Augmentin 625mg tablets

Country: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ixtrih issa

Ingredjent attiv:

Amoxicillin trihydrate; Potassium clavulanate

Disponibbli minn:

Waymade Healthcare Plc

Kodiċi ATC:

J01CR02

INN (Isem Internazzjonali):

Amoxicillin trihydrate; Potassium clavulanate

Dożaġġ:

500mg ; 125mg

Għamla farmaċewtika:

Oral tablet

Rotta amministrattiva:

Oral

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 05010103

Fuljett ta 'informazzjoni

                                
Keep out of the sight and reach of children.

Do not store above 25°C.

Store in the original package.

Do not take the tablets out of the blister strip
until it is time to take your dose.

Do not take the tablets after the expiry date
which is stated on the carton and blister labels
after ‘Exp’. The expiry date refers to the last day
of that month.

If the tablet becomes discoloured or shows any
signs of deterioration, seek the advice of your
pharmacist.

Remember if your doctor tells you to stop taking
this medicine, return any unused medicine to
your pharmacist for safe disposal. Only keep
this medicine if your doctor tells you to.
WHAT AUGMENTIN CONTAINS
Each tablet contains 500mg amoxicillin (as the
trihydrate) and 125mg of clavulanic acid (as the
potassium salt) as the active ingredient.
The other ingredients are crospovidone, hydrated
colloidal silica, low-substituted hypromellose,
magnesium stearate (E572), colloidal anhydrous
silica, titanium dioxide (E171), hypromellose,
macrogol 4000, macrogol 6000 and dimeticone 500.
WHAT AUGMENTIN LOOKS LIKE AND CONTENTS OF
THE PACK
Augmentin is white, oval, film-coated tablet, marked
'A/C' on one side and plain on the other side. Each
blister pack contains 12 tablets.
MANUFACTURED BY:
Glaxo Wellcome Production,
Z.I. de la Peyenniere, 53101 Mayenne Cedex
France.
PROCURED FROM WITHIN THE EU AND
REPACKAGED BY THE PRODUCT LICENCE HOLDER:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
AUGMENTIN
® 625MG TABLETS; PL 18799/0082
Leaflet date: 14.08.2018
Augmentin is a registered trademark of the Glaxo
Group Ltd.
ADVICE/MEDICAL EDUCATION
Antibiotics are used to treat infections caused by
bacteria. They have no effect against infections
caused by viruses.
Sometimes an infection caused by bacteria does not
respond to a course of an antibiotic. One of the
commonest reasons for this to occur is because the
bacteria causing the infection are resistant to the
antibiotic that is being taken.
This means that they can survive and e
                                
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Karatteristiċi tal-prodott

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Augmentin 625 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains amoxicillin trihydrate equivalent to
500 mg
amoxicillin and potassium clavulanate equivalent to 125 mg of
clavulanic
acid.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
F
ilm-coated tablet
White to off-white, oval film-coated tablets debossed with ‘AC’
and a score line one
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
Augmentin 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
Posology
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 Augmentin 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 Augmentin (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 Augm
                                
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