Idilico 100 mg, filmomhulde tablet

Land: Niederlande

Sprache: Niederländisch

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

Wirkstoff:

SILDENAFILCITRAAT 140,6 mg/stuk SAMENSTELLING overeenkomend met ; SILDENAFIL 100 mg/stuk

Verfügbar ab:

Laboratorios Liconsa S.A. C/ Dulcinea S/N 28805 MADRID (SPANJE)

ATC-Code:

G04BE03

INN (Internationale Bezeichnung):

SILDENAFILCITRAAT 140,6 mg/stuk SAMENSTELLING overeenkomend met ; SILDENAFIL 100 mg/stuk

Darreichungsform:

Filmomhulde tablet

Zusammensetzung:

CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Verabreichungsweg:

Oraal gebruik

Therapiebereich:

Sildenafil

Produktbesonderheiten:

Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE (E 464); INDIGOKARMIJN ALUMINIUMLAK (E 132); MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Berechtigungsdatum:

1900-01-01

Gebrauchsinformation

LF-Sildenafil-CC-AT.0302.001-003.IB.014
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IDILICO 25 MG, FILMOMHULDE TABLET
IDILICO 50 MG, FILMOMHULDE TABLET
IDILICO 100 MG, FILMOMHULDE TABLET
Sildenafil
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, pharmacist or
nurse.
•
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, pharmacist or nurse.
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 sildenafil which belongs
to a group of medicines
called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping
to relax the blood vessels
in your penis, allowing blood to flow into your penis when you get
sexually excited. will only help you to get an erection if you are sexually
stimulated.
is a treatment for adult men with erectile
dysfunction, sometimes known as
impotence. This is when a man cannot get, or keep a hard, erect penis
suitable for sexual activity.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE
−
If you are allergic to sildenafil or any of the other ingredients of
this medicine (listed in
section 6).
−
If you are taking medicines called nitrates, as the combination may
lead to a dangerous fall
in your blood pressure. Tell your doctor if you are taking any of
these medicines which are
often given for relief of an

Fachinformation

SPC-Sildenafil-CC-AT.0302.001-003.IB.014
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Idilico 25 mg, filmomhulde Tablet
Idilico 50 mg, filmomhulde Tablet
Idilico 100 mg, filmomhulde Tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
25 MG FILM-COATED TABLETS
Each tablet contains sildenafil citrate equivalent to 25 mg of
sildenafil.
50 MG FILM-COATED TABLETS
Each tablet contains sildenafil citrate equivalent to 50 mg of
sildenafil.
100 MG FILM-COATED TABLETS
Each tablet contains sildenafil citrate equivalent to 100 mg of
sildenafil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
25 mg film-coated tablets are blue, enlongated
and marked with “25”.
50 mg film-coated tablets are blue, enlongated and
marked with “50”.
100 mg film-coated tablets are blue, enlongated and
marked with “100”.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
is indicated in adult men with erectile dysfunction,
which is the inability to achieve or
maintain a penile erection sufficient for satisfactory sexual
performance.
In order for to be effective, sexual stimulation is
required.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Use in adults: _
The recommended dose is 50 mg taken as needed approximately one hour
before sexual activity. Based on
efficacy and tolerability, the dose may be increased to 100 mg or
decreased to 25 mg. The maximum
recommended dose is 100 mg. The maximum recommended dosing frequency
is once per day. If is taken with food, the onset of activity may be delayed
compared to the fasted state (see section 5.2)
_ _
Special populations
_ _
_Elderly _
Dosage adjustments are not required in elderly patients (≥ 65 years
old).
_ _
_ Renal impairment _
SPC-Sildenafil-CC-AT.0302.001-003.IB.014
The dosing recommendations described in ‘Use in adults’ apply to
patients with mild to moderate ren