Cefuroxime 250mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Prenos Navodilo za uporabo (PIL)
01-02-2016
Prenos Lastnosti izdelka (SPC)
08-04-2016
Prenos Javno poročilo o oceni (PAR)
30-11--0001

Aktivna sestavina:

Cefuroxime axetil

Dostopno od:

Teva UK Ltd

Koda artikla:

J01DC02

INN (mednarodno ime):

Cefuroxime axetil

Odmerek:

250mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 05010201; GTIN: 5020220565023

Navodilo za uporabo

                                PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CEFUROXIME 125 MG, 250 MG AND 500 MG FILM-COATED TABLETS
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 IS AND WHAT THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CEFUROXIME
3.
HOW TO TAKE CEFUROXIME
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE CEFUROXIME
6.
CONTENTS OF THE PACK AND OTHER
INFORMATION
1.
WHAT CEFUROXIME IS AND WHAT THEY ARE USED FOR
Cefuroxime 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 is used to treat infections of:
•
the throat
•
sinus
•
middle ear
•
the lungs or chest
•
the urinary tract
•
the skin and soft tissues.
Cefuroxime Film-coated Tablets can also be used:
•
to treat Lyme disease (an infection spread by parasites called ticks).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CEFUROXIME
DON’T NOT TAKE CEFUROXIME:
•
if you are allergic (hypersensitive) 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).
If you think this applies to you,
DO NOT TAKE CEFUROXIME
until you have checked with your doctor.
If you are not sure whether any of the above apply to you speak to
your doctor or pharmacist before
taking this medicine.
WARNINGS AND PRECAUTIONS
Talk to y
                                
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                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cefuroxime 250 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 250 mg film-coated tablet contains 250 mg cefuroxime (as
cefuroxime axetil)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Light blue coloured film-coated tablets engraved with “250” on one
side and “P125”
on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cefuroxime 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)
_Paediatric population _
_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
Children aged two years or older with otitis
media or, where appropriate, with more severe
infections
15 mg/kg twice daily to a maximum of 250
mg twice daily
Cystitis
15 mg/kg twice daily to a maximum of 250
mg twice daily
Pyelonephritis
15 mg/kg twice daily to a maximum of 250
mg twice daily for 10
                                
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