Tadalafil STADA 20 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

TADALAFIL 20 mg/stuk

Beschikbaar vanaf:

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

ATC-code:

G04BE08

INN (Algemene Internationale Benaming):

TADALAFIL 20 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 20 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] 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.
[Product Νame] contains the active substance tadalafil which belongs
to a group of medicines
called phosphodiesterase type 5 inhibitors. Following sexual
stimulation [Product Νame] 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 Νame] will
not help you if you do not
have erectile dysfunction.
It is important to note that [Product Νame] 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 [PRODUCT ΝAME]
DO NOT TAKE [PRODUCT NAME]:
•
if you are allergic to tadalafil or any of the other ingredients of
this medicin

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Tadalafil STADA 20 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
[Product Name] 20 mg: Each film-coated tablet contains 20 mg
tadalafil.
Excipient with known effect
Each 20 mg tablet contains 315.3 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] 20 mg: yellow coloured, caplet shaped, biconvex, film
coated tablet, debossed
with “T 20” on one side and plain on the other, with nominal
dimensions 13.5 mm x 6.6 mm.
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.
[Product Name] 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