ORELOX 200mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CEFPODOXIME

Available from:

Sanofi Malta Limited Level2, Fort Business Centre, Mriehel Bypass, Birkirkara, Malta

ATC code:

J01DD13

INN (International Name):

CEFPODOXIME 200 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

CEFPODOXIME 200 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2011-05-06

Patient Information leaflet

1 PACKAGE LEAFLET:INFORMATION FOR THE USER
ORELOX 200mg film coated tablets
Cefpodoxime
READ ALL OF THIS LEAFLET CAREFULLY BEFORE 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 your
pharmacist.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may
harm them, even if their symptoms are the same as yours.
• If you get any side effects , talk to your doctor or pharmacist.
This includes any possible side effectsnot
listed in
this leaflet. See section 4.
IN THIS LEAFLET:
1. What ORELOX Tablets 200mg are and what they are used for
2. What you need to know before you take ORELOX Tablets 200mg
3. How to take ORELOX Tablets 200mg
4. Possible side effects
5. How to store ORELOX Tablets 200mg
6. Contents of the pack and other information
1. WHAT ORELOX TABLETS ARE AND WHAT THEY ARE USED FOR
ORELOX Tablets are used to inhibit the growth of bacteria causing
infections in the body. It belongs to a
group of antibiotics called ‘cephalosporins’.
The doctor has prescribed ORELOX for one (or more) of the following
types of infection:
• Tonsillitis (throat inflammation), only for the 100mg tablets
• Acute sinusitis (nose inflammation)
• Acute exacerbations of chronic bronchitis (chronic pulmonary
disease)
• Pneumonia (lung inflammation).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ORELOX TABLETS 200MG
DO NOT TAKE ORELOX IF:
-
YOU ARE ALLERGIC
to
CEFPODOXIME
or other cephalosporins or any of the other ingredients of this
medicine (listed in section 6)
-
you had a
SERIOUS
and/or immediate
ALLERGIC REACTION
to
ANTIBIOTICS
such as penicillin or beta-
lactams.
TALK TO YOUR DOCTOR
before taking this medicine if the above applies to anyone who must
take it. In cases
like these, your doctor will not prescribe cefpodoxime.
WARNING AND PRECAUTIONS
Talk to your doctor or pharmacist before taking ORELOX.
In particular, please inform your doctor if:
• your kidneys

Summary of Product characteristics

Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Orelox film coated tablets 200 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Orelox 200mg film coated tablet:
Each tablet contains:
Active ingredient: 260.90 mg of cefpodoxime proxetil (equivalent to
200 mg cefpodoxime).
Excipient: 43.1mg lactose
3.
PHARMACEUTICAL FORM
Film-coated tablet
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cefpodoxime is indicated for the treatment in adults of the following
infections caused by
bacteria of established sensitivity ( see paragraphs 4.4 and 5.1 )
-
UPPER RESPIRATORY TRACT INFECTIONS:
Acute bacterial sinusitis
Tonsillitis ( only for the 100mg tablets )
-
LOWER RESPIRATORY TRACT INFECTIONS:
Acute exacerbations of chronic bronchitis
Bacterial pneumonia – cefpodoxime may not be the ideal option for
the causative micro-
organism
The official guidelines for appropriate use of antibacterial agents
have to be taken in
consideration.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral.
The tablets have to be taken with food for optimum absorption.
Adults and adolescents with normal renal function:
_UPPER RESPIRATORY TRACT INFECTIONS_:
Acute bacterial sinusitis: 200mg twice daily.
Tonsillitis: 100mg twice daily ( only for the 100mg tablets)
Page 2 of 10
_ LOWER RESPIRATORY TRACT INFECTIONS_:
Acute exacerbations of chronic bronchitis:
200mg twice daily.
Bacterial pneumonia: 200mg twice daily.
Elderly:
It is not necessary to modify the dose in elderly patients with normal
renal function.
Children:
Orelox paediatric is available to treat infants and children.
Hepatic impairment:
The dosage does not require modification in cases of hepatic
impairment.
Renal impairment:
The dosage of Orelox does not require modification if creatinine
clearance exceeds 40 ml/min.
Below this value, pharmacokinetic studies indicate an increase in
plasma elimination half-life and
the maximum plasma concentrations, and hence the dosage should be
adjusted appropriately.
CREATININE CLEARANCE (_ML/MIN_