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CO-AMOXICLAV 400 MG/57 MG/5 ML SUGAR FREE POWDER FOR ORAL SUSPENSION

Active substance(s): AMOXICILLIN TRIHYDRATE / POTASSIUM CLAVULANATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Co-amoxiclav 400 mg/57 mg/5 mL Sugar Free Powder for Oral Suspension.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Co-amoxiclav Sugar Free Suspension Each 5ml of reconstituted suspension contains
400 mg amoxicillin (as amoxicillin trihydrate) and 57 mg clavulanic acid (as
potassium clavulanate).
Excipients:
Co-amoxiclav contains 2.5 mg of aspartame (E951) per ml.

3

PHARMACEUTICAL FORM
Powder for oral suspension.
White to off-white powder which on reconstitution with water gives white to offwhite suspension with fruity aromatic odor

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
White to off-white powder which on reconstitution with water gives white to
off-white suspension with fruity aromatic odor
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 1750 mg amoxicillin/ 250 mg clavulanic acid with twice
daily dosing and 2625 mg amoxicillin/375 mg clavulanic acid with three times
daily dosing, when administered as recommended below. For children < 40
kg, this formulation of Augmentin provides a maximum daily dose of 10002800 mg amoxicillin/143-400 mg clavulanic acid, when administered as
recommended below. If it is considered that a higher daily dose of amoxicillin
is required, it is recommended that another preparation of Co-amoxiclav is
selected in order to avoid administration of unnecessarily high daily doses of
clavulanic acid (see sections 4.4 and 5.1).
The duration of therapy should be determined by the response of the patient.
Some infections (e.g. osteomyelitis) require longer periods of treatment.
Treatment should not be extended beyond 14 days without review (see section
4.4 regarding prolonged therapy).
Adults and children ≥ 40 kg

Recommended doses:


standard dose: (for all indications) 875 mg/125 mg two times a day;



higher dose - (particularly for infections such as otitis media, sinusitis, lower
respiratory tract infections and urinary tract infections): 875 mg/125 mg three
times a day.
Children < 40 kg
Children may be treated with Co-amoxiclav tablets, suspensions or paediatric
sachets.
Recommended doses:



25 mg/3.6 mg/kg/day to 45 mg/6.4 mg/kg/day given as two divided doses;



up to 70 mg/10 mg/kg/day given as two divided doses may be considered for
some infections (such as otitis media, sinusitis and lower respiratory tract
infections).
No clinical data are available for Co-amoxiclav 7:1 formulations regarding
doses higher than 45 mg/6.4 mg per kg per day in children under 2 years
There are no clinical data for Co-amoxiclav 7:1 formulations for patients
under 2 months of age. Dosing recommendations in this population therefore
cannot be made.
Elderly
No dose adjustment is considered necessary.
Renal impairment
No dose adjustment is required in patients with creatinine clearance (CrCl)
greater than 30 ml/min.
In patients with creatinine clearance less than 30 ml/min, the use of Coamoxiclav presentations with an amoxicillin to clavulanic acid ratio of 7:1 is
not recommended, as no recommendations for dose adjustments are available.
Hepatic impairment
Dose with caution and monitor hepatic function at regular intervals (see
sections 4.3 and 4.4).
Method of administration

Co-amoxiclav is for oral use.
Administer at the start of a meal to minimise potential gastrointestinal
intolerance and optimise absorption of amoxicillin/clavulanic acid.
Therapy can be started parenterally according to the SmPC of the IVformulation and continued with an oral preparation.
Shake to loosen powder, add water as directed, invert and shake.
Shake the bottle before each dose (see section 6.6 and 12).
4.3

Contraindications
Hypersensitivity to the active substances, to any of the penicillins or to any of the
excipients listed in section 6.1.
History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another
beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam).
History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid (see
section 4.8).

