Amoxicilline/Clavulaanzuur Devatis 875 mg/125 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

AMOXICILLINE 3-WATER 1004,3 mg/stuk SAMENSTELLING overeenkomend met ; AMOXICILLINE 0-WATER 875 mg/stuk ; KALIUMCLAVULANAAT 148,9 mg/stuk SAMENSTELLING overeenkomend met ; CLAVULAANZUUR 125 mg/stuk

Beschikbaar vanaf:

Devatis GmbH Spitalstrasse 22 795 39 LORRACH (DUITSLAND)

ATC-code:

J01CR02

INN (Algemene Internationale Benaming):

AMOXICILLINE 3-WATER 1004,3 mg/stuk SAMENSTELLING overeenkomend met ; AMOXICILLINE 0-WATER 875 mg/stuk ; KALIUMCLAVULANAAT 148,9 mg/stuk SAMENSTELLING overeenkomend met ; CLAVULAANZUUR 125 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; COPOVIDON (E 1208) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYDEXTROSE (E 1200) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; TRIGLYCERIDEN MIDDELLANGE KETEN, CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOVIDON ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYDEXTROSE (E 1200) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; TRIGLYCERIDEN MIDDELLANGE KETEN, CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; CROSCARMELLOSE NATRIUM (E 468) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Amoxicillin and beta-lactamase inhibitor

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1); CROSCARMELLOSE NATRIUM (E 468); MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); NATRIUMWATERSTOFCARBONAAT (E 500 (II)); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2018-04-11

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOXICILLINE/CLAVULAANZUUR DEVATIS 500 MG/125 MG FILMOMHULDE TABLETTEN
AMOXICILLINE/CLAVULAANZUUR DEVATIS 875 MG/125 MG FILMOMHULDE TABLETTEN
amoxicilline/clavulaanzuur
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 (or for your child) 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 Amoxicilline/Clavulaanzuur Devatis is and what it is used for
2.
What you need to know before you take Amoxicilline/Clavulaanzuur
Devatis
3.
How to take Amoxicilline/Clavulaanzuur Devatis
4.
Possible side effects
5.
How to store Amoxicilline/Clavulaanzuur Devatis
6.
Contents of the pack and other information
1.
WHAT AMOXICILLINE/CLAVULAANZUUR DEVATIS IS AND WHAT IT IS USED FOR
Amoxicilline/Clavulaanzuur Devatis is an antibiotic and works by
killing bacteria that cause infections. It
contains two different medicines called amoxicillin and clavulanic
acid. Amoxicillin belongs to a group of
medicines called “penicillins” that can sometimes be stopped from
working (made inactive). The other active
component (clavulanic acid) stops this from happening.
Amoxicilline/Clavulaanzuur Devatis is used in adults and children to
treat the following infections:
-
middle ear and sinus infections
-
respiratory tract infections
-
urinary tract infections
-
skin and soft tissue infections including dental infections
-
bone and joint infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMOXICILLINE/CLAVULAANZUUR
DEVATIS
DO NOT TAKE AMOXICILLINE/CLAVULAANZUUR DEVATIS:
-
if you are allergic to amoxicillin, clavulanic acid, penicillin or

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amoxicilline/Clavulaanzuur Devatis 500 mg/125 mg filmomhulde tabletten
Amoxicilline/Clavulaanzuur Devatis 875 mg/125 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
AMOXICILLINE/CLAVULAANZUUR DEVATIS 500 MG/125 MG FILM-COATED TABLETS
Each film-coated tablet contains amoxicillin trihydrate equivalent to
500 mg amoxicillin and potassium
clavulanate equivalent to 125 mg clavulanic acid.
AMOXICILLINE/CLAVULAANZUUR DEVATIS 875 MG/125 MG FILM-COATED TABLETS
Each film-coated tablet contains amoxicillin trihydrate equivalent to
875 mg amoxicillin and potassium
clavulanate equivalent to 125 mg clavulanic acid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Amoxicilline/Clavulaanzuur Devatis 500 mg/125 mg film-coated tablets
are white to off white, oval-shaped,
biconvex film coated tablets, 21.1 mm x 10.3 mm x 6.2 mm, debossed
with ‘500’ on one side and ‘D V’ on
the other side.
Amoxicilline/Clavulaanzuur Devatis 875 mg/125 mg film-coated tablets
are white to off white, capsule-
shaped, biconvex film coated scored tablets, 22.1 mm x 10.5 mm x 7.4
mm, debossed with ‘875’ on one side
and a score line in between ‘D’ and ‘V’ on the other side.
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
Amoxicilline/Clavulaanzuur Devatis is indicated for the treatment of
the following infections in adults and
children (see sections 4.2, 4.4 and 5.1):
-
Acute bacterial sinusitis (adequately diagnosed)
-
Acute otitis media
-
Acute exacerbations of chronic bronchitis (adequately diagnosed)
-
Community acquired pneumonia
-
Cystitis
-
Pyelonephritis
-
Skin and soft tissue infections in particular cellulitis, animal
bites, severe dental abscess with
spreading cellulitis
-
Bone and joint infections, in particular osteomyelitis.
Consideration should be given to official guidance on the ap