Clavamel Forte 500mg/125mg film-coated tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amoxicillin; Clavulanic acid

Available from:

Clonmel Healthcare Ltd

ATC code:

J01CR; J01CR02

INN (International Name):

Amoxicillin; Clavulanic acid

Dosage:

500 /125 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

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

Authorization status:

Marketed

Authorization date:

2014-03-21

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CLAVAMEL FORTE 500 MG/125 MG FILM-COATED TABLETS
Amoxicillin/clavulanic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 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 Clavamel Forte is and what it is used for
2. What you need to know before you take Clavamel Forte
3. How to take Clavamel Forte
4. Possible side effects
5. How to store Clavamel Forte
6. Contents of the pack and other information
1. WHAT CLAVAMEL FORTE IS AND WHAT IT IS USED FOR
Clavamel Forte 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.
Clavamel Forte 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 CLAVAMEL FORTE
DO NOT TAKE CLAVAMEL FORTE:
•
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 (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 jaun

Summary of Product characteristics

Health Products Regulatory Authority
16 August 2023
CRN00DKQT
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clavamel Forte 500mg/125mg film-coated tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains Amoxicillin Trihydrate equivalent to
500 mg Amoxicillin and Potassium Clavulanate equivalent
to 125 mg clavulanic acid.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Oblong, white to slightly yellowish film-coated tablets (10 mm x 21
mm), embossed on one side (GG N6).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clavamel Forte 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 Clavamel Forte 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 Clavamel Forte (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 formulati