4.4

Special warnings and precautions for use
Before initiating therapy with amoxicillin/clavulanic acid, careful enquiry should be
made concerning previous hypersensitivity reactions to penicillins, cephalosporins or
other beta-lactam agents (see sections 4.3 and 4.8).
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been
reported in patients on penicillin therapy. These reactions are more likely to occur in
individuals with a history of penicillin hypersensitivity and in atopic individuals. If an
allergic reaction occurs, amoxicillin/clavulanic acid therapy must be discontinued and
appropriate alternative therapy instituted.
In the case that an infection is proven to be due to an amoxicillin-susceptible
organisms(s), consideration should be given to switching from amoxicillin/clavulanic
acid to amoxicillin in accordance with official guidance.
This presentation of Co-amoxiclav is not suitable for use when there is a high risk
that the presumptive pathogens have resistance to beta-lactam agents that is not
mediated by beta-lactamases susceptible to inhibition by clavulanic acid. This
presentation should not be used to treat penicillin-resistant S. pneumoniae.

Convulsions may occur in patients with impaired renal function or in those receiving
high doses (see 4.8).
Amoxicillin/clavulanic acid 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.
Concomitant use of allopurinol during treatment with amoxicillin can increase the
likelihood of allergic skin reactions.
Prolonged use may occasionally result in overgrowth of non-susceptible organisms.
The occurrence at the treatment initiation of a feverish generalised erythema
associated with pustulae may be a symptom of acute generalised exanthemous
pustulosis (AGEP) (see Section 4.8). This reaction requires Co-amoxiclav
discontinuation and contra-indicates any subsequent administration of amoxicillin.
Amoxicillin/clavulanic acid should be used with caution in patients with evidence of
hepatic impairment (see sections 4.2, 4.3 and 4.8).
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. In all populations, 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 (see section
4.8).
Antibiotic-associated colitis has been reported with nearly all antibacterial agents
including amoxicillin and may range in severity from mild to life threatening (see
section 4.8). Therefore, it is important to consider this diagnosis in patients who
present with diarrhoea during or subsequent to the administration of any antibiotics.
Should antibiotic-associated colitis occur, Co-amoxiclav should immediately be
discontinued, a physician be consulted and an appropriate therapy initiated. Antiperistaltic drugs are contra-indicated in this situation.
Periodic assessment of organ system functions, including renal, hepatic and
haematopoietic function is advisable during prolonged therapy.
Prolongation of prothrombin time has been reported rarely in patients receiving
amoxicillin/clavulanic acid. Appropriate monitoring should be undertaken when
anticoagulants are prescribed concomitantly. Adjustments in the dose of oral
anticoagulants may be necessary to maintain the desired level of anticoagulation (see
section 4.5 and 4.8).

In patients with renal impairment, the dose should be adjusted according to the degree
of impairment (see section 4.2).
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. In patients with bladder
catheters, a regular check of patency should be maintained (see section 4.9).
During treatment with amoxicillin, enzymatic glucose oxidase methods should be
used whenever testing for the presence of glucose in urine because false positive
results may occur with non-enzymatic methods.
The presence of clavulanic acid in Co-amoxiclav may cause a non-specific binding of
IgG and albumin by red cell membranes leading to a false positive Coombs test.
There have been reports of positive test results using the Bio-Rad Laboratories
Platelia Aspergillus EIA test in patients receiving amoxicillin/clavulanic acid who
were subsequently found to be free of Aspergillus infection. Cross-reactions with
non- Aspergillus polysaccharides and polyfuranoses with Bio-Rad Laboratories
Platelia Aspergillus EIA test have been reported. Therefore, positive test results in
patients receiving amoxicillin/clavulanic acid should be interpreted cautiously and
confirmed by other diagnostic methods.
Co-amoxiclav contains 2.5 mg of aspartame (E951) per ml, a source of
phenylalanine.
This medicine should be used with caution in patients with phenylketonuria.

4.5

Interaction with other medicinal products and other forms of interaction
Oral anticoagulants
Oral anticoagulants and penicillin antibiotics have been widely used in practice
without reports of interaction. However, in the literature there are 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 amoxicillin. Moreover, adjustments in the dose of oral
anticoagulants may be necessary (see sections 4.4 and 4.8).
Methotrexate

Penicillins may reduce the excretion of methotrexate causing a potential increase in
toxicity.
Probenecid
Concomitant use of probenecid is not recommended. Probenecid decreases the renal
tubular secretion of amoxicillin. Concomitant use of probenecid may result in
increased and prolonged blood levels of amoxicillin but not of clavulanic acid.

