Germentin 125 mg/31.25 mg per 5 ml Powder for Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clavulanic acid; Amoxicillin

Available from:

Viatris Limited

ATC code:

J01CR; J01CR02

INN (International Name):

Clavulanic acid; Amoxicillin

Pharmaceutical form:

Powder for oral suspension

Therapeutic area:

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

Authorization status:

Marketed

Authorization date:

2004-03-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GERMENTIN 125 MG/31.25 MG PER 5 ML POWDER FOR ORAL SUSPENSION
(amoxicillin and clavulanic acid)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START GIVING YOUR CHILD
THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU. IF YOU ARE AN ADULT WHO HAS
BEEN GIVEN THIS MEDICINE,
THIS INFORMATION APPLIES TO YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for a baby or child. Do not pass it
on to others. It may
harm them, even if their signs of illness are the same as your
child’s.
-
If your child gets any side effects, talk to your doctor, pharmacist
or nurse. 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 give Germentin
3.
How to give 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
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.
Germentin is used in adults, babies 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.
You must talk to a doctor if your child does not feel better or if
your child feels worse after 14 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU GIVE GERMENTIN
DO NOT GIVE YOUR CHILD GERMENTIN:
• if they are allergic to amoxicillin, clavulanic acid, penicillin
or any of the other ingredients of this
medici

Summary of Product characteristics

Health Products Regulatory Authority
15 March 2024
CRN00F26V
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Germentin 125 mg/31.25 mg per 5 ml Powder for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
5 ml reconstituted suspension contains:
Amoxicillin trihydrate equivalent to 125 mg amoxicillin
Potassium clavulanate equivalent to 31.25 mg clavulanic acid
Excipients with known effect: each 5 ml reconstituted suspension
contains 8.5 mg aspartame (E951), less than 0.15 mg sorbitol
and less than 0.7 mg glucose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral suspension.
Off-white granules.
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):

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 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.
Health Products Regulatory Authority
15 March 2024
CRN00F26V
Page 2 of 13
The use of alternative presentations of Germentin (e.g_. _those that
provide higher doses of amoxicillin and/or d