Augmentin tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

amoxicillin (amoxicillin trihydrate), clavulanic acid (potassium clavulanate)

Available from:

SmithKline Beecham Limited

ATC code:

J01CR02

INN (International Name):

amoxicillin (amoxicillin trihydrate), clavulanic acid (potassium clavulanate)

Dosage:

500mg+ 125mg

Pharmaceutical form:

tablets film-coated

Units in package:

(14/2x7/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2023-07-08

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
AUGMENTIN
Tablets, 500 mg/125 mg
Tablets, 875 mg/125 mg
_(Amoxicillin and 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 Augmentin is and what it is used for
2.
What you need to know before you take Augmentin
3.
How to take Augmentin
4.
Possible side effects
5.
How to store Augmentin
6.
Contents of the pack and other information
1.
WHAT AUGMENTIN IS AND WHAT IT IS USED FOR
_ _
Augmentin 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.
Augmentin 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 DO YOU NEED TO KNOW BEFORE YOU TAKE AUGMENTIN
DO NOT TAKE AUGMENTIN:

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 throat.

if you have ever had liver problems or jaundice

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
AUGMENTIN, Amoxicillin trihydrate - Potassium clavulanate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
AUGMENTIN 500/125 mg tablets: Each tablet contains 500 mg amoxicillin
(as amoxicillin
trihydrate) and 125 mg clavulanic acid (as potassium clavulanate).
AUGMENTIN 875/125 mg tablets: Each tablet contains 875 mg amoxicillin
(as amoxicillin
trihydrate) and 125 mg clavulanic acid (as potassium clavulanate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
AUGMENTIN 500/125 mg tablets: A white to off-white oval-shaped
film-coated tablet,
debossed with ‘AC’ and a score line on one side and plain on the
other side.
AUGMENTIN 875/125 mg tablets: A white to off-white capsule-shaped
film-coated tablet,
debossed with ‘AC’ on both sides and a score line on one side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Augmentin 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.
Dosage depends on the age and renal function of the patient and the
severity of the infection.
To minimise potential gastrointestinal intolerance, administer at the
start of a meal. The
absorption of
_AUGMENTIN_
is optimised when taken at the start of a meal.
Treatment should not be extended be