Augmentin 875 mg/125 mg film-coated tablets

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Amoxicillin trihydrate; Clavulanic acid

Disponible des:

Lexon Pharmaceuticals (Ireland) Limited

Codi ATC:

J01CR; J01CR02

Designació comuna internacional (DCI):

Amoxicillin trihydrate; Clavulanic acid

Dosis:

875/125 milligram(s)

formulario farmacéutico:

Film-coated tablet

Área terapéutica:

Combinations of penicillins, incl. beta-lactamase inhibitors; amoxicillin and enzyme inhibitor

Data d'autorització:

2018-03-16

Informació per a l'usuari

AUGMENTIN 875 MG/125 MG FILM-COATED TABLETS
amoxicillin/clavulanic acid
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
What Augmentin is and what it is used for
What you need to know before you take Augmentin
How to take Augmentin
Possible side effects
How to store Augmentin
Contents of the pack and other information
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:
*
middle ear and sinus infections
*
respiratory tract infections
*
urinary tract infections
*
skin and soft tissue infections including dental infections
*
bone and joint infections.
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, t

Fitxa tècnica

Health Products Regulatory Authority
04 February 2022
CRN00CS1K
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Augmentin 875 mg/125 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains amoxicillin trihydrate equivalent to
875 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.
_Product imported from the Czech Republic_
White to off-white, capsule shaped tablets debossed with “AC” on
both sides and a score line on one side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
As per PA1077/019/005
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/019/005
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Tablet core_
Magnesium stearate
Sodium carboxymethyl starch (Type A)
Colloidal anhydrous silica
Microcrystalline cellulose
_Tablet film-coat_
Titanium dioxide (E171)
Hypromellose (2506/5, 2506/15)
Macrogol (4000, 6000)
Dimeticone
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the pouch, blister and outer package of the product on
the market in the country of origin.
Tablets in desiccated pouch packs should be used within 30 days of
opening.
Health Products Regulatory Authority
04 February 2022
CRN00CS1K
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25ºC
Store in the original package in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister enclosed within a pouch containing a dessicant sachet,
referred to as a desiccated pouch pack (DPP) containing 14
tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Lexon Pharmaceuticals (Ireland) Limited
Block 3
Harcourt Centre
Har