CLAVAMEL 500/125 Milligram Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
26-04-2024
Summary of Product characteristics
(SPC)
26-04-2024
Active ingredient:
AMOXICILLIN CLAVULANIC ACID
Available from:
Clonmel Healthcare Ltd
INN (International Name):
AMOXICILLIN CLAVULANIC ACID
Dosage:
500/125 Milligram
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Authorised
Authorization date:
0000-00-00
Patient Information leaflet
Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLAVAMEL FORTE 500/125MG TABLETS
Active substance: amoxicillin and clavulanic acid
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. 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 Clavamel Forte 500/125 mg tablets are and
what they are used for
2. Before you take Clavamel Forte 500/125 mg tablets
3. How to take Clavamel Forte 500/125 mg tablets
4. Possible side effects
5. How to store Clavamel Forte 500/125 mg tablets
6. Further information
1. WHAT CLAVAMEL FORTE 500/125 MG TABLETS ARE AND WHAT THEY
ARE USED FOR
Co-amoxiclav 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 500/125 mg tablets are 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 GIVE CLAVAMEL FORTE 500/125 MG TABLETS
DO NOT TAKE CLAVAMEL FORTE 500/125 MG TABLETS:
if you a
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clavamel Forte 500/125 mg Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 500 mg amoxicillin (as amoxicillin trihydrate) and 125 mg clavulanic acid (as potassium
clavulanate).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Yellowish white to light yellow oblong tablets with an embossment “625” on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amoxicillin/Clavulanic acid 500/125 tablets 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 Amoxicillin/Clavulanic acid 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 Amoxicillin/Clavulanic acid (e.g. those that provide higher doses of amoxicillin
and/or different ratios of amoxicillin to clavulanic acid) should be considere
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