Tadalafil Apotex 20 mg, filmomhulde tabletten

País: Países Bajos

Idioma: neerlandés

Fuente: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Ingredientes activos:

TADALAFIL

Disponible desde:

Apotex Europe BV Archimedesweg 2 2333 CN LEIDEN

Código ATC:

G04BE08

Designación común internacional (DCI):

TADALAFIL

formulario farmacéutico:

Filmomhulde tablet

Composición:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLOXAMEER 407 ; TITAANDIOXIDE (E 171),

Vía de administración:

Oraal gebruik

Área terapéutica:

Tadalafil

Resumen del producto:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROLOSE (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); LACTOSE 1-WATER; MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); POLOXAMEER 407; TITAANDIOXIDE (E 171);

Fecha de autorización:

2018-01-03

Información para el usuario

TADALAFIL APOTEX 10 AND 20 MG, FILMOMHULDE TABLETTEN –
RVG 117849/50
MODULE 1.3
Product Information
VERSION 2020-09-28
MODULE 1.3.3
Patient Information Leaflet
REPLACES: 2018-04-19
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Tadalafil Apotex 10 mg, filmomhulde tabletten
Tadalafil Apotex 20 mg, filmomhulde tabletten
(tadalafil)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE, BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Tadalafil Apotex is and what it is used for
2.
What you need to know before you take Tadalafil Apotex
3.
How to use Tadalafil Apotex
4.
Possible side effects
5.
How to store Tadalafil Apotex
6.
Contents of the pack and other information
1.
WHAT TADALAFIL APOTEX IS AND WHAT IT IS USED FOR
Tadalafil Apotex is a treatment for adult men with erectile
dysfunction. This is when a
man cannot get, or keep a hard, erect penis suitable for sexual
activity. Tadalafil has been
shown to significantly improve the ability of obtaining a hard, erect
penis suitable for
sexual activity.
Tadalafil Apotex contains the active substance tadalafil which belongs
to a group of
medicines called phosphodiesterase type 5 inhibitors. Following sexual
stimulation
Tadalafil Apotex works by helping the blood vessels in your penis to
relax, allowing the
flow of blood into your penis. The result of this is improved erectile
function. Tadalafil
Apotex will not help you if you do not have erectile dysfunction.
It is important to note that tadalafil does not work if there is no
sexual stimulation. You
and your partner will need to engage in foreplay, just

Ficha técnica

TADALAFIL APOTEX 10 EN 20 MG, FILMOMHULDE TABLETTEN
RVG 117849/50
MODULE 1.3
Product Information
Version: 2020-09-28
MODULE 1.3.1
Summary of Product Characteristics
Replaces: 2018-04-19
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tadalafil Apotex 10 mg, filmomhulde tabletten
Tadalafil Apotex 20 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg tadalafil.
Each film-coated tablet contains 20 mg tadalafil.
Excipient(s) with known effect:
Each film-coated tablet contains 100.21 mg lactose monohydrate.
Each film-coated tablet contains 158.7 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, almond shaped, biconvex film coated tablets (10.80 mm x 6.59
mm). Engraved
“APO” on one side, “T10” on the other side
Yellow, almond shaped, biconvex film coated tablets (11.86 mm x 7.37
mm). Engraved
“APO” on one side, “T20” on the other side
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of erectile dysfunction in adult males.
In order for tadalafil to be effective, sexual stimulation is
required.
Tadalafil Apotex is not indicated for use by women.
TADALAFIL APOTEX 10 EN 20 MG, FILMOMHULDE TABLETTEN
RVG 117849/50
MODULE 1.3
Product Information
Version: 2020-09-28
MODULE 1.3.1
Summary of Product Characteristics
Replaces: 2018-04-19
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adult men _
In general, the recommended dose is 10 mg taken prior to anticipated
sexual activity and
with or without food.
In those patients in whom tadalafil 10 mg does not produce an adequate
effect, 20 mg
might be tried. It may be taken at least 30 minutes prior to sexual
activity.
The maximum dose frequency is once per day.
Tadalafil 10 and 20 mg is intended for use prior to anticipated sexual
activity and it is not
recommended for continuous daily use.
In patients who anticipate a frequent use of tadalafil (i.e., at least
twice weekly) a once
daily regimen wi