International Product Information CONFIDENTIAL

AUGMENTIN BD TABLETS
Amoxicillin trihydrate - Potassium clavulanate

QUALITATIVE AND QUANTITATIVE COMPOSITION

AUGMENTIN 625 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.

Each tablet contains 500 mg amoxicillin (as amoxicillin trihydrate) and 125 mg
clavulanic acid (as potassium clavulanate).

AUGMENTIN 1 g tablets: A white to off-white capsule-shaped film-coated tablet,

debossed with ‘AC’ on both sides and a score line on one side.

Each tablet contains 875 mg amoxicillin (as amoxicillin trihydrate) and 125 mg
clavulanic acid (as potassium clavulanate).

CLINICAL INFORMATION

Indications

AUGMENTIN is an antibiotic agent with a notably broad-spectrum of activity against the

commonly occurring bacterial pathogens in general practice and hospital. The beta-
lactamase inhibitory action of clavulanate extends the spectrum of amoxicillin to embrace
a wider range of organisms, including many resistant to other beta-lactam antibiotics.

AUGMENTIN should be used in accordance with local official antibiotic-prescribing

guidelines and local susceptibility data.

AUGMENTIN oral presentations for twice daily dosing, are indicated for short-term
treatment of bacterial infections at the following sites:

Upper respiratory tract infections (including ENT) e.g. recurrent tonsillitis, sinusitis,
otitis media.

Lower respiratory tract infections e.g. acute exacerbation of chronic obstructive

pulmonary disease (AECOPD)/acute exacerbation of chronic bronchitis (AECB), lobar
and bronchopneumonia.

Genito-urinary tract infections e.g. cystitis, urethritis, pyelonephritis.

Skin and soft tissue infections, e.g. boils, abscesses, cellulitis, wound infections.

Bone and joint infections e.g. osteomyelitis.

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Dental infections e.g. dentoalveolar abscess

Other infections e.g. septic abortion, puerperal sepsis, intra-abdominal sepsis.

Susceptibility to AUGMENTIN will vary with geography and time (see Pharmacological
Properties, Pharmacodynamics for further information). Local susceptibility data should
be consulted where available, and microbiological sampling and susceptibility testing
performed where necessary.

Dosage and Administration

Pharmaceutical form: Film-coated tablets

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 beyond 14 days without review.

Therapy can be started parenterally and continued with an oral preparation.

Tablets should be swallowed whole without chewing. If required, tablets may be broken
in half and swallowed without chewing.

AUGMENTIN tablets are not recommended in children of 12 years and under.

Adults and Children over 12 years

The usual recommended daily dosage is:
Mild - Moderate infections One AUGMENTIN 625 mg tablet every 12 hours.
Severe infections One AUGMENTIN 1 g tablet every 12 hours.

Renal Impairment
No adjustment in dose is required in patients with creatinine clearance (CrCl) greater than
30 mL/min. The AUGMENTIN 1g tablet should only be used in patients with a creatinine
clearance (CrCl) rate of more than 30 mL/min.
CrCl 10-30 mL/min One AUGMENTIN 625 mg tablet every 12 hours.

CrCl < 10 mL/min One AUGMENTIN 625 mg tablet every 24 hours.

Haemodialysis One AUGMENTIN 625 mg tablet every 24 hours, plus a
further one tablet during dialysis, to be repeated at the
end of dialysis (as serum concentrations of both
amoxicillin and clavulanic acid are decreased).
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Hepatic Impairment

Dose with caution; monitor hepatic function at regular intervals.

Contraindications
AUGMENTIN is contraindicated in patients with a history of hypersensitivity to beta-
lactams, e.g. penicillins and cephalosporins.

AUGMENTIN is contraindicated in patients with a previous history of AUGMENTIN-

associated jaundice/hepatic dysfunction.

Warnings and Precautions

Before initiating therapy with AUGMENTIN, careful enquiry should be made concerning
previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.

Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and

severe cutaneous adverse reactions) have been reported in patients on penicillin therapy.
These reactions are more likely to occur in individuals with a history of penicillin
hypersensitivity (see Contraindications). Hypersensitivity reactions can also progress to
Kounis syndrome, a serious allergic reaction that can result in myocardial infarction.
Presenting symptoms of such reactions can include chest pain occurring in association
with an allergic reaction to AUGMENTIN (see Adverse Reactions). Drug-induced
enterocolitis syndrome has been reported mainly in children receiving AUGMENTIN (see
Adverse Reactions). Drug-induced enterocolitis syndrome is an allergic reaction with the
leading symptom of protracted vomiting (1-4 hours after medicinal product
administration) in the absence of allergic skin or respiratory symptoms. Further
symptoms could comprise abdominal pain, lethargy, diarrhoea, hypotension or
leucocytosis with neutrophilia. In severe cases, drug-induced enterocolitis syndrome can
progress to shock. If an allergic reaction occurs, AUGMENTIN therapy should be
discontinued and appropriate alternative therapy instituted.

Serious anaphylactic reactions require immediate emergency treatment with adrenaline.

Oxygen, intravenous (i.v.) steroids and airway management, including intubation may
also be required.

AUGMENTIN should be avoided if infectious mononucleosis is suspected since the

occurrence of a morbilliform rash has been associated with this condition following the
use of amoxicillin.

Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.

Pseudomembranous colitis has been reported with the use of antibiotics and may range in
severity from mild to life-threatening. Therefore, it is important to consider its diagnosis
in patients who develop diarrhoea during or after antibiotic use. If prolonged or
significant diarrhoea occurs or the patient experiences abdominal cramps, treatment
should be discontinued immediately and the patient investigated further.
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Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in
patients receiving AUGMENTIN and oral anticoagulants. Appropriate monitoring should
be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose
of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.

Changes in liver function tests have been observed in some patients receiving
AUGMENTIN. The clinical significance of these changes is uncertain. AUGMENTIN
should be used with caution in patients with evidence of hepatic dysfunction.

Cholestatic jaundice, which may be severe, but is usually reversible, has been reported
rarely. Signs and symptoms may not become apparent for up to six weeks after treatment
has ceased.

In patients with renal impairment AUGMENTIN dosage should be adjusted as

recommended in the Dosage and Administration section.

In patients with reduced urine output, crystalluria has been observed very rarely,
predominantly with parenteral therapy. During the administration of high doses of
amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order
to reduce the possibility of amoxicillin crystalluria (see Overdose).

Interactions
Concomitant use of probenecid is not recommended. Probenecid decreases the renal
tubular secretion of amoxicillin. Concomitant use with AUGMENTIN may result in
increased and prolonged blood levels of amoxicillin, but not of clavulanic acid.

Concomitant use of allopurinol during treatment with amoxicillin can increase the
likelihood of allergic skin reactions. There are no data on the concomitant use of
AUGMENTIN and allopurinol.

In common with other antibiotics, AUGMENTIN may affect the gut flora, leading to
lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.

In the literature, there are rare cases of increased international normalised ratio in patients
maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-
administration is necessary, the prothrombin time or international normalised ratio should
be carefully monitored with the addition or withdrawal of AUGMENTIN.

In patients receiving mycophenolate mofetil, reduction in pre-dose concentration of the

active metabolite mycophenolic acid of approximately 50% has been reported following
commencement of oral amoxicillin plus clavulanic acid. The change in pre-dose level
may not accurately represent changes in overall MPA exposure.

Penicillins may reduce the excretion of methotrexate causing a potential increase in

toxicity.
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Pregnancy and Lactation

Reproduction studies in animals (mice and rats at doses up to 10 times the human dose)
with orally and parenterally administered AUGMENTIN have shown no teratogenic
effects. In a single study in women with pre-term, premature rupture of the foetal
membrane (pPROM), it was reported that prophylactic treatment with AUGMENTIN may
be associated with an increased risk of necrotising enterocolitis in neonates. As with all
medicines, use should be avoided in pregnancy, especially during the first trimester,
unless considered essential by the physician.

