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AMOXIL PAEDIATRIC SUSPENSION

Active substance(s): AMOXYCILLIN TRIHYDRATE / AMOXYCILLIN TRIHYDRATE / AMOXYCILLIN TRIHYDRATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Amoxil Paediatric Suspension

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

When reconstituted, every 1.25 ml of oral suspension contains amoxicillin trihydrate
equivalent to 125 mg amoxicillin (100 mg per ml).
Excipients with known effect
Contains 4 mg of aspartame per 1.25 ml (3.2 mg per ml).
Contains 2 mg sodium benzoate per 1.25 ml (1.6 mg per ml).
Contains maltodextrin (glucose).
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM

Powder for oral suspension
White powder with yellowish grains.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Amoxil 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
Acute otitis media
Acute streptococcal tonsillitis and pharyngitis
Acute exacerbations of chronic bronchitis
Community acquired pneumonia
Acute cystitis
Asymptomatic bacteriuria in pregnancy
Acute pyelonephritis
Typhoid and paratyphoid fever
Dental abscess with spreading cellulitis
Prosthetic joint infections
Helicobacter pylori eradication



Lyme disease

Amoxil is also indicated for the prophylaxis of endocarditis.
Consideration should be given to official guidance on the appropriate use of antibacterial
agents.

4.2

Posology and method of administration

Posology
The dose of Amoxil 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 duration of therapy should be determined by the type of infection and the response of the
patient, and should generally be as short as possible. Some infections require longer periods
of treatment (see section 4.4 regarding prolonged therapy).
Adults and children ≥40 kg

Indication*

Dose*

Acute bacterial sinusitis
Asymptomatic bacteriuria in pregnancy

250 mg to 500 mg every 8 hours or 750 mg
to 1 g every 12 hours

Acute pyelonephritis
Dental abscess with spreading cellulitis
Acute cystitis

For severe infections 750 mg to 1 g every 8
hours
Acute cystitis may be treated with 3 g twice
daily for one day

Acute otitis media
Acute streptococcal tonsillitis and pharyngitis
Acute exacerbations of
chronic bronchitis
Community acquired pneumonia
Typhoid and paratyphoid fever
Prosthetic joint infections
Prophylaxis of endocarditis
Helicobacter pylori eradication

500 mg every 8 hours, 750 mg to 1 g every
12 hours
For severe infections 750 mg to 1 g every 8
hours for 10 days
500 mg to 1 g every 8 hours
500 mg to 2 g every 8 hours
500 mg to 1 g every 8 hours
2 g orally, single dose 30 to 60 minutes
before procedure
750 mg to 1 g twice daily in combination
with a proton pump inhibitor (e.g.

Indication*

Lyme disease (see section 4.4)

Dose*
omeprazole, lansoprazole) and another
antibiotic (e.g. clarithromycin,
metronidazole) for 7 days
Early stage: 500 mg to 1 g every 8 hours up
to a maximum of 4 g/day in divided doses for
14 days (10 to 21 days)

Late stage (systemic involvement): 500 mg to
2 g every 8 hours up to a maximum of
6 g/day in divided doses for 10 to 30 days
*
Consideration should be given to the official treatment guidelines for each indication
Children <40 kg
Children may be treated with Amoxil capsules, dispersible tablets suspensions or sachets.
Amoxil Paediatric Suspension is recommended for children under six months of age.
Children weighing 40 kg or more should be prescribed the adult dosage.
Recommended doses:
Indication+
Acute bacterial sinusitis
Acute otitis media
Community acquired pneumonia
Acute cystitis
Acute pyelonephritis
Dental abscess with spreading cellulitis
Acute streptococcal tonsillitis and pharyngitis
Typhoid and paratyphoid fever
Prophylaxis of endocarditis
Lyme disease (see section 4.4)

Dose+
20 to 90 mg/kg/day in divided doses*

40 to 90 mg/kg/day in divided doses*
100 mg/kg/day in three divided doses
50 mg/kg orally, single dose 30 to 60 minutes
before procedure
Early stage: 25 to 50 mg/kg/day in three
divided doses for 10 to 21 days
Late stage (systemic involvement):
100 mg/kg/day in three divided doses for 10
to 30 days

+ Consideration should be given to the official treatment guidelines for each indication.
*Twice daily dosing regimens should only be considered when the dose is in the upper range.
Elderly

No dose adjustment is considered necessary.
Renal impairment
GFR (ml/min)
greater than 30
10 to 30

Adults and children ≥ 40 kg
no adjustment necessary
maximum 500 mg twice daily

less than 10

maximum 500 mg/day.

