Sildenafil Teva 25 mg, kauwtabletten

Šalis: Nyderlandai

kalba: olandų

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

Veiklioji medžiaga:

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

Prieinama:

Teva Nederland B.V. Swensweg 5 2031 GA HAARLEM

ATC kodas:

G04BE03

INN (Tarptautinis Pavadinimas):

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

Vaisto forma:

Kauwtablet

Sudėtis:

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

Vartojimo būdas:

Oraal gebruik

Gydymo sritis:

Sildenafil

Produkto santrauka:

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);

Leidimo data:

1900-01-01

Pakuotės lapelis

Sildenafil, NL/H/2396/001-003, 26.04.22
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SILDENAFIL TEVA 25 MG, KAUWTABLETTEN
SILDENAFIL TEVA 50 MG, KAUWTABLETTEN SILDENAFIL TEVA 100 MG, KAUWTABLETTEN
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 {Product name} is and what it is used for
2.
What you need to know before you take {Product name}
_ _
3.
How to take {Product name}
4.
Possible side effects
5.
How to store {Product name}
6.
Contents of the pack and other information
1.
WHAT {PRODUCT NAME} 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.
{Product 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.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE {PRODUCT NAME}
DO NOT TAKE {PRODUCT 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 dangerous fall in your blood
pressure. Tell your doctor if you are taking any of these medicines
which are often given for relief of

Prekės savybės

Sildenafil, NL/H/2396/001-003, 26.04.22
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Sildenafil Teva 25 mg, kauwtabletten
Sildenafil Teva 50 mg, kauwtabletten
Sildenafil Teva 100 mg, kauwtabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains 25 mg sildenafil (as citrate).
Excipients with known effect
Each chewable tablet contains 2.15 mg of aspartame (E951) and 70.46 mg
of lactose monohydrate.
Each chewable tablet contains 50 mg sildenafil (as citrate).
Excipients with known effect
Each chewable tablet contains 4.30 mg of aspartame (E951) and 140.92
mg of lactose monohydrate.
Each chewable tablet contains 100 mg sildenafil (as citrate).
Excipients with known effect
Each chewable tablet contains 8.60 mg of aspartame (E951) and 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
{Product name} 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 {Product name} to be effective, sexual stimulation is
required.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
_ _
Sildenafil, NL/H/2396/001-003, 26.04.22
2
_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.
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 {Product
name} is taken with food, the onset of activity may be delayed
compared to the