AMOXICILLIN/CLAVULANIC ACID SINOCHEM DSM

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

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

Available from:

DSM Sinochem Pharmaceuticals Netherlands B.V.

ATC code:

J01CR02

INN (International Name):

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

Dosage:

500/125 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 indications:

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

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMOXICILLIN/CLAVULANIC ACID DSM-SINOCHEM 500 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 DSM-Sinochem is and what it is used
for
2.
What you need to know before you take Amoxicillin/Clavulanic acid
DSM-Sinochem
3.
How to take Amoxicillin/Clavulanic acid DSM-Sinochem
4.
Possible side effects
5.
How to store Amoxicillin/Clavulanic acid DSM-Sinochem
6.
Contents of the pack and other information
1.
WHAT AMOXICILLIN/CLAVULANIC ACID DSM-SINOCHEM IS AND WHAT IT IS USED
FOR
Amoxicillin/Clavulanic acid DSM-Sinochem 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 DSM-Sinochem 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
DSM-SINOCHEM
DO NOT TAKE AMOXICILLIN/CLAVULANIC ACID DSM-SINOCHEM :

if you are allergic (hypersensitive) to amoxicillin, clavulanic acid,
pen

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amoxicillin/Clavulanic acid Sinochem DSM 500 mg/125 mg film-coated
tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains amoxicillin trihydrate equivalent to
500 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 8 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 Sinochem DSM 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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