Project: CO-0030407 Document: PPC-3300645 Version: 3

e-Banner Site Code: 62000000052147 Operator: NB216483 Date/Time Created: 17.Jun.2020 17:38 GMT+1

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Artwork Information Panel
Manufacturing Site Number: 6200000 Renal Impairment In the literature there are rare cases of increased international normalised ratio in patients maintained on
0052147
62000000052147 No adjustment in dose is required in patients with creatinine clearance (CrCl) greater than 30 mL/min. acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-administration is necessary, the
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The AUGMENTIN 1g tablet should only be used in patients with a creatinine clearance (CrCl) rate of prothrombin time or international normalised ratio should be carefully monitored with the addition or
Manufacturing Site(s):
more than 30 mL/min. withdrawal of AUGMENTIN.

AUGMENTIN BD TABLETS
GSK_WORTHING_UNITED KINGDOM
CrCl 10-30 mL/min One AUGMENTIN 625 mg tablet every 12 hours. In patients receiving mycophenolate mofetil, reduction in pre-dose concentration of the active
Product Market Trade Name:

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metabolite mycophenolic acid of approximately 50% has been reported following commencement
Augmentin Amoxicillin trihydrate - Potassium clavulanate CrCl < 10 mL/min One AUGMENTIN 625 mg tablet every 24 hours. of oral amoxicillin plus clavulanic acid. The change in pre-dose level may not accurately represent
Approving Market(s): Haemodialysis One AUGMENTIN 625 mg tablet every 24 hours, plus a further one changes in overall MPA exposure.
CFUN-GRA Labelling-General Export Pack tablet during dialysis, to be repeated at the end of dialysis (as serum Pregnancy and Lactation
concentrations of both amoxicillin and clavulanic acid are decreased). Reproduction studies in animals (mice and rats) with orally and parenterally administered
Print Process: QUALITATIVE AND QUANTITATIVE COMPOSITION
N/A Hepatic Impairment AUGMENTIN have shown no teratogenic effects. In a single study in women with pre-term,
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AUGMENTIN 625 mg tablets: Each tablet contains 500 mg premature rupture of the foetal membrane (pPROM), it was reported that prophylactic treatment
Colour Standard Reference: Dose with caution; monitor hepatic function at regular intervals.
amoxicillin (as amoxicillin trihydrate) and 125 mg clavulanic acid with AUGMENTIN may be associated with an increased risk of necrotising enterocolitis in neonates.
IMPORTANT
N/A Contraindications
(as potassium clavulanate). As with all medicines, use should be avoided in pregnancy, especially during the first trimester,
AUGMENTIN is contraindicated in patients with a history of hypersensitivity to beta-lactams,
Technical Drawing (Do NOT include version number): AUGMENTIN 1 g tablets: Each tablet contains 875 mg amoxicillin unless considered essential by the physician.
e.g. penicillins and cephalosporins.
LF035 (as amoxicillin trihydrate) and 125 mg clavulanic acid (as AUGMENTIN may be administered during the period of lactation. With the exception of the risk of
GSK LOC is responsible to AUGMENTIN is contraindicated in patients with a previous history of AUGMENTIN-associated
potassium clavulanate). sensitisation, associated with the excretion of trace quantities in breast milk, there are no
Material Spec. (Do NOT include version number): approve the change jaundice/hepatic dysfunction.
N/A PHARMACEUTICAL FORM Warnings and Precautions detrimental effects for the infant.
documentation, artwork brief
AUGMENTIN 625 mg tablets: A white to off-white oval-shaped film-coated tablet, debossed with Before initiating therapy with AUGMENTIN careful enquiry should be made concerning previous Effects on Ability to Drive and Use Machines
Material Type: and final artwork, ensuring ‘AC’ and a score line on one side and plain on the other side. Adverse effects on the ability to drive or operate machinery have not been observed.
N/A hypersensitivity reactions to penicillins, cephalosporins, or other allergens.
N/A that it is accurate, consistent AUGMENTIN 1 g tablets: A white to off-white capsule-shaped film-coated tablet, debossed with Adverse Reactions
Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe
and complete.
200 mm Measuring Bar

