Amoxicilline/ Clavulaanzuur Actavis 500/125 mg, filmomhulde tabletten

Country: Belanda

Bahasa: Belanda

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

Bahan aktif:

AMOXICILLINE 3-WATER SAMENSTELLING overeenkomend met; AMOXICILLINE 0-WATER; KALIUMCLAVULANAAT SAMENSTELLING overeenkomend met; CLAVULAANZUUR;

Boleh didapati daripada:

Actavis Group PTC ehf

Kod ATC:

J01CR02

INN (Nama Antarabangsa):

AMOXICILLINE 3-WATER COMPOSITION corresponding to; AMOXICILLIN 0-WATER; KALIUMCLAVULANAAT COMPOSITION corresponding to; clavulan

Borang farmaseutikal:

Filmomhulde tablet

Laluan pentadbiran:

Oraal gebruik

Kawasan terapeutik:

Amoxicillin and beta-lactamase inhibitor

Ringkasan produk:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Risalah maklumat

1
BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER AMOXICILLINE/CLAVULAANZUUR ACTAVIS 500/125 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 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
/…/ 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.
/…/ 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 /…/
DO NOT TAKE /…/:
-
if you are allergic to amoxicillin, clavulanic acid, penicillin or any
of the other ingredients of
this medicine (listed in section 6).
-
if you have ever had a severe allergic reaction to any other
antibiotic. This can include a skin
rash or swelling of the face or neck.
-
if you have ever had liver problems or jaundice (yellowing of the
skin) when taking an
antibiotic.
DO NOT TAKE /…/ IF ANY OF THE ABOVE APPLY T

Ciri produk

1
1.
NAAM VAN HET GENEESMIDDEL
Amoxicilline/Clavulaanzuur Actavis 500/125 mg, filmomhulde tabletten.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains amoxicillin trihydrate corresponding
to 500 mg amoxicillin and
potassium clavulanate corresponding to 125 mg clavulanic acid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablet.
/…/ 500 mg/125 mg tablets are white, oval, 20.2 mm x 9.8 mm
film-coated tablets inscribed with ‘A’
on one side and ‘64’ on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
/…/ 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 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 Amoxicillin/Clavulanic acid that is selected to treat an
individual infection should take
into account:
-
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. formulations that provide
higher doses of amoxicillin and/or different ratios of amoxicillin to
clavulanic acid) should be
considered as necessary (see sections 4.4 and 5.1).
2
For adults and children ≥ 40 kg, this formulation of Amoxicillin /
Clavula