperplasia in men. Finasteride TecniGen may reduce levels of prostate-specific antigen (PSA, a substance in the body that increases when the prostate enlarges). 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 ideation 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.

Talk to your doctor or pharmacist before starting to take Finasteride TecniGen 5 mg tablets.

Use of Finasteride TecniGen with other medicines

Finasteride TecniGen 5 mg tablets generally do not interfere with other medicines. However, inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Taking Finasteride TecniGen with food, drinks and alcohol

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

Pregnancy, breastfeeding and fertility

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

Women who are or could be pregnant must not handle crushed or split tablets of Finasteride TecniGen due to the potential risk of absorption of finasteride and the consequent potential risk to a male fetus.

Finasteride TecniGen tablets are film-coated, which prevents contact with the active substance during normal handling, provided the tablets are not crushed or broken.

If the active substance in Finasteride TecniGen is absorbed orally or through the skin by a woman who is pregnant with a male fetus, the baby may be born with abnormalities of the genital organs. If a pregnant woman comes into contact with the active substance in Finasteride TecniGen, she must consult a doctor.

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

Driving and using machines

There are no data suggesting that Finasteride TecniGen affects the ability to drive or use machinery.

Finasteride TecniGen 5 mg tablets contain lactose.

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

Finasteride TecniGen 5 mg tablets contain sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; i.e., essentially “sodium-free”.

3. How to take Finasteride TecniGen 5 mg tablets

Follow exactly the instructions for use of this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one Finasteride TecniGen tablet daily.

If you take more Finasteride TecniGen 5 mg tablets than you should

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number: 91 562 0420. You must also inform your doctor immediately.

If you forget to take Finasteride TecniGen 5 mg tablets

Do not take a double dose to make up for missed doses. Wait until your next scheduled dose.

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

4. Possible adverse effects

Like all medicines, Finasterida TecniGen may cause adverse effects, although not everyone experiences them. The following adverse effects have been reported with finasteride:

• Decreased volume of semen released during sexual activity, impotence (inability to achieve or maintain an erection), ejaculation disorders
• Decreased sexual desire
• Palpitations
• Skin rash, pruritus, and urticaria; swelling of the lips and face
• Elevated liver enzymes
• Breast tenderness or enlargement of the breasts

Testicular pain

• Depression
• Decreased libido that persists after discontinuation of treatment
• Erectile dysfunction that persists after discontinuation of treatment; male infertility and/or poor semen quality. Improvement in semen quality has been reported after discontinuation of treatment.
• Anxiety (frequency not known)
• Suicidal thoughts (frequency not known)

You should immediately inform your doctor 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 of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products. Website: www.notificaRAM.es.

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

5. Storage of Finasteride TecniGen 5 mg tablets

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

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

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Finasteride TecniGen 5 mg tablets
The active substance is finasteride. Each tablet contains 5 mg of finasteride.

• Other components (excipients) are:

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

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

Appearance of the product and contents of the container

Film-coated tablet.

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

Finasteride TecniGen 5 mg is available in packs of 10, 14, 28, 30, 60, 90, 100 and 500 tablets. Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.
Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,
28108 Alcobendas (Madrid), Spain

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 medicinal product is authorized in the Member States of the EEA under the following names:

Portugal: Finasterida Impruve 5 mg tablets
Spain: Finasteride TecniGen 5 mg tablets
Greece: Glopisine
Czech Republic: Finard
Hungary: Finasteride Pharmacenter

Date of the most recent revision of this leaflet: November 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/