AUGMENTIN may be administered during the period of lactation. With the exception of
the risk of sensitisation, associated with the excretion of trace quantities in breast milk,
there are no known detrimental effects for the breast-fed infant.

Effects on Ability to Drive and Use Machines

Adverse effects on the ability to drive or operate machinery have not been observed.

Adverse Reactions

Data from large clinical trials was used to determine the frequency of very common to
rare undesirable effects. The frequencies assigned to all other undesirable effects (i.e.,
those occurring at < 1/10,000) were mainly determined using post-marketing data and
refer to a reporting rate rather than a true frequency.

The following convention has been used for the classification of frequency:

very common ≥ 1/10

common ≥ 1/100 to < 1/10

uncommon ≥ 1/1000 to < 1/100

rare ≥ 1/10,000 to < 1/1000

very rare < 1/10,000.

Infections and infestations

Common Mucocutaneous candidiasis

Blood and lymphatic system disorders

Rare Reversible leucopenia (including neutropenia) and thrombocytopenia

Very rare Reversible agranulocytosis and haemolytic anaemia. Prolongation of

bleeding time and prothrombin time.
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Immune system disorders

Very rare Angioneurotic oedema, anaphylaxis (see Warnings and Precautions),

serum sickness-like syndrome, hypersensitivity vasculitis (see also Skin
and subcutaneous tissue disorders).

Nervous system disorders

Uncommon Dizziness, headache

Very rare Reversible hyperactivity, aseptic meningitis, convulsions. Convulsions

may occur in patients with impaired renal function or in those receiving
high doses.

Cardiac disorders

Very rare Kounis syndrome (see Warnings and Precautions).

Gastrointestinal disorders

Adults

Very common Diarrhoea

Common Nausea, vomiting

Children

Common Diarrhoea, nausea, vomiting

All populations

Nausea is more often associated with higher oral dosages. If gastrointestinal reactions are
evident, they may be reduced by taking AUGMENTIN at the start of a meal.

Uncommon Indigestion

Very rare Antibiotic-associated colitis (including pseudomembranous colitis and

haemorrhagic colitis), drug-induced enterocolitis syndrome (see
Warnings and Precautions).

Black hairy tongue

Hepatobiliary disorders

Uncommon A moderate rise in AST and/or ALT has been noted in patients treated
with beta-lactam class antibiotics, but the significance of these findings
is unknown.
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Very rare Hepatitis and cholestatic jaundice. These events have been noted with
other penicillins and cephalosporins.

Hepatic events have been reported predominantly in males and elderly patients and may
be associated with prolonged treatment. These events have been very rarely reported in
children.

Signs and symptoms usually occur during or shortly after treatment but in some cases
may not become apparent until several weeks after treatment has ceased. These are
usually reversible. Hepatic events may be severe and in extremely rare circumstances,
deaths have been reported. These have almost always occurred in patients with serious
underlying disease or taking concomitant medications known to have the potential for
hepatic effects.

Skin and subcutaneous tissue disorders

Uncommon Skin rash, pruritus, urticaria

Rare Erythema multiforme

Very rare Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous

exfoliative-dermatitis, acute generalised exanthemous pustulosis
(AGEP), and drug reaction with eosinophilia and systemic symptoms
(DRESS) (see also Immune system disorders).

If any hypersensitivity dermatitis reaction occurs, treatment should be

discontinued.

Linear IgA disease.

Renal and urinary disorders

Very rare Interstitial nephritis, crystalluria (see Overdose)

Overdose
Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be
evident. Gastrointestinal symptoms may be treated symptomatically, with attention to the
water/electrolyte balance.

Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see
Warnings and Precautions).

AUGMENTIN can be removed from the circulation by haemodialysis.

