Amoclav 500mg/125mg Film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

potassium clavulanate; Amoxicillin trihydrate

Available from:

Rowex Ltd

ATC code:

J01CR; J01CR02

INN (International Name):

potassium clavulanate; Amoxicillin trihydrate

Dosage:

500mg/125 milligram(s)

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; amoxicillin and enzyme inhibitor

Authorization status:

Marketed

Authorization date:

2014-04-11

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMOCLAV 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 Amoclav is and what it is used for
2.
What you need to know before you take Amoclav
3.
How to take Amoclav
4.
Possible side effects
5.
How to store Amoclav
6.
Contents of the pack and other information
1. WHAT AMOCLAV IS AND WHAT IT IS USED FOR
Amoclav 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.
Amoclav 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 AMOCLAV
DO NOT TAKE AMOCLAV:
•
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 AMOCLAV IF ANY OF THE ABOVE

Summary of Product characteristics

Health Products Regulatory Authority
14 August 2023
CRN00DFV9
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amoclav 500mg/125mg 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.
Oblong, white to slightly yellowish film-coated tablets (10 mm x 21
mm), embossed on one side (GG N6).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amoclav 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 Amoclav 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 Amoclav (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 children ≥ 40 kg, this formulation of Amoclav
provides a t