4.6

Pregnancy and lactation
Pregnancy
Animal studies do not indicate direct or indirect harmful effects with respect to
pregnancy, embryonal/foetal development, parturition or postnatal development (see
section 5.3). Limited data on the use of amoxicillin/clavulanic acid during pregnancy
in humans do not indicate an increased risk of congenital malformations. In a single
study in women with preterm, premature rupture of the foetal membrane it was
reported that prophylactic treatment with amoxicillin/clavulanic acid may be
associated with an increased risk of necrotising enterocolitis in neonates. Use should
be avoided during pregnancy, unless considered essential by the physician.
Breastfeeding
Both substances are excreted into breast milk (nothing is known of the effects of
clavulanic acid on the breast-fed infant). Consequently, diarrhoea and fungus
infection of the mucous membranes are possible in the breast-fed infant, so that
breast-feeding might have to be discontinued. Amoxicillin/clavulanic acid should
only be used during breast-feeding after benefit/risk assessment by the physician in
charge.

4.7

Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been
performed. However, undesirable effects may occur (e.g. allergic reactions, dizziness,
convulsions), which may influence the ability to drive and use machines (see section
4.8).

4.8

Undesirable effects
The most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea
and vomiting.

The ADRs sorted by MedDRA System Organ Class are listed below.
The following terminologies have been used in order to classify the occurrence of
undesirable effects.
Very common ( 1/10)



Common ( 1/100 to <1/10)



Uncommon ( 1/1,000 to <1/100)



Rare ( 1/10,000 to <1/1,000)



Very rare (<1/10,000)
Not known (cannot be estimated from the available data)

Infections and infestations

Mucocutaneous candidosis

Common

Overgrowth of non-susceptible organisms

Not known

Blood and lymphatic system disorders

Reversible leucopenia (including neutropenia)

Rare

Thrombocytopenia

Rare

Reversible agranulocytosis

Not known

Haemolytic anaemia

Not known

Prolongation of bleeding time and prothrombin
time1

Not known

Immune system disorders10

Angioneurotic oedema

Not known

Anaphylaxis

Not known

Serum sickness-like syndrome

Not known

Hypersensitivity vasculitis

Not known

Nervous system disorders

Dizziness

Uncommon

Headache

Uncommon

Reversible hyperactivity
Convulsions

Not known

2

Not known

Gastrointestinal disorders

Diarrhoea

Common

Nausea3

Common

Vomiting

Common

Indigestion

Uncommon

Antibiotic-associated colitis

4

Not known

Black hairy tongue

Not known

Tooth discolouration11

Not known

Hepatobiliary disorders
Rises in AST and/or ALT5
Hepatitis

6

Uncommon
Not known

6

Cholestatic jaundice

Not known

Skin and subcutaneous tissue disorders 7

Skin rash

Uncommon

Pruritus

Uncommon

Urticaria

Uncommon

Erythema multiforme

Rare

Stevens-Johnson syndrome

Not known

Toxic epidermal necrolysis

Not known

Bullous exfoliative-dermatitis

Not known

Acute generalised exanthemous pustulosis
(AGEP)9

Not known

Renal and urinary disorders

Interstitial nephritis

Not known

Crystalluria8

Not known

1

See section 4.4

2

See section 4.4

3

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

4

Including pseudomembranous colitis and haemorrhagic colitis (see section
4.4)

5

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.

6

These events have been noted with other penicillins and cephalosporins (see
section 4.4).

7

If any hypersensitivity dermatitis reaction occurs, treatment should be
discontinued (see section 4.4).

8

See section 4.9

9

See section 4.3

10

11

See section 4.4

Superficial tooth discolouration has been reported very rarely in children.
Good oral hygiene may help to prevent tooth discolouration as it can usually
be removed by brushing.