Total Colours & Varnishes: 2 ‘AC’ on both sides and a score line on one side. cutaneous adverse reactions) have been reported in patients on penicillin therapy. These reactions Data from large clinical trials were used to determine the frequency of very common to rare
CLINICAL PARTICULARS are more likely to occur in individuals with a history of penicillin hypersensitivity (see undesirable effects. The frequencies assigned to all other undesirable effects (i.e., those
GSK SDC is responsible for site
BLACK 527 Indications Contraindications). If an allergic reaction occurs, AUGMENTIN therapy must be discontinued and occurring at < 1/10,000) were mainly determined using post-marketing data and refer to a
technical requirements and reporting rate rather than a true frequency.
AUGMENTIN is an antibiotic agent with a notably broad spectrum of activity against the commonly appropriate alternative therapy instituted. Serious anaphylactic reactions require immediate
pre-press suitability. The following convention has been used for the classification of frequency:
occurring bacterial pathogens in general practice and hospital. The beta-lactamase inhibitory action of emergency treatment with adrenaline. Oxygen, intravenous (i.v.) steroids and airway management
GSK Market is responsible clavulanate extends the spectrum of amoxicillin to embrace a wider range of organisms, including (including intubation) may also be required. very common ≥ 1/10
many resistant to other beta-lactam antibiotics. AUGMENTIN should be avoided if infectious mononucleosis is suspected since the occurrence of a common ≥ 1/100 to < 1/10
to advise SDC when changes
AUGMENTIN should be used in accordance with local official antibiotic-prescribing guidelines and morbilliform rash has been associated with this condition following the use of amoxicillin. uncommon ≥ 1/1000 to < 1/100
required impact the following: rare ≥ 1/10,000 to < 1/1000
local susceptibility data. Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.
Formulation AUGMENTIN oral presentations for twice daily dosing, are indicated for short-term treatment of Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity very rare < 1/10,000.
Infections and infestations
bacterial infections at the following sites: from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients who
Tablet embossing Upper respiratory tract infections (including ENT) e.g. tonsillitis, sinusitis, otitis media. develop diarrhoea during or after antibiotic use. If prolonged or significant diarrhoea occurs or the Common Mucocutaneous candidiasis
Total Special Finishes: 0 patient experiences abdominal cramps, treatment should be discontinued immediately and the Blood and lymphatic system disorders
Storage conditions Lower respiratory tract infections e.g. acute exacerbation of chronic bronchitis, lobar and
bronchopneumonia. patient investigated further. Rare Reversible leucopenia (including neutropenia) and thrombocytopenia
Very rare Reversible agranulocytosis and haemolytic anaemia. Prolongation of bleeding
Shelf Life Genito-urinary tract infections e.g. cystitis, urethritis, pyelonephritis.
Skin and soft tissue infections, e.g. boils, abscesses, cellulitis, wound infections.
Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients
receiving AUGMENTIN and oral anticoagulants. Appropriate monitoring should be undertaken when time and prothrombin time.
Bone and joint infections e.g. osteomyelitis. anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be Immune system disorders
Dental infections e.g. dentoalveolar abscess necessary to maintain the desired level of anticoagulation. Very rare Angioneurotic oedema, anaphylaxis, serum sickness-like syndrome,
Body Text Size: hypersensitivity vasculitis
8.0pt Other infections e.g. septic abortion, puerperal sepsis, intra-abdominal sepsis. Changes in liver function tests have been observed in some patients receiving AUGMENTIN. The
Susceptibility to AUGMENTIN will vary with geography and time (see Pharmacological Properties, clinical significance of these changes is uncertain. AUGMENTIN should be used with caution in Nervous system disorders
Smallest Text Size: Pharmacodynamics for further information). Local susceptibility data should be consulted where patients with evidence of hepatic dysfunction. Uncommon Dizziness, headache
8.0pt available, and microbiological sampling and susceptibility testing performed where necessary. Cholestatic jaundice, which may be severe, but is usually reversible, has been reported rarely. Signs Very rare Reversible hyperactivity, aseptic meningitis, convulsions. Convulsions may
Leading: Dosage and Administration and symptoms may not become apparent for up to six weeks after treatment has ceased. occur in patients with impaired renal function or in those receiving high doses.
9.0pt Dosage depends on the age and renal function of the patient and the severity of the infection. In patients with renal impairment AUGMENTIN dosage should be adjusted as recommended in the Gastrointestinal disorders
To minimise potential gastrointestinal intolerance, administer at the start of a meal. The absorption Dosage and Administration section. Adults
Horizontal Scale: Very common Diarrhoea
95% of AUGMENTIN is optimised when taken at the start of a meal. In patients with reduced urine output, crystalluria has been observed very rarely, predominantly
Treatment should not be extended beyond 14 days without review. with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to Common Nausea, vomiting
Microtext: Therapy can be started parenterally and continued with an oral preparation. maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin Children
N Tablets should be swallowed whole without chewing. If required, tablets may be broken in half and crystalluria (see Overdose). Common Diarrhoea, nausea, vomiting
Additional Info (1): swallowed without chewing. Interactions All populations
N/A AUGMENTIN tablets are not recommended in children of 12 years and under. Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular Nausea is more often associated with higher oral dosages. If gastrointestinal reactions are evident,
Adults and Children over 12 years secretion of amoxicillin. Concomitant use with AUGMENTIN may result in increased and prolonged they may be reduced by taking AUGMENTIN at the start of a meal.
Additional Info (2): Uncommon Indigestion
N/A The usual recommended daily dosage is: blood levels of amoxicillin but not of clavulanate.
Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic Very rare Antibiotic-associated colitis (including pseudomembranous colitis and
Additional Info (3): Mild - Moderate infections One AUGMENTIN 625 mg tablet every 12 hours. haemorrhagic colitis – see Warnings and Precautions).
Severe infections One AUGMENTIN 1 g tablet every 12 hours. skin reactions. There are no data on the concomitant use of AUGMENTIN and allopurinol.
N/A In common with other antibiotics, AUGMENTIN may affect the gut flora, leading to lower oestrogen Black hairy tongue
AIP_Production_V_INDD - 04_2017 - Harmony - Version 2 reabsorption and reduced efficacy of combined oral contraceptives.

