Cefuroxime Milpharm 250mg Film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cefuroxime axetil (amorphous)

Available from:

Aurobindo Pharma (Malta) Limited

ATC code:

J01DA

INN (International Name):

Cefuroxime axetil (amorphous)

Dosage:

250 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

CEPHALOSPORINS AND RELATED SUBSTANCES

Authorization status:

Not marketed

Authorization date:

2015-10-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CEFUROXIME AUROBINDO 250 MG FILM-COATED
TABLETS
CEFUROXIME AUROBINDO 500 MG FILM-COATED
TABLETS
Cefuroxime
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 Cefuroxime Aurobindo is and what it is used for
2.
What you need to know before you take Cefuroxime Aurobindo
3.
How to take Cefuroxime Aurobindo
4.
Possible side effects
5.
How to store Cefuroxime Aurobindo
6.
Contents of the pack and other further information
1.
WHAT CEFUROXIME AUROBINDO IS AND WHAT IT IS USED FOR
Cefuroxime Aurobindo is an antibiotic used in adults and children. It
works by killing bacteria that
cause infections. It belongs to a group of medicines called
cephalosporins.
Cefuroxime Aurobindo is used to treat infections of:
•
the throat
•
sinus
•
middle ear
•
the lungs or chest
•
the urinary tract
•
the skin and soft tissues.
Cefuroxime Aurobindo can also be used:
•
to treat Lyme disease (an infection spread by parasites called ticks).
Your doctor may test the type of bacteria causing your infection and
monitor whether the bacteria are
sensitive to Cefuroxime Aurobindo during your treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CEFUROXIME AUROBINDO
_ _
DO NOT TAKE CEFUROXIME AUROBINDO:
•
if you are allergic to any cephalosporin antibiotics or any of the
other ingredients of this medicine
(listed in section 6).
•
if you have ever had a severe allergic (hypersensitive) reaction to
any other type of betalactam
antibiotic (penicillins, monobactams and carbapenems)

Summary of Product characteristics

Health Products Regulatory Authority
11 August 2023
CRN00DL4Z
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cefuroxime Milpharm 250mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 300.72 mg cefuroxime axetil
equivalent to 250 mg cefuroxime.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, film-coated capsule shaped tablets with ‘A33’
debossed on one side and plain on the other side. The size is
16.1 mm X 6.6 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cefuroxime Milpharm is indicated for the treatment of the infections
listed below in adults and children from the age of 3
months (see sections 4.4 and 5.1).
• Acute streptococcal tonsillitis and pharyngitis.
• Acute bacterial sinusitis.
• Acute otitis media.
• Acute exacerbations of chronic bronchitis.
• Cystitis.
• Pyelonephritis.
• Uncomplicated skin and soft tissue infections.
• Treatment of early Lyme disease.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual course of therapy is seven days (may range from five to ten
days).
_Table 1. Adults and children (≥40 kg)_
INDICATION
DOSAGE
Acute tonsillitis and pharyngitis, acute bacterial sinusitis
250 mg twice daily
Acute otitis media
500 mg twice daily
Acute exacerbations of chronic bronchitis
500 mg twice daily
Cystitis
250 mg twice daily
Pyelonephritis
250 mg twice daily
Uncomplicated skin and soft tissue infections
250 mg twice daily
Lyme disease
500 mg twice daily for 14 days (range of 10 to 21 days)
_Table 2. Children (<40 kg)_
INDICATION
DOSAGE
Acute tonsillitis and pharyngitis, acute bacterial
sinusitis
10 mg/kg twice daily to a maximum of 125 mg twice daily
Health Products Regulatory Authority
11 August 2023
CRN00DL4Z
Page 2 of 10
Children aged two years or older with otitis media or,
where appropriate, with more severe inf