AMOXICILLIN/CLAVULANIC ACID DSM-SINOCHEM

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

AMOXICILLIN TRIHYDRATE ; CLAVULANIC ACID (AS POTASSIUM CLAVULANATE, DILUTED WITH MICROCRYSTALLINE CELLULOSE (1:1))

MAH:

DSM Sinochem Pharmaceuticals Netherlands B.V.

ATC_code:

J01CR02

INN:

AMOXICILLIN TRIHYDRATE ; CLAVULANIC ACID (AS POTASSIUM CLAVULANATE, DILUTED WITH MICROCRYSTALLINE CELLULOSE (1:1))

dosage:

875/125 Milligram

pharmaceutical_form:

Film Coated Tablet

administration_route:

oral use

units_in_package:

4/5/6/10/12/14/15/16/18/20/21/24/30/36/42/48/54/60/66/72/78/84/90/96/100/500 film-coated tablets.

prescription_type:

Product subject to prescription which may not be renewed (A)

manufactured_by:

PenCef Pharma GmbH

therapeutic_group:

: Combination of penicillins, incl. beta-lactamase inhibitors

therapeutic_area:

amoxicillin and enzyme inhibitor

therapeutic_indication:

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.

authorization_status:

Not Marketed

authorization_date:

2015-09-03

PIL

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMOXICILLIN/CLAVULANIC ACID 875 MG/125 MG FILM-COATED TABLETS
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 any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or pharmacist.
WHAT IS IN THIS LEAFLET
1.
What Amoxicillin/Clavulanic acid is and what it is used for
2.
What you need to know before you take Amoxicillin/Clavulanic acid

3.
How to take Amoxicillin/Clavulanic acid
4.
Possible side effects
5.
How to store Amoxicillin/Clavulanic acid
6.
Contents of the pack and other information
1.
WHAT AMOXICILLIN/CLAVULANIC ACID IS AND WHAT IT IS USED FOR
Amoxicillin/Clavulanic acid 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.
Amoxicillin/Clavulanic acid 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 AMOXICILLIN/CLAVULANIC ACID

DO NOT TAKE AMOXICILLIN/CLAVULANIC ACID :
•
if you are allergic (hypersensitive) to amoxicillin, clavulanic acid,
penicillin or any of the other
ingredients of this medicine (lis

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amoxicillin/Clavulanic acid DSM-Sinochem 875 mg/125 mg film-coated
tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
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 Amoxicillin/Clavulanic acid DSM-Sinochem 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. those that provide higher doses of amoxicillin
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