Amoxicillin/Clavulanic acid Aurobindo 875mg/125mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AMOXICILLIN, CLAVULANIC ACID

Available from:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC code:

J01CR02

INN (International Name):

AMOXICILLIN 875 mg CLAVULANIC ACID 125 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

AMOXICILLIN 875 mg CLAVULANIC ACID 125 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2019-01-24

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOXICILLIN/CLAVULANIC ACID AUROBINDO 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) 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 Amoxicillin/Clavulanic acid Aurobindo is and what it is used for
2.
What you need to know before you take Amoxicillin/Clavulanic acid
Aurobindo
3.
How to take Amoxicillin/Clavulanic acid Aurobindo
4.
Possible side effects
5.
How to store Amoxicillin/Clavulanic acid Aurobindo
6.
Contents of the pack and other information
1.
WHAT AMOXICILLIN/CLAVULANIC ACID AUROBINDO IS AND WHAT IS IT USED FOR
Amoxicillin/Clavulanic acid Aurobindo 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 Aurobindo 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
AUROBINDO
_ _
DO NOT TAKE AMOXICILLIN/CLAVULANIC ACID AUROBINDO
•
If you are allergic to amoxicillin, clavulanic acid, penicillins or
any of the other ingredients

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amoxicillin/Clavulanic acid Aurobindo 875mg/125mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains amoxicillin trihydrate equivalent to
875mg amoxicillin with
potassium clavulanate equivalent to 125mg clavulanic acid.
Excipients with known Effect: Each tablet contains 0.60 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablet.
White colored, capsule shaped, film coated tablets debossed with
“A” on one side and with a
score line in between ‘6’ and ‘5’ on the other side.
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 Aurobindo 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 Aurobindo 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 amoxicilli