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 Project: CO-0030407 Document: PPC-3300645 Version: 3

e-Banner Site Code: 62000000052147 Operator: NB216483 Date/Time Created: 17.Jun.2020 17:38 GMT+1

2
Artwork copyright is the property of the GSK Group of Companies. All suppliers providing a service to GSK for printed components of any description must ensure that they have a licence for all fonts / software used in conjunction with GSK artwork.

Harmony AMS
Artwork Information Panel
Manufacturing Site Number: Hepatobiliary disorders Gram-negative aerobes: Others:
62000000052147 Uncommon A moderate rise in AST and/or ALT has been noted in patients treated with
The distribution and use of fonts / software without a licence constitutes an intellectual property infringement. GSK will not accept any liability for the breach of third party intellectual property rights by printed component suppliers.

Bordetella pertussis Chlamydia pneumoniae

beta-lactam class antibiotics, but the significance of these findings is unknown. Haemophilus influenzae* Chlamydia psittaci
Manufacturing Site(s):
Very rare Hepatitis and cholestatic jaundice. These events have been noted with other Haemophilus parainfluenzae Chlamydia spp.
GSK_WORTHING_UNITED KINGDOM
penicillins and cephalosporins. Helicobacter pylori Coxiella burnetti
Product Market Trade Name:

If an e-banner DOES NOT appear on the top of this document, THEN this document has NOT been printed from the Harmony system.
Hepatic events have been reported predominantly in males and elderly patients and may be Moraxella catarrhalis* Mycoplasma spp.
Augmentin associated with prolonged treatment. These events have been very rarely reported in children. Neisseria gonorrhoeae Pharmacokinetics
Approving Market(s): Signs and symptoms usually occur during or shortly after treatment but in some cases may not Pasteurella multocida The pharmacokinetics of the two components of AUGMENTIN are closely matched. Peak serum levels
CFUN-GRA Labelling-General Export Pack become apparent until several weeks after treatment has ceased. These are usually reversible. Vibrio cholerae of both occur about 1 hour after oral administration. Absorption of AUGMENTIN is optimised at the
Print Process: Hepatic events may be severe and in extremely rare circumstances, deaths have been Other: start of a meal.
N/A reported. These have almost always occurred in patients with serious underlying disease or Borrelia burgdorferi Doubling the dosage of AUGMENTIN approximately doubles the serum levels achieved.
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taking concomitant medications known to have the potential for hepatic effects. Leptospira ictterohaemorrhagiae
Colour Standard Reference: Both clavulanate and amoxicillin have low levels of serum
Skin and subcutaneous tissue disorders
IMPORTANT
Treponema pallidum binding; about 70% remains free in the serum.
N/A Uncommon Skin rash, pruritus, urticaria Gram positive anaerobes: Pre-clinical Safety Data
Technical Drawing (Do NOT include version number): Rare Erythema multiforme Clostridium spp. No further information of relevance.
LF035 GSK LOC is responsible to Very rare Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative- Peptococcus niger
dermatitis, acute generalised exanthemous pustulosis (AGEP), and drug PHARMACEUTICAL PARTICULARS
Material Spec. (Do NOT include version number): approve the change Peptostreptococcus magnus List of Excipients
N/A reaction with eosinophilia and systemic symptoms (DRESS) Peptostreptococcus micros
documentation, artwork brief AUGMENTIN tablets contain sodium starch glycolate, magnesium stearate (E572), colloidal silica,
If any hypersensitivity dermatitis reaction occurs, treatment should be discontinued. Peptostreptococcus spp.
Material Type: and final artwork, ensuring Renal and urinary disorders microcrystalline cellulose, titanium dioxide (E171), hydroxypropyl methylcellulose, polyethylene
N/A Gram-negative anaerobes:
N/A that it is accurate, consistent Very rare Interstitial nephritis, crystalluria (see Overdose) glycol, dimeticone (silicone oil).
and complete. Bacteroides fragilis Incompatibilities
200 mm Measuring Bar

