Azulsix 25 mg, kauwtabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

SILDENAFILCITRAAT 35,1 mg/stuk SAMENSTELLING overeenkomend met ; SILDENAFIL 25 mg/stuk

Beschikbaar vanaf:

Farmalider S.A. C/A Aragoneses 15 28108 MADRID (SPANJE)

ATC-code:

G04BE03

INN (Algemene Internationale Benaming):

SILDENAFILCITRAAT 35,1 mg/stuk SAMENSTELLING overeenkomend met ; SILDENAFIL 25 mg/stuk

farmaceutische vorm:

Kauwtablet

Samenstelling:

ASPARTAAM (E 951) ; CROSCARMELLOSE NATRIUM (E 468) ; KALIUMHYDROXIDE (E 525) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; PEPERMUNTSMAAKSTOF ; POLACRILINE KALIUM ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; ZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND) (E 1440) ; ZOUTZUUR (E 507), ASPARTAAM (E 951) ; CROSCARMELLOSE NATRIUM (E 468) ; KALIUMHYDROXIDE (E 525) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; PEPERMUNTSMAAKSTOF ; POLACRILINE KALIUM ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; ZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND) ; ZOUTZUUR (E 507),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Sildenafil

Product samenvatting:

Hulpstoffen: ASPARTAAM (E 951); CROSCARMELLOSE NATRIUM (E 468); KALIUMHYDROXIDE (E 525); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MALTODEXTRINE; PEPERMUNTSMAAKSTOF; POLACRILINE KALIUM; POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551); ZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND); ZOUTZUUR (E 507);

Autorisatie datum:

1900-01-01

Bijsluiter

PIL-Sildenafil chewable- Day 160-v.2
PACKAGE LEAFLET: INFORMATION FOR THE USER
Azulsix 25 mg,
kauwtabletten
Azulsix 50 mg,
kauwtabletten
Azulsix 100 mg,
kauwtabletten
Sildenafil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
x
Keep this leaflet. You may need to read it again.
x
If you have any further questions, ask your doctor or pharmacist.
x
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
x
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What
_/../ _
is and what it is used for
2. Before you take
_/../_
3. How to take
_/../_
4. Possible side effects
5. How to store
_/../_
6. Further information
1. WHAT _/../ _IS AND WHAT IT IS USED FOR
Sildenafil 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. Sildenafil will only help you to get an erection if
you are sexually stimulated. You
should not take sildenafil if you do not have erectile dysfunction.
You should not take sildenafil if you are
a woman.
/../ is a treatment for 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. BEFORE YOU TAKE _/../_
DO NOT TAKE /../
x
If you are taking medicines called nitrates, as the combination may
cause a potentially dangerous
decrease in your blood pressure. Tell your doctor if you are taking
any of these medicines which are
often given for relief of angina pectoris (or “chest pain”). If
you are not certain, ask your doctor or
pharmacist.
x
If you are using any of the drugs known as nitric oxide donors such as
amyl nitrite (“poppers”), as the
combination may also lead to a potentially dangerous decrease in your
blood pressure.
x
If you

Productkenmerken

SPC-Sildenafil chewable-Day 195-v.3
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Azulsix
25 mg, kauwtabletten
Azulsix
50 mg, kauwtabletten
Azulsix
100 mg, kauwtabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains 25 mg sildenafil formed in situ from
35.12 mg Sildenafil citrate.
Excipients:
2.15mg of aspartame
70.4575 mg of lactose monohydrate
Each chewable tablet contains 50 mg sildenafil formed in situ from
70.24 mg Sildenafil citrate.
Excipients:
4.30mg of aspartame
140.915 mg of lactose monohydrate
Each chewable tablet contains 100 mg sildenafil formed in situ from
140.48 mg Sildenafil citrate.
Excipients:
8.60mg of aspartame
281.83 mg of lactose
monohydrate
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Chewable tablet.
25 mg: White, triangular, biconvex, embossed with “25” on one
side.
50 mg: White, triangular, biconvex, embossed with “50” on one
side.
100 mg: White, triangular, biconvex, embossed with “100” on one
side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of 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
_Use in adults:_
The recommended dose is 50 mg taken as needed approximately one hour
before sexual activity.
The tablets should be chewed before swallowed.
SPC-Sildenafil chewable-Day 195-v.3
Based on efficacy and toleration, 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).
_Use in the elderly:_
Dosage adjustments are not required in elderly patients.
_Use in patients with impaired renal function:_
The dosing recommendations described in ‘Use in adults’ applies to
patient