Co-amoxiclav Bluefish 875 mg/125 mg film- coated tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
21-04-2023
Summary of Product characteristics
(SPC)
21-04-2023
Active ingredient:
Amoxicillin; Clavulanic acid
Available from:
Bluefish Pharmaceuticals AB
ATC code:
J01CR; J01CR02
INN (International Name):
Amoxicillin; Clavulanic acid
Dosage:
875/125 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:
2009-11-06
Patient Information leaflet
1.3.1 SPC, LABELLING AND PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
CO-AMOXICLAV BLUEFISH 875 MG/125 MG FILM-COATED TABLETS
(Amoxicillin and 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 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 Co-amoxiclav Bluefish is and what it is used for
2.
What you need to know before you take Co-amoxiclav Bluefish
3.
How to take Co-amoxiclav Bluefish
4.
Possible side effects
5.
How to store Co-amoxiclav Bluefish
6.
Contents of the pack and other information
1.
WHAT CO-AMOXICLAV BLUEFISH IS AND WHAT IT IS USED FOR
Co-amoxiclav Bluefish 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. Co-amoxiclav
Bluefish 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 CO-AMOXICLAV BLUEFISH
DO NOT TAKE CO-AMOXICLAV BLUEFISH :
•
if you are allergic (hypersensitive) to amoxicillin, clavulanic acid
or any of the other
ingredients of this medicine (listed in section 6).
1.3.1 SPC, LABELLING AND PACKAGE LEAFLET
•
severe allergic (hypersensitive) rea
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
05 April 2023
CRN00DFS0
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Co-amoxiclav Bluefish 875 mg/125 mg film- coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 1006.25 mg amoxicillin trihydrate
equivalent to 875 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.
A white, elongated capsule shaped film coated tablets with breakline
on both sides..
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide in to equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amoxicillin-clavulanic acid 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 and 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
Dosages 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 ra
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