Orelox children and infants 40mg/5 ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CEFPODOXIME

Available from:

Sanofi Malta Limited

ATC code:

J01DD13

INN (International Name):

CEFPODOXIME

Pharmaceutical form:

GRANULES FOR ORAL SUSPENSION

Composition:

CEFPODOXIME 40 mg/5ml

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2005-09-28

Patient Information leaflet

PATIENT INFORMATION LEAFLET
ORELOX
® 40 MG/5 ML GRANULES FOR ORAL SUSPENSION
CEFPODOXIME PROXETIL
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.
IN THIS LEAFLET:
1.
What Orelox 40 mg/5 ml granules for oral suspension are and what they
are used for
2.
What you need to know before you use Orelox children and infants 40
mg/5 ml granules for oral suspension
3.
How to use Orelox 40mg/5 ml granules for oral suspension
4.
Possible side effects
5.
How to store Orelox 40 mg/5 ml granules for oral suspension
6.
Contents of the pack and other information
1. WHAT ORELOX 40 MG/5 ML GRANULES ARE AND WHAT THEY ARE USED FOR
Pharmacotherapeutic group: Antibacterials for systemic use, ATC code:
J01DA33.
(J: Anti-infectives).
This medicine is an antibacterial antibiotic belonging to the
beta-lactam group.
This medicine is used in children to treat certain bacterial
infections susceptible to this drug.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ORELOX 40MG /5 ML GRANULES
DO NOT USE ORELOX 40 MG/5 ML GRANULES FOR ORAL SUSPENSION:
• In children with a known allergy to cephalosporin antibiotics.
• In children with phenylketonuria (hereditary disease screened for
at birth), because this medicine
contains aspartame.
WARNINGS AND PRECAUTIONS FOR USE
• Any signs of allergy (skin rash, itching, etc.) during treatment
must be reported to your doctor
immediately.
• There is a 5-10% possibility of an allergic reaction in patients
who are allergic to penicillin.
• Inform your doctor of any allergy or allergic reaction that
occurred during tre

Summary of Product characteristics

Page 1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Orelox children and infants 40 mg/5 ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cefpodoxime proxetil
................................................................................................................
6.261 g
Equivalent amount of cefpodoxime
...........................................................................................
4.800 g
For 100 g of granules.
16.7 g of granules is equivalent to 100 ml of reconstituted
suspension, i.e. 200 graduated doses.
Excipient with known effect: lactose,
sucrose, sodium,
aspartame
(source
of
phenylaline)
(E951), potassium,sorbitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Granules for oral suspension
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The therapeutic indications of cefpodoxime are based on its
antibacterial activity and pharmacokinetic
properties.
In children, they are limited to the treatment of infections due to
bacteria susceptible to cefpodoxime, in
particular:
•
Acute otitis media.
•
Documented group A beta-hemolytic streptococcal sore throat.
•
Sinusitis.
•
Lower respiratory tract infections.
Consideration should be given to the official guidance on the
appropriate use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The oral suspension is recommended for use in children. In certain
cases, use of a tablet can be
considered in approved pediatric indications at approved pediatric
dosages, if the child is able to swallow
the tablet.
DOSAGE
_Children with normal kidney function: _
The mean dosage is 8 mg/kg/day, without exceeding the adult dose (200
mg/day for sore throat and 400
_mg/day for all other indications), administered in 2 divided doses at
12-hour intervals. _
Page 2
Duration of treatment for sore throat is 5 days.
_Kidney failure: _
If creatinine clearance is over 40 ml/min/1.73m², the dosage for
patients with normal kidney function
should be referred to.
If creatinine clearance is below 40 ml/m