CO-AMOXICLAV 875 MG/125 MG FILM-COATED TABLETS

Active substance: POTASSIUM CLAVULANATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Co-amoxiclav 875mg/125mg film-coated tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Co-amoxiclav 875mg/125mg film-coated tablets
Each film-coated tablet contains amoxicillin trihydrate equivalent to 875mg
amoxicillin with potassium clavulanate equivalent to 125mg clavulanic acid.
For a full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Film coated tablet.
Co-amoxiclav 875mg/125mg tablets are white, capsule shaped, film-coated
tablets inscribed with ‘A’ on one side and with a score line in between ‘6’ and
‘5’ on the other side.
The score line is only to facilitate breaking for ease of swallowing and not to
divide into equal doses.

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 amoxicillin/clavulanic acid (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 Coamoxiclav provides a maximum daily dose of 1000-2800 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 amoxicillin/clavulanic acid 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
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 amoxicillin/clavulanic acid 7:1 formulations
regarding doses higher than 45 mg/ 6.4mg/kg per day in children under 2 years.
There are no clinical data for amoxicillin/ clavulanic acid 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
amoxicillin/clavulanic acid presentations with 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.

4.3

Contraindications



Hypersensitivity to the active substances, to any of the penicillins or to any
of the excipients.
History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis)
to another beta-lactam agent (e.g. cephalosporin, carbapenem or
monobactam).



4.4

History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid
(see section 4.8).

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
organism(s) then 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 reduced susceptibility or 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 sections 4.8).
Co-amoxiclav 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 pustula 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.

Co-amoxiclav 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. Anti-peristaltic medicinal products 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. Crossreactions with non-Aspergillus polysaccharides and polyfuranoses with BioRad 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.

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.
Lactation

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 derived from clinical studies and post-marketing surveillance with
amoxicillin/clavulanic acid, 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
Not known
organisms
Blood and lymphatic system disorders
Reversible leucopenia (including
Rare
neutropenia)
Thrombocytopenia
Rare
Reversible agranulocytosis
Not known
Haemolytic anaemia
Not known
Prolongation of bleeding time and
Not known
prothrombin time1
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
Not known
2
Convulsions
Not known
Gastrointestinal disorders
Diarrhoea
Very common
Nausea3
Common
Vomiting
Common
Indigestion
Uncommon
Antibiotic-associated colitis4
Not known
Black hairy tongue
Not known
Hepatobiliary disorders
Rises in AST and/or ALT5
Uncommon
Hepatitis6
Not known
6
Cholestatic jaundice
Not known
Skin and subcutaneous tissue disorders7
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 generalized exanthemous
Not known
9
pustulosis (AGEP)
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 amoxicillin/clavulanic
acid 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 4.4
10
See sections 4.3 and 4.4

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 J01CR 02.

Mode of action
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)
Organism

Susceptibility Breakpoints (µg/ml)
Susceptible Intermediate Resistant

Haemophilus
≤1
>1
1
influenzae
Moraxella
≤1
>1
1
catarrhalis
Staphylococcus
≤2
>2
2
aureus
Coagulase-negative
≤ 0.25
> 0.25
2
staphylococci
Enterococcus1
≤4
8
>8
Streptococcus A, B,
≤ 0.25
> 0.25
C, G5
Streptococcus
≤ 0.5
1-2
>2
pneumoniae3
Enterobacteriaceae1,4 >8
Gram-negative
≤4
8
>8
Anaerobes1
Gram-positive
≤4
8
>8
Anaerobes1
Non-species related
≤2
4-8
>8
breakpoints1
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)£
Coagulase-negative staphylococci (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%.

5.2

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
Active
Dose Cmax
Tmax*
substance(s)
(mg) (µg/ml)
(h)
administered
Amoxicillin
AMX/CA
875
11.64 ±
1.50 (1.0875/125mg
2.78
2.5)
Clavulanic acid

AUC (0-24h)
(µg.h/ml)

T 1/2
(h)

53.52 ±
12.31

1.19 ±
0.21

AMX/CA
125
2.18 ±
1.25 (1.0875/125mg
0.99
2.0)
AMX-amoxicillin, CA-clavulanic acid
* Median (range)

10.16 ±
3.04

0.96 ± 0.12

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
drug derived 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 non-renal 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 6h
after administration of single amoxicillin/Clavulanic acid 250mg/125mg or
500mg/125mg 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 amoxicillin/clavulanic
acid or its components.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Core:

Microcrystalline cellulose (E460)

Colloidal anhydrous silica
Magnesium stearate (E470b)
Sodium starch glycolate (Type A)

Film coating

Hypromellose (E464)
Macrogol 400
Titanium dioxide (E171)

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
2 years

6.4

Special precautions for storage
Store in the original package in order to protect from light and moisture.

6.5

Nature and contents of container

The tablets are packed in Alu/Alu (polyamide/aluminium/PVC - aluminium foil)
blister packs in a cardboard box.
Co-amoxiclav tablets are available in blister packs with 4, 5, 6, 7, 8, 10, 12, 14, 15,
16, 20, 21, 25, 30, 35, 40, 50, 100 and 500 film-coated tablets.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
Any unused product or waste material should be disposed of in accordance
with local requirements.

7

MARKETING AUTHORISATION HOLDER
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay,
Dublin 2,
Ireland.

8

MARKETING AUTHORISATION NUMBER(S)
PL 42357/0007

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
30/11/2012

10

DATE OF REVISION OF THE TEXT
04/09/2013

10

DATE OF REVISION OF THE TEXT
04/09/2013

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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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