Tadalafil Apotex 5 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

TADALAFIL

Beschikbaar vanaf:

Apotex Europe BV Archimedesweg 2 2333 CN LEIDEN

ATC-code:

G04BE08

INN (Algemene Internationale Benaming):

TADALAFIL

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Tadalafil

Product samenvatting:

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);

Autorisatie datum:

2018-01-03

Bijsluiter

TADALAFIL APOTEX 5 MG, FILMOMHULDE TABLETTEN – RVG
117848
MODULE 1.3
Product Information
VERSION 2020-09-28
MODULE 1.3.3
Patient Information Leaflet
REPLACES: 2018-10-18
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Tadalafil Apotex 5 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 contains the active substance tadalafil which belongs
to a group of
medicines called phosphodiesterase type 5 inhibitors.
Tadalafil Apotex 5 mg is used to treat 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.
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 Apotex for the treatment of erectile
dysfunction does
not work if there is no sexual stimulation.
You and your partner will need to engage in foreplay

Productkenmerken

TADALAFIL APOTEX 5 MG, FILMOMHULDE TABLETTEN – RVG
117848
MODULE 1.3
Product Information
Version: 2020-09-28
MODULE 1.3.1
Summary of Product Characteristics
Replaces: 2018-07-10
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tadalafil Apotex 5 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg tadalafil.
Excipient(s) with known effect:
Each film-coated tablet contains 73.01 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 (9.59 mm x 5.85
mm). Engraved
“APO” on one side, “T5” 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.
Treatment of the signs and symptoms of benign prostatic hyperplasia in
adult males.
Tadalafil Apotex is not indicated for use by women.
TADALAFIL APOTEX 5 MG, FILMOMHULDE TABLETTEN – RVG
117848
MODULE 1.3
Product Information
Version: 2020-09-28
MODULE 1.3.1
Summary of Product Characteristics
Replaces: 2018-07-10
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_ _
_Erectile dysfunction in 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 with the lowest doses of tadalafil might be considered
suitable, based on
patient choice and the physician’s judgement.
In these patients the recommended dose is 5 mg taken once a day at
approxim