Co-amoxiclav 250mg/125mg Film-coated tablets

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Amoxicillin; Clavulanic acid

थमां उपलब्ध:

Brown & Burk IR Limited

ए.टी.सी कोड:

J01CR; J01CR02

INN (इंटरनेशनल नाम):

Amoxicillin; Clavulanic acid

डोज़:

250 mg/125 milligram(s)

फार्मास्यूटिकल फॉर्म:

Film-coated tablet

चिकित्सीय क्षेत्र:

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

प्राधिकरण का दर्जा:

Marketed

प्राधिकरण की तारीख:

2012-03-09

सूचना पत्रक

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
CO-AMOXICLAV 250MG/125MG FILM-COATED TABLETS
CO-AMOXICLAV 500MG/125MG 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. 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 leaflets. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Co-amoxiclav Tablets are and what they areused for
2.
What you need to know before you take Co-amoxiclav Tablets
3.
How to use Co-amoxiclav Tablets.
4.
Possible side effects
5.
How to store co-amoxiclav tablets
6.
Content of the pack and other information
1.
WHAT CO-AMOXICLAV TABLETS ARE AND WHAT THEY ARE USED FOR
Co-amoxiclav 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.
Co-amoxiclav is used in adults and children to treat the following
infections:
_250 mg/125 mg film-_
_coated tablets: _
•
sinus infections
•
urinary tract infections
•
skin infections
•
dental infections.
_500 mg/125 mg film-coated tablets: _
•
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 CO-AMOXICLAV TABLETS
DO NOT TAKE CO-AMOXICLAV:
•
if you are allergic to amoxicillin, clavulanic acid, penicillin or any
of the other i

उत्पाद विशेषताएं

Health Products Regulatory Authority
22 February 2024
CRN00F17V
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Co-amoxiclav 250mg/125mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg amoxicillin as amoxicillin
trihydrate and 125 mg of clavulanic acid as potassium
clavulanate diluted
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White coloured capsule shaped film coated tablet debossed with ‘I
05’ on one side and plain on other side. Tablet length =
16.70 ± 0.10mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Co-amoxiclav 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)
• Cystitis
• Pyelonephritis
• Cellulitis
• Animal bites
• Severe dental abscess with spreading cellulitis.
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 Co-amoxiclav 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 Co-amoxiclav (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 Co-amoxiclav
provides a total daily dose of 750 mg amoxicillin/375 mg
clavulanic acid, when administered as recommended below. If it is
considered that a higher daily dose of amoxicillin is required,
it