Co-amoxiclav 500mg/125mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amoxicillin trihydrate; Potassium clavulanate

Available from:

Sun Pharma UK Ltd

ATC code:

J01CR02

INN (International Name):

Amoxicillin trihydrate; Potassium clavulanate

Dosage:

500mg ; 125mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010103; GTIN: 5015525039874

Patient Information leaflet

PATIENT INFORMATION FOR THE USER CO-AMOXICLAV 500MG/125 MG FILM-COATED TABLETS
(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 your 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 Co-amoxiclav film-coated tablets are and what are they used for
2.
What you need to know before you take Co-amoxiclav film-coated tablets
3.
How to take Co-amoxiclav film-coated tablets
4.
Possible side effects
5.
How to store Co-amoxiclav film-coated tablets
6.
Contents of the pack and other information
_ _
_ _
1.
WHAT CO-AMOXICLAV FILM-COATED TABLETS ARE AND WHAT ARE THEY 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 film-coated tablets are 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 CO-AMOXICLAV FILM-COATED TABLETS
DO NOT TAKE CO-AMOXICLAV FILM-COATED TABLETS

if you are allergic (hypersensitive) to amoxicillin, clavulanic acid,
penicillin or
any of the other ingredients of Co-amoxiclav film-coated tablets
(listed in

Summary of Product characteristics

OBJECT 1
CO-AMOXICLAV 500MG /125 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 02-Nov-2017 | Ranbaxy (UK)
Limited a Sun
Pharmaceutical Company
1. Name of the medicinal product
Co-amoxiclav 500mg /125 mg film-coated Tablets
2. Qualitative and quantitative composition
Each 500mg/125mg film-coated tablet contains 573.96 mg amoxicillin
trihydrate equivalent to 500 mg
amoxicillin and 297.81 mg potassium clavulanate equivalent to 125 mg
clavulanic acid.
For the full list of excipients see section 6.1.
3. Pharmaceutical form
Film coated tablet.
White to off-white film-coated oval shaped tablets debossed with RX713
on one side and plain on the
other side.
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)
• 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
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 nec