Tadalafil Denk 10 mg filmomhulde tabletten

Страна: Нидерландия

Език: нидерландски

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

Активна съставка:

TADALAFIL

Предлага се от:

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

АТС код:

G04BE08

INN (Международно Name):

TADALAFIL

Лекарствена форма:

Filmomhulde tablet

Композиция:

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

Начин на приложение:

Oraal gebruik

Терапевтична област:

Tadalafil

Каталог на резюме:

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 ZWART (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);

Дата Оторизация:

2017-12-06

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE USER
TADALAFIL DENK 10 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 in

Данни за продукта

1
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1
.
NAME OF THE MEDICINAL PRODUCT
Tadalafil Denk 10 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tadalafil Denk 10 mg: Each film-coated tablet contains 10 mg
tadalafil.
Excipient with known effect:
Each 10 mg tablet contains 156.25 mg of lactose anhydrous and 1.4 mg
of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Tadalafil Denk 10 mg: yellow colored, caplet shaped, biconvex, film
coated tablet,
with dimensions of 11.0 mm x 5.0 x mm, debossed with “T 10” 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 not req