Germentin 500 mg/125 mg film coated tablets

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Amoxicillin trihydrate; potassium clavulanate

Dostupno od:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC koda:

J01CR; J01CR02

INN (International ime):

Amoxicillin trihydrate; potassium clavulanate

Doziranje:

500 mg/125 milligram(s)

Farmaceutski oblik:

Film-coated tablet

Tip recepta:

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

Područje terapije:

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

Status autorizacije:

Marketed

Datum autorizacije:

2000-08-18

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GERMENTIN 500 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
:
1. What Germentin is and what it is used for
2. What you need to know before you take Germentin
3. How to take Germentin
4. Possible side effects
5. How to store Germentin
6. Contents of the pack and other information
1.
WHAT GERMENTIN IS AND WHAT IT IS USED FOR
Germentin is an antibiotic and works by killing bacteria that cause
infections. It contains two active
substances 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.
Germentin 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GERMENTIN
DO NOT TAKE GERMENTIN:
• 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 neck
• if you have ever had liver problems or jaundice (yellowing of the
skin) when taking an antib

Svojstava lijeka

Health Products Regulatory Authority
11 May 2023
CRN00DFPZ
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Germentin 500 mg/125 mg film coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 574 mg amoxicillin trihydrate
(equivalent to 500 mg amoxicillin) and 148.9 mg potassium
clavulanate (equivalent to 125 mg clavulanicacid).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
The film-coated tablets are off-white, oval, and biconvex with a score
line on both sides.
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
Germentin is indicated for the treatment of the following infections
in adults and children (see sections 4.2, 4.4 and 5.1):
o Acute bacterial sinusitis (adequately diagnosed)
o Acute otitis media
o Acute exacerbations of chronic bronchitis (adequately diagnosed)
o Community acquired pneumonia
o Cystitis
o Pyelonephritis
o Skin and soft tissue infections in particular cellulitis, animal
bites, severe dental abscess with spreading cellulitis.
o 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 Germentin 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 Germentin (e.g. those that
provide higher doses of amoxicillin and/or different ratios of
amoxicillin to clavulanic acid) should be considered as necessary (