Amoxicillin/clavulanic acid Aurobindo 875 mg/125 mg powder for oral suspension in sachet

Country: Malta

Language: English

Source: Medicines Authority

Available from:

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

ATC code:

J01CR02

INN (International Name):

CLAVULANIC ACID 125 mg AMOXICILLIN 875 mg

Pharmaceutical form:

POWDER FOR ORAL SUSPENSION

Composition:

CLAVULANIC ACID 125 mg AMOXICILLIN 875 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2023-08-08

Patient Information leaflet

1.3.1 SPC, PACKAGE LEAFLET AND LABELLING
MARKETING AUTHORISATION APPLICATION AMOXICILLIN/CLAVULANIC ACID AUROBINDO
875 MG/125 MG & 1000 MG/125 MG PFOS IN SACHET
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOXICILLIN/CLAVULANIC ACID AUROBINDO 875 MG/125 MG POWDER FOR ORAL
SUSPENSION IN SACHET
AMOXICILLIN/CLAVULANIC ACID AUROBINDO 1000 MG/125 MG POWDER FOR ORAL
SUSPENSION IN SACHET
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 is usually prescribed for you (or for your child). 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 or
nurse. 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 use Amoxicillin/clavulanic acid
Aurobindo
3.
How to use 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 IT IS 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 in

Summary of Product characteristics

1.3.1 SPC, PACKAGE LEAFLET AND LABELLING
MARKETING AUTHORISATION APPLICATION AMOXICILLIN/CLAVULANIC ACID AUROBINDO
875 MG/125 MG & 1000 MG/125 MG PFOS IN SACHETS
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amoxicillin/clavulanic acid Aurobindo 875 mg/125 mg powder for oral
suspension in sachet
Amoxicillin/clavulanic acid Aurobindo 1000 mg/125 mg powder for oral
suspension in sachet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains amoxicillin trihydrate equivalent to 875 mg
amoxicillin and potassium
clavulanate equivalent to 125 mg clavulanic acid.
Each sachet contains amoxicillin trihydrate equivalent to 1000 mg
amoxicillin and potassium
clavulanate equivalent to 125 mg clavulanic acid.
Excipients with known effect
:
Each 875 mg/125 mg sachet contains 22.5 mg aspartame (E 951). The
flavouring in
Amoxicillin/clavulanic acid Aurobindo contains maltodextrin (glucose)
(see section 4.4).
Each 1000 mg/125 mg sachet contains 25 mg aspartame (E 951). The
flavouring in
Amoxicillin/clavulanic acid Aurobindo contains maltodextrin (glucose)
(see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral suspension in sachet.
Off white to pale yellow coloured powder.
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
1.3.1 SPC, PACKAGE LEAFLET AND LABELLING