Tadalafil STADA 10 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

TADALAFIL 10 mg/stuk

INN (Algemene Internationale Benaming):

TADALAFIL 10 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2022-12-28

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
TADALAFIL STADA 10 MG, FILMOMHULDE TABLETTEN
tadalafil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your pharmacist or doctor
has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects talk to your pharmacist or doctor. This
includes any possible
side effects not listed in this leaflet. See section 4.
-
If you have taken as directed (see section 3) and were
not able to get or
keep an erection hard enough for satisfactory sex, you should talk to
your pharmacist or
doctor.
WHAT IS IN THIS LEAFLET
1. What is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1. WHAT IS AND WHAT IT IS USED FOR

is
a
treatment
for
adult
men
who
have
erection
problems
(erectile
dysfunction). This is when a man cannot get or keep an erection hard
enough for satisfactory
sexual activity.
contain the active substance tadalafil. It belongs to a
group of medicines
called phosphodiesterase type 5 (PDE5) inhibitors.
It works by relaxing the blood vessels in your penis, allowing blood
flow into your penis.
It is important to know that you will not get an erection just by
taking . This
medicine works with your body’s natural function to get an erection
only when you are
sexually stimulated.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE IF YOU:
•
do not have an erection problem, as this medicine will not provide any
benefit to you
•
are allergic to tadalafil or any of the other ingredients in this
medicine (listed in section 6)
•
take any MEDICINES CALLED NITRATES OR NITRIC

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Tadalafil STADA 10 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
10 mg: Each film-coated tablet contains 10 mg
tadalafil.
Excipient with known effect
Each 10 mg tablet contains 116.3 mg of lactose (as lactose
monohydrate) and 1.1 mg
sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
Yellow, round, biconvex, film-coated tablet with score line on one
side, white at the cross
section with 8.1
±
0.2 mm diameter.
The tablet can be divided into equal doses.
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.
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.
Doses of 10 and 20 mg are intended for use prior to anticipated sexual
activity and are 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
approximately the
same time of day. The dose may be decreased to 2.5 mg once a day based
on individual
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 required in patients with mild to moderate
renal i