4.9

Overdose
Symptoms and signs of overdose
Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may
be evident. Amoxicillin crystalluria, in some cases leading to renal failure, has been
observed (see section 4.4).
Convulsions may occur in patients with impaired renal function or in those receiving
high doses.
Amoxicillin has been reported to precipitate in bladder catheters, predominantly after
intravenous administration of large doses. A regular check of patency should be
maintained (see section 4.4)
Treatment of intoxication
Gastrointestinal symptoms may be treated symptomatically, with attention to the
water/electrolyte balance.
Amoxicillin/clavulanic acid can be removed from the circulation by haemodialysis.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Combinations of penicillins, incl. beta-lactamase
inhibitors; ATC code: J01CR02.
Mechanism
Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or
more enzymes (often referred to as penicillin-binding proteins, PBPs) in the
biosynthetic pathway of bacterial peptidoglycan, which is an integral structural
component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to
weakening of the cell wall, which is usually followed by cell lysis and death.
Amoxicillin is susceptible to degradation by beta-lactamases produced by resistant
bacteria and therefore the spectrum of activity of amoxicillin alone does not include
organisms which produce these enzymes.

Clavulanic acid is a beta-lactam structurally related to penicillins. It inactivates some
beta-lactamase enzymes thereby preventing inactivation of amoxicillin. Clavulanic
acid alone does not exert a clinically useful antibacterial effect.
PK/PD relationship
The time above the minimum inhibitory concentration (T>MIC) is considered to be
the major determinant of efficacy for amoxicillin.

Mechanisms of resistance
The two main mechanisms of resistance to amoxicillin/clavulanic acid are:
• Inactivation by those bacterial beta-lactamases that are not themselves inhibited by
clavulanic acid, including class B, C and D.
• Alteration of PBPs, which reduce the affinity of the antibacterial agent for the target.
Impermeability of bacteria or efflux pump mechanisms may cause or contribute to
bacterial resistance, particularly in Gram-negative bacteria.
Breakpoints
MIC breakpoints for amoxicillin/clavulanic acid are those of the European Committee
on Antimicrobial Susceptibility Testing (EUCAST)

Susceptibility Breakpoints ( g/ml)

Organism

μ

Susceptible

-

>1

1

-

>1

2

-

>2



Enterococcus1
5

Streptococcus A, B, C, G

0.25



Coagulase-negative
staphylococci 2

1



Staphylococcus aureus 2

Resistant



Moraxella catarrhalis

1

Intermediate



Haemophilus influenzae

1

4

8

>8

-

> 0.25

1-2

>2

-

>8



0.25

Streptococcus
pneumoniae3



0.5

Enterobacteriaceae1,4

-

> 0.25

8

>8

4

8

>8



Non-species related
breakpoints1

4



Gram-positive
Anaerobes1



Gram-negative
Anaerobes1

2

4-8

>8

1

The reported values are for Amoxicillin concentrations. For susceptibility testing
purposes, the concentration of Clavulanic acid is fixed at 2 mg/l.

2

The reported values are Oxacillin concentrations.

3

Breakpoint values in the table are based on Ampicillin breakpoints.

4

The resistant breakpoint of R>8 mg/l ensures that all isolates with resistance
mechanisms are reported resistant.
5

Breakpoint values in the table are based on Benzylpenicillin breakpoints.

The prevalence of resistance may vary geographically and with time for selected
species, and local information on resistance is desirable, particularly when treating
severe infections. As necessary, expert advice should be sought when the local
prevalence of resistance is such that the utility of the agent in at least some types of
infections is questionable.

Commonly susceptible species

Aerobic Gram-positive micro-organisms
Enterococcus faecalis
Gardnerella vaginalis
Staphylococcus aureus ( methicillin-susceptible)
Streptococcus agalactiae

Streptococcus pneumoniae1
Streptococcus pyogenes and other beta-haemolytic streptococci
Streptococcus viridans group
Aerobic Gram-negative micro-organisms
Capnocytophaga spp.
Eikenella corrodens
Haemophilus influenzae2
Moraxella catarrhalis
Pasteurella multocida
Anaerobic micro-organisms
Bacteroides fragilis
Fusobacterium nucleatum
Prevotella spp.