#

Children < 40 kg#
no adjustment necessary
15 mg/kg given twice daily
(maximum 500 mg twice daily)
15 mg/kg given as a single daily
dose (maximum 500 mg)

In the majority of cases, parenteral therapy is preferred.

In patients receiving haemodialysis
Amoxicillin may be removed from the circulation by haemodialysis.

Adults and children
over 40 kg

Children under 40
kg

Haemodialysis
500 mg every 24 h
Prior to haemodialysis one additional dose of 500 mg should be
administered. In order to restore circulating drug levels, another dose
of 500 mg should be administered after haemodialysis.
15 mg/kg/day given as a single daily dose (maximum 500 mg).
Prior to haemodialysis one additional dose of 15 mg/kg should be
administered. In order to restore circulating drug levels, another dose
of 15 mg/kg should be administered after haemodialysis.

In patients receiving peritoneal dialysis
Amoxicillin maximum 500 mg/day.
Hepatic impairment
Dose with caution and monitor hepatic function at regular intervals (see sections 4.4 and 4.8).
Method of administration
Amoxil is for oral use.
Absorption of Amoxil is unimpaired by food.
Therapy can be started parenterally according to the dosing recommendations of the
intravenous formulation and continued with an oral preparation.
For instructions on reconstitution of the medicinal product before administration, see section
6.6.

4.3

Contraindications

Hypersensitivity to the active substance, 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 betalactam agent (e.g. a cephalosporin, carbapenem or monobactam).

4.4

Special warnings and precautions for use

Hypersensitivity reactions
Before initiating therapy with amoxicillin, 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 therapy must be discontinued and appropriate alternative therapy instituted.
Non-susceptible microorganisms
Amoxicillin is not suitable for the treatment of some types of infection unless the pathogen is
already documented and known to be susceptible or there is a very high likelihood that the
pathogen would be suitable for treatment with amoxicillin (see section 5.1). This particularly
applies when considering the treatment of patients with urinary tract infections and severe
infections of the ear, nose and throat.
Convulsions
Convulsions may occur in patients with impaired renal function or in those receiving high
doses or in patients with predisposing factors (e.g. history of seizures, treated epilepsy or
meningeal disorders (see section 4.8).
Renal impairment
In patients with renal impairment, the dose should be adjusted according to the degree of
impairment (see section 4.2).
Skin reactions
The occurrence at the treatment initiation of a feverish generalised erythema associated with
pustula may be a symptom of acute generalised exanthemous pustulosis (AEGP, see section
4.8). This reaction requires amoxicillin discontinuation and contra-indicates any subsequent
administration.
Amoxicillin 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.
Jarisch-Herxheimer reaction

The Jarisch-Herxheimer reaction has been seen following amoxicillin treatment of Lyme
disease (see section 4.8). It results directly from the bactericidal activity of amoxicillin on the
causative bacteria of Lyme disease, the spirochaete Borrelia burgdorferi. Patients should be
reassured that this is a common and usually self-limiting consequence of antibiotic treatment
of Lyme disease.
Overgrowth of non-susceptible microorganisms
Prolonged use may occasionally result in overgrowth of non-susceptible organisms.
Antibiotic-associated colitis has been reported with nearly all antibacterial agents 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, amoxicillin
should immediately be discontinued, a physician consulted and an appropriate therapy
initiated. Anti-peristaltic medicinal products are contra-indicated in this situation.
Prolonged therapy
Periodic assessment of organ system functions; including renal, hepatic and haematopoietic
function is advisable during prolonged therapy. Elevated liver enzymes and changes in blood
counts have been reported (see section 4.8).
Anticoagulants
Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin.
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).
Crystalluria
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 4.8 and 4.9).
Interference with diagnostic tests
Elevated serum and urinary levels of amoxicillin are likely to affect certain laboratory tests.
Due to the high urinary concentrations of amoxicillin, false positive readings are common
with chemical methods.
It is recommended that when testing for the presence of glucose in urine during amoxicillin
treatment, enzymatic glucose oxidase methods should be used.
The presence of amoxicillin may distort assay results for oestriol in pregnant women.
Important information about excipients
This medicinal product contains aspartame, a source of phenylalanine. This medicine should
be used with caution in patients with phenylketonuria.

