Amoxicilline/Clavulaanzuur Polpharma 875 mg/125 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

AMOXICILLINE 3-WATER 1004,4 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:

Pharmaceutical Works Polpharma S.A. 19, Pelplinska Street 83-200 STAROGARD GDANSKI (POLEN)

ATC-code:

J01CR02

INN (Algemene Internationale Benaming):

AMOXICILLINE 3-WATER 1004,4 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:

BASISCH GEBUTYLEERD METHACRYLAAT COPOLYMEER ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; CROSPOVIDON (E 1202) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Amoxicillin and beta-lactamase inhibitor

Autorisatie datum:

2019-04-11

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMOXICILLINE/CLAVULAANZUUR POLPHARMA 875 MG/125 MG FILMOMHULDE
TABLETTEN
Amoxicillin/Clavulanic acid
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). Do not
pass it on to others. It may harm
them, even if their symptoms 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 Polpharma is and what it is used for
2.
What you need to know before you take Amoxicilline/Clavulaanzuur
Polpharma
3.
How to take Amoxicilline/Clavulaanzuur Polpharma
4.
Possible side effects
5.
How to store Amoxicilline/Clavulaanzuur Polpharma
6.
Contents of the pack and other information
1.
WHAT AMOXICILLINE/CLAVULAANZUUR POLPHARMA IS AND WHAT IT IS USED FOR
Amoxicilline/Clavulaanzuur Polpharma 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 Polpharma 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
POLPHARMA
DO NOT TAKE AMOXICILLINE/CLAVULAANZUUR POLPHARMA:
•
if you are allergic to amoxicillin, clavulanic acid, penicillin or any
of the other ingredients of this
medicine (

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amoxicilline/Clavulaanzuur Polpharma 875 mg/125 mg filmomhulde
tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains amoxicillin trihydrate equivalent to
875 mg amoxicillin
(
_Amoxicillinum_
) and
potassium clavulanate equivalent to 125 mg clavulanic acid (
_Acidum clavulanicum_
).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off white 22 mm by 10 mm oblong film-coated tablet with score
line.
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
Amoxicillin/clavulanic acid 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
and severe dental abscess with
spreading cellulitis
_ _
•
Bone and joint infections, in particular osteomyelitis.
_ _
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Doses are expressed throughout in terms of amoxicillin/clavulanic acid
content except when doses are
stated in terms of an individual component.
The dose of Amoxicilline/Clavulaanzuur Polpharma that is selected to
treat an individual infection
should take into account:
2
•
The expected pathogens and their likely susceptibility to
antibacterial agents (see section 4.4)
•
The severity and the site of the infection
•
The age, weight and renal function of the patient as shown below.
The use of alternative presentations of amoxicillin/clavulanic acid
(e.g. those that provide higher doses
of amoxicilli