Tadalafil STADA 5 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

TADALAFIL 5 mg/stuk

Beschikbaar vanaf:

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

ATC-code:

G04BE08

INN (Algemene Internationale Benaming):

TADALAFIL 5 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Tadalafil

Product samenvatting:

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);

Autorisatie datum:

2017-01-10

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
TADALAFIL STADA 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 [Product Νame] is and what it is used for
2. What you need to know before you take [Product Νame]
3. How to take [Product Νame]
4. Possible side effects
5. How to store [Product Νame]
6. Contents of the pack and other information
1. WHAT [PRODUCT ΝAME] IS AND WHAT IT IS USED FOR
[Product Νame] contains the active substance tadalafil which belongs
to a group of medicines
called phosphodiesterase type 5 inhibitors.
[Product Name] 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 [Product Name] 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.
[Product Name] will not help you if you do not have erectile
dysfunction. It is important to
note that [Product Name] 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

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Tadalafil STADA 5 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
[Product Name] 5 mg: Each film-coated tablet contains 5 mg tadalafil.
Excipient with known effect
Each 5 mg tablet contains 78.825 mg of lactose (as lactose and lactose
monohydrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
[Product Name] 5 mg: yellow coloured, caplet shaped, biconvex, film
coated tablet, debossed
with “T 5” on one side and plain on the other, with nominal
dimensions 8.2 mm x 4.1 mm.
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.
[Product Name] 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.
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.
_Benign prostatic hyperplasia in adult men