This medicinal product contains maltodextrin (glucose). Patients with rare glucose-galactose
malabsorption should not take this medicine.
This medicinal product contains sodium benzoate (E211) which is a mild irritant to the eyes,
skin and mucous membrane. May increase the risk of jaundice in new born babies.

4.5

Interaction with other medicinal products and other forms of interaction

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.
Allopurinol
Concurrent administration of allopurinol during treatment with amoxicillin can increase the
likelihood of allergic skin reactions.
Tetracyclines
Tetracyclines and other bacteriostatic drugs may interfere with the bactericidal effects of
amoxicillin.
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.

4.6

Fertility, pregnancy and lactation

Pregnancy
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive
toxicity. Limited data on the use of amoxicillin during pregnancy in humans do not indicate
an increased risk of congenital malformations. Amoxicillin may be used in pregnancy when
the potential benefits outweigh the potential risks associated with treatment.
Breastfeeding
Amoxicillin is excreted into breast milk in small quantities with the possible risk of
sensitisation. 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 should only be used during breast-feeding after benefit/risk assessment by the
physician in charge.
Fertility
There are no data on the effects of amoxicillin on fertility in humans. Reproductive studies in
animals have shown no effects on fertility.

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 skin
rash.
The ADRs derived from clinical studies and post-marketing surveillance with amoxicillin,
presented 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
Very rare
Blood and lymphatic system disorders
Very rare

Mucocutaneous candidiasis
Reversible leucopenia (including severe
neutropenia or agranulocytosis), reversible
thrombocytopenia and haemolytic anaemia.
Prolongation of bleeding time and
prothrombin time (see section 4.4).

Immune system disorders
Very rare

Not known
Nervous system disorders
Very rare
Gastrointestinal disorders
Clinical Trial Data

Severe allergic reactions, including
angioneurotic oedema, anaphylaxis, serum
sickness and hypersensitivity vasculitis (see
section 4.4).
Jarisch-Herxheimer reaction (see section 4.4).

Hyperkinesia, dizziness and convulsions (see
section 4.4).

*Common
*Uncommon
Post-marketing Data
Very rare

Diarrhoea and nausea
Vomiting
Antibiotic associated colitis (including
pseudomembraneous colitis and haemorrhagic
colitis see section 4.4).
Black hairy tongue
Superficial tooth discolouration#

Hepatobiliary disorders
Very rare

Skin and subcutaneous tissue disorders
Clinical Trial Data
*Common
*Uncommon
Post-marketing Data
Very rare

Renal and urinary tract disorders
Very rare:

Hepatitis and cholestatic jaundice. A moderate
rise in AST and/or ALT.

Skin rash
Urticaria and pruritus
Skin reactions such as erythema multiforme,
Stevens-Johnson syndrome, toxic epidermal
necrolysis, bullous and exfoliative dermatitis
and acute generalised exanthematous
pustulosis (AGEP) (see section 4.4).
Interstitial nephritis

Crystalluria (see sections 4.4 and 4.9
Overdose)
* The incidence of these AEs was derived from clinical studies involving a total of
approximately 6,000 adult and paediatric patients taking amoxicillin.
#
Superficial tooth discolouration has been reported in children. Good oral hygiene
may help to prevent tooth discolouration as it can usually be removed by brushing.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard

4.9

Overdose

Symptoms and signs of overdose
Gastrointestinal symptoms (such as nausea, vomiting and diarrhoea) and disturbance of the
fluid and electrolyte balances may be evident. Amoxicillin crystalluria, in some cases leading
to renal failure, has been observed. Convulsions may occur in patients with impaired renal
function or in those receiving high doses (see sections 4.4 and 4.8).
Treatment of intoxication

