Tadalafil STADA 10 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

TADALAFIL 10 mg/stuk

Beschikbaar vanaf:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

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:

2020-05-25

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.
•
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 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
contains the active substance tadalafil which belongs
to a group of medicines
called phosphodiesterase type 5 inhibitors.
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
your ability to obtain
this.
Following sexual stimulation 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.
will not help you if you do not have erectile
dysfunction. It is important to
note that 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE IF YOU
•
are allergic to tadalafil or any of the other ingredients of this
medicine (listed in section 6)
•
are taking any for

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