CO-AMOXICLAV 500/125 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

AMOXICILLINE TRIHYDRATE, POTASSIUM CLAVULANATE & AVICEL (1:1) PH. EUR. EQUIVALENT TO CLAVULANIC ACID

Available from:

Actavis Group PTC ehf

ATC code:

J01CR02

INN (International Name):

AMOXICILLINE TRIHYDRATE, POTASSIUM CLAVULANATE & AVICEL (1:1) PH. EUR. EQUIVALENT TO CLAVULANIC ACID

Dosage:

500/125 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

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

Therapeutic area:

Combinations of penicillins, incl. beta-lactamase inhibitors

Authorization status:

Authorised

Authorization date:

2013-09-27

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CO-AMOXICLAV 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 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 is and what it is used for
2.
What you need to know before you take Co-amoxiclav
3.
How to take Co-amoxiclav
4.
Possible side effects
5.
How to store Co-amoxiclav
6.
Contents of the pack and other information
1. WHAT CO-AMOXICLAV 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
DO NOT TAKE CO-AMOXICLAV:

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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Co-amoxiclav 500mg/125mg Film-coated Tablets
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.
Co-amoxiclav 500 mg/125 mg tablets are white, oval, film-coated
tablets inscribed with ‘A’ on one side and ‘64’ on the
other side.
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 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).
For adults and children
40 kg, this formulation of Amoxicillin / Clavulanic acid provides a
tot