Co-Amoxiclav Tablets BP 250-125mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AMOXICILLIN, CLAVULANIC ACID

Available from:

Generics UK Limited Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

ATC code:

J01CR02

INN (International Name):

AMOXICILLIN 250 mg CLAVULANIC ACID 125 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

AMOXICILLIN 250 mg CLAVULANIC ACID 125 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2006-11-10

Patient Information leaflet

  WHAT YOU SHOULD KNOW ABOUT CO-AMOXICLAV
Please read this leaflet carefully before you start to take your medicine. This leaflet does 
not contain the complete information about your medicine. If you have any questions or 
are not sure about anything ask your doctor or pharmacist.
  WHAT DOES CO-AMOXICLAV DO ?
The name of your medicine is Co-Amoxiclav Tablets. This is one of several medicines 
called antibiotics. It belongs to a group of antibiotics called 'Penicillins'. Antibiotics are 
used to kill bacteria or bacteria which cause infections.
  WHAT DOES CO-AMOXICLAV CONTAIN ?
The active ingredients of Co-Amoxiclav Tablets are Amoxicillin 250 mg as Amoxicillin 
Trihydrate and Clavulanic Acid 125 mg as Potassium Clavulanate. This combination of 
antibiotics is also known as Co-Amoxiclav Tablets BP 250/125 mg. Co-Amoxiclav Tablets 
also contain: magnesium stearate (E572), talc, povidone, microcrystalline cellulose, 
croscarmellose sodium, triethyl citrate, ethyl cellulose, sodium lauryl sulphate, cetyl 
alcohol, hypromellose and titanium dioxide (E171). Co-Amoxiclav Tablets come in packs 
of 21 or 100 tablets. Co-Amoxiclav Tablets are oblong, convex and off-white in colour. The 
tablets are scored on both sides and marked "AXC 375" on one side and "GG" on the other.
Product Licence Holder and Manufacturer: Generics [UK] Limited, Station Close, Potters 
Bar, Herts, EN6 1TL.
  WHAT ARE CO-AMOXICLAV TABLETS FOR ?
Your doctor will have prescribed Co-Amoxiclav Tablets for treating an infection.
Co-Amoxiclav can be used for treating a wide range of infections, for example, infections 
of the chest (bronchitis or pneumonia), sinuses (sinusitis), ears (otitis media), throat 
(tonsillitis), kidneys, urinary tract, genitals, abdomen, skin and soft tissues.

  BEFORE�

Summary of Product characteristics

Page 1 of 11 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
TRADE NAME OF THE MEDICINAL PRODUCT 

Co-amoxiclav tablets BP 250/125mg  

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

1 film-coated tablet contains: 

Amoxicillin trihydrate 
0.287 g 
_corresponding to 250 mg amoxicillin _
Potassium Clavulanate  
0.149 g 
_corresponding to 125 mg clavulanic acid_ 

3. PHARMACEUTICAL 
FORM 

Film-coated tablets 
Off white, oblong, convex tablets scored on both sides.  The
tablets are 7 x 18 mm in size.  

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Co-amoxiclav is an antibiotic agent with a notably broad spectrum of
activity against the commonly 
occurring bacterial pathogens in general practice and hospital.
 The 
β-lactamase inhibitory action of 
clavulanate extends the spectrum of amoxicillin to
embrace a wider range of organisms, including 
many resistant to other 
β-lactam antibiotics. 

Co-amoxiclav oral preparations are indicated for
short term treatment of bacterial infections at the 
following sites when amoxicillin resistant beta-lactamase
producing strains are suspected as the 
cause.  In other situations, amoxicillin alone should be
considered. 

_Upper Respiratory Tract Infections (including ENT)_ in particular
sinusitis, otitis media,_ _
recurrent tonsillitis.  These infections are often caused
by _Streptococcus pneumoniae,  _
_Haemophilia influenzae*, Moraxella
catarrhalis*_ and _Streptococcus  _
_pyogenes. _

_Lower Respiratory Tract Infections_  in
particular acute exacerbations of chronic bronchitis 
(especially if considered severe), bronchopneumonia.  These
infections are often caused by 
_Streptococcus pneumoniae, Haemophilus influenzae*_ and _Moraxella
catarrhalis*_ 

_Genitourinary Tract and Abdominal Infections _in
particular cystitis (especially when recurrent or 
complicated –excluding prostatitis), septic abortion, pelvic or