Sildenafil DOC Generici 100 mg, kauwtabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

SILDENAFILCITRAAT 140,8 mg/stuk SAMENSTELLING overeenkomend met ; SILDENAFIL 100 mg/stuk

Beschikbaar vanaf:

DOC Generici S.r.l. Via Filippo Turati 40 20121 MILANO (ITALIË)

ATC-code:

G04BE03

INN (Algemene Internationale Benaming):

SILDENAFILCITRAAT 140,8 mg/stuk SAMENSTELLING overeenkomend met ; SILDENAFIL 100 mg/stuk

farmaceutische vorm:

Kauwtablet

Samenstelling:

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

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Sildenafil

Product samenvatting:

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);

Autorisatie datum:

1900-01-01

Bijsluiter

Approved on 16.08.2014 with var.03 harmonization to originator (EPAR
last update 06.06.2014),
October 2015 approval of var. NL/H/2395/01-03/IA/006 type IA A.7, 11
May 2016 approved
with Renewal (EoP), approved with NL/H/2395/001-003/IB/011
excipients+QRD on 31.12.2020;
approved with NL/H/2395/001-003/IB/013 IB C.I.2.a on 24.02.2022;
NL/H/2395/001-
003/IB/015 IB C.I.2.a
PACKAGE LEAFLET
Approved on 16.08.2014 with var.03 harmonization to originator (EPAR
last update 06.06.2014),
October 2015 approval of var. NL/H/2395/01-03/IA/006 type IA A.7, 11
May 2016 approved
with Renewal (EoP), approved with NL/H/2395/001-003/IB/011
excipients+QRD on 31.12.2020;
approved with NL/H/2395/001-003/IB/013 IB C.I.2.a on 24.02.2022;
NL/H/2395/001-
003/IB/015 IB C.I.2.a
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SILDENAFIL DOC GENERICI 25 MG, KAUWTABLETTEN
SILDENAFIL DOC GENERICI 50 MG, KAUWTABLETTEN
SILDENAFIL DOC GENERICI 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, 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

Productkenmerken

Approved on 16.08.2014 with var.03 harmonization to originator (EPAR
last update 06.06.2014);
11 May 2016 approved with Renewal (EoP), approved with
NL/H/2395/001-003/IB/011
excipients+QRD on 31.10.2020, NL/H/2395/001-003/IB/012 IB
B.II.f.1.b.1; NL/H/2395/001-
003/IB/013 IB C.I.2.a approved on 24.02.2022; ;
NL/H/2395/001-003/IB/015 IB C.I.2.a
SUMMARY OF PRODUCT CHARACTERISTICS
Approved on 16.08.2014 with var.03 harmonization to originator (EPAR
last update 06.06.2014);
11 May 2016 approved with Renewal (EoP), approved with
NL/H/2395/001-003/IB/011
excipients+QRD on 31.10.2020, NL/H/2395/001-003/IB/012 IB
B.II.f.1.b.1; NL/H/2395/001-
003/IB/013 IB C.I.2.a approved on 24.02.2022; ;
NL/H/2395/001-003/IB/015 IB C.I.2.a
1.
NAME OF THE MEDICINAL PRODUCT
Sildenafil DOC Generici 25 mg, kauwtabletten
Sildenafil DOC Generici 50 mg, kauwtabletten
Sildenafil DOC Generici 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:
2.15mg of aspartame (E951)
70.4575 mg of lactose monohydrate
less than 1 mmol sodium (23 mg)
Each chewable tablet contains 50 mg sildenafil formed in situ from
70.24 mg sildenafil citrate.
Excipients with known effect:
4.30mg of aspartame (E951)
140.915 mg of lactose monohydrate
less than 1 mmol sodium (23 mg)
Each chewable tablet contains 100 mg sildenafil formed in situ from
140.48 mg sildenafil citrate.
Excipients with known effect:
8.60mg of aspartame (E951)
281.83 mg of lactose monohydrate
less than 1 mmol sodium (23 mg)
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 a