Gastrointestinal symptoms may be treated symptomatically, with attention to the
water/electrolyte balance.
Amoxicillin can be removed from the circulation by haemodialysis.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: penicillins with extended spectrum; ATC code: J01CA04.
Mechanism 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.
Pharmacokinetic/pharmacodynamic 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 main mechanisms of resistance to amoxicillin are:



Inactivation by bacterial beta-lactamases.
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 are those of the European Committee on Antimicrobial
Susceptibility Testing (EUCAST) version 5.0.
Organism

Enterobacteriaceae
Staphylococcus spp.
Enterococcus spp.3
Streptococcus groups A, B, C and
G
Streptococcus pneumoniae

Susceptible ≤

MIC breakpoint (mg/L)
Resistant >

81
Note2
4
Note 4

8
Note 2
8
Note 4

Note 5

Note 5

Viridans group steprococci
0.5
2
6
Haemophilus influenzae
2
26
7
Moraxella catarrhalis
Note
Note 7
Neisseria meningitidis
0.125
1
Gram positive anaerobes except
4
8
Clostridium difficile8
Gram negative anaerobes8
0.5
2
9
Helicobacter pylori
0.125
0.1259
Pasteurella multocida
1
1
Non- species related breakpoints10 2
8
1
Wild type Enterobacteriaceae are categorised as susceptible to aminopenicillins. Some
countries prefer to categorise wild type isolates of E. coli and P. mirabilis as intermediate.
When this is the case, use the MIC breakpoint S ≤ 0.5 mg/L
2
Most staphylococci are penicillinase producers, which are resistant to amoxicillin.
Methicillin resistant isolates are, with few exceptions, resistant to all beta-lactam agents.
3
Susceptibility to amoxicillin can be inferred from ampicillin
4
The susceptibility of streptococcus groups A, B, C and G to penicillins is inferred from the
benzylpenicillin susceptibility.
5
Breakpoints relate only to non-meningitis isolates. For isolates categorised as intermediate to
ampicillin avoid oral treatment with amoxicillin. Susceptibility inferred from the MIC of
ampicillin.
6
Breakpoints are based on intravenous administration. Beta-lactamase positive isolates should
be reported resistant.
7
Beta lactamase producers should be reported resistant
8
Susceptibility to amoxicillin can be inferred from benzylpenicillin.
9
The breakpoints are based on epidemiological cut-off values (ECOFFs), which distinguish
wild-type isolates from those with reduced susceptibility.
10
The non-species related breakpoints are based on doses of at least 0.5 g x 3or 4 doses daily
(1.5 to 2 g/day).
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.
In vitro susceptibility of micro-organisms to Amoxicillin
Commonly Susceptible Species
Gram-positive aerobes:
Enterococcus faecalis
Beta-hemolytic streptococci (Groups A, B, C and G)
Listeria monocytogenes
Species for which acquired resistance may be a problem
Gram-negative aerobes:
Escherichia coli
Haemophilus influenzae
Helicobacter pylori
Proteus mirabilis

Salmonella typhi
Salmonella paratyphi
Pasteurella multocida
Gram-positive aerobes:
Coagulase negative staphylococcus
Staphylococcus aureus£
Streptococcus pneumoniae
Viridans group streptococcus
Gram-positive anaerobes:
Clostridium spp.
Gram-negative anaerobes:
Fusobacterium spp.
Other:
Borrelia burgdorferi
Inherently resistant organisms†
Gram-positive aerobes:
Enterococcus faecium†
Gram-negative aerobes:
Acinetobacter spp.
Enterobacter spp.
Klebsiella spp.
Pseudomonas spp.
Gram-negative anaerobes:
Bacteroides spp. (many strains of Bacteroides fragilis are resistant).
Others:
Chlamydia spp.
Mycoplasma spp.
Legionella spp.


Natural intermediate susceptibility in the absence of acquired mechanism of resistance.
Almost all S.aureus are resistant to amoxilcillin due to production of penicillinase. In
addition, all methicillin-resistant strains are resistant to amoxicillin.