Species for which acquired resistance may be a problem

Aerobic Gram-positive micro-organisms
Enterococcus faecium $
Aerobic Gram-negative micro-organisms
Escherichia coli

Klebsiella oxytoca
Klebsiella pneumoniae
Proteus mirabilis
Proteus vulgaris

Inherently resistant organisms

Aerobic Gram-negative micro-organisms
Acinetobacter sp.
Citrobacter freundii
Enterobacter sp.
Legionella pneumophila
Morganella morganii
Providencia spp.
Pseudomonas sp.
Serratia sp.
Stenotrophomonas maltophilia
Other micro-organisms
Chlamydophila pneumoniae

Chlamydophila psittaci
Coxiella burnetti
Mycoplasma pneumoniae

$

Natural intermediate susceptibility in the absence of acquired mechanism of
resistance.

£

All methicillin-resistant staphylococci are resistant to amoxicillin/clavulanic
acid

1

Streptococcus pneumoniae that are resistant to penicillin should not be treated
with this presentation of amoxicillin/clavulanic acid (see sections 4.2 and 4.4).

2

Strains with decreased susceptibility have been reported in some countries in the
EU with a frequency higher than 10%.

Pharmacokinetic properties
Absorption
Amoxicillin and clavulanic acid, are fully dissociated in aqueous solution at
physiological pH. Both components are rapidly and well absorbed by the oral route of
administration. Absorption of amoxicillin/clavulanic acid is optimised when taken at
the start of a meal. Following oral administration, amoxicillin and clavulanic acid are
approximately 70% bioavailable. The plasma profiles of both components are similar
and the time to peak plasma concentration (Tmax) in each case is approximately one
hour.
The pharmacokinetic results for a study, in which amoxicillin/clavulanic acid (875
mg/125 mg tablets given twice daily) was administered in the fasting state to groups
of healthy volunteers are presented below.

Mean (± SD) pharmacokinetic parameters
Dose

Tmax *

AUC (0-24h)

T 1/2

(mg)

( g/ml)

(h)

( g.h/ml)

(h)

μ

Active substance(s)
administered

Cmax

μ

5.2

Amoxicillin
AMX/CA

875

1.50

53.52

1.19

± 2.78

875 mg/125 mg

11.64

(1.02.5)

± 12.31

±
0.21

2.18

1.25

10.16

0.96

± 0.99

(1.02.0)

± 3.04

±
0.12

Clavulanic acid
AMX/CA
875 mg/125 mg

125

AMX – amoxicillin, CA – clavulanic acid
*

Median (range)

Amoxicillin and clavulanic acid serum concentrations achieved with
amoxicillin/clavulanic acid are similar to those produced by the oral administration of
equivalent doses of amoxicillin or clavulanic acid alone.
Distribution
About 25% of total plasma clavulanic acid and 18% of total plasma amoxicillin is
bound to protein. The apparent volume of distribution is around 0.3-0.4 l/kg for
amoxicillin and around 0.2 l/kg for clavulanic acid.
Following intravenous administration, both amoxicillin and clavulanic acid have been
found in gall bladder, abdominal tissue, skin, fat, muscle tissues, synovial and
peritoneal fluids, bile and pus. Amoxicillin does not adequately distribute into the
cerebrospinal fluid.
From animal studies there is no evidence for significant tissue retention of drugderived material for either component. Amoxicillin, like most penicillins, can be
detected in breast milk. Trace quantities of clavulanic acid can also be detected in
breast milk (see section 4.6).
Both amoxicillin and clavulanic acid have been shown to cross the placental barrier
(see section 4.6).
Biotransformation
Amoxicillin is partly excreted in the urine as the inactive penicilloic acid in quantities
equivalent to up to 10 to 25% of the initial dose. Clavulanic acid is extensively
metabolized in man and eliminated in urine and faeces and as carbon dioxide in
expired air.

