Rosytona 25 mg, kauwtabletten

Country: Belanda

Bahasa: Belanda

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

Bahan aktif:

SILDENAFILCITRAAT 35,12 mg/stuk SAMENSTELLING overeenkomend met ; SILDENAFIL 25 mg/stuk

Boleh didapati daripada:

Aurobindo Pharma B.V. Baarnsche Dijk 1 3741 LN BAARN

Kod ATC:

G04BE03

INN (Nama Antarabangsa):

SILDENAFILCITRAAT 35,12 mg/stuk SAMENSTELLING overeenkomend met ; SILDENAFIL 25 mg/stuk

Borang farmaseutikal:

Kauwtablet

Komposisi:

ASPARTAAM (E 951) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; PEPERMUNTSMAAKSTOF ; POLACRILINE KALIUM ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551),

Laluan pentadbiran:

Oraal gebruik

Kawasan terapeutik:

Sildenafil

Ringkasan produk:

Hulpstoffen: ASPARTAAM (E 951); CROSCARMELLOSE NATRIUM (E 468); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); PEPERMUNTSMAAKSTOF; POLACRILINE KALIUM; POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551);

Tarikh kebenaran:

1900-01-01

Risalah maklumat

_Version 2303 _
PACKAGE LEAFLET
_Version 2303 _
PACKAGE LEAFLET: INFORMATION FOR THE USER
/../ 25 MG CHEWABLE TABLETS
/../ 50 MG CHEWABLE TABLETS
/../ 100 MG CHEWABLE TABLETS
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 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
_/../_
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.
Sildenafil 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 dangerous fall 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.
-
If you are using any of the medicin

Ciri produk

_Version 2303 _
SUMMARY OF PRODUCT CHARACTERISTICS
_Version 2303 _
1.
NAME OF THE MEDICINAL PRODUCT
Rosytona 25 mg, kauwtabletten
Rosytona 50 mg, kauwtabletten
Rosytona 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 with known effect:
2.15 mg of aspartame (E951)
70.4575 mg of lactose monohydrate
Each chewable tablet contains 50 mg sildenafil formed in situ from
70.24 mg sildenafil citrate.
Excipients with known effect:
4.30 mg of aspartame (E951)
140.915 mg of lactose monohydrate
Each chewable tablet contains 100 mg sildenafil formed in situ from
140.48 mg sildenafil citrate.
Excipients with known effect:
8.60 mg of aspartame (E951)
281.83 mg of lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet.
25 mg: White, triangular, with a side of 7.3 mm, biconvex, embossed
with “25” on one side.
50 mg: White, triangular, with a side of 8.8 mm, biconvex, embossed
with “50” on one side.
100 mg: White, triangular, with a side of 11.8 mm, biconvex, embossed
with “100” on one side.
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.
The tablets should be chewed before swallowed.
_Version 2303 _
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 patients: _