Co-amoxiclav 875mg/125mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amoxicillin (as amoxicillin trihydrate); Clavulanic acid (as potassium clavulanate, diluted with microcrystalline cellulose (1:1))

Available from:

Brown & Burk UK LTD

ATC code:

J01CA; J01CA04

INN (International Name):

Amoxicillin (as amoxicillin trihydrate); Clavulanic acid (as potassium clavulanate, diluted with microcrystalline cellulose (1:1))

Dosage:

875 mg/125 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Penicillins with extended spectrum; amoxicillin

Authorization status:

Marketed

Authorization date:

2012-03-09

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CO-AMOXICLAV 875MG/125MG 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 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 Co-amoxiclav Tablet is and what it is used for
2.
What you need to know before you take Co-amoxiclav Tablets
3.
How to take Co-amoxiclav Tablets
4.
Possible side effects
5.
How to store Co-amoxiclav tablets
6.
Contents of the pack and other information
1.
WHAT CO-AMOXICLAV TABLETS IS AND WHAT IT IS USED FOR
Co-amoxiclav 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.
Co-amoxiclav 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 CO-AMOXICLAV TABLETS
DO NOT TAKE CO-AMOXICLAV:

if you are allergic to amoxicillin, clavulanic acid, penicillins 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 throat.

if you have ever had liver problems or j

Summary of Product characteristics

Health Products Regulatory Authority
10 September 2019
CRN008JPX
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Co-amoxiclav 875mg/125mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 875mg amoxicillin as amoxicillin
trihydrate and 125mg of clavulanic acid as potassium
clavulanate diluted.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White coloured capsule shaped film coated tablet debossed with ‘I
07’ on one side and plain on other side. Tablet length =
21.70 ± 0.10mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Co-amoxiclav 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 Co-amoxiclav 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 and/or
different ratios of amoxicillin to clavulanic acid) should be
considered as necessary (see sections 4.4 and 5.1).
For adults and