Amoxicillin/clavulanic acid Krka 500 mg/125 mg Film-Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amoxicillin; Clavulanic acid

Available from:

KRKA, d.d., Novo mesto

ATC code:

J01CR; J01CR02

INN (International Name):

Amoxicillin; Clavulanic acid

Dosage:

500 mg/ 125 milligram(s)

Pharmaceutical form:

Film-coated tablet

Administration route:

oral use

Units in package:

: 10, 12, 14, 16, 20, 21, 24, 30, 100 or 500 film-coated tablets, in a box.

Prescription type:

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

Manufactured by:

KRKA, d.d.

Therapeutic group:

: Antibacterials for systemic use, Combinations of penicillins, incl. beta-lactamase inhibitors

Therapeutic area:

Combinations of penicillins, incl. beta-lactamase inhibitors; amoxicillin and enzyme inhibitor

Therapeutic indications:

- 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.

Authorization status:

Not marketed

Authorization date:

2015-09-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMOXICILLIN/CLAVULANIC ACID KRKA 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 Amoxicillin/clavulanic acid Krka is and what it is used for
2.
What you need to know before you take Amoxicillin/clavulanic acid Krka
3.
How to take Amoxicillin/clavulanic acid Krka
4.
Possible side effects
5.
How to store Amoxicillin/clavulanic acid Krka
6.
Contents of the pack and other information
1.
WHAT AMOXICILLIN/CLAVULANIC ACID KRKA IS AND WHAT IT IS USED FOR
Amoxicillin/clavulanic acid Krka is an antibiotic and works by killing
bacteria that cause infections. It
contains two different active ingredients 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 Krka 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 KRKA
DO NOT TAKE AMOXICILLIN/CLAVULANIC ACID KRKA
-
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 al

Summary of Product characteristics

Health Products Regulatory Authority
20 February 2024
CRN00DTMN
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amoxicillin/clavulanic acid Krka 500 mg/125 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg amoxicillin (as amoxicillin
trihydrate) and 125 mg of clavulanic acid (as potassium
clavulanate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
White coloured capsule shaped film coated tablet debossed with "I 06"
on one side and plain on other side, tablet length:
19.40 ± 0.10 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amoxicillin/clavulanic acid Krka 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 Krka 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
Krka (e.g. those that provide higher doses of amoxicillin
and/or different ratios of amoxicillin to clavulanic acid) should be
considered