Finasterida tecnigen 5 mg comprimidos recubiertos con pelÍcula efg

NotomeFinasteridaTecniGen:

It is not intended for female use.

siesalérgicoafinasteridaoacualquieradelosdemás componentes de estemedicamento(incluidosenlasección6).

-Siesmujeryestáopudieraestar embarazadanodebeutilizarFinasteridaTecniGen,nitampocomanipularcomprimidostrituradosopartidosdeFinasteridaTecniGen(ver Embarazoylactancia).

- FinasteridaTecnigenseprescribesolamentea varones.Nodebe serutilizadoenmujeresnienniños.

Advertenciasyprecauciones

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

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

Alteraciones del estado de ánimo y depresión

Depression, mood changes, and, less frequently, suicidal ideation have been reported in patients treated with Finasterida 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 Finasterida TecniGen 5 mg tablets.

Uso deFinasteridaTecniGenconotrosmedicamentos

Finasterida Tecnigen 5 mg tablets do not usually interfere with other medications. However, inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those acquired without a prescription.

TomadeFinasteridaTecnigen conalimentos,bebidasyalcohol

Finasterida Tecnigen 5 mg tablets can be taken with or without food.

Embarazo,lactanciayfertilidad

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

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

Finasterida Tecnigen 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 the active ingredient of Finasterida Tecnigen is absorbed after oral use or through the skin by a pregnant woman, the male fetus may be born with abnormalities in its sexual organs. If the pregnant woman has come into contact with the active ingredient of Finasterida Tecnigen, she should consult her 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.

Conducción yuso de máquinas

There is no evidence to suggest that Finasterida Tecnigen affects the ability to drive or use machinery.

Finasterida TecniGen 5 mg comprimidos contiene lactosa.

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

Finasterida TecniGen 5 mg comprimidos contiene sodio

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

Follow these instructions exactly as directed by your doctor.lasinstrucciónde estemedicamentoindicadaspor sumédico.Encasode duda,consultede nuevo a sumédicoofarmacéutico.

The recommended dose is onecomprimidodeFinasteridaTecniGencadadía.

Take oneFinasteridaTecniGen5 mgcomprimidosdelquedebe

If you have taken more FinasteridaTecniGendelquedebiera,contacteconsumédicoofarmacéuticoo conel

call your doctor immediately.

In case ofsobredosisooingestiónaccidental,consultaralServiciodeInformaciónToxicológica.Teléfono:

91 562 0420. Additionally, you shouldavisara sumédicodeinmediato.

If youolvidótomarFinasteridaTecniGen5 mgcomprimidos

Do not take a double dose to compensate for a missed dose or to make up for a missed dose.lasinstrucciónde estemedicamentoindicadaspor sumédico.Espere alasiguientetoma.

If you have any further questions about the use of this medication,pregunte a sumédicoofarmacéutico.

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

- Decreased semen volume during sexual intercourse, impotence (inability to obtain or maintain an erection), ejaculation disorders

- Decreased sexual desire

- Palpitations

- Skin rash, itching, and urticaria, swelling of the lips and face

- Elevated liver enzymes

- Breast tenderness or enlargement

Dull testicular pain

- Depression

- Decreased libido that persists after treatment is stopped

- Persistent erectile dysfunction after treatment is stopped, male infertility, and/or poor semen quality. Improvement in semen quality has been reported after treatment is stopped.

- Anxiety (unknown frequency).

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 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use. Website: www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication

.

Maintainthismedicamenttopreventthevisistyandthealcancedethenewbirthcildren.Noconditionsespecialesofconservation.

DonoutilizethismedicamentafterthefechadthatappearsinthecatheterafterCAD.Thefechadthatappearsisthelastdayofthemonththatitisindicated.

Themedicamentsmustnotbedisposedintothedrainorthetrash.DisposethepackagingandthemedicamentsthatdonotappearintheSIGREpointofyourhealthcareprovider.AskyyourhealthcareproviderhowtodisposethepackagingandthemedicamentsthatalreadydonotappearintheSIGREpointofyourhealthcareprovider.Thiswillhelptoprotectyyourhealthandtheenvironment.

Compositionof Finasteride TecniGen5 mgcomprimidosThe active ingredient is finasteride. Each tablet contains 5 mg of finasteride.

-The other components (excipients) are:

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

Coating:Hypromellose, titanium dioxide (E171), macrogol 400, indigotin (E132).

Appearance of the product and contents of the package

Coated tablet.

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

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

Legalauthorityof thecommercializationandresponsibilityof thedistributor

Legalauthorityof thecommercializationandresponsibilityof thedistributor

Tecnimede España Industria Farmacéutica, S.A.

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

28108 Alcobendas (Madrid), España

Responsable de la fabricación

Tecnimede – Sociedade Técnico Medicinal, S.A.

Quinta da Cerca, Caixaria

2565-187 Dois Portos

Portugal

o

One Pharma Industrial Pharmaceutical Company Societe

Anonyme60th Km N.N.R.

Athens-Lamia.Postal Code 32009

Greece

EstaemedicamentoestautorizadoenlosestadosmiembrosdelEEAbajolossiguientesnombres:

Portugal:FinasteridaImpruve5mg comprimidos

Spain:FinasterideTecnigen5mg comprimidos

Greece:Glopisine

CzechRepublic:Finard

Hungary: FinasteridePharmacenter

Fecha delaúltimarevisióndeesteprospecto:Agosto 2022

Lainformacióndetalladayactualizadade estemedicamentoestádisponibleenlapáginaWeb delaAgencia

EspañoladeMedicamentosyProductosSanitarios(AEMPS)http://www.aemps.gob.es/