Orelox Tablet 100mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CEFPODOXIME

Available from:

Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy

ATC code:

J01DD13

INN (International Name):

CEFPODOXIME 100 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

CEFPODOXIME 100 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2005-10-12

Patient Information leaflet

PACKAGE INFORMATION LEAFLET
ORELOX 100MG TABLETS
Cefpodoxime proxetil
WHAT IS IN THIS LEAFLET?
1.
What ORELOX 100 mg film-coated tablets are and what they are used for
2.
What you need to know before you take ORELOX 100 mg film-coated
tablets
3.
How to take ORELOX 100 mg film-coated tablets
4.
Possible side effects
5.
How to store ORELOX 100 mg film-coated tablets
6.
Contents of the pack and other information
1.
WHAT ORELOX 100 MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
Pharmacotherapeutic group - Antibacterials for systemic use, ATC code:
J01DD13.
(J: Anti-infectives).
This medicine is an antibacterial antibiotic belonging to the
beta-lactam group.
This medicine is used in adults to treat certain bacterial infections
susceptible to this drug.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ORELOX 100 MG FILM-COATED
TABLETS
DO NOT TAKE ORELOX 100 MG FILM-COATED TABLETS:
•
If you are allergic to cephalosporin antibiotics.
WARNINGS AND PRECAUTIONS
•
You must inform your doctor immediately if you have any allergy
symptoms (e.g. skin rash, itching)
during treatment.
•
There is a 5-10% possibility of an allergic reaction in patients who
are allergic to penicillin.
•
Tell your doctor if you have ever had an allergy or allergic symptoms
during treatment with
penicillin antibiotics.
•
If you have diarrhea while taking a course of antibiotics, do not
treat it without first talking to your
doctor.
•
As this medicine contains lactose, do not use it if you have
galactosemia, glucose-galactose
malabsorption syndrome or lactase deficiency (rare metabolic
diseases).
•
It is important that you inform your doctor if you have a kidney
disorder, as your treatment will need
to be adjusted.
•
This medicine can trigger false-positive results in certain laboratory
tests (urine glucose test,
Coombs test).
•
As with all medicines belonging to this group of antibiotics
(beta-lactams), use of this medicine can
cause encephalopathy, which can lead to seizures, confusion,
consciousness disorders, or even
READ ALL OF THI

Summary of Product characteristics

Page 1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Orelox tablets 100 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Orelox tablet contains 130.45 mg of cefpodoxime proxetil
(equivalent to 100 mg cefpodoxime).
3.
PHARMACEUTICAL FORM
Film-coated tablet for oral use
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The therapeutic indications of cefpodoxime are based on its
antibacterial activity and pharmacokinetic
properties.
In adults, they are limited to the treatment of infections due to
susceptible bacteria, in particular:
•
Documented group A beta-hemolytic streptococcal sore throat.
•
Acute sinusitis.
•
Acute bronchial suppuration in at-risk patients (particularly
alcoholics, smokers, patients over 65
years of age, etc.).
•
Exacerbation of chronic obstructive pulmonary disease, particularly in
repeat episodes or in at-risk
patients.
•
Bacterial lung diseases, particularly in at-risk patients.
Consideration should be given to the official guidance on the
appropriate use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS
200 mg or 400 mg to be taken as 2 divided doses, 12 hours apart during
meals, i.e.:
•
2 x 200 mg per day, i.e. 2 tablets morning and evening in:
o acute sinusitis,
In acute maxillary sinusitis, a 5-day treatment has been shown to be
effective.
o acute bronchial suppuration in at-risk patients,
o exacerbation of chronic obstructive pulmonary disease, particularly
in repeat episodes or in at-
risk patients,
o bacterial lung diseases, particularly in at-risk patients,
•
2 x 100 mg per day, i.e. 1 tablet morning and evening in sore throat.
The duration of treatment for sore throat is 5 days.
Page 2
ELDERLY
No dose adjustment is required if the elderly subject has normal renal
function.
PATIENTS WITH KIDNEY FAILURE
No dose adjustment is required if creatinine clearance is over 40
ml/min.
If creatinine clearance is below 40 ml/min, the daily dose should be
halved and limited to one single
daily dose.
PATIENTS WITH LIVER FAILURE
No