Cefaclor 250mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cefaclor monohydrate

Available from:

Focus Pharmaceuticals Ltd

ATC code:

J01DC04

INN (International Name):

Cefaclor monohydrate

Dosage:

250mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010201

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CEFACLOR CAPSULES 250MG AND 500MG
(Cefaclor Monohydrate)
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Cefaclor Capsules are and what they are used for
2.
What you need to know before you take Cefaclor Capsules
3.
How to take Cefaclor Capsules
4.
Possible side effects
5.
How to store Cefaclor Capsules
6.
Contents of the pack and other information
1.
WHAT CEFACLOR CAPSULES ARE AND WHAT THEY ARE USED
FOR
This medicine is called Cefaclor Capsules. Cefaclor Capsules contain
the active
substance cefaclor, which belongs to a group of medicines called
cephalosporin
antibiotics.
Cefaclor is used to kill bacteria that cause infections in your body.
These include
throat, chest and ear infections, sinus infections, infections of the
skin and soft tissue
and urinary tract infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CEFACLOR
CAPSULES
DO NOT TAKE CEFACLOR CAPSULES:

if you are allergic to cefaclor or to any of the other ingredients of
this medicine
(listed in section 6)

if you are allergic to any other cephalosporin antibiotic, such as
cefalexin,
cefuroxime or cefradine.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Cefaclor
Capsules:
−
if you have had an allergic reaction to penicillins, such as
penicillin, ampicillin,
amoxicillin or flucloxicillin
−
if you have a history of gastrointestinal disease, especially
inflammation of the
colon (colitis)
−
if you have severe kidney problems
Tell your doctor if y

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cefaclor Capsules 250mg
Keftid Capsules 250mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per Capsule
Cefaclor Monohydrate Ph Eur
Equivalent to Cefaclor 250.00mg.
3
PHARMACEUTICAL FORM
Capsules.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cefaclor is indicated
for the treatment of infections caused by sensitive
microorganisms. These are infections of the respiratory tract which
include
pneumonia,
bronchitis
(including
deteriorations
in
chronic
bronchitis),
tonsillitis,
pharyngitis
and
the
management
of
sinusitis.
Cefaclor
is
also
effective
in
otitis
media.
It
is
active
in
acute
and
chronic
urinary
tract
infections including cystitis and pyelonephritis and also in
infections of the
skin
and
soft
tissues.
Cefaclor
may
also
be
used
in
the
eradication
of
nasopharyngeal streptococci but resulting prevention of rheumatic
fever and/or
bacterial endocarditis has not been proven.
The following microorganisms are susceptible _in vitro _to cefaclor:
- Alpha and beta-haemolytic streptococci
-
Staphylococci
(including
coagulase-negative,
coagulase-positive
and
penicillinase- producing strains)
- _Strep. pneumoniae _
- _Strep. pyogenes _(group A beta-haemolytic streptococci)
- _Branhamella catarrhalis _
- _E. ccli _
- _Proteus mirabilis _
- _Klebsiella spp. _
- _Haemophilus influenzae _(including ampicillin-resistant strains)
Cefaclor is inactive against _Pseudomonas _and _Acinetobacter _spp.,
most strains
of _Enterobacter _and _Serratia _spp., _Morganella morganii, Proteus
vulgaris _and
_Providencia rettgeri. _ Methicillin-resistant staphylococci and most
strains of
enterococci including _Strep. faecalis _are resistant to cefaclor.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and the elderly: _
The usual dosage is 250mg every eight hours, may be doubled to 500mg
every eight hours for more severe infections or those caused by less
susceptible organisms. Doses of 4g per day have been administered
safely to
normal subjects for 28 days, but the