Augmentin 375mg tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Potassium clavulanate; Amoxicillin trihydrate

Disponible depuis:

Dowelhurst Ltd

Code ATC:

J01CR02

DCI (Dénomination commune internationale):

Potassium clavulanate; Amoxicillin trihydrate

Dosage:

125mg ; 250mg

forme pharmaceutique:

Oral tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 05010103

Notice patient

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you
(or for your child) only. Do not pass it on to
others. It may harm them, even if their signs
of illness are the same as yours.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1 What Augmentin is and what it is used for
2 What you need to know before you take
Augmentin
3 How to take Augmentin
4 Possible side effects
5 How to store Augmentin
6 Contents of the pack and other information
1
WHAT AUGMENTIN IS AND WHAT IT
IS USED FOR
Augmentin is an antibiotic and works by killing
bacteria that cause infections. It contains two
different medicines called amoxicillin and
clavulanic acid. Amoxicillin belongs to a group
of medicines called “penicillins” that can
sometimes be stopped from working (made
inactive). The other active component
(clavulanic acid) stops this from happening.
Augmentin is used in adults and children to
treat the following infections:
• sinus infections
• urinary tract infections
• skin infections
• dental infections.
2
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE AUGMENTIN
DO NOT TAKE AUGMENTIN:
• if you are allergic to amoxicillin, clavulanic
acid, penicillin or any of the other ingredients
of this medicine (listed in section 6)
• if you have ever had a severe allergic
reaction to any other antibiotic. This can
include a skin rash or swelling of the face or
throat.
• if you have ever had liver problems or
jaundice (yellowing of the skin) when taking
an antibiotic.
➔ DO NOT TAKE AUGMENTIN IF ANY OF THE ABOVE
APPLY TO YOU. If you are not sure, talk to your
doctor or pharmacist before taking
Augmentin.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
A

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Augmentin 375 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains amoxicillin trihydrate equivalent to
250 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
Film-coated tablet.
White to off-white, oval shaped tablets debossed with “Augmentin”
on one
side.
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)
Cystitis
Pyelonephritis
Cellulitis
Animal bites
Severe dental abscess with spreading cellulitis.
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 Augmentin provides a
total daily dose of 750 mg amoxicillin/375 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
Augmentin is selected in order to avoid administration of
unnecessarily high
daily doses of clavulanic acid (see sections 4.4 and 5.1).
Tre