Total Colours & Varnishes: 2 Overdose

Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. Bacteroides spp. None known.
GSK SDC is responsible for site Capnocytophaga spp. Shelf Life
BLACK 527
Gastrointestinal symptoms may be treated symptomatically with attention to the water electrolyte
technical requirements and balance. Eikenella corrodens The expiry date is indicated on the packaging.
pre-press suitability. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Warnings Fusobacterium nucleatum Special Precautions for Storage
and Precautions). Fusobacterium spp. Do not take after the expiry date shown on the pack.
GSK Market is responsible Porphyromonas spp. Store in a dry place in the original packaging to protect from moisture.
AUGMENTIN can be removed from the circulation by haemodialysis.
to advise SDC when changes Prevotella spp. Refer to pack for storage temperature.
required impact the following: PHARMACOLOGICAL PROPERTIES
Species for which acquired resistance may be a problem For AUGMENTIN tablet packs with a storage temperature up to 25°C, use tablets within 30 days of
Pharmacodynamics
Formulation Resistance to many antibiotics is caused by bacterial enzymes which destroy the antibiotic before it Gram-negative aerobes:
Escherichia coli*
opening (see also Instructions for Use/Handling).
For AUGMENTIN tablet packs with a storage temperature up to 30°C, use tablets within 14 days of
can act on the pathogen. The clavulanate in AUGMENTIN anticipates this defence mechanism by
Tablet embossing blocking the beta-lactamase enzymes, thus rendering the organisms susceptible to amoxicillin’s rapid Klebsiella oxytoca
Klebsiella pneumoniae*
opening (see also Instructions for Use/Handling).
AUGMENTIN tablet packs contain desiccant sachets. Do not remove or eat.
Total Special Finishes: 0 bactericidal effect at concentrations readily attainable in the body. Clavulanate by itself has little
Storage conditions antibacterial activity; however, in association with amoxicillin as AUGMENTIN it produces an antibiotic Klebsiella spp. Nature and Contents of Container
Proteus mirabilis AUGMENTIN tablets are suppled in a carton containing blister packs. Each blister pack is stored
Shelf Life 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.
Proteus vulgaris within a sealed pouch, with a desiccant sachet.
Proteus spp. Instructions for Use/Handling
In vitro susceptibility of micro-organisms to AUGMENTIN Salmonella spp. Blister pouches contain a desiccant sachet; do not remove or eat. Discard any opened and unused
Body Text Size: Where clinical efficacy of AUGMENTIN has been demonstrated in clinical trials this is Shigella spp. tablets after storing as directed in the Special Precautions for Storage section.
8.0pt indicated with an asterisk (*). Gram-positive aerobes: Any unused medicinal product or waste material should be disposed of in accordance with local
Smallest Text Size: Organisms that do not produce beta-lactamase are identified (with †). If an isolate is Corynebacterium spp. requirements.
8.0pt susceptible to amoxicillin, it can be considered susceptible to AUGMENTIN. Enterococcus faecium Not all presentations are available in every country.
Commonly susceptible species Streptococcus pneumoniae*† Manufactured by:
Leading:
Gram-positive aerobes: Viridans group streptococcus SmithKline Beecham Limited*
9.0pt
Bacillius anthracis Inherently resistant organisms Clarendon Road
Horizontal Scale: Enterococcus faecalis Worthing
95% Gram-negative aerobes: West Sussex, BN14 8QH
Listeria monocytogenes Acinetobacter spp.
Microtext: Nocardia asteroides United Kingdom.
Citrobacter freundii *Member of GSK group of companies
N Streptococcus pyogenes*† Enterobacter spp.
Streptococcus agalactiae*† Trade marks are owned by or licensed to the GSK group of companies.
Additional Info (1): Hafnia alvei © 2020 GSK group of companies or its licensor.
N/A Streptococcus spp. (other beta-hemolytic)*† Legionella pneumophila
Staphylococcus aureus (methicillin susceptible)* Version number: GDS26/IPI13
Additional Info (2): Morganella morganii Date of issue: 13 June 2019
Staphylococcus saprophyticus (methicillin susceptible) Providencia spp.
N/A Coagulase negative staphylococcus (methicillin susceptible) Pseudomonas spp.
Additional Info (3): Serratia spp.
N/A Stenotrophomas maltophilia
AIP_Production_V_INDD - 04_2017 - Harmony - Version 2
Yersinia enterolitica 6200000
0052147

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