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PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

ATC code: J01CR02.

Pharmacotherapeutic group: Combinations of penicillins, incl. beta-lactamase inhibitors.
Resistance to many antibiotics is caused by bacterial enzymes which destroy the
antibiotic before it can act on the pathogen. The clavulanate in AUGMENTIN anticipates
this defence mechanism by blocking the beta-lactamase enzymes, thus rendering the
organisms susceptible to amoxicillin’s rapid bactericidal effect at concentrations readily
attainable in the body. Clavulanate by itself has little antibacterial activity; however, in
association with amoxicillin as AUGMENTIN it produces an antibiotic agent of broad-
spectrum with wide application in hospital and general practice.

In the list below, organisms are categorised according to their in vitro susceptibility to
AUGMENTIN.

In vitro susceptibility of micro-organisms to AUGMENTIN

Where clinical efficacy of AUGMENTIN has been demonstrated in clinical trials this is
indicated with an asterisk (*).
Organisms that do not produce beta-lactamase are identified (with †). If an isolate is
susceptible to amoxicillin, it can be considered susceptible to AUGMENTIN.
Commonly susceptible species
Gram-positive aerobes:
Bacillius anthracis
Enterococcus faecalis
Listeria monocytogenes
Nocardia asteroides
Streptococcus pyogenes*†
Streptococcus agalactiae*†
Streptococcus spp. (other beta-hemolytic)*†
Staphylococcus aureus (methicillin susceptible)*
Staphylococcus saprophyticus (methicillin susceptible)
Coagulase negative staphylococcus (methicillin susceptible)
Gram-negative aerobes:
Bordetella pertussis
Haemophilus influenzae*
Haemophilus parainfluenzae
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Helicobacter pylori
Moraxella catarrhalis*
Neisseria gonorrhoeae
Pasteurella multocida
Vibrio cholerae
Other:
Borrelia burgdorferi
Leptospira ictterohaemorrhagiae
Treponema pallidum
Gram positive anaerobes:
Clostridium spp.
Peptococcus niger
Peptostreptococcus magnus
Peptostreptococcus micros
Peptostreptococcus spp.
Gram-negative anaerobes:
Bacteroides fragilis
Bacteroides spp.
Capnocytophaga spp.
Eikenella corrodens
Fusobacterium nucleatum
Fusobacterium spp.
Porphyromonas spp.
Prevotella spp.
Species for which acquired resistance may be a problem
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Gram-negative aerobes:
Escherichia coli*
Klebsiella oxytoca
Klebsiella pneumoniae*
Klebsiella spp.
Proteus mirabilis
Proteus vulgaris
Proteus spp.
Salmonella spp.
Shigella spp.
Gram-positive aerobes:
Corynebacterium spp.
Enterococcus faecium
Streptococcus pneumoniae*†
Viridans group streptococcus
Inherently resistant organisms
Gram-negative aerobes:
Acinetobacter spp.
Citrobacter freundii
Enterobacter spp.
Hafnia alvei
Legionella pneumophila
Morganella morganii
Providencia spp.
Pseudomonas spp.
Serratia spp.
Stenotrophomas maltophilia
Yersinia enterolitica
Others:
Chlamydia pneumoniae
Chlamydia psittaci
Chlamydia spp.
Coxiella burnetti
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Mycoplasma spp.

Pharmacokinetics
The pharmacokinetics of the two components of AUGMENTIN are closely matched. Peak
serum levels of both occur about 1 hour after oral administration. Absorption of
AUGMENTIN is optimised at the start of a meal.

Doubling the dosage of AUGMENTIN approximately doubles the serum levels achieved.

Both clavulanate and amoxicillin have low levels of serum binding; about 70% remains
free in the serum.

Non-Clinical Information

No further information of relevance.

