Gerocilan 2,5 mg filmomhulde tabletten

Country: Netherlands

Language: Dutch

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

Active ingredient:

TADALAFIL 2,5 mg/stuk

Available from:

G.L. Pharma GmbH Schlossplatz 1 A-8502 LANNACH (OOSTENRIJK)

ATC code:

G04BE08

INN (International Name):

TADALAFIL 2,5 mg/stuk

Pharmaceutical form:

Filmomhulde tablet

Composition:

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

Administration route:

Oraal gebruik

Therapeutic area:

Tadalafil

Product summary:

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 ROOD (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);

Authorization date:

2017-01-25

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
GEROCILAN 2.5 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 Gerocilan is and what it is used for
2.
What you need to know before you take Gerocilan
3.
How to take Gerocilan
4.
Possible side effects
5.
How to store Gerocilan
6.
Contents of the pack and other information
1.
WHAT GEROCILAN IS AND WHAT IT IS USED FOR
Gerocilan 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.
Gerocilan contains the active substance tadalafil which belongs to a
group of medicines called
phosphodiesterase type 5 inhibitors. Following sexual stimulation
Gerocilan 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. Gerocilan will not help you if
you do not have erectile
dysfunction.
It is important to note that Gerocilan 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 GEROCILAN
DO NOT TAKE GEROCILAN:
-
if you are allergic to tadalafil or any of the other ingredients of
this medicine (listed in
section 6).
-
if you are taking any form of organic nitrate or n

Summary of Product characteristics

1
.
NAME OF THE MEDICINAL PRODUCT
Gerocilan 2.5 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Gerocilan 2.5 mg: Each film-coated tablet contains 2.5 mg tadalafil.
Excipient with known effect:
Each 2.5 mg tablet contains 80.625 mg of lactose and 0.7 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Gerocilan 2.5 mg: Yellow-orange colored, caplet shaped, biconvex, film
coated tablet,
debossed with “T 2” 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, sexual stimulation is
required.
Gerocilan 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.
Tadalafil 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 Gerocilan (i.e., at least
twice weekly) a once
daily regimen with the lowest doses of Gerocilan 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 period-
ically.
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 impairment.
For patients with sev