Tadalafil Denk 2,5 mg filmomhulde tabletten

Země: Nizozemsko

Jazyk: nizozemština

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

Aktivní složka:

TADALAFIL

Dostupné s:

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

ATC kód:

G04BE08

INN (Mezinárodní Name):

TADALAFIL

Léková forma:

Filmomhulde tablet

Složení:

CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (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),

Podání:

Oraal gebruik

Terapeutické oblasti:

Tadalafil

Přehled produktů:

Hulpstoffen: CROSCARMELLOSE NATRIUM (E 468); GLYCEROLTRIACETAAT (E 1518); HYPROLOSE (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (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);

Datum autorizace:

2017-12-06

Informace pro uživatele

PACKAGE LEAFLET: INFORMATION FOR THE USER
TADALAFIL DENK 2,5 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 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 Denk contains the active substance tadalafil which belongs
to a group of
medicines called phosphodiesterase type 5 inhibitors. 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 important to note that Tadalafil Denk does not work if there is
no sexual stimula-
tion. You and your partner will need to engage in foreplay, just as
you would if you
were not taking a medicine for erectile dysfunction.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TADALAFIL DENK
DO NOT TAKE TADALAFIL DENK:
-
if you are allergic to tadalafil or any of the other ingredients of
this medicine
(listed i

Charakteristika produktu

1
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1
.
NAME OF THE MEDICINAL PRODUCT
Tadalafil Denk 2,5 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tadalafil Denk 2.5 mg: Each film-coated tablet contains 2.5 mg
tadalafil.
Excipient with known effect:
Each 2.5 mg tablet contains 80.625 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 2.5 mg: yellow-orange colored, caplet shaped, biconvex,
film coated
tablet, with dimensions of 8.2 mm x 4.1 mm, debossed with “T 2” 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, sexual stimulation is
required.
Tadalafil Denk is not indicated for use by women.
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.
2
_ _
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.
Special populations
_Elderly men _
Dose adjustments are not required in elderly patients.
_ _
_Men with renal impairment _
Dose adjustments are