Tadalafil Denk 5 mg filmomhulde tabletten

Land: Nederland

Språk: nederlandsk

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

Aktiv ingrediens:

TADALAFIL

Tilgjengelig fra:

Denk Pharma GmbH & Co. KG Prinzregentenstrasse 79 81675 MÜNCHEN (DUITSLAND)

ATC-kode:

G04BE08

INN (International Name):

TADALAFIL

Legemiddelform:

Filmomhulde tablet

Sammensetning:

CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Administreringsrute:

Oraal gebruik

Terapeutisk område:

Tadalafil

Produkt oppsummering:

Hulpstoffen: CROSCARMELLOSE NATRIUM (E 468); GLYCEROLTRIACETAAT (E 1518); HYPROLOSE (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); LACTOSE 0-WATER; LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); POLYSORBAAT 80 (E 433); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisasjon dato:

2017-12-06

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
TADALAFIL DENK 5 MG FILMOMHULDE TABLETTEN
TADALAFIL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Denk is and what it is used for
2.
What you need to know before you take Tadalafil Denk
3.
How to take Tadalafil Denk
4.
Possible side effects
5.
How to store Tadalafil Denk
6.
Contents of the pack and other information
1.
WHAT TADALAFIL DENK IS AND WHAT IT IS USED FOR
Tadalafil Denk contains the active substance tadalafil which belongs
to a group of
medicines called phosphodiesterase type 5 inhibitors.
Tadalafil Denk 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 Denk 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 Denk will not help you if you do not have erectile
dysfunction. It is im-
portant to note that Tadalafil Denk 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, just as you
would if you
were not taking a medicine for erectile dysfunction.
-
urinary symptoms associated with a common condition called BENIGN
PROSTATIC
HYPERPLASIA.
This is when the prostate gland gets big

Preparatomtale

1
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1
.
NAME OF THE MEDICINAL PRODUCT
Tadalafil Denk 5 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tadalafil Denk 5 mg: Each film-coated tablet contains 5 mg tadalafil.
Excipient with known effect:
Each 5 mg tablet contains 78.125 mg of lactose anhydrous and 0.7 mg of
lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Tadalafil Denk 5 mg: yellow colored, caplet shaped, biconvex, film
coated tablet,
with dimensions of 8.2 mm x 4.1 mm, debossed with “T 5” on one
side and plain on
the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of erectile dysfunction in adult males.
In order for tadalafil to be effective for the treatment of erectile
dysfunction, sexual
stimulation is required.
Treatment of the signs and symptoms of benign prostatic hyperplasia in
adult males.
Tadalafil Denk is not indicated for use by women.
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.
2
_ _
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 Denk 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 Denk (i.e., at
least twice weekly)
a once daily regimen with the lowest doses of Tadalafil Denk 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
approximately the
same time of day. The dose may be decreased to 2.5 mg once a day based
on individ-
ual tolerability.
The appropriateness of continued use of the daily regimen should be
reassessed
periodically.
_Benign pr