£

5.2

Pharmacokinetic properties

Absorption

Amoxicillin fully dissociates in aqueous solution at physiological pH. It is rapidly and well
absorbed by the oral route of administration. Following oral administration, amoxicillin is
approximately 70% bioavailable. The time to peak plasma concentration (Tmax) is
approximately one hour.
The pharmacokinetic results for a study, in which an amoxicillin dose of 250 mg three times
daily was administered in the fasting state to groups of healthy volunteers are presented
below.
Cmax
(μg/ml)
3.3 ± 1.12
*Median (range)

Tmax *
(h)
1.5 (1.0-2.0)

AUC (0-24h)
((μg.h/ml)
26.7 ± 4.56


(h)
1.36 ± 0.56

In the range 250 to 3000 mg the bioavailability is linear in proportion to dose (measured as
Cmax and AUC). The absorption is not influenced by simultaneous food intake.
Haemodialysis can be used for elimination of amoxicillin.
Distribution
About 18% of total plasma amoxicillin is bound to protein and the apparent volume of
distribution is around 0.3 to 0.4 l/kg.
Following intravenous administration, amoxicillin has 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. Amoxicillin, like most penicillins, can be detected in breast milk (see section 4.6).
Amoxicillin has 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.
Elimination
The major route of elimination for amoxicillin is via the kidney.
Amoxicillin has a mean elimination half-life of approximately one hour and a mean total
clearance of approximately 25 l/hour in healthy subjects. Approximately 60 to 70% of the
amoxicillin is excreted unchanged in urine during the first 6 hours after administration of a
single 250 mg or 500 mg dose of amoxicillin. Various studies have found the urinary
excretion to be 50-85% for amoxicillin over a 24 hour period.
Concomitant use of probenecid delays amoxicillin excretion (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/ to healthy males and female subjects, gender
has no significant impact on the pharmacokinetics of amoxicillin.
Renal impairment
The total serum clearance of amoxicillin decreases proportionately with decreasing renal
function (see sections 4.2 and 4.4).
Hepatic impairment
Hepatically impaired patients should be dosed with caution and hepatic function monitored at
regular intervals.

5.3

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on studies of safety
pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and
development.
Carcinogenicity studies have not been conducted with amoxicillin.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Carboxymethylcellulose Sodium 12
Lemon-Peach-Strawberry Dry Flavour
Crospovidone
Aspartame (E951)
Sodium Benzoate (E211)
Xanthan Gum (E415)
Silica Hydrophobic Colloidal
Magnesium Stearate

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

Dry powder: 3 years
Reconstituted suspension: 14 days
Reconstituted suspensions: Do not store above 25°C.

6.4

Special precautions for storage

Do not store above 25°C.
For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5

Nature and contents of container

Amoxil 125 mg/1.25 ml powder for oral suspension is filled into clear glass bottles (Ph. Eur.
Type III) with a nominal volume of 45 ml (for a 20 ml presentation) closed with aluminium
closures containing polymer liners. These primary packs are placed in a carton with a syringe.

6.6

Special precautions for disposal

Check cap seal is intact before use.
Invert and shake bottle to loosen powder.
Fill the bottle with water to just below the mark on the bottle label.
Invert and shake well, then top up with water to the mark. Invert and shake again.
Shake well before taking each dose.
Any unused medicinal product or waste material should be disposed of in accordance with
local requirements.

7

MARKETING AUTHORISATION HOLDER

Beecham Group plc
Great West Road, Brentford, Middlesex TW8 9GS
Trading as GlaxoSmithKline UK Stockley Park West, Uxbridge, Middlesex UB11 1BT
And/or
Bencard or SmithKline Beecham Pharmaceuticals, Mundells, Welwyn Garden City,
Hertfordshire AL7 1EY

8

MARKETING AUTHORISATION NUMBER(S)

PL 00038/0107

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION

Date of first authorisation: 07 March 1972
Date of latest renewal: 16 June 2008

10

DATE OF REVISION OF THE TEXT

22/03/2017

Expand Transcript

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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