CEFUROXIME MILPHARM 500 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CEFUROXIME AXETIL (AMORPHOUS)

Available from:

Milpharm Limited

ATC code:

J01DA

INN (International Name):

CEFUROXIME AXETIL (AMORPHOUS)

Dosage:

500 Milligram

Pharmaceutical form:

Film Coated Tablet

Administration route:

oral use

Units in package:

6, 8, 10, 12, 14, 15, 16, 20, 24, 30, 50, 100 & 500 film-coated tablets

Prescription type:

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

Manufactured by:

APL Swift Services (Malta) Limited, Milpharm Limited

Therapeutic group:

antibacterials for systemic use, second-generation cephalosporins

Therapeutic area:

CEPHALOSPORINS AND RELATED SUBSTANCES

Therapeutic indications:

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.

Authorization status:

Transfer Pending

Authorization date:

2015-10-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CEFUROXIME MILPHARM 250 MG FILM-COATED TABLETS
CEFUROXIME MILPHARM 500 MG FILM-COATED TABLETS
Cefuroxime
CEFUROXIME MILPHARM
P150
CEFUROXIME MILPHARM
P150
Medicines used to REDUCE THE AMOUNT OF ACID IN YOUR STOMACH
(e.g. antacids used to treat heartburn) can affect how Cefuroxime
Milpharm works.
Probenecid
Oral anticoagulants
"
TELL YOUR DOCTOR OR PHARMACIST if you are taking any medicine
like this.
PREGNANCY AND BREAST-FEEDING AND FERTILITY
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine
Tell your doctor before you take Cefuroxime Milpharm:
•
if you are pregnant, think you might be pregnant or are planning
to become pregnant
•
if you are breastfeeding.
Your doctor will consider the benefit of treating you with Cefuroxime
Milpharm against the risk to your baby.
DRIVING AND USING MACHINES
Cefuroxime Milpharm CAN MAKE YOU DIZZY and have other side
effects that make you less alert.
" DON'T DRIVE OR USE MACHINES if you do not feel well.
Always take this medicine exactly as your doctor or pharmacist has
told you to. Check with your doctor or pharmacist if you are not
sure.
TAKE CEFUROXIME MILPHARM AFTER FOOD. This will help to make the
treatment more effective.
Swallow Cefuroxime Milpharm tablets whole with some water.
DON'T CHEW, CRUSH OR SPLIT THE TABLETS — this may make the
treatment less effective.
THE RECOMMENDED DOSE
ADULTS
The recommended dose of Cefuroxime Milpharm is 250 mg to
500 mg twice daily depending on the severity and type of infection.
CHILDREN
The recommended dose of Cefuroxime is 10 mg/kg (to a maximum
of 125 mg) to 15 mg/kg (to a maximum of 250 mg) twice daily
depending on:
•
the severity and type of infection
CEFUROXIME MILPHARM IS NOT RECOMMENDED FOR CHILDREN AGED
UNDER 3 MONTHS, as the safety and effectiveness are not known in
this age group.
Depending on the illness or how you or your child responds to
treatment, the initial dose

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cefuroxime Milpharm 500mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 601.44 mg cefuroxime axetil
equivalent to 500 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 ‘A34’ debossed on one side
and plain on the other side.
The size is
20.1 mm X 8.6 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)
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