AUGMENTIN 875/125 Milligram Film Coated Tablet

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

AMOXICILLIN TRIHYDRATE CLAVULANATE POTASSIUM

Dostupné s:

GlaxoSmithKline Consumer Healthcare (Ireland) Limited

INN (Mezinárodní Name):

AMOXICILLIN TRIHYDRATE CLAVULANATE POTASSIUM

Dávkování:

875/125 Milligram

Léková forma:

Film Coated Tablet

Druh předpisu:

Product subject to prescription which may not be renewed (A)

Stav Autorizace:

Authorised

Datum autorizace:

0000-00-00

Informace pro uživatele

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START 
TAKING THIS MEDICINE.
-  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). Do not pass it on to others. It may harm 
them, even if their symptoms are the same as yours.
-   If any of the side effects gets serious, or if you 
notice any side effects not listed in this leaflet, 
please tell your doctor or pharmacist.
IN THIS LEAFLET: 
1. What Augmentin is and what it is used for
2. Before you take Augmentin
3. How to take Augmentin
4. Possible side effects
5. How to store Augmentin
6. Further 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:
•  middle ear and sinus infections
•  respiratory tract infections
•  urinary tract infections
•   skin and soft tissue infections including dental
infections
•  bone and joint infections.
2. BEFORE YOU TAKE AUGMENTIN
DO NOT TAKE AUGMENTIN:
•   if you are allergic (hypersensitive) to amoxicillin,
clavulanic acid, penicillin or any of the other 
ingredients of Augmentin (listed in section 6)
•   if you have ever had a severe allergic
(hypersensitive) reaction to any other antibiotic. 
This can include a skin rash or swelling of the face 
or neck
•   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 yo

Charakteristika produktu

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 a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, capsule shaped tablets debossed with “AC” on both sides and a scoreline 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
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
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 Augment