Sildenafil Sandoz 100 mg, tabletten

Kraj: Holandia

Język: niderlandzki

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

Składnik aktywny:

SILDENAFILCITRAAT 140,5 mg/stuk SAMENSTELLING overeenkomend met ; SILDENAFIL 100 mg/stuk

Dostępny od:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Kod ATC:

G04BE03

INN (International Nazwa):

SILDENAFILCITRAAT 140,5 mg/stuk SAMENSTELLING overeenkomend met ; SILDENAFIL 100 mg/stuk

Forma farmaceutyczna:

Tablet

Skład:

CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; COPOVIDON (E 1208) ; CROSCARMELLOSE NATRIUM (E 468) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MAGNESIUMSTEARAAT (E 470b) ; SACCHAROIDE NATRIUM X-WATER (E 954), CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOVIDON ; CROSCARMELLOSE NATRIUM (E 468) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MAGNESIUMSTEARAAT (E 470b) ; SACCHAROIDE NATRIUM X-WATER (E 954), CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOVIDON ; CROSCARMELLOSE NATRIUM (E 468) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MAGNESIUMSTEARAAT (E 470b) ; SACCHAROIDE NATRIUM X-WATER (E 954)

Droga podania:

Oraal gebruik

Dziedzina terapeutyczna:

Sildenafil

Data autoryzacji:

1900-01-01

Ulotka dla pacjenta

Sandoz B.V.
Sildenafil Sandoz 100 mg, tabletten
Page 1/8
RVG 121771
1311-V6
1.3.1.1 Samenvatting van de Productkenmerken
Mei 2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SILDENAFIL SANDOZ 100 MG, TABLETTEN
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 [nationally completed name] is and what it is used for
2.
What you need to know before you take [nationally completed name]
3.
How to take [nationally completed name]
4.
Possible side effects
5.
How to store [nationally completed name]
6.
Contents of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] 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.
[Nationally completed name] will only help you to get an erection if
you are sexually stimulated.
[Nationally completed name] 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 [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME]
_ _
-
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

Charakterystyka produktu

Sandoz B.V.
Sildenafil Sandoz 100 mg, tabletten
Page 1/14
RVG 121771
1311-V6
1.3.1.1 Samenvatting van de Productkenmerken
Mei 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Sildenafil Sandoz 100 mg, tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg of sildenafil (as citrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
Light blue round slightly dotted tablets, with cross breaking notch on
both sides and “100”
debossed on one side.
Diameter: 12.5 mm
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal
doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sildenafil 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 sildenafil 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 sildenafil is taken with food, the onset of activity may be
delayed compared to the fasted state
(see section 5.2).
Special populations
_Elderly _
Dose adjustments are not required in elderly patients (≥ 65 years
old).
_Renal impairment _
The dosing recommendations described in “Use in adults” apply to
patients with mild to moderate
Sandoz B.V.
Sildenafil Sandoz 100 mg, tabletten
Page 2/14
RVG 121771
1311-V6
1.3.1.1 Samenvatting van de Productkenmerken
Mei 2023
renal impairment (creatinine clearance = 30-80 mL/min).
Since sildenafil clearance is reduced in patients with severe renal
impairment (creatinine clearance
< 30 mL/min) a 25 mg dose should be considered. Based on efficacy and
tolerability, the dose may
be inc