PHARMACEUTICAL INFORMATION

List of Excipients
AUGMENTIN tablets contain sodium starch glycolate, magnesium stearate (E572),
colloidal silica, microcrystalline cellulose, titanium dioxide (E171), hydroxypropyl
methylcellulose, polyethylene glycol, dimeticone (silicone oil).

Shelf Life

The expiry date is indicated on the packaging.

Storage

The storage conditions are detailed on the packaging.

Do not take after the expiry date shown on the pack.

Store in a dry place in the original packaging to protect from moisture.

AUGMENTIN tablet packs contain desiccant sachets. Do not remove or eat.

Nature and Contents of Container

AUGMENTIN tablets are supplied in a carton containing blister packs. Each blister pack
is stored within a sealed pouch, with a desiccant sachet.
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Incompatibilities

None known.

Use and Handling

Blister pouches contain a desiccant sachet; do not remove or eat. Discard any opened and
unused tablets after storing as directed on the packaging .

Any unused medicinal product or waste material should be disposed of in accordance

with local requirements.

Not all presentations are available in every country.

Version number: GDS28/IPI15

Date of issue: 23 February 2023

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LABELLING TEXT (PHARMA)

PARTICULARS TO APPEAR ON THE CARTON LABEL

NAME OF THE MEDICINAL PRODUCT

AUGMENTIN 625 mg
AUGMENTIN 1 g
Amoxicillin trihydrate – Potassium clavulanate

STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 500 mg amoxicillin (as amoxicillin trihydrate) and 125 mg clavulanic acid
(as potassium clavulanate).
Each tablet contains 875 mg amoxicillin (as amoxicillin trihydrate) and 125 mg clavulanic acid
(as potassium clavulanate).

EXCIPIENTS WARNING(S), IF NECESSARY

PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

METHOD AND ROUTE(S) OF ADMINISTRATION

Twice Daily Dosing.

Oral use.
To be used as directed by your physician.
Read the package leaflet before use.

OTHER SPECIAL WARNING(S), IF NECESSARY

Keep out of the sight and reach of children.

PRE-PRINT INFORMATION

BN
MAN
EXP

STORAGE CONDITIONS
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Do not store above 25°C. Use tablets within 30 days of opening.

Or
Do not store above 30°C. Use tablets within 14 days of opening

Store in a dry place in the original packaging to protect from moisture.

(For Desiccated blister pouch packs only): Contain desiccant sachets, do not remove or eat.

MANUFACTURING SITE ADDRESS (PACKAGING SITE ADDRESS IF DIFFERENT)

Manufactured by:
SmithKline Beecham Limited*
Clarendon Road
Worthing
West Sussex BN14 8QH
United Kingdom

*Member of GSK group of companies

TRADE MARK STATEMENTS

Trade marks are owned by or licensed to the GSK group of companies.

COPYRIGHT STATEMENTS

© [year] GSK group of companies or its licensor.

LOGO(S)

GSK

QR CODE TEXT
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PARTICULARS TO APPEAR ON BLISTER FOILS OR STRIPS

NAME OF THE MEDICINAL PRODUCT

AUGMENTIN 625 mg
AUGMENTIN 1 g
Amoxicillin trihydrate – Potassium clavulanate

PRE-PRINT INFORMATION

OTHER

For each dose, Press other side to release tablet.

TRADE MARK STATEMENTS (IF REQUIRED)

COPYRIGHT STATEMENTS (IF REQUIRED)

LOGO(S)

GSK
International Product Information CONFIDENTIAL

DETAILS FOR LEAFLET

MANUFACTURING SITE ADDRESS (PACKAGING SITE ADDRESS IF DIFFERENT)

Manufactured by:

SmithKline Beecham Limited*

Clarendon Road
Worthing
West Sussex BN14 8QH
United Kingdom

*Member of GSK group of companies

TRADEMARK STATEMENTS

Trade marks are owned by or licensed to the GSK group of companies.

COPYRIGHT STATEMENTS

© [year] GSK group of companies or its licensor.

LOGO(S)

GSK