Elimination
The major route of elimination for amoxicillin is via the kidney, whereas for
clavulanic acid it is by both renal and nonrenal mechanisms.
Amoxicillin/clavulanic acid has a mean elimination half-life of approximately one
hour and a mean total clearance of approximately 25 l/h in healthy subjects.
Approximately 60 to 70% of the amoxicillin and approximately 40 to 65% of the
clavulanic acid are excreted unchanged in urine during the first 6 h after
administration of single Co-amoxiclav 250 mg/125 mg or 500 mg/125 mg tablets.
Various studies have found the urinary excretion to be 50-85% for amoxicillin and
between 27-60% for clavulanic acid over a 24 hour period. In the case of clavulanic
acid, the largest amount of drug is excreted during the first 2 hours after
administration.
Concomitant use of probenecid delays amoxicillin excretion but does not delay renal
excretion of clavulanic acid (see section 4.5).
Age
The elimination half-life of amoxicillin is similar for children aged around 3 months
to 2 years and older children and adults. For very young children (including preterm
newborns) in the first week of life the interval of administration should not exceed
twice daily administration due to immaturity of the renal pathway of elimination.
Because elderly patients are more likely to have decreased renal function, care should
be taken in dose selection, and it may be useful to monitor renal function.
Gender
Following oral administration of amoxicillin/clavulanic acid to healthy males and
female subjects, gender has no significant impact on the pharmacokinetics of either
amoxicillin or clavulanic acid.
Renal impairment
The total serum clearance of amoxicillin/clavulanic acid decreases proportionately
with decreasing renal function. The reduction in drug clearance is more pronounced
for amoxicillin than for clavulanic acid, as a higher proportion of amoxicillin is
excreted via the renal route. Doses in renal impairment must therefore prevent undue
accumulation of amoxicillin while maintaining adequate levels of clavulanic acid (see
section 4.2).
Hepatic impairment

Hepatically impaired patients should be dosed with caution and hepatic function
monitored at regular intervals.

5.3

Preclinical safety data
Nonclinical data reveal no special hazard for humans based on studies of safety
pharmacology, genotoxicity and toxicity to reproduction.
Repeat dose toxicity studies performed in dogs with amoxicillin/clavulanic acid
demonstrate gastric irritancy and vomiting, and discoloured tongue.
Carcinogenicity studies have not been conducted with Co-amoxiclav or its
components.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Silicon Dioxide (E551)
Aspartame (E951)
Succinic acid (E363)
Xanthan Gum (E415)
Hypromellose (E464)
Colloidal anhydrous silica (E551)
Raspberry Flavour [Acacia gum (E414), Nature identical flavouring substance,
Propylene glycol (E1520), Artificial flavouring substance and Flavouring
preparation]
Orange Flavour [Acacia gum (E414), Flavouring preparation and Butylated
hydroxyanisole (E320)]
Golden Caramel [Maltodextrin, Triethyl Citrate (E1505), Artificial Flavours and
Acetic acid (E260)]

6.2

Incompatibilities
Not Applicable

6.3

Shelf life

Dry powder: 3 Years

Reconstituted suspension: 7 days, when stored between 2°C to 8°C

6.4

Special precautions for storage
Dry powder: This medicinal product does not require any special temperature storage
conditions. Store in the original package in order to protect from moisture.
After reconstitution: Store in a refrigerator between 2°C to 8°C in the container
supplied and use within 7 days.

6.5

Nature and contents of container
Presentation 1: 5ml polystyrene syringe dosing device supplied in carton
Presentation 2: No syringe dosing device supplied in carton
HDPE bottle with 28mm polypropylene round CRC cap containing 6g, 12g, 14g and
20g of powder for reconstitution to 30ml, 60ml, 70ml and 100ml respectively.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
White to off-white powder which on reconstitution with water gives white to offwhite suspension with fruity aromatic odor
Check cap seal is intact before using. Shake bottle to loosen powder. Add volume of
water (as indicated below) invert and shake well.

Volume of water to be added at
reconstitution (ml)

Final volume of reconstituted oral
suspension (ml)

25 ml

30 ml

56 ml

60 ml

61 ml

70 ml

87 ml

100 ml

Any unused medicinal product or waste should be disposed of in accordance with
local requirements.

7

MARKETING AUTHORISATION HOLDER
Brown & Burk UK Limited
5 Marryat Close
Hounslow West
Middlesex
TW4 5DQ
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 25298/0006

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
16/08/2012

10

DATE OF REVISION OF THE